[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]




                  REUSE OF SINGLE-USE MEDICAL DEVICES

=======================================================================

                                HEARING

                               before the

                            SUBCOMMITTEE ON
                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 10, 2000

                               __________

                           Serial No. 106-89

                               __________

            Printed for the use of the Committee on Commerce

                     U.S. GOVERNMENT PRINTING OFFICE
62-970CC                     WASHINGTON : 2000




                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    TOM SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

JOE BARTON, Texas                    RON KLINK, Pennsylvania
CHRISTOPHER COX, California          HENRY A. WAXMAN, California
RICHARD BURR, North Carolina         BART STUPAK, Michigan
  Vice Chairman                      GENE GREEN, Texas
BRIAN P. BILBRAY, California         KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee                   (Ex Officio)
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Feigal, David W., Director, Food and Drug Administration.....     9
    Feltner, Vern, President, Alliance Medical Corporation.......   123
    Fielder, John H., Professor of Philosophy, Ethics Consultant, 
      Villanova University.......................................   113
    Grossman, Philip.............................................   107
    Lindsay, Bruce D., Associate Professor of Medicine, 
      Washington University School of Medicine...................   159
    Maurer, Walter G., Cleveland Clinic Foundation, on behalf of 
      American Hospital Association..............................   118
    O'Holla, Robert H., Vice President Regulatory Affairs, 
      Johnson & Johnson..........................................   103
    Trotter, C. Griffin, Center for Healthcare Ethics............   155
    West, Laurene................................................   100
Material submitted for the record by:
    National Consumers League, prepared statement of.............   183

                                 (iii)

  

 
                  REUSE OF SINGLE-USE MEDICAL DEVICES

                              ----------                              


                      THURSDAY, FEBRUARY 10, 2000

                  House of Representatives,
                             Committee on Commerce,
              Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:21 a.m. in 
room 2322, Rayburn House Office Building, Hon. Fred Upton 
(chairman) presiding.
    Members present: Representatives Upton, Barton, Burr, 
Whitfield, Ganske, Bryant, Bliley (ex officio), Waxman, Stupak, 
and Strickland.
    Also present: Representatives Eshoo and Pickering.
    Staff present: Alan Slobodin, majority counsel; Anthony 
Habib, legislative clerk; and John Ford, minority counsel.
    Mr. Upton. Good morning, everybody. Sorry we are a little 
bit tardy starting. For those not realizing what the buzzer 
meant, we had a vote. So we are all ready to start promptly at 
10, and then we had to walk over the Capitol and come back. 
Before I proceed with my opening statement, I do want to ask 
unanimous consent that other members of the full committee, 
although not on this subcommittee, be allowed to sit in, 
provide opening statements, and also proceed with the question 
and answer period of both Dr. Feigal and the second panel. 
Without objection that will be the order of the day.
    Good morning again. Today this subcommittee holds a hearing 
on the reuse of medical devices, labeled and approved by the 
Food and Drug Administration for single-use only. Within the 
last year there has been extensive debate, both on and off the 
Hill regarding the practice of reprocessing medical devices 
that have been designed, manufactured, and approved by the FDA 
for single-use only.
    As many of you know, before a device may legally enter the 
market, original medical device manufacturers must submit 
product approval applications to FDA which may include 
extensive sterility and clinical data that demonstrate the 
safety and efficacy of the device. The original manufacturer 
must also comply with the extensive FDA regulations regarding 
the manufacturing of the device, as well as post-market 
controls that give both the FDA and the manufacturer the 
ability to continue to assess the safety and efficacy of the 
device, and ensure that patients are adequately protected.
    For patients, original device manufacturers and the FDA, 
this system works. However, there is a significant and perhaps 
even a dangerous, gap in FDA's existing enforcement practices. 
In some instances, hospitals, either using in-house facilities 
or third parties, will reprocess a disposable medical device 
that has been approved by FDA for use in a single patient only, 
and reuse the device several times on additional patients in 
most instances without notifying patients that the device may 
have already been used.
    Much to my surprise I have learned that this practice 
includes reusing devices that have been inserted into other 
patients, including biopsy forceps and catheters. This practice 
raises two patient safety concerns. One, whether single-use 
devices can be adequately cleaned and sterilized for use in 
other patients, and two, whether attempts to clean and 
sterilize these devices may lead to product failures or in any 
way significantly affect performance and design specifications.
    These concerns are not theoretical to me. I am alarmed by 
reports that there may be unsterile and contaminated medical 
devices on hospital shelves ready to be reused on patients. 
There is the report of a broken heart catheter in a 32 year old 
woman that lodged in the atrium of her heart. I am also 
concerned about how one knows whether the reprocessed single-
use device has been used a second time, or an eighth time, or 
maybe even a tenth time. We need to make sure that these 
complex, hard to clean medical devices are really sterile and 
functional.
    These products may look fine and dandy to the naked eye, or 
even one with Lasik, but under a microscope or in a patient it 
could be a completely different story. I am well aware that 
some hospitals and reprocessing companies take many precautions 
and work very hard to produce safe and effective reprocessed 
single-use medical devices. I am also aware of many studies on 
this issue, some showing problems with reprocessed single-use 
devices, and others indicating that single-use devices can be 
reprocessed and reused safely. But in the end, there seems to 
me to be too many questions about the risks to patients, the 
lack of informed consent, regulatory fairness, whether the 
newer and more complex devices really can be cleaned. That is 
why we need this hearing to help us understand the issues 
involved with reprocessing, to get some answers to some 
questions, and to assure ourselves that the FDA is 
appropriately regulating the practice of reprocessing. The FDA 
has acknowledged that it presently has the authority under the 
Federal Food, Drug and Cosmetic Act to regulate both on a pre-
market and a post-market basis. To date, the Agency has chosen 
not to fully enforce all of the statutory and regulatory 
requirements over reprocessing of single-use devices that 
original manufacturers must comply with. Most notably, pre-
market review. I look forward to hearing directly from the 
Agency about how it plans to address this issue, both now and 
in the future to ensure that American patients are not 
unnecessarily put at risk.
    I welcome particularly Dr. David Feigal of the FDA before 
this subcommittee. I want to express my deep appreciation to 
Dr. Feigal who only a few months ago became the Director for 
FDA's Center for Devices and has already helped lead the FDA to 
a reassessment of an issue that the FDA has struggled over for 
many, many years. I also want to thank Chairman Bliley for his 
support of this hearing and the inquiry. I also want to welcome 
Ms. Anna Eshoo for raising attention to this issue, 
particularly with her legislation that she has introduced and 
monitor work with her on behalf of patient safety.
    We will be hearing from outstanding witnesses on both sides 
of this medical controversy. I thank all of our witnesses for 
taking the time to be here, and I also want to thank the staff 
which has helped us prepare, not only Mr. Alan Slobodin, but 
Mr. John Ford on the Democratic side as well. And with that I 
will yield for an opening statement to my friend from the great 
State--awesome State--of Michigan, Mr. Stupak.
    Mr. Stupak. Thank you Mr. Chairman, and thank you for 
holding these very important hearings. I appreciate the hard 
work that you and our colleague, Ms. Eshoo from California, 
have put into this issue.
    Now, Americans expect when they go to the hospital that 
catheters and devices used in their hospital stay are safe, 
effective, and sterile. And Mr. Chairman, you commented a 
little bit, and I know you have some of these with you too, but 
the catheter it is basically all plastic. The little balloon on 
the end there. And then you have another one over here which is 
a little different device but it has a metal tip. And it is 
more than just plastic versus metal. I think what we're all 
looking for in these devices is to make sure that they are 
sterile and safe for the patient. And I know that has been the 
focus of your query here, but we have a number of these devices 
with us. I know you have them with you too, but I think it 
gives us a good opportunity to take a look at exactly what are 
we talking about.
    Because Americans want to ensure that when they go to the 
hospital they have affordable health care at reasonable prices 
and really they don't care to pay retail all the time if there 
is a better way of doing it. Today's hearing is about striking 
a balance, Mr. Chairman, between patient safety and controlling 
costs in our health care system and all the devices that we use 
in modern medicine. But patient safety must be our first 
priority. Cost containment that puts patients at risk does not 
control costs at all. If a patient develops an infection or has 
complications due to a device malfunction, saving 50 percent on 
the device is no savings at all. Even if it was, I would not 
want to put the lives of my wife or our sons at risk to save a 
few dollars. Thus, I believe our guiding light should really be 
are we ensuring patient safety.
    The FDA, the Food and Drug Administration, has up until 
recently, had a policy of nonenforcement with respect to the 
single-use requirement. In fact, medical device reprocessing 
has been going on for over 20 years. However, due to the ever 
increasing complexity of medical devices, much like I have 
shown us today, the FDA has decided to review its enforcement 
policy and increase the oversight of reprocessed devices. I 
know some people believe that the FDA has taken too long to 
act, but I applaud the FDA for beginning the process of 
ensuring that reprocessed devices will be safe, sterile, and 
effective.
    I want to hear about the FDA's proposed guidance on 
classification and enforcement of the reprocess and reuse of 
single devices. I understand that some believe the guidance 
goes too far, and others believe the guidance does not go far 
enough or quick enough. I am interested in hearing all of these 
points of view. Mr. Chairman, these issues are always difficult 
for members up here on the dais. We are forced to chose between 
competing business, patient safety, and healthcare cost 
containment. I am hopeful that this hearing will shed some 
light on these issues and help provide both this committee and 
the FDA with input on where we go from here.
    I want to once again thank you and Ms. Eshoo for your hard 
work on this issue and I yield back my time, Mr. Chairman.
    Mr. Upton. Thank you.
    I would also make unanimous consent request that all 
members of this subcommittee be allowed to put their statements 
into the record in their entirety. Without objection, that will 
be the rule.
    Mr. Bryant from Tennessee?
    Mr. Bryant. Thank you Mr. Chairman. I would simply echo 
what the two previous speakers have raised in their opening 
statements. And I think there are very important issues here 
today. I know we have some very distinguished panelists to 
testify.
    The issue of the economy, of why this is done is important, 
but certainly the issue of safety, the issue of functionality 
of these products, all are very important and I look forward to 
hearing testimony on both sides of the issue.
    I think my main concern in reviewing this in preparation 
for the hearing is with the FDA. And I am glad that, Doctor, 
you are here today to open the testimony. I look forward to 
hearing from you. I get a sense that the FDA is on the 
sidelines, and I want to know when the FDA is going to come in 
and start playing on this very important issue. And I look 
forward to your testimony to that effect and would yield back 
my time.
    Mr. Upton. Mr. Whitfield from Kentucky?
    Mr. Whitfield. Mr. Chairman, thank you very much and I 
think all of us are looking forward to this hearing for a 
number of reasons, obviously, its impact on good quality and 
safe healthcare. Before a medical device can legally enter the 
market we know that the manufacturer must demonstrate to the 
Food and Drug Administration is safe and effective. And I know 
from discussions that I have had with other colleagues, we are 
disappointed by FDA's failure to enforce existing laws and 
apply them to reprocessed medical devices.
    It is difficult to understand how an Agency which 
continually seeks to broaden its scope of authority can leave 
the impression that it is not really doing very much in this 
area. Yesterday we had a hearing on safety in hospitals and in 
healthcare, and we talked about the number of deaths because of 
mistakes made in the healthcare delivery system. And this is a 
particularly important area, and it is squarely within the 
jurisdiction of FDA. We all recognize the role that reprocessed 
medical devices play in keeping medical care accessable by 
containing costs, but this is not an excuse for FDA to leave 
the impression and to permit unsafe medical devices to be used 
in our hospitals.
    Having said that, we are delighted that Dr. Feigal is here 
today to talk about this issue, to let us know what he intends 
to do about it, and I understand that he has been instrumental 
in trying to move the Agency forward in that direction. And I, 
for one, am disappointed, however, that we did not have an 
opportunity to even review your testimony because I guess we 
didn't receive it until this morning. But hopefully you will do 
a great job of presenting that testimony and we thank you for 
being here this morning.
    Mr. Upton. Dr. Ganske from Iowa.
    Mr. Ganske. I Thank you Mr. Chairman. I will be brief. We 
want to make sure that patients are getting quality care. We 
have medical devices that need to be safe and clean. As a 
medical practitioner before coming to Congress I have used 
disposable equipment. I am concerned about some of the data 
that will be presented today. We want to make sure that it is 
accurate and I think the FDA has a role in the oversight of 
whether single-use medical devices can be reprocessed and used 
again.
    There are some questions about health costs that are 
involved with this. I think it would be also useful at some 
time, Mr. Chairman, to have the Healthcare Financing 
Administration present, because I am concerned about how 
charges are made to our Federal system for single-use devices. 
For instance, does a hospital get paid the same amount of money 
by Medicare if they reprocess a device that then costs them 
half of what a new single-use device would be, and are they 
just pocketing the difference? I am interested in finding out 
how the calculations are made by HCFA for the device component 
of some of the services that are being billed to the Federal 
Government. Maybe we will get into that today. I yield back.
    Mr. Upton. It is my understanding that the answer to that 
question is yes. It is a very good question. Even without their 
presence here today, I think maybe members of this subcommittee 
can follow-up with HCFA in written form following the hearing. 
Mr. Strickland, from Ohio.
    Mr. Strickland. No opening statement, thank you.
    Mr. Upton. Mr. Burr from North Carolina.
    Mr. Burr. No opening.
    Mr. Upton. Ms. Eshoo from California.
    Ms. Eshoo. Thank you very much, Mr. Chairman, and I want to 
salute you for holding this very important hearing on what I 
think is a critical issue that is not only before the Congress, 
but something that the American people deal with--patients deal 
with really day in and day out. I know that I am a guest of 
this Committee of Investigations and Oversight, and I 
appreciate the hospitality, the legislative hospitality that 
you have extended to me.
    For those of you in the audience, I am not a member of this 
subcommittee and so it's really up to the chairman to say that 
it is absolutely fine for me to come and testify. I was a 
member of this distinguished committee in my first term in 
serving on Commerce. I come to this issue from the perspective 
of both legislator and a consumer. As a legislator I have great 
concerns about the FDA's failure to require that reprocessed 
single-use medical devices meet safety and effectiveness 
standards. It makes no sense to me that new medical devices 
must meet these standards, yet the used ones do not.
    As a consumer I was horrified to learn that complex 
delicate devices such as cardiac balloon catheters and biopsy 
forceps are being cleaned and used again on different patients. 
Now, this could happen to any one of us and there is not 
anything that is put before the patient to ask them whether 
they chose to have a reprocessed device used on them or not. So 
there is not any choice, there is not any disclosure to the 
American patient today on this issue. I first learned of this 
problem last August after reading reports of an outbreak of 
bacterial toxins in a Colorado hospital that were traced back 
to reprocessed cardiac catheters. One person died from this 
particular outbreak, but it raises the question of how many 
deaths, or injuries occur from reprocessed devices that are 
unsterile or are made less effective due to the process that 
they are put through to clean them today.
    FDA files on adverse outcomes from reused disposable 
devices tell of reprocessed electrophysiology catheters likely 
weakened by the harsh chemicals and intense temperatures 
required to sterilize them breaking inside of patients. I think 
we should always just keep ourselves in mind before we ever 
place this on a family member or anyone else. I certainly would 
not want that happening to me. In one case, the tip of the 
catheter remained lodged in the patient's heart requiring 
constant monitoring. In another the four inch long tip traveled 
from the patient's heart to his stomach. Surgeons had to open 
the man's stomach to remove the tip. Premature babies have 
suffered infections from unsterile sutures. A patient was 
contaminated with Hepatitis B from reused biopsy forceps.
    The source of this is U.S. News and World Report in their 
September 20, 1999 edition. It is estimated that as many as one 
in every three hospitals are reusing medical devices that are 
designed, manufactured, and FDA approved for one use only. FDA 
clearly has the authority to enforce safety and effectiveness 
standards. Yet in my view, after reviewing the record and 
seeing how the policies are working, they have essentially 
looked the other way allowing the practice to go on, within my 
view, very little oversight.
    In fact, in a letter dated July 9, 1999, which I will 
submit for the record, Mr. Chairman, with the committee's 
approval, the FDA admitted that reprocessed devices are subject 
to all safety and effectiveness standards, but said that they 
had chosen not to enforce these standards. This approach fails 
to ensure that devices designed for one use only can be 
sterilized and reused safely and effectively. That is why I 
introduced legislation on this issue. Mr. Chairman, the FDA 
policy permits practice of withholding information from the 
patient that he or she is getting a previously used device. It 
is also common to charge the patient and the Federal Government 
through Medicare for a new device when a secondhand one is 
actually being used. Now, when we buy a part for our car, the 
mechanic is required to tell us if that part is new or rebuilt 
and we are charged accordingly. Now, why is it that our laws 
are doing a better job covering car parts than they are 
protecting patients in our country?
    I am very proud, Mr. Chairman, to have you join me in 
introducing the Reprocessed Single Use Medical Device Patient 
Safety Act of 1999. The bill is H.R. 3148. The bill would 
ensure the protection of patients by requiring reprocessed 
medical devices to meet the same standards for safety and 
effectiveness that new products today must meet. When the FDA 
approves a device for single-use only, that is exactly what it 
means--that the data submitted by the manufacturer has to show 
that this device can be safely used once.
    Thus, in order to avoid injuries and infections to 
patients, I think that we should be requiring that those who 
clean devices for reuse prove that it can be done safely and 
effectively. H.R. 3148 will increase awareness about 
reprocessed devices by requiring a patient's informed consent 
before that single-use medical device is used on them, and by 
requiring hospitals to monitor and report injuries or 
infections that occur as a result.
    We have very little information about the scope of patient 
injuries that occur as a result of reused medical devices 
because patient consent is not required, and tracking is not 
required to determine if a reused device was involved in an 
adverse event. I am pleased that the FDA has finally developed 
a proposed policy with regard to reprocessing and reuse, but I 
am still concerned that it is an extension of their current 
practice of essentially looking the other way. In their 
proposed enforcement guidance they again state that all 
reprocessed single use devices are subject to the same pre-
market requirements to prove safety and effectiveness, as new 
devices do, yet they do not or will not, as the way I read it, 
and maybe Dr. Feigal will point this out in his testimony, 
enforce these requirements unless the device is considered high 
risk. How will we know whether reuse of a particular device 
poses a high risk to patients without the data? Under FDA's 
proposal reprocessors will never have to submit data to prove 
the risk to patients of devices that are arbitrarily determined 
to be moderate or low risk. Moreover, even for high risk 
devices, no data will be required for at least 1 year. I 
understand very well the fiscal restraints that our hospitals 
all over the country are under, what they are operating under.
    I have worked closely with the hospitals before I came to 
the House of Representatives, and I still do today. So, I 
understand very well the pressures that they work under. 
Between managed healthcare and reduced Medicare reimbursements, 
hospitals indeed do feel the intense pressure to cut costs 
wherever possible. However, we can't put patients at risk in 
order to save a few dollars. I think my colleagues that have 
spoken before me have really stated that quite eloquently. We 
have to always put patients before profits. I know it is a 
struggle to do that, but I think the American people expect our 
public policy to reflect that. The Reprocessed Single-use 
Medical Device Patient Safety Act is about putting patients 
first.
    I think that it is sound public policy, and I have no doubt 
that today's hearing is going to be very instructive to members 
of this very important subcommittee about this issue. So I look 
forward to working with you, Mr. Chairman, and the rest of the 
members of this very distinguished subcommittee, all of the 
members of the full committee, because this is the place where 
the legislation obviously will be heard and considered. And 
again I thank you for your legislative hospitality in inviting 
me here and being able to speak to this issue today. Thank you.
    Mr. Upton. Thank you. Mr. Pickering, do you have an opening 
statement that you would like to----
    Mr. Pickering. Not at this time.
    [Additional statements submitted for the record follow:]
 Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
    Mr. Upton, thank you for this hearing. I am eager to get action and 
some answers for the American public about the safety of reprocessing 
medical devices designed, manufactured, and approved by the Food and 
Drug Administration for single-use only.
    I am proud of this Committee's accomplishments in the last five 
years to make the FDA a better scientific agency, one that serves the 
American people, promotes innovation, and protects the public health. 
We have streamlined FDA procedures and cut FDA red tape. We have made 
the FDA more effective.
    Today's hearing looks at reused single-use medical devices. I 
believe FDA has acted with uncertainty about its own authority. For the 
last several years, the FDA has sent conflicting signals about the 
legality and safety of reprocessing single-use devices. The result has 
been that patients without their knowledge have been exposed to unknown 
risks from devices that were used on other patients. Thus, for example, 
there is the possibility that tiny, hard-to-clean, disposable catheters 
used in patients with hepatitis are being reprocessed and reused in 
patients without their knowledge. That is an outrage.
    But this is not all. The result of FDA uncertainty has been that 
the original equipment manufacturers find their good name and liability 
on the line because their disposable products have been reused without 
their knowledge or approval. The result of FDA's confused policy has 
helped lead to a surge of reprocessing single-use devices because 
hospitals and health care firms had assumed FDA's acceptance of the 
practice of reprocessing.
    I want the inconsistencies and uncertainties to end today. We are 
at long last getting some answers and actions from FDA and other 
interested parties. FDA's leadership is late. I believe the FDA 
deserves credit for its hard work over the last several months. I hope 
FDA's new policy is reasonable and protects patients.
    I commend Commissioner Jane Henney and FDA Devices Director David 
Feigal, both of whom came on the scene during the past year to steer 
FDA in a better direction on its reuse policy. I also commend Mr. Upton 
and Mrs. Eshoo for their leadership on this issue. I look forward to 
working with all concerned to give the American people the facts and 
swift, common-sense action.
                                 ______
                                 
    Prepared Statement of Hon. Henry A. Waxman, a Representative in 
                 Congress from the State of California
    Mr. Chairman, as the author of the Safe Medical Devices Act of 
1990, I am pleased that you have convened this morning's hearing.
    Ten years ago, the safety of medical devices and the practices of 
the device industry came into serious question. Fatal product failures 
like the Shiley heart valve taught Congress and the public an important 
lesson--there is no substitute for stringent FDA enforcement of 
rigorous standards of safety and effectiveness.
    That lesson holds true today. Due in no small part to the efforts 
of my friend, Senator Durbin, there is enormous interest in the 
regulation of reprocessed devices. Consumer, patient and health 
provider groups all agree that FDA must ensure such devices are safe 
and effective whether they are used once or reused.
    Clearly, there are categories of use for which devices may be 
safely reprocessed. Just as clearly, there have been instances of 
unsafe hospital practices or inadequate safeguards on the part of 
reprocessors. From the written testimony submitted by both device 
reprocessors and the manufacturers, it appears that they agree on the 
need for rigorous FDA oversight and enforcement of risk-based 
standards. As a result, I am pleased that FDA has issued its new 
guidance document, which prioritizes the scrutiny of reprocessed 
devices.
    FDA clearly lacks the resources to do all it should. Last year, 
Senator Durbin secured an additional $1 million for the FDA to 
establish safety standards for reprocessed devices. But that is only a 
small step towards closing the widening gap between FDA's obligations 
and its resources. For years, Congress has forced FDA onto a starvation 
diet while we look to the agency to do more--more about tobacco, more 
about online drug sales, more about drug safety, and now, more about 
reprocessed devices.
    FDA also lacks the authority to adequately answer basic questions 
about the products it regulates. The recent IOM report on medical 
errors stresses the urgency of better understanding the rates and 
severity of medical mistakes including medication errors. The GAO and 
Inspector General recently concluded that we must enhance FDA's adverse 
drug event reporting system and post-market surveillance authority to 
help eliminate the 7,000 annual deaths from medication errors.
    And in the case of devices, are we certain FDA has the resources to 
properly analyze the 100,000 reports it receives annually? And does 
anyone believe those reports comprise the whole universe of device 
malfunctions and misadventure?
    Mr. Chairman, I look forward to hearing from our witnesses. I look 
forward to learning more about this important issue.

    Mr. Upton. Okay. We are ready to proceed. Dr. Feigal is our 
first witness, the Director for the Center for Devices and 
Radiological Health, FDA. Dr. Feigal, we welcome you to our 
subcommittee. We have a long standing honored tradition of 
taking testimony under oath. Do you have any objection to that? 
Committee rules also provide that you are entitled to counsel 
if you would like such. Do you have any need to have counsel 
with you today?
    Dr. Feigal. Not yet.
    Mr. Upton. Not yet.
    If you could stand and raise your right hand.
    [Witness sworn.]
    Mr. Upton. You are now under oath. Your testimony in its 
entirety is made part of the record. We would like to think 
that you would sum up your testimony in about 5 minutes or so, 
and the time is now yours. Welcome.

     TESTIMONY OF DAVID W. FEIGAL, DIRECTOR, FOOD AND DRUG 
                         ADMINISTRATION

    Mr. Feigal. Thank you very much. Mr. Chairman, members of 
the committee, and guests. I am pleased to be here today to 
discuss our approach to the issue of reusing medical devices 
labeled for single-use. I would appreciate if my entire written 
testimony would also be entered into the record. We value your 
interest and input as we study this complex issue and move 
forward to change our regulatory approach.
    The public expects and the law requires that all devices be 
safe, effective, and manufactured in accordance with good 
manufacturing practices. As you know, FDA is currently in the 
process of reexamining its policy in the area of reuse of 
single-use devices. Our primary goal is to protect the public 
health by ensuring that reprocessed, single-use devices are 
safe, effective, and well manufactured. Let me say at the 
outset that I believe we have the regulatory tools to ensure 
that this will happen. We are crafting a regulatory approach 
that will apply equal treatment to the original manufacturers 
of devices, and those who reprocess them, including commercial 
reprocessing firms and hospitals. I think this approach will 
assure the desired public health protection.
    Just this week we posted on our Web site two draft guidance 
documents that pertain to the reuse of single-use devices. One 
describes a proposed risk categorization scheme for reprocessed 
devices. The other describes our enforcement priorities based 
on that risk categorization scheme. We will publish a notice of 
availability of these documents in the Federal Register. I 
realize that since we just posted these draft guidances, they 
were not available for your second panel of witnesses to review 
before they submitted their testimony. But we hope they will be 
helpful in moving this debate forward.
    By way of background, let me describe how reuse has grown 
over the years and why it poses a problem today that did not 
exist a few decades ago. The practice of reusing medical 
devices intended only for one use began in hospitals in the 
late 1970's. Prior to that time most medical devices were 
designed to be reusable. Because most devices were made of 
glass, rubber, hard plastic, or metal, early reprocessing 
involved little more than heat sterilization, wiping, dipping, 
or soaking in disinfectant. Things began to change as a result 
of market demand for disposable equipment, the development of 
new plastics, the miniaturization of devices, and the advent of 
ethylene oxide sterilization.
    These factors prompted the manufacturers to sell more and 
more single-use only medical devices. And as a result, 
hospitals began to receive products labeled single-use only 
that were similar to reuseable devices. In fact, outside of 
their packaging even today some of them look identical to 
devices that had formerly been sold as reusable. The practice 
of reprocessing single-use devices expanded when an increasing 
number of hospitals found that reuse was a cost-saving measure 
and when they became concerned about the amount of medical 
waste generated by the use of disposable devices. The hospitals 
themselves began reprocessing more complex products such as 
balloon angioplasty and cardiac catheters.
    Reprocessing of these devices required more complicated 
decontamination and sterilization procedures and as a result a 
new industry of third-party reprocessor evolved in response to 
the reprocessing needs of the hospitals. All of this has 
resulted in heightened concerns about the safety and 
effectiveness of reused single-use devices, and about the 
equitable regulation of the original equipment manufacturers 
and the reprocessing firms.
    Where does FDA stand on this issue? We have concluded that 
the practice of reuse does need additional attention and 
controls. We have come to that conclusion even though we do not 
have clear evidence that the reprocessing of single-use devices 
changes or increases the types of risks to patients beyond 
those posed by the original device. We recognize that we may 
not have some of the evidence because our medical device 
reporting systems do not capture all of the information. But 
patient injuries are not the only reason for our taking action. 
Even without documented injury, the law still requires that we 
assure that reprocessed devices are safe, effective, and 
manufactured properly.
    I do not want to leave you with the impression that FDA is 
coming anew to this issue. Although we only received research 
reports from the original equipment manufacturer industry 
within the last year, we have been actively engaged in the 
reuse issue for some time. In the past year, we have held 
numerous meetings and conferences with industry, health 
professionals, and consumers to determine the extent, 
magnitude, and changing nature of the practice. We have 
evaluated and conducted research to develop a scientific basis 
for addressing the issue. We have inspected third-party 
reprocessors and as a result have issued ten Warning Letters 
for various violations. And, we have investigated reports of 
patient injuries.
    Now, let me describe what we are proposing to do in this 
area. Fundamentally, our proposed strategy is based on the 
degree of risk posed by the device. The primary factors we will 
use to determine the level of risk are the risk of infection 
and the risk of performance deterioration if a device is 
reused. There are four steps in developing this regulatory 
system which we proposed for comment last November. First, we 
identified the need to develop a list of the commonly reused 
single-use devices. Second, we developed a list of the factors 
that will determine the degree of risk or complexity associated 
with reprocessing. Third, we will use this information to 
divide the list of commonly reprocessed single-use devices into 
high, moderate, and low categories of risk. And fourth, we will 
develop priorities for enforcement of our regulatory 
requirement for hospitals and third-party reprocessors based on 
this category of risk.
    Since announcing this strategy in November, we have made 
significant progress. On February 8th, we posted on our Web 
site two companion draft guidance documents. One is entitled, 
``Reprocessing and Reuse of Single-Use Devices: A Review 
Prioritization Scheme''. It sets forth the factors that we 
would consider in categorizing a reprocessed device as high, 
moderate, or low risk. It also includes a list of commonly 
reprocessed single-use devices and the degree of risk that FDA 
believes each type of device poses when it is reprocessed. The 
other draft guidance entitled, ``Enforcement Priorities for 
Single-Use Devices Reprocessed by Third Parties and 
Hospitals,'' sets forth our priorities for enforcing various 
regulatory requirements, based on the level of risk associated 
with reusing the device.
    Specifically FDA intends to begin enforcing pre-market 
notification and pre-market application requirements within 6 
months of issuing the final guidance if the reprocessed device 
is categorized as high risk, within 12 months if the device is 
moderate risk, and with 18 months if the device is low risk. I 
would like to close by giving a couple examples of how this 
proposed risk categorization scheme and other enforcement 
strategies would affect the reprocessors of various devices. 
Let's take as examples oral and nasal catheters. These are 
fairly simple devices. They are currently Class I and they are 
exempt from pre-market notification. They would be considered 
low risk under the risk categorization schemed just described.
    Six months after a guidance became final, FDA would 
actively enforce all post-marketing requirements for hospitals 
that reprocess these oral and nasal catheters, just as we 
currently do for manufacturers of original equipment and third-
party reprocessors. These include registration, listing, 
manufacturer adverse event reporting, labeling, corrections and 
removals, and adherence to the quality system manufacturing 
requirements. At the other end of the spectrum let's consider 
the percutaneous transluminal angioplasty catheters or intra-
aortal balloon catheters, which are Class III devices. Based on 
our own studies and other information, we have determined that 
cleaning and sterilizing these devices is very difficult, and 
so they would be considered high risk under this scheme. 
Hospitals and third parties that reprocess these devices would 
be required to submit to us pre-market approval applications to 
demonstrate that the reprocessing of these devices results in a 
product that is safe, effective, and well-manufactured.
    Where do we stand right now? After the Federal Register 
publication of these guidances and review during the comment 
period, we will issue final versions. At that point, we will be 
ready to enforce the regulatory scheme for third parties and 
hospitals that reprocess single-use devices. Mr. Chairman, let 
me close by saying that although we have no clear data to 
indicate that people are being harmed at a higher rate by the 
reuse of single-use devices, the results of our own research 
and the information provided by various stakeholders have 
convinced us that this growing practice needs closer scrutiny 
and oversight.
    We are committed to addressing this in an open and 
cooperative fashion with the industries involved, the 
healthcare community, the public, and of course, Congress. We 
want a reasonable and fair-minded policy, but at the same time 
we want to ensure that when a single use device is reused it 
doesn't expose the patient to more risk than a new device would 
have. I thank you for this opportunity to be here today. I look 
forward to answering any questions that you may have.
    [The prepared statement of David W. Feigal follows:]
Prepared Statement of David W. Feigal, Director, Center for Devices and 
           Radiological Health, Food and Drug Administration
                              introduction
    Mr. Chairman, Members of the Committee, I am Dr. David Feigal, 
Director of the Center for Devices and Radiological Health (CDRH) at 
the Food and Drug Administration (FDA or the Agency). I am very pleased 
to have the opportunity to be here today to discuss the Agency's 
approach to the issue of reuse of medical devices labeled for single-
use. As you know, FDA is currently in the process of reexamining its 
policy on the reuse of medical devices labeled for single-use. Our 
primary goal in doing so is to protect the public health by assuring 
that the practice of reprocessing and reusing single-use devices (SUDs) 
is safe and effective and based on good science. We value your interest 
and input as we study this complex issue and move forward to change our 
regulatory approach.
    The public expects and the law requires all devices to be safe, 
effective and manufactured in accordance with Good Manufacturing 
Practices (GMPs). Let me say at the outset that I believe FDA does have 
the tools to ensure the safety, effectiveness and manufacturing quality 
of reprocessed single-use devices. We have been actively engaged in 
reuse issues for some time and our efforts have included research, 
outreach, inspections and compliance investigations. We are currently 
in the midst of crafting a new regulatory approach that will treat 
Original Equipment Manufacturers (OEMs), third parties and hospitals in 
a similar manner to minimize risks associated with reused single-use 
devices.
    We have held numerous meetings and conferences with industry, 
health professionals, and consumers over the past several years to 
determine the extent, magnitude and changing nature of the practice. 
FDA has evaluated and conducted research to begin to develop the 
scientific basis for addressing the issue. We have inspected third 
party reprocessors and issued ten Warning Letters for various 
violations. We have evaluated and investigated reports of patient 
injuries.
    That being said, medical progress has been accompanied by changes 
in technology, resulting in more devices with features that may make 
reprocessing difficult or impossible. At the same time, economic 
pressures create incentives for reuse. Despite a lack of clear data 
that suggests that many injuries are occurring due to reprocessing 
practices, FDA has concluded that the practice of reuse of SUDs needs 
additional attention and controls. We recognize the limitations of our 
medical device problem reporting systems in capturing this information. 
We take the reports we do get very seriously, but at the same time, 
even if there were no injuries, a driving question remains: Are 
reprocessed SUDs being manufactured properly, that is, in accordance 
with the Quality Systems Regulation (QSR)?
    On February 8, 2000, FDA posted on its web site two draft guidance 
documents that pertain to the reuse of SUDs. One describes a proposed 
risk categorization scheme for reprocessed SUDs. The other describes 
the Agency's priorities for enforcing various regulatory requirements 
based on the risk categorization of a reprocessed SUD. We will be 
publishing a Notice of Availability of the documents in the Federal 
Register imminently and asking for public comments on these two 
documents.
                               background
The History of Hospital Reuse
    The practice of reusing medical devices labeled, or otherwise 
intended, for only one use began in hospitals in the late 1970s. Prior 
to this time, most medical devices were considered to be ``reusable.'' 
Because most reusable devices were fabricated from glass, rubber, or 
metal, early reprocessing of reusable products, such as probes and 
surgical instruments, involved little more than hand wiping, dipping, 
and soaking in disinfection solutions. OEMs began to sell ``single-
use'' medical devices as a result of market demand for disposable 
equipment, the development of new plastics, and the use of ethylene 
oxide sterilization. Hospitals began to see products labeled ``single-
use only'' that were similar to devices that had been formerly 
distributed or continued to be distributed as ``reusable.''
    The practice of reprocessing single-use devices expanded when an 
increasing number of hospitals decided that reuse was a cost-saving 
measure and when they became concerned about the amount of medical 
waste generated by the use of disposable devices. Hospitals started 
reprocessing more complex products, such as balloon angioplasty 
catheters and cardiac catheters. Reprocessing of these devices required 
more complicated decontamination sterilization procedures. As a result, 
an industry of third party reprocessors evolved in response to the 
reprocessing needs of hospitals. Expanded use of third party 
reprocessors and an increase in the types of single-use products 
subjected to reprocessing heightened concerns regarding patient safety, 
and equitable regulation of OEMs and reprocessing firms.
The Scope of Reuse Today
    The Agency has developed a list of frequently reprocessed SUDs, 
which includes devices that range from the technologically simple to 
the complex. Examples include:

 Surgical Saw Blades
 Surgical Drills
 Laparoscopy Scissors
 Orthodontic (metal) Braces
 Electrophysiology Catheters
 Electrosurgical Electrodes and Pencils
 Respiratory Therapy and Anesthesia Breathing Circuits
 Endotracheal Tubes
 Balloon Angioplasty (PTCA) Catheters
 Biopsy Forceps
    The list varies greatly in type of device, material, risk of use 
and severity of clinical conditions of typical use. Some products have 
features such as long narrow lumens, fragile plastic components, and/or 
unsealed electronic controls that make them very difficult to clean. 
Other products on the list, e.g., drill bits, are technologically less 
complex and are relatively easy to clean.
    A common type of reuse in hospitals occurs when a sterile product, 
such as a suture, is opened during a medical procedure but not used. 
Typically these are re-sterilized and re-packaged at the hospital. 
OEM's often provide instructions for hospitals to do so. The Agency has 
published applicable guidance on these products and does not consider 
opened-but-unused SUDs to be reused devices that are within the scope 
of the proposed strategy.
                      agency involvement in reuse
Reports of Patient Injuries
    There have been stories in the media which have reported catheter 
tip separations, faulty cataract surgical equipment, and other problems 
attributed to failure of a reused SUD. A recent review of Medical 
Device Reporting (MDR) reports received by CDRH from August 19, 1996 
through December 7, 1999 revealed 464 reports (out of 300,000) of 
adverse events that could possibly be attributed to reuse of a SUD. The 
245 reports spanned approximately 70 different types of products. From 
this data we can discern no pattern of failures with reused SUDs that 
differs from patterns observed with the initial use of SUDs.
    MDR reports do not enable accurate assessment of failure rates, 
whatever the type of device. Detecting SUD problems is even more 
challenging in that they are often not labeled as SUDs (other than on 
the original packaging). In addition, device failures may be 
particularly under-reported (to manufacturers) when the hospital 
recognizes that the device that failed was a reused SUD. Also, 
infections that may have resulted from an improperly reprocessed SUD 
may be hard to trace back to the reused device.
Research Findings
    CDRH has implemented a research program to explore safety and 
effectiveness issues associated with the reprocessing of single-use 
devices. Information on difficulty of cleaning the devices, effect of 
sterilization on material, efficacy of resterilization, and alteration 
in performance criteria are all being investigated. CDRH has had the 
opportunity to examine SUDs after one-time use, compare them to devices 
that have not been used, and do simulated reuse laboratory studies. 
Loss of elasticity in inflatable balloons, persistence of blood and 
biofilms, loss of original lubricants and the effect on catheter 
threading, and crystallization of liquid x-ray contrast material are 
just some of the factors that we have examined. This research program 
has expanded our ability to evaluate reports, scientific studies, and 
comments from the healthcare community.
    Hospital infection control programs rarely identify specific 
incidents of patient infection caused by reuse of SUDs. Our research 
has shown, however, that the performance of some products is degraded 
by the effects of biofilms and repeated use. We have presented our 
laboratory findings at many scientific meetings. We continue to believe 
that solid research by industry, academia and FDA is the best way to 
understand the issues that need to be addressed and to develop 
consensus standards for reprocessing practices.
Outreach
    The Agency has conducted numerous outreach efforts to further 
understanding of and participation in this issue. We have organized and 
participated in public meetings and conducted videoconferences. We have 
met with individual manufacturers and reprocessors; manufacturers' and 
reprocessors' trade associations; the American Hospital Association; 
the Joint Commission of Health Care Organizations (JCAHO); the Health 
Care Financing Administration (HCFA); and medical professionals and 
some of their associations on this issue. Two meetings with broad scope 
that occurred in 1999 were particularly useful in furthering our 
understanding of this issue.
    On May 5-6, 1999, FDA and the Association for the Advancement of 
Medical Instrumentation (AAMI) co-sponsored a conference on the 
practice of reprocessing and reusing SUDs. Participants included 
representatives of health care facilities, firms that reprocess 
devices, OEMs, national oversight organizations, State governments, 
academia, medical ethicists, and standards organizations. This provided 
FDA the opportunity to hear a wide range of views and concerns from 
individuals and organizations involved in or affected by this practice.
    FDA received divergent opinions on how reprocessing and reuse of 
single-use devices should be regulated. Some participants believed that 
reprocessors should be regulated in the same manner as OEMs and that 
510(k)s or Premarket Approval applications (PMAs) demonstrating the 
safety and effectiveness of the reprocessed device should be required. 
Others believe that OEMs should be required to provide instructions on 
how to reprocess their devices unless they can demonstrate that the 
device cannot be reprocessed. Still others stated that the general 
controls under which reprocessing is regulated currently are sufficient 
to ensure protection of the public health.
    Participants identified the need for additional guidance on 
reprocessing. Among the suggestions were: standards to assure that 
cleaning, disinfection, and sterilization processes are validated and 
that reprocessing may be performed properly; a determination of what 
types of devices can and cannot be reprocessed; a classification scheme 
establishing critical, semi-critical, and non-critical categories for 
reprocessed devices; and clearer definitions for the terms ``reuse,'' 
``reprocessing,'' and ``resterilization.''
    Participants suggested that clinical data and experience on reuse 
could be obtained through hospitals' existing surveillance activities; 
long-term clinical studies; the establishment of a clearinghouse for 
data; National Institutes of Health funds and studies of reprocessing; 
and research by professional societies with funding provided by OEMs 
and reprocessors.
    FDA held an open meeting, on December 14, 1999, to obtain feedback 
from stakeholders and interested parties on its proposed strategy on 
reuse of SUDs. Twenty-eight public presenters voiced a variety of 
concerns during the first part of the meeting, and workshops in the 
afternoon provided attendees with an opportunity to explore particular 
issues in smaller groups. An Executive Summary which describes the 
input we received on many aspects of this complex issue is available on 
our web site at http://www.fda.gov/cdrh/reuse/1214execsum.pdf.
                          fda's current policy
    As I noted at the outset, the American public expects, and the 
Federal Food, Drug, and Cosmetic (FD&C) Act requires, that devices be 
safe, effective, and manufactured in accordance with GMPs. When a SUD 
is prepared for reuse by cleaning, repairing, or refurbishing, it is 
being remanufactured and the FD&C Act provides controls to address 
these reprocessed devices, however, FDA has not regulated OEMs, third 
party reprocessors and hospitals that reprocess devices in the same 
manner.
Original Equipment Manufacturers (OEMs)
    OEMs are subject to all requirements of the FD&C Act including: 
registration and listing, premarket notification and approval 
requirements, submission of adverse event reports under the MDR 
regulation, manufacturing requirements under the QSR; Labeling 
requirements, Medical Device Tracking, and Medical Device Corrections 
and Removals. The Agency has enforced all of these requirements with 
respect to OEMs.
Third Party Reprocessors
    Third party reprocessors are subject to the same regulatory 
requirements as other manufacturers, including premarket requirements. 
As discussed previously, FDA has issued Warning Letters to third party 
reprocessors for various violations; however, to date, FDA has not 
actively enforced premarket requirements against third parties. (Note 
that many devices that are commonly reprocessed are exempt, by 
regulation, from premarket requirements.)
Hospitals
    According to the Agency's Compliance Policy Guide, hospitals that 
reprocess single-use devices assume full liability and responsibility 
for their reprocessing actions and should ensure that the products are 
adequately cleaned and sterilized, and that device safety, 
effectiveness, and quality are maintained. The Agency currently 
provides no direct oversight or routine enforcement for in-hospital 
reprocessing. If a serious adverse event involving a reprocessed (or 
any other) device occurred in a hospital, however, FDA would conduct an 
investigation and take appropriate action, as necessary.
                        fda's proposed strategy
    As I stated earlier, FDA is reevaluating its position on the reuse 
of single-use devices. In November 1999, the Agency made a document 
available on its web site for public review and comment which described 
a proposed strategy to address reuse of SUDs. One of the principal 
components of FDA's proposed strategy was the establishment of agency 
enforcement priorities concerning regulatory requirements for third 
party and hospital reprocessors of SUDs. FDA proposed to prioritize its 
enforcement activities based on the degree of risk posed by the 
reprocessing. To accomplish this process, FDA proposed the following 
steps:

(1) develop a list of commonly-reused SUDs;
(2) develop a list of factors to determine the degree of risk 
        associated with reprocessing devices;
(3) use that list of factors to divide the list of commonly-reprocessed 
        SUDs into three categories of risk--high, moderate, and low; 
        and
(4) develop priorities for enforcement of regulatory requirements for 
        hospitals and third party reprocessors, based on the category 
        of risk.
    Since the announcement of FDA's proposed strategy, FDA has made 
significant progress. On February 8, 2000, FDA posted on its web site 
two companion draft guidance documents. One is entitled, ``Reprocessing 
and Reuse of Single-Use Devices: Review Prioritization Scheme.'' This 
draft guidance set forth factors we would consider in categorizing a 
reprocessed devices as high, moderate or low risk and includes a list 
of commonly-reprocessed SUDs and the degree of risk FDA believes each 
type of device poses when reprocessed. The other draft guidance, 
entitled ``Enforcement Priorities for Single-Use Devices Reprocessed by 
Third Parties and Hospitals,'' sets forth our priorities for enforcing 
various regulatory requirements, based on the categorization of a 
device, as described in the Risk Categorization guidance.
    The risk scheme guidance describes specific factors FDA would use 
to determine whether reprocessing posed high, medium, or low risk. This 
guidance has two flowcharts to help FDA and industry categorize the 
reprocessing risks. One flowchart addresses factors that relate to 
risks of infection that may accompany reprocessing. The other flowchart 
addresses factors that relate to risks of performance failures that may 
accompany reprocessing. Using these two flowcharts, FDA has categorized 
all currently known reused SUDS into three categories of risk--high, 
medium, and low. We have clarified that the risk categorization scheme 
does not in any way change the classification of a device under the 
statute.
    The enforcement priority guidance bases the Agency's timing of 
enforcement of premarket requirements on the level of risk determined 
under the risk categorization scheme. Specifically, FDA intends to 
begin to enforce premarket notification and premarket application 
requirements within six months of issuance of a final guidance if the 
reprocessed device is categorized as high risk, within 12 months if the 
device is categorized as moderate risk, and within 18 months if the 
device is categorized as low risk. Although FDA has not previously 
enforced premarket requirements for third party reprocessors, FDA 
currently enforces all other requirements applicable to manufacturers 
against third party reprocessors. The issuance of this draft or any 
final guidance will not change the continuing obligation of third party 
reprocessors to comply with those provisions of the FD&C Act. FDA would 
not enforce those requirements for hospitals, however, until six months 
from the issuance of a final guidance document.
    I would like to give a couple of examples of how this proposed risk 
categorization scheme and our enforcement strategy would affect 
reprocessors of devices of disparate complexity and risk. Oral and 
nasal catheters, fairly simple devices, are currently class I and 
exempt from premarket notification. They would be considered ``low 
risk'' under the risk categorization scheme I just described. Six 
months after a guidance became final, FDA would actively enforce all 
non-premarket requirements for hospitals that reprocess oral and nasal 
catheters, just as we currently do for OEMs and third party 
reprocessors, including registration, listing, manufacturer adverse 
event reports, labeling, corrections and removals, and quality system 
manufacturing requirements.
    Percutaneous transluminal angioplasty catheters or intra-aortal 
balloon catheters, class III, would be considered ``high risk'' under 
the scheme. Based on our own studies, we have determined that cleaning 
and sterilizing these devices are very difficult. Hospitals and third 
parties that reprocess these devices would be required to submit to the 
Agency PMAs demonstrating that their reprocessing of these devices is 
safe and effective, in addition to conforming to the general controls 
of the FD&C Act.
    At this time, the Agency is limiting its focus to SUD reprocessing 
by third parties and hospitals. The draft SUD enforcement guidance does 
not apply to permanently implantable pacemakers (the reuse of which is 
already addressed in a Compliance Policy Guide), ``opened-but-unused'' 
SUDs, and healthcare facilities that are not hospitals.
                               next steps
Issuance of Final Guidance Documents
    The guidance documents I mentioned are not final, nor are they in 
effect at this time. These documents incorporate comments to our 
proposed strategy that we received at the December 14 public meeting 
and written submissions. We are in the process of publishing in the 
Federal Register of a notice of availability of these documents and are 
asking for comments. After reviewing the comments received, the Agency 
will issue final guidance documents.
Phased-In Enforcement
    As I have stated earlier, FDA is planning to phase in the 
enforcement of regulatory requirements for third parties and hospitals 
that reprocess SUDs. After receiving public comment on our draft 
guidances, including factors used to categorize risks, and timing of 
our enforcement based on those risks, we will issue final guidances and 
begin implementation of our enforcement strategy that would regulate 
OEMs, and third party and hospital reprocessors in the same manner.
Collaboration with Other Parties
    The direction in which we are headed could impact significantly on 
the Agency's resources, particularly for conducting inspections of 
hospitals that reprocess. We will be collaborating with third parties, 
such as JCAHO, HCFA and State agencies that currently perform oversight 
of the health care sector to assist us in implementing the new policy.
Outreach
    We will be continuing our outreach efforts to ensure that the 
health care community, manufacturers, reprocessors, patients, and the 
public are fully aware of the issues involving the reprocessing and 
reuse of SUDs. Our efforts will include talk papers, public health 
notifications, and lay articles on an FDA web page.
SUD Labeling
    We will be considering changes to the labeling of SUDs by OEMs. One 
option the Agency is considering is requesting OEMs who label their 
devices ``single-use'' to provide, as part of the device's labeling, 
any information of which they are aware regarding the potential risks 
associated with reusing their SUDs. This information would serve as a 
caution to users and reprocessors who might attempt to reprocess these 
SUDs.
Institute an Expanded Research Program for Reuse
    The Agency has conducted several in vitro studies on reused SUDs 
and is considering additional studies on the effects of reprocessing. 
Expansion of our research efforts may facilitate collaboration with 
stakeholders and interested parties to conduct more in vivo and in 
vitro studies.
                               conclusion
    Mr. Chairman, although we have no data to indicate that people are 
being injured or put at increased risk by the reuse of SUDs, the 
results of our own research and the information provided by various 
stakeholders have convinced us that this growing practice needs closer 
scrutiny and oversight. We are committed to addressing reuse in an open 
and cooperative fashion with the industries involved, the health care 
community, the public, and, of course, the Congress to craft a policy 
that is reasonable yet effective in minimizing the risks associated 
with this practice. Thank you for the opportunity to be here today. I 
am happy to answer any questions you may have.

    Mr. Upton. Thank you very much. Now we will work this clock 
for us. We are going to take 5 minutes each, rotating on both 
sides for questions. One of the items that you used last in 
your testimony was, in fact, this one right here, which is--I 
don't know if I want to take it out because then no one would 
be able to use it. This is an emergency coronary artery bypass 
graft surgery instrument?
    Mr. Feigal. Yes.
    Mr. Upton. And as you have indicated, it is a Class III. 
Okay. Currently this could be reprocessed, is that right, 
without the new regulations in place?
    Mr. Feigal. That is correct. We have not been calling for 
pre-market applications for reprocessors for such devices.
    Mr. Upton. But in fact this could be used more than once?
    Mr. Feigal. Yes, that is correct.
    Mr. Upton. And under the regulations that you put on the 
Web page earlier this week, if they become final then for this 
to be used a second, third, or however many times, the 
reprocessor would have to, in fact, demonstrate that it was 
absolutely clean and safe, and there should be no problems, and 
it would only be used X amount of times, is that correct? Is 
that basically how it is going to work?
    Mr. Feigal. They would need to demonstrate that their 
cleaning process could assure that the product was clean and 
free from infection risk, and that the cleaning process did not 
degrade the performance of the item. The exact mechanism for 
doing that may involve testing and assessing the devices or 
tracking the number of times a device is used. I think there is 
not a single answer for all types of devices, but it would be 
up to the applicant to tell us that they had a way to assure 
that each time that device was going to be used that you could 
expect that it would perform as intended and be safe and 
effective.
    Mr. Upton. Assuming that they could show that it was safe 
and clean, they would have to somehow tag this so that it 
didn't exceed so many, whatever you defined as the number of 
uses, is that right?
    Mr. Feigal. It has to be accurately labeled. A reused 
product should identify the fact that it has been reused. The 
hospital should know whether it is opening something that is 
new or opening something that is reprocessed. I think whether 
each device needs to be tracked each time it is used will vary 
with the type of device. That would be one way that someone 
could propose that they would control the aging of the device.
    Our concern would be if someone said well, we could always 
use these four times so we'll count to four and throw it away, 
when in fact, it might show degradation after the second use. 
So, in fact, each time it is cleaned they need to assure that 
the product will perform as expected, and that may require a 
different approach than actually counting the number of uses to 
assure that it met adequate performance specifications.
    Mr. Upton. How would they determine the number of uses? 
Would there be a clinical trial? Would they like test it or 
just stand back until they figured out when it broke down?
    Mr. Feigal. This is one of the questions that we've been 
trying to address with our own laboratories looking at some of 
the research methods. For example, a common problem with 
catheters. When they are first manufactured they are coated 
with a lubricant to facilitate threading. As you clean it the 
lubricant is stripped.
    Mr. Upton. That's right.
    Mr. Feigal. And so rather than finding out in patients 
whether or not it is tougher to thread these things after the 
lubricants are stripped, we have actually done a bit of 
research to try and develop a mechanical way of measuring how 
smoothly something moves through narrow spaces. This is the 
kind of evidence and research we would expect the applicants to 
provide to address all the aspects of why products perform well 
and why they are failing. The issue of brittleness has been 
raised a number of times. That is another example of something 
that probably can be assessed by looking at multiple cleaning 
cycles and simulated use. Breakage of these fragile devices is 
something that even new devices are susceptible to, and I think 
we can learn more about product mode failure through this 
process.
    Mr. Upton. Now, in your deeming whether this should remain 
a single-use or not, would you, as part of the regulations or 
part of the design, would you go back to the manufacturer of 
this and get their comments as well?
    Mr. Feigal. Well, what the reprocessor is doing is taking a 
discarded single-use device, if you will, and using that as his 
starting material. Obviously he can do a better job of 
assessing what he is up against in reprocessing if he has 
information from the original manufacturer. But we do not have 
any authority to require this. In fact, our authority and our 
requirements actually protect the trade secrets of the original 
manufacturers.
    So, actually the burden on the reprocessor would be to show 
that he could clean it, not even knowing exactly how well it 
was made. We would certainly have the information in most cases 
ourselves as to how it had been manufactured, but we would not 
be allowed to share that with the reprocessor.
    Mr. Upton. Just to finish then, so it is or is not part of 
the process that you would have to go back to the original 
manufacturer to get their comments as to whether or not this 
should be used a second time?
    Mr. Feigal. The application actually of the new 
manufacturer is a trade secret as much as the application of 
the OEM is a trade secret. And so that is one of the 
difficulties in this.
    Mr. Upton. You have got to make the judgment as to----
    Mr. Feigal. Yes.
    Mr. Upton. [continuing] whether or not it is going to be 
effective as it was the first time that it was used, and 
therefore you would have some statistics that they, I would 
think they, would be willing to offer to say yes or no.
    Mr. Feigal. Yes. Well, that is why the law gives us the 
ability to know all the information from both manufacturers and 
to consider everything we know in assessing safety and 
effectiveness, including all the information we have across 
manufacturers for multiple different types from our adverse 
experience reporting. There are a lot of details, I think, that 
you are bringing up that are important in how this will 
actually work. We need to do it in a way that both insures the 
public health, but also respects the trade secrets of the 
manufacturers who have applications before us.
    Mr. Upton. Okay. Mr. Stupak.
    Mr. Stupak. Thanks, Mr. Chairman. Is there reported cases 
of infection associated with single-use instruments?
    Mr. Feigal. I'm sorry. Could you repeat the question?
    Mr. Stupak. Single-use instruments, first time they have 
been used, has there been reported cases of infection 
associated with them?
    Mr. Feigal. That would be very unusual. What is more common 
is to have cases of infection reported to us from the lax 
cleaning procedures of devices designed for reuse. So, for 
example, bronchoscopes and endoscope, there have been reports 
of infections that have been spread because these devices, 
which are designed for reuse, were not properly cleaned by the 
hospitals. So, that is the more common type of infection that 
we have reported associated with devices.
    Mr. Stupak. Those scopes though, when they are 
manufactured, are they manufactured and received from the 
manufacturer as being a single-use item?
    Mr. Feigal. No. They are not. They are actually marketed 
with detailed instructions for cleaning and disinfecting. And 
despite that, in hospitals, we still have infections.
    Mr. Stupak. Okay. So they are manufactured, and when they 
come in the package or whatever, there are instructions on how 
to reprocess them for reuse and how to sterilize and take care 
of them?
    Mr. Feigal. Yes. And that information is provided by the 
manufacturer in their application to us so we can assess 
whether they have adequate instructions for cleaning and 
sterilization.
    Mr. Stupak. So the sterilization, the chemical reaction, 
the lubricants, that is all taken into consideration if they 
allow it to be a reused item?
    Mr. Feigal. That is right. We have to consider all of that 
for reused items.
    Mr. Stupak. If I am a hospital and--it may not be a fair 
question to you, but if I am at the hospital and I get a 
single-use item, am I required before I use it to go through 
some type of sterilization, or can I take it out of the 
packaging knowing I can use it immediately, or is there a 
requirement of the hospital to also do sterilization before 
they ever use a single-use item?
    Dr. Feigal. Most devices that are intended for sterile use 
are shipped sterile in packing that can be opened. A common 
challenge for hospitals is that often devices are opened and 
made available in the operating room that are not used, and 
then the hospitals have to know how to repackage and re-
sterilize those. The most common product for which that occurs 
is sutures, but it occurs for hip implants, all sorts of 
different things. So hospitals actually do this day in, day out 
and have considerable skill at doing this.
    Mr. Stupak. Okay. And Doctor, the issue of alteration of 
performance criteria is mentioned in your description of FDA's 
research on reuse issues. Could you tell us how alterations of 
performance criteria are handled in the draft guidance?
    Mr. Feigal. Well, this is one of the two key factors that 
are identified to establish the level of risk and our level of 
concern about the product. The device laws are risk-based and 
devices are risk-stratified. We do not have the same 
application process for all devices. We have taken the same 
approach with the reusable devices in that we will start with 
the products that concern us the most and work our way out from 
there. Eventually we will cover them all. But we will start 
with the products of greatest concern, either because of risk 
of infection or difficulty in cleaning. The other factor is 
evidence that the material or product will not be degraded with 
repeated use and cleaning.
    Mr. Stupak. What are the ones that concern you the most?
    Mr. Feigal. The products that have delicate materials or 
that were already Class III devices concern us the most. For us 
to even approve them in the first place required clinical data. 
Many of these devices, if you look at our prioritization 
scheme, are at the top of the list. The things that are low on 
the list are things that have large lumens or are made out of 
hard materials and are relatively straightforward to clean. 
There are many single use products. Many are not labeled as to 
why they are single use and many of the single-use products are 
labeled that way for convenience. If you look at some of the 
products in the low risk categories probably relatively 
straightforward to clean.
    Mr. Stupak. Okay. Using one or two devices as examples, 
could you give us a brief overview of the similarities and the 
differences between the quality system regulations for OEMs and 
reprocessors?
    Mr. Feigal. There will be none under our proposed scheme. 
Whatever standard the OEM has to meet, the reprocessor has to 
meet. If there are differences, the differences have to do with 
the starting material. The OEM builds their device from 
scratch. The reprocessor starts with a used device. So there 
would be differences in the manufacturing steps, differences in 
some of the things that the OEM might have to do to fabricate a 
device. But in terms of the nature of the law and the 
requirements, our proposal makes them identical. There will be 
a completely level playing field for OEMs and reprocessors.
    Mr. Stupak. Okay. Well then would the guidelines then 
permit significant variability among reprocessors in terms of 
the number of times devices are used, reused?
    Mr. Feigal. We will ask the reprocessors to tell us how 
they know that a device addresses our concern of infection and 
integrity of performance. If they can do that without counting 
the number of times it is used, for example, by testing it 
before re-release, that may be adequate. And I think that there 
will not be a single way to safely clean and reprocess all 
devices. We will ask for the applications and we will review 
them critically. There may be times when it will be appropriate 
to keep a detailed record, and others when it may be more 
important to test to see how brittle the device is, no matter 
how many times it has been used.
    Mr. Stupak. The reprocessors in this case would that be 
like the hospitals, or could it be the manufacturer?
    Mr. Feigal. The reprocessor is either the hospital or a 
third-party commercial reprocessor. There is, of course, some 
level of reprocessing that occurs, mostly in the setting of 
open-but-not-used devices, that is actually done cooperatively 
between the original equipment manufacturer and the hospital. 
So I think we are going to see a variety of different ways that 
this problem is approached, and I think some of the economic 
pressures will change. We may see new partnerships develop and 
problem solving in some of these areas. We would welcome 
research to develop reusable devices that can be safely 
manufactured, and currently are only labeled single-use for 
convenience or other reasons.
    Mr. Upton. We can go another round if you want?
    Mr. Stupak. Okay. Can I ask one more question? Economics I 
just want to ask.
    Mr. Upton. Sure. Okay.
    Mr. Stupak. One question on economics, Dr. Ganske had 
brought that up, and there is obviously a savings here, but is 
some of the pressure on reprocessing because the DRGs, I mean, 
you get paid a certain amount if you are doing a procedure 
underneath a DRG, correct? And if you can cut the cost of doing 
it by using a reprocess you would make cost benefit then would 
be--go to the hospital then because you get paid an amount 
whether it is reused or new, correct?
    Mr. Feigal. This is a question outside of my authority, but 
it is a question I happen to know the answer to so I will be 
brave and answer it for HCFA. The DRG does pay a flat fee, and 
in fact, one of the questions about reuse is, ``Are used 
devices billed individually in an itemized bill?'' Under that 
system, and many other types of systems, they are not. The 
hospital makes its own choice in the equipment it purchases, 
the professional services it uses, and they provide that 
service for that cost. And there is no representation to the 
third party, where the products came from or what they were. If 
you want any more detail than that, I am completely out of my 
element so you are best to discuss this with HCFA.
    Mr. Stupak. Thank you Mr. Chairman, for allowing me that 
last question.
    Mr. Upton. Dr. Ganske?
    Mr. Ganske. Thanks Mr. Chairman. As a surgeon who goes 
oversees on surgical missions we take all of our own medical 
equipment provided for free, and I am always interested in the 
fact that for all the single-use tubing and equipment that we 
take over, that in this country is typically just thrown away, 
we will frequently see the hospital workers in these third-
world countries pulling them out of the garbage, cleaning them 
out, sterilizing them and using them many, many times because 
they just simply cannot afford the equipment otherwise.
    It is clear to me that there are some types of single-use 
items that probably can be safely cleaned, assuming that they 
are adequately cleaned and sterilized and reused. It also looks 
to me that it is possible for us to be comparing apples to 
oranges. There is a dispute between the medical manufacturers 
and the reprocessors. It is fair to say that there are 
economic, big economic factors involved. Some would say that 
manufacturers will label a device a single-use device for their 
own purposes so that it should be only used once and then they 
have to buy another one.
    There are also allegations of, and I am sure we will see 
some testimony today, inadequately cleaned devices. Does your 
organization have any information on who has done the 
``inadequate cleaning'', for example, a lot of re-sterilization 
is done by individual hospitals. They are under the auspices 
for doing sterilization properly, of the JCAH, and they have 
protocols, but obviously if you are sterilizing millions and 
millions of pieces of equipment every day, it is dependent on 
how thorough those pieces of equipment are cleaned. As you 
pointed out in your testimony, not just for single-use items, 
but for permanent items.
    Mr. Feigal. Uh-huh.
    Mr. Ganske. Like for a steel bronchoscope that is clearly 
meant to be used thousands and thousands of times, but if it is 
not cleansed properly by the technician in the hospital, then 
it does not matter whether it is a single-use device or a 
permanent device, you have the risk of contamination. And I 
guess my point is this--my question to you is have you looked 
at any of the data that the manufacturers are presenting that 
distinguishes between whether hospital contaminations after 
``reprocessing'' were done by reprocessors, commercial 
reprocessors, as versus hospitals.
    Mr. Feigal. The types of research submitted to us last 
February by the manufacturers came from a variety of sources. 
Sometimes the devices were not being sold as reprocessed 
devices, they were simply devices that had been used. And the 
purpose of the research was to identify the kind of condition 
that the device was in after use and how use had changed it. 
Other types of research has actually tried to look at devices 
which were purported to be cleaned, usually by third-party 
reprocessors. We, ourselves, have gone into the reprocessors 
and done inspections and if you look through our findings and 
our Warning Letters you will see the public comments that we 
have made about how they do their business.
    Mr. Ganske. Well, summarize that for me.
    Mr. Feigal. That industry is not terribly different than 
many device manufacturers, in that if you go in and look in 
detail at how they follow their good manufacturing practices 
and their quality systems, you find areas where they need to 
make improvements. What we did not find were devices that were 
volatile and needed to be seized, or products that required 
public health alerts, or other types of problems.
    Mr. Ganske. When you went into those reprocessors and 
looked at their results, in their reprocessed equipment sealed, 
ready to be sent back, did you find pieces of tissue?
    Mr. Feigal. We did not do those types of studies. The 
research that we have done on devices has been done with 
single-use devices that have been donated to us from other 
Federal hospitals that were not going to reuse those devices, 
so we could study them. One of the issues that addresses both 
the reprocessor and the hospital, to get back to one of your 
earlier points, is to look and see what the role of cleaning 
and reprocessing standards would be.
    Certainly the OEMs are not calling for an application from 
hospitals on their cleaning procedure model by model, device by 
device, for their reusables. We need to look and, again, our 
approach is to look at the risk of the product and say which of 
the devices concerns us enough that we really want to see a 
pre-marketing application, and which are the ones for which the 
rigor of the quality systems regulation and adhere to certain 
standards can do the job.
    Mr. Ganske. Let me give you an example of this then.
    Mr. Feigal. Okay.
    Mr. Ganske. Let's say you have a balloon angioplasty 
catheter that has a little, you know, latex balloon on it that 
you put into the coronary artery, and you blow it up, and you 
can crack open a narrowing of the coronary artery. Now, are 
those catheters, which are probably labeled single-use, are 
they being sterilized--cleansed and sterilized in hospitals?
    Mr. Feigal. In some hospitals, yes.
    Mr. Ganske. Okay. Now, do those hospitals have the ability 
to determine whether that little latex balloon after it has 
been re-sterilized, has the same dimensions as it came from the 
manufacturer?
    Mr. Feigal. We don't know what the practice is in the 
hospitals, to date, because we have not been in the hospitals. 
This is an issue that needs to be addressed. There are other 
issues that we have identified, such as persistence of 
crystallized dye in the catheters and in the lumens.
    Mr. Ganske. Do reprocessors routinely check for that?
    Mr. Feigal. Yes.
    Mr. Ganske. A commercial reprocessors?
    Mr. Feigal. The reason I cannot answer that is we have not 
yet asked them to file applications with us to show how they do 
these things: how they clean them, what they know. What our 
framework says is that they will have to tell us that in the 
future. That will be our approach. We will know what they are 
doing, what their standards are, and we will assess those to 
assure that a reprocessed device is safe and effective and 
manufactured to the kind of quality we would expect of an OEM.
    Mr. Ganske. Thank you Mr. Chairman.
    Mr. Upton. Okay. Thank you. Mr. Strickland.
    Mr. Strickland. Thank you Mr. Chairman. Dr. Feigal, Boston 
Scientific has done a study, which I am sure you are aware of, 
35 reprocessed devices were pulled from hospital shelves and 
tested for sterility. Of the 35, 25 had been reprocessed by the 
hospital, and 10 by a third party. They found that 6 of the 35 
were sterile. And my question has to do with FDA research and 
attempt to replicate this study. I understand that FDA has 
attempted to replicate the study and I would like to ask you 
what the results of that study by FDA found.
    Mr. Feigal. When we repeated the study we did not find that 
the catheters would have transmitted infection. Part of the 
issue comes down to the definition of what the findings were, 
that is, whether we are talking about a clean but residual 
tissue or clean but residual films on the forceps. Those may be 
other issues that are also important to address. Where we are 
at this point is that we have compared notes with Boston 
Scientific, we have asked to see their methods so we can see if 
we can repeat the experiment exactly the way they did it and 
see if we get the results. And that is in progress. We would be 
happy to report back to you our findings when we complete that.
    Mr. Strickland. So are you telling me that there may have 
been residual materials found, but that they were not found to 
be a threat for infection?
    Mr. Feigal. That is correct.
    Mr. Strickland. And I have also been told, and I would like 
for you to deny or confirm this, that at least in one of the 
studies that the devices were subject to bleach before they 
were examined for being sterile or being safe. Can you tell me 
whether or not that is a----
    Mr. Feigal. I can answer that question, but I will have to 
submit it as part of the record. It depends on where we got the 
samples. Some of the hospitals that have been donating the 
equipment do soak them in bleach to disinfect them. Bleach is a 
good antiviral, virucidal agent. But I am not sure that is 
related.
    Mr. Strickland. But it does seem to be related to the 
validity of the attempt to replicate the study and that is what 
I am getting at.
    Mr. Feigal. Well, that is correct. And if, in fact, we did 
the study in some way that clouded the issue, we are trying to 
do the study exactly the way they did it and see what we can 
find.
    Mr. Strickland. And are you saying to me now that based on 
your current knowledge you cannot say that you have done a 
study that, in fact, replicated the methodology of the Boston 
Scientific study?
    Mr. Feigal. Not every detail, but we tried to do it 
according to our understanding of how they did the study and 
then when we got the results, we compared notes with them and 
said well, what might we have done different. And that is what 
we are trying to----
    Mr. Strickland. I guess an observation I would make, if you 
found materials on these reprocessed devices, that the 
materials were not considered to be a danger of infection, is 
it possible that they were not a danger of infection due to the 
fact that they had been bleached?
    Mr. Feigal. I take your point that it depends on how the 
materials were handled, and we should make sure that the two 
experiments were done the same way.
    Mr. Strickland. No more questions, Mr. Chairman.
    Mr. Upton. Thank you. Mr. Whitfield.
    Mr. Whitfield. Thank you Mr. Chairman. I am sorry I missed 
the testimony after saying how much I wanted to hear it. But I 
was called to the House, but I will read your testimony, Dr. 
Feigal, and one question I had. In the European Union, do they 
allow reprocessed medical devices in European countries or do 
you know?
    Mr. Feigal. European device laws vary considerably from 
country to country. Some of the device laws do not require any 
type of pre-market application and rely on quality system 
requirements, and there is some effort to harmonize those. I 
think if we would go country by country I think we would find 
countries that ignore the problem entirely and others that have 
some rules about it. And we could provide more detail as 
follow-up if you like. I don't have that information with me 
today.
    Mr. Whitfield. That's okay. Now it is my understanding that 
on many of these devices the name or the initials of the 
original manufacturer are on the device, and then once it is 
reprocessed that would still be on there.
    Mr. Feigal. Yes. Although we heard, actually we heard on a 
visit to Michigan stories of someone who was grinding off the 
name of the OEM and claiming that the product was just as good 
as the OEM's product, which was a fair statement because it was 
the OEM's product, just with the name ground off, but recleaned 
and reprocessed. That is right.
    You usually can identify it, but I think one of the 
challenges for hospitals is, if you look at some of the 
catheters the members of the committee brought or that I 
brought today, you see there isn't very much room for very 
large lettering or detailed descriptions. So it usually takes 
someone who technically knows exactly what they are dealing 
with to identify the manufacturer and the model in some of 
these cases.
    Mr. Whitfield. Would that subject a reprocessor to a charge 
of misbranding or not?
    Mr. Feigal. I think it depends on what they claim. You need 
to claim accurately what you have got. If you claim you have 
got a reprocessed device that was originally manufactured by a 
specific company, then that is the truth. Now, whether you are 
infringing on their patents or other kinds of things, that 
would be Better Business Law. But I think that they need to 
disclose what they know about the product that is relevant for 
the safe and effective use of the product.
    Mr. Whitfield. It is my understanding that in the past the 
FDA has claimed that they have been unable to find clear 
evidence of adverse patient outcomes as a result of using 
reprocessed devices. Is clear evidence of adverse patient 
outcomes the sole basis on which the FDA would determine if 
there is a major public health problem?
    Mr. Feigal. No, it is not. There are times when a single 
serious failure of a product can result in an FDA action to 
correct a product. So it is not that it takes large numbers, 
and it is not that we do not have any reports. In fact, if you 
go through our MDR reporting system over a several year period, 
we have about 245 reports of injuries associated with reused 
devices. The difficultly for us is that the system does not 
tell us the volume of use of the product or of the different 
types of problems.
    And so, for example, we have reports of broken catheter 
tips, but we also have 11 reports of catheter tips that broke 
in brand new devices the first time they were used. And we 
don't have the kind of information and the type of system to 
tell whether the reused device has a higher risk. Your other 
question is one that I think is an important one, which is that 
the law does not just require that the products be safe and 
effective. They also require that they be well manufactured, 
that is, manufactured under quality system regulations 
according to good manufacturing practices. So even if they were 
safe enough and usually did not cause problems, we still expect 
that the reprocessors and the remanufacturers of these products 
will meet the same standards that we expect of the original 
equipment manufacturers.
    Mr. Whitfield. Mr. Chairman, thank you. I just want to 
thank Dr. Feigal for being here, and we all recognize that you 
have been sort of a leader in trying to reestablish focus on 
this issue. And thank you very much.
    Mr. Upton. Thank you. Mr. Bryant.
    Mr. Bryant. Thank you Mr. Chairman. Dr. Feigal, let me also 
join with my colleague to thank you for what you have done in 
the short time that you have been at FDA. I think everybody 
from hospitals to all sides of this issue are really desirous 
of the FDA moving on this and issuing the instructions and 
advice that is necessary so that we can have clarification in 
this issue. And I think that is the goal of everybody. I sit 
here thinking what we are talking about here is reusable 
single-use equipment. And is that an oxymoron or what?
    Mr. Feigal. It sounds like it, doesn't it?
    Mr. Bryant. Why did we ever go from reusable equipment to 
single-use equipment?
    Mr. Feigal. There are a variety of different reasons. 
Sometimes there was a request for disposable equipment for 
convenience and it was more expensive to clean the product than 
it was to manufacture a disposable product. There are times 
when a product changes status. It has been on the market as a 
multiple use and the manufacturer changes it to a single-use 
and it is not clear always why that happens.
    If someone is coming in for the first time it is a simpler 
application to have it be a disposable device than a device 
which is cleaned. If they are asserting to us that it can be 
cleaned, they have to include in their application the studies 
that show how to clean it and that those studies do not damage 
the device. And so there are probably some business decisions 
that at times they will get to market more quickly with a 
product if it is labeled for single-use only.
    Mr. Bryant. But originally wasn't the dominant reason had 
been infections and simply the safety of the product?
    Mr. Feigal. I don't believe that there are really very many 
reports with medical devices that are being reused causing 
infections. The manufacturers are required to tell us what they 
know.
    Mr. Bryant. I mean originally, back in the 1950's or 
whenever.
    Mr. Feigal. Well, this sort of started in the 1970's and it 
would be interesting to ask some of the manufacturers who have 
been in this business a long time the history from their 
individual companies. We can only speculate, but I think it is 
often many reasons.
    And one of the things that we have asked for feedback about 
is whether it would be useful, if a company knows that 
reprocessing damages a product or that if a product is 
susceptible to infection if it is reused, that they should 
include that information in the labeling. Now there is concern 
by the OEMs that that is requiring them to say something about 
a use for the product they never intended and puts them at a 
marketing disadvantage. So we understand that. On the other 
hand, if it is a common practice and the device looks very 
similar to devices that once their labeling is off, their 
packaging is off, all look alike, then if they know their 
product can be damaged or made less effective that information 
would be useful to the medical consumer.
    Mr. Bryant. Right. And I would assume trial lawyers to know 
also.
    Mr. Feigal. Uh-huh.
    Mr. Bryant. Did I understand you correctly to say that when 
a manufacturer comes to the FDA they have to, on a single-use 
product, they have to provide you with instructions on how to 
clean it?
    Mr. Feigal. Only if it is a multiple use. If they have a 
device that is going to be reused again and again, then part of 
the application process is to show the performance of that 
device with multiple use.
    Mr. Bryant. Okay. All right. You testified that the FDA had 
no clear studies, and I think I wrote that down correctly. I am 
just wondering that maybe you have been unable to find any 
clear evidence of adverse patient outcomes associated with the 
reuse of single-use devices from any source. Is the clear 
evidence of adverse patient outcomes the sole basis of the FDA 
to determine if there is a major public health problem? And if 
not, what else would the FDA rely on?
    Mr. Feigal. Certainly anything that resulted in patient 
injuries would be an important criterion, but when we are 
looking at the device we look at how complex is the cleaning 
process, how delicate are the materials with which it is 
manufactured? Is it likely that you are either not going to be 
able to clean it because you have got lots of crevices and 
narrow lumens, and areas where you are going to get residual 
body fluids or biofilms or even tissue?
    Beyond that, even if someone can clean the device well, we 
look at whether or not the cleaning process itself is likely to 
damage the device and make it less effective. So the two 
primary criteria that we look at is whether you can clean it in 
a way that makes it safe and does not degrade the performance. 
So, those are the two key issues that we have said we would use 
to determine our level of concern with the device and how 
rapidly we would move it into our priorities for taking action.
    Mr. Bryant. Given what I understand to be your testimony 
that the FDA believes this issue of reusable equipment ought to 
have more oversight and regulation, do you think it would be 
appropriate at this time that a patient should be informed 
ahead of time that reprocessed equipment might be used on them?
    Mr. Feigal. I think this is a question about which you will 
hear testimony from the other panelists. When it is not in the 
setting of an experimental device, then we are looking at the 
use of informed consent and the practice of medicine. And there 
are many things that you do in the practice of medicine, such 
as agreeing to surgery or agreeing to the examination of a 
child, where national norms state that informed consent is 
appropriate in that setting. The kinds of details, the kinds of 
issues that are disclosed, I think, are part of that broader 
issue of informed consent relating to the practice of medicine. 
And so our position as the Agency is that that would not be 
something that we would consider, but it is a very important 
issue for the healthcare community to address and decide what 
is appropriate.
    Mr. Bryant. Thank you, doctor. I see my time is up and I 
would yield back.
    Mr. Upton. Mr. Burr.
    Mr. Burr. Thank you Mr. Chairman.
    Dr. Feigal, welcome. Do you regret the move from biologics 
to devices?
    Mr. Feigal. Well, I came from drugs before that, so I am 
not yet looking for my next home.
    Mr. Burr. Have you figured out which direction they are 
sending you yet?
    Mr. Feigal. No. I am enjoying myself very much, thank you.
    Mr. Burr. Let me take the opportunity to thank you. Since 
1976, I think, that we have had in the law the responsibilities 
for this area, and I think since you got there you have taken 
this in a very serious way as a safety issue and as an equity 
issue within the world of OEM and reprocessors. And I think to 
a large degree taking into account the need that hospitals have 
and for that I am very thankful. There are not too many people 
that would try to sort through this. And I realize that it is a 
process in work. But let me be real specific on some questions 
if I could.
    Now, you said that under the scheme that FDA has designed, 
that reprocessors would file a 510(k) application and they 
would have to prove that the device was safe, effective, and 
well manufacturerd. How could we expect a reprocessor to prove 
that it was well manufactured?
    Mr. Feigal. Let me start by saying that the reprocessors 
would have to file the same kind of application that the OEM 
would have to file for the same device. And so in some settings 
that would be a PMA, in some settings it would be a 510(k), and 
in still other settings where the OEM is exempt from pre-market 
application the reprocessor is exempt from a pre-market 
application. They are still required to meet all of the other 
standards, including our inspectional standards and their 
requirements for quality systems.
    The cornerstone of this is that you have processes in place 
where you identify where the hazards are to your product, and 
you identify the kind of controls that are necessary in your 
manufacturing that can address those hazards, and you do it in 
a way that you can document and quantify. You do not wait for 
them to fail and work backwards from failure analysis, but you 
work forward from the start and say there has to be integrity 
in this system, it has to be a high quality system. Certainly 
as you get failures and complaints you feed those back in and 
you see why those were missed.
    Mr. Burr. I think it is also safe to say that we would not 
design a system that would not work, right?
    Mr. Feigal. That is correct.
    Mr. Burr. And you mentioned earlier the proprietary 
information and the FDA's position on that information, and 
certainly this committee has learned in the past what happens 
when that information leaks out of the FDA, especially as it 
relates to laser surgery. Let me ask you, given the need to 
withhold so much information about the product, is it fair to 
believe that they can prove the well manufactured part, or is 
that just the wrong word?
    Mr. Feigal. Well, withhold is probably the wrong word. We 
certainly don't share the companies' information with each 
other, but we don't withhold our concerns. And we can express 
our concerns and what the issues are that they need to address 
for a product--we learn across a whole product class what the 
issues are with that product.
    And we lay those out for the manufacturers and now whether 
they are an OEM or a reprocessor, and those are the things they 
need to address. You have allowed us in the way that you have 
structured us to use all the information we have without being 
required to share or disclose it in order that we can meet that 
balance of protecting the public health but still maintaining 
the trade secrets that are useful in commerce. And so that is 
the balance that we need to do. It is a process that has to go 
device by device and model by model to look at how this is 
done.
    Mr. Burr. Who determines the single-use labeling?
    Mr. Feigal. The manufacturer.
    Mr. Burr. And in the absence of any request on their 
application, what does the FDA put on the labeling?
    Mr. Feigal. The manufacturer does the labeling. In fact, 
they have under the law the ability to actually make some 
changes in the label without even informing us. It has been our 
practice in the past if the manufacturer asked to label for 
single-use, to take that at face value and to evaluate how it 
would perform with one use.
    Mr. Burr. Under your proposal, would a reprocessor be 
required to test every device for functionality?
    Mr. Feigal. They have to think about the device they are 
dealing with and say what are the critical performance aspects 
of this device and how can I assure that every time I release 
this device it still meets those standards.
    Mr. Burr. Are original equipment manufacturers, do they 
test every device for functionality or do they batch test, do 
you know?
    Mr. Feigal. It depends on the type of testing. Some types 
of product testing are destructive and so you would not have 
any product if you tested them all. In those kinds of settings 
manufacturers typically sample. But the important thing about 
the way that the law and our regulations have constructed the 
manufacturing process for human medical products, whether it is 
a drug, biologic or device, is to emphasize the integrity of 
the manufacturing process. We emphasize the quality of the 
manufacturing process, rather than defect analysis at the end 
of the game. And we would expect that same philosophy to be 
adopted by re-manufacturers.
    Mr. Burr. When you look at reprocessors, and I put third 
party in hospitals.
    Mr. Feigal. Yes.
    Mr. Burr. Do you look at them separate? Are they different 
or are they one in the same as you wrote this regulation?
    Mr. Feigal. Our proposal is to begin treating them all the 
same. Each one that is its own business entity will have a 
separate relationship with us.
    Mr. Burr. How long does it take for 510(k) to get approval 
in the FDA on average?
    Mr. Feigal. The average is about 180 days, I believe, but 
there are types of 510(k)s that are simpler and actually are 
approved in as short as an average of 29 days. So it varies. 
But you raise an issue that we thought about, which is how this 
is going to impact our resources since the average number of 
reviewer hours to assess a 510(k) is about 55. But that's for 
all 510(k)s and they vary widely in complexity. We imagine some 
of these would be simple, others would be very complex.
    Mr. Burr. I found it a little odd that in this years budget 
there was four times as much money sought for tobacco out of 
FDA than the issue of reprocessing of devices. And I would ask 
you to share that with the Administrator when you get back that 
it was noticed. Let me just ask you, under FEDMA we created the 
ability for 510(k)s specifically to go through a third party 
approval process. Do you see this as an appropriate area for 
the trial of third party approval?
    Mr. Feigal. The way that we constructed the third party 
system was to establish standards so that both the third party 
and the applicant would know what the review criteria were. And 
I think certainly that in some of the areas of very commonly 
used devices this could potentially work very well with third 
party. We are very committed to expanding that program. We have 
actually put specific proposals in this year's budget to expand 
that program and whether it is expanded in the way that is 
proposed in the budget or not, we are committed to seeing that 
program succeed. It is one of the ways in which we can expand 
our scope without always doing it with Federal workers.
    Mr. Burr. Last question, Mr. Chairman. You have been there 
a limited amount of time, I realize that. But in your research 
of this issue, which is not new, did any point did reprocessors 
come to the FDA seeking guidance or seeking the process that 
the FDA expected them to follow?
    Mr. Feigal. We have met with the reprocessors, and the 
reprocessors actually have asked us for letters clarifying----
    Mr. Burr. But prior to your passion for this issue, do the 
records show that at any point that this industry----
    Mr. Feigal. Yes.
    Mr. Burr. [continuing] be it hospitals or be it third party 
reprocessors, look to the FDA for the guidance for the 
procedures or to set up the procedures?
    Mr. Feigal. Yes. That did occur, and many of the efforts 
actually predated me. You have been kind to attribute as much 
progress to my getting there as you have.
    Mr. Burr. I thank you for your willingness. I yield back.
    Mr. Upton. I would just like to note that we will proceed 
with Mr. Barton and we will take a brief recess for folks to 
vote. Mr. Burr is going to be asked to come back and chair 
while I vote and after that we will proceed with the other 
members that are here. Mr. Barton.
    Mr. Barton. Thank you. Mr. Chairman is this 5 minute or 2 
minute questions?
    Mr. Upton. You get 5 minutes, and if you want more time we 
can have another round.
    Mr. Barton. No, sir, I can comply with it. I want to ask 
unanimous consent that my opening statement----
    Mr. Upton. It. That has already been done.
    Mr. Barton. Thank you. Doctor, we are glad to have you. I 
am going to be very quick because we have a vote on. The first 
question I have is there any reason not to treat all 
manufacturers and reprocessors the same?
    Mr. Feigal. No. And that is why the approach that we 
proposed just this week in our guidance really does take that 
philosophy.
    Mr. Barton. Okay. And on the informed consent issue, is 
there any reason not to require informed consent for a device 
that is going to be reused? Why would we not do that 
permanently?
    Mr. Feigal. I think that that is a good question, but I 
don't think it is an FDA question in the same way that we don't 
specify the informed consent for putting in a hip implant or 
other types of things. These are the kinds of informed consent 
that are done in the practice of medicine and I think it is 
important to get some consensus on whether this is one of those 
things, like the examination of a child or surgery where 
informed consent is routinely used. But it is not something I 
think that is part of FDA's purview.
    Mr. Barton. If we want to give some Congressional guidance, 
the FDA would not object if we had some truth in advertising 
requirements so to speak that informed consent should be 
allowed? If I go buy a car I want to know if it has been pre-
owned, you know, whatever I purchase I would like to know 
whether it is brand new or somebody else has owned it. I mean, 
I would think if you are going to put something in my body I 
have a right to know that it may have been in somebody else's 
body.
    Mr. Feigal. Yes. One thing to consider is that part of our 
approach is to assure that the reused device will perform as 
well as the original device. And I think that needs to be part 
of the debate about the role of informed consent. And then 
beyond that there is the issue, if informed consent is needed, 
do you try and do that with labeling on the packaging or 
exactly what is the mechanism for that? But I think our 
fundamental start was we shouldn't be in a position where 
someone has to be informed that we are using a device on you 
that may not be very good.
    Mr. Barton. Right.
    Mr. Feigal. We think the quality of the device is the 
fundamental issue, and then it makes the informed consent less 
of an issue.
    Mr. Barton. Well, I have read your testimony on page 11 as 
you go through the process of looking at your existing 
proposal. You have a list of five steps here, or four steps. 
The only question I have, what kind of procedure do you have in 
place for interested parties and stakeholders to interface with 
the FDA?
    Mr. Feigal. We have a comment period open now on the two 
guidances that identify a list and give our proposal for risk 
scheme and for an enforcement time table. And those policies 
will not be made final until we have had that input. We also 
have had public meetings. There have been three or four in the 
last year and workshops, and there are ways to address us 
through our Web pages, through other types of things.
    Mr. Barton. Now, we assume that you are going to have an 
open process, that if you are a remanufacturer, an original 
equipment manufacturer, or an advocacy group or hospital group, 
you can have an honest dialog with the FDA and the FDA will 
listen?
    Mr. Feigal. Absolutely.
    Mr. Barton. Okay. Mr. Chairman, that concludes my 
questions. I appreciate you holding this hearing and I will 
follow it very closely and work with the chairman and other 
interested parties on this issue.
    Mr. Upton. I know that you will. But we will take a brief 
adjournment. Mr. Burr will vote, come back. We will start with 
the members that have not asked questions and proceed from 
there. So it will probably be about 10 minutes.
    [Brief recess.]
    Mr. Burr [presiding]. If I could call the hearing back to 
order and ask Dr. Feigal to return to the table. I actually 
thought they would finish with you before that break. As is 
tradition here, that means that other members will have 
additional questions, so I can't swear to you this is the last, 
but the Chair would recognize Ms. Eshoo for 5 minutes of 
questions.
    Ms. Eshoo. Thank you Mr. Chairman. I have several questions 
as you might guess, Dr. Feigal. What I want to do is to read 
the questions first. My experience is I ask the first question, 
most of the time is used up and then we never get to the 
others. So, it is going to be up to you to divide the time 
judicially so that you can answer them all. First of all, thank 
you for your testimony today. I just have a couple of 
observations. One, in how we use the words single-use. I think 
it is a real contradiction to be talking about the reuse of 
single-use. If we are going to be talking about the reuse of 
medical devices we should just say so. And we should establish 
a national policy that guarantees patients across the country 
that they are indeed safe. But to continue to use this reuse of 
single-use, I really do find it to be a contradiction.
    Second, most of your testimony, and I think that it was 
excellent. You have been very direct, honest. You are a 
wonderful professional, and I am proud that you are in public 
service. Most of your testimony has really been directed toward 
what the FDA hopes to do--with your proposed guidelines. I want 
to remind members of the committee that that is not in place. 
There is not the kind of system that has been eluded to or 
spoken to during this hearing. So here are my questions.
    FDA has an approval process today for medical devices, and 
you know that I have a lot of experience in that, having 
launched from the Democratic side with Joe Barton on the 
Republican side the reforms that we brought about, as well as 
many members of the committee on this issue. So you have a 
process for medical devices that is in place today. The PMAs, 
the 510(k)s, and it goes along the lines of risk. In your 
proposal do you bring the same consistent policies for the 
reuse of medical devices? Do your proposals contain that?
    Would the FDA oppose, would you come out against the issues 
of tracking and consent? I know that you have commented on 
them, but I would like to know if the FDA would oppose those--
if those directives came from the Congress. Of course, those 
are two issues that are in the Bill that I have introduced. Is 
the Federal Government actually paying first rate medical 
device prices or reused products? Is Medicare reimbursing for 
that? And if so, would FDA have any voice in this or do you 
plan to? And can you tell us how many times a ``single use'' 
device, has actually been reused?
    And what exactly is FDA's oversight today for reused 
products? I am very pleased that 2 days before the hearing you 
have come out with your proposed policies. I would like to 
think that maybe my legislation has spurred FDA to really take 
this issue, not only seriously, but to take action on it. So, 
if you could address yourself to those. If you do not finish 
answering them, hopefully you can, you know, get the written 
answers back to us. And I also, Mr. Chairman, in my opening 
statement I made reference to a letter that the FDA wrote and 
asked that there be unanimous consent that that be entered into 
the record, and I would like that. We didn't do that----
    Mr. Burr. Without permission, of course.
    Ms. Eshoo. Thank you. Okay. He doesn't know what I asked 
for, does he? Okay. No, he does. I'm teasing. Thank you.
    Mr. Feigal. Well, thank you for your questions. And we 
actually appreciate your interest in this area and look forward 
to working with you, and looking at your proposals and seeing 
how they fit in the area. I began my testimony by asserting 
that we felt we had the authority. We didn't want any confusion 
out there that we needed new legislation before we acted, and 
that we can act within our existing authorities. And part of 
the reason that we are doing this with guidance rather than 
regulations is that we feel our regulations have the authority 
for us to do this. Part of the reason for a staged approach is 
because this process should not be brought to a screeching halt 
with supply problems, disruption of patterns. There are people 
on both sides of this issue, as you will hear today, that we 
wanted to engage.
    One of your fundamental questions is, will we treat 
everybody the same? We will. That is one of the basic issues. 
One of the things I think underlies some of the questions is 
that, in the past, when we classified a device we really did 
not pay much attention to whether it was single-use or multiple 
use. One of the things we will have to address is whether 
single-use and multiple use of the same device actually might 
in some cases even have different classifications one might be 
exempt but by reusing it you have changed the safety profile. 
And so I think there are some issues there, but our approach to 
that would be to say, what applies to the reprocessor applies 
to the OEMs. If it is an issue for the reprocessors, then it is 
also an issue for the OEMs.
    Ms. Eshoo. I didn't hear that in your discussion of the 
proposals, but if they are going to be equal, than I think that 
that's a big step.
    Mr. Feigal. On the consent, I think we don't view that as 
our responsibility for this type of consent, and it probably 
wouldn't be most effectively implemented through a change in 
labeling.
    Ms. Eshoo. But would you oppose it, that is what I asked.
    Mr. Feigal. I personally would not oppose it.
    Ms. Eshoo. Okay. I'm not talking about personal. This is 
all public.
    Mr. Feigal. Well, when I say speak personally, I mean my 
part of the Agency. We could give you a more thoughtful answer 
about what we see are the pros and cons to this type of 
approach. I think the issue relates more to a device which is 
being cleaned and reused again and again, whether that is the 
element of consent. In which case it would apply more broadly 
than if the issue is simply that someone wanted to use a 
disposed of device as their starting material to craft a new 
device with an application for it to be used again. Your 
questions about payment are questions you need to ask HCFA----
    Ms. Eshoo. Tracking?
    Mr. Feigal. [continuing] ask HCFA and others.
    Ms. Eshoo. Tracking?
    Mr. Feigal. Oh, and tracking.
    Ms. Eshoo. I keep track, see.
    Mr. Feigal. Yes. You do. That is good. That is the third 
time. We have tracking authority in a different context for 
products. We do not apply it to all products. Not even all high 
risk products. I think again if this is an approach that would 
increase the safety and would be the best way to make a product 
safe and effective, then it would be appropriate to use it. 
Whether it would be the approach for all devices, I do not 
think would be the case. I think there are probably some 
disposables that would not need to be tracked, you would just 
need to look at what has happened to them as they were being 
cleaned.
    Ms. Eshoo. Uh-huh.
    Mr. Feigal. The issue about the tracking and putting 
information into patient's medical records, that is a practice 
that is commonly done with implantable devices. They are an 
example of a product area where it is common for manufacturers 
to have a peal-off label that goes on the chart. Sometimes even 
the patient gets a card if they are being tracked. So there is 
precedent for this. I think what I would do is say let us take 
a look at the kinds of products where this makes the most sense 
and where it adds something. It is more cumbersome than some of 
the other mechanisms. Getting hold of the right chart that has 
the label in it is not totally straightforward in our medical 
system. And so I think we need to make the solution fit the 
problem. But it is something that has been done. It is 
something that we should talk about more.
    Your one last question is, do we have a Guinness Book of 
World Records for the single-use device that has been used the 
most times. And probably not. I would suspect it is probably an 
anesthesia circuit somewhere that has been cleaned and cleaned 
again. The real challenge, even for the people who clean these 
things, is that there is no marking on the products themselves 
to indicate that they were a disposable device for the vast 
majority of these devices. And many of them look identical to 
the reusable devices, and I think that is another issue that I 
mentioned before that we need to deal with.
    Ms. Eshoo. And what exactly is FDA's oversight today? How 
does it work? What do you actually do?
    Mr. Feigal. Well, I am not sure I understand the question. 
In terms of rolling out this framework?
    Ms. Eshoo. No. I am not talking about----
    Mr. Feigal. Or in terms of our oversight?
    Ms. Eshoo. I am talking about today.
    Mr. Feigal. Yes.
    Ms. Eshoo. What is your oversight with the reuse of 
manufacturer's----
    Mr. Feigal. Okay. What we have done today is that we are 
actively inspecting and looking at the manufacturing practices 
of the reprocessors of----
    Ms. Eshoo. Since the late 1970's, what has the FDA's 
practice been?
    Mr. Feigal. Well, in the late 1970's FDA wrote a letter 
strongly discouraging the practice and telling the hospitals 
that they accepted complete liability if they did this. Then 
there was a long time period where this issue really did not 
get very much attention, and I think the assumption was that 
not very much of that was going on. It has really only been in 
the last year that there has been more attention to this. Some 
of that has been economic and there have been attempts to focus 
on the ethics of doing this. Some of this has been because of 
patient's insurance. Some of this has been because of reports 
of injuries. Our approach is to investigate the reports of 
injuries, to contact the reprocessors. Some of them, when we 
first contacted them didn't think they were manufacturers. We 
have let them know that they are.
    Ms. Eshoo. But who do you react to? Your oversight is 
essentially reacting or responding to something that is----
    Mr. Feigal. Not entirely. But it is appropriate for us to 
be reactive when we get a report of an injury or of a problem.
    Ms. Eshoo. No. I am not suggesting that it isn't.
    Mr. Feigal. Yes.
    Ms. Eshoo. But if that is your oversight----
    Mr. Feigal. No. No. It's not.
    Ms. Eshoo. [continuing] I think the committee needs to----
    Mr. Feigal. We are also being proactive. We have sought 
out, for example, detailed lists of who is remanufacturing. For 
example, we have identified the companies who specialize in 
cleaning Sharps containers, which come in both single-use 
disposable and reusable varieties, and to inspect those and 
look at those patterns in a very, very narrow area. But we have 
not just been reactive. We have proactively sought feedback on 
the approach, on how to prioritize, how we begin with this 
problem, and we haven't waited to go out and inspect. We have 
gone out and actively engaged these companies.
    Ms. Eshoo. So, you only inspect those places where items 
are reprocessed or the devices are reprocessed? The devices 
themselves or?
    Mr. Feigal. Our normal inspection process is to, in fact, 
regulate the manufacturer who produces it and not to inspect 
devices.
    Ms. Eshoo. I think this is a very important distinction 
though to many members to hear.
    Mr. Feigal. Well, this is also true for original equipment 
manufacturers. We do not inspect their devices. Now there are 
cases where the device fails, where we actually bring the 
device into our laboratories and work with it. In fact, if 
there had not been so many samples brought by members of the 
committee I would have passed out my own. And we do work with 
the devices themselves in a hands on sort of way. But the 
fundamental way that the law is written to regulate devices, as 
you know, is to really ensure the integrity of the 
manufacturing process. We go in and look at the company's 
quality systems and the way that they have dealt with the 
problems that have been reported to them. And that is our 
fundamental way of addresing the problem. This occurs more 
often where there has been a specific problem with a type of 
product and we have been asked to look into it.
    Ms. Eshoo. Can I ask the indulgence of the chairman to ask 
one more question?
    Mr. Burr. Okay. One more.
    Ms. Eshoo. One more?
    Mr. Burr. We are going to have another round, I just want 
to--for those members with additional questions.
    Ms. Eshoo. Is there a problem inside the FDA relative to 
resources in order to wrap up this policy you may need more 
people to implement it, is there, you know, to ask this 
publicly may not be all that comfortable for you. But I have 
found with Federal agencies that at least sometimes they are 
reluctant to take on more responsibility, because as they carry 
out what they are directed to do, they know that there is going 
to be a strain of resources, and in my view there already is a 
strain at the FDA, given the very important legislation, I 
think needed legislation we passed relative to, you know, the 
reform on medical devices in another areas that you have 
jurisdiction over.
    So have you undergone or undertaken any kind of analysis of 
your proposals and what that would call for monetarily inside 
the Agency that you can tell us about? Because I do not want 
one to get in front in the way of the other. I think that 
public policy has to take precedence here, and then it is up to 
the Congress to deal with what you may come forward with and 
say we need more to implement this. We have done it in other 
instances, we have risen to that occasion I think pretty 
fairly, and I think we have the capacity to do so again. But 
can you just touch on this?
    Mr. Feigal. Sure. If you look at the current budget 
proposal that the President announced you will not see a 
specific request for reprocessing in this years budget. That is 
for two reasons. The most practical one is that with the long 
budget cycle, that budget was prepared about 18 months ago. And 
the activities have significantly evolved only in the last 
year.
    Ms. Eshoo. Well, I was calling and writing in December, in 
the beginning of January, so I do not necessarily agree with 
that, but go ahead.
    Mr. Feigal. In our appropriation language last year there 
was language that we should spend at least $1 million on the 
issue of reprocessing in this year. That was not difficult for 
us to agree with because our effort, even last year, was 
approximately that magnitude and this year it is somewhat 
larger than that. One of the things that makes it difficult for 
us to plan is that we do not know how many hospitals are going 
to decide to file pre-market applications. We do not know how 
many places are going to register and list and need to be 
inspected.
    At this point because our change in the policy is so 
recent, there are not the kind of resources that we need. It 
has mostly been in the area of policy development, research, 
and other areas. And we have the capacity to turn and focus on 
an issue and not wait for a funding cycle to catch up to a 
public health program. One of the natures of FDA in general is 
that we are asked to prioritize risks and act on them. And 
there have been decisions that have been made in the past where 
this one, quite frankly, did not rise to the top of the list 
and other things, such as reducing backlogs to get products to 
market more quickly, implementing FDAMA and other things got 
more attention. But as the committee is aware within the last 
year there has been much more intense interest in this and we 
have turned our resources to this problem now. We do not, yet, 
have a proposal of where this is going. I think we need to hear 
more from the effected parties, what their reaction is going to 
be, to have an idea of the scale of what we will need. And as 
we need resources we will request them.
    Ms. Eshoo. Thank you. Thank you Mr. Chairman.
    Mr. Upton. You are welcome.
    Mr. Pickering?
    Mr. Pickering. Mr. Chairman, thank you.
    Dr. Feigal, if a device is FDA approved for single-use, why 
is it possible to reuse these devices?
    Mr. Feigal. Well, the simplest way to explain that is that 
there is nothing that is illegal about using a pre-existing 
device as a starting material for a new device. In fact, there 
is sort of a misconception that the remanufacturer is trying to 
restore something identical to what the original manufacturer 
produced. That is not the requirement. The requirement is that 
they produce a device that is well manufactured, safe and 
effective for its intended use, and that they show us that they 
can do that. And the difference is that they are using a used 
device, they are using the components of the used device as a 
starting material.
    And if you look at refurbishers, particularly of more 
complex materials, that is not even the case that they use the 
entire device. They may just salvage part of it. And so this is 
something that is common, I think, throughout many industries 
and so long as the device is well made, safe, and effective, 
there is nothing in the law that precludes someone from doing 
that, despite the fact that the manufacturer wanted it thrown 
away after the first use.
    Mr. Pickering. Yes. But does the FDA need to clarify their 
approval description? If it is FDA approved for single-use, but 
you are saying that it is legitimate for multiple use, should 
you change your labeling?
    Mr. Feigal. Well, the manufacturer brings the labeling to 
us and then we determine whether or not the product will be 
safe and effective as labeled. One of the complexities of the 
device laws is what FDA approval means. In some cases, such as 
a PMA, it is an evaluation of whether or not the product is 
safe and effective for use. But more often the standard is that 
the device is substantially equivalent to another device that 
is legally marketed. And within that framework some of those 
devices are exempt from pre-market applications and only are 
required to have registration and listing--actually I shouldn't 
say only.
    It is actually a relatively long list of things that they 
are required to do. But that is one of the complexities for the 
public to understand. The way that the device laws have been 
written is that there are a variety of standards depending on 
the type of the device. The underlying principle that we are 
trying to apply to this situation is to say that there should 
be no distinction between the OEMs and the reprocessors. If you 
are manufacturing a device from another device, that should 
have the same standards as if you are manufacturing a device 
from first components, you know, from scratch.
    Mr. Pickering. Now, do you give any guidelines for 
hospitals who may have a device that is open but unused and 
then they take precautionary steps to make sure that it is 
clean and sanitary? Are you looking at any----
    Mr. Feigal. Those types of instructions and the testing and 
the adequacy, that is provided by the manufacturer. It is part 
of the instructions for use. We evaluate the adequacy of those 
instructions and that is a very common phenomenon. In fact, it 
lead to some of the confusion when we put together some of the 
initial lists, about commonly reused devices. Very many of them 
on the list were things that were simply being opened in the 
operating room and then being repackaged and sterilized for 
another day.
    Mr. Pickering. And you have no problem with that? You don't 
see a problem?
    Mr. Feigal. It has to be done with attention to detail and 
that is what the manufacturers have to assert to us that they 
know how to do. So, for example, if you are reprocessing suture 
material, for example, you have to know that the way that you 
are going to repackage and sterilize that does not damage even 
the packaging which could breach the sterility of those 
sutures. But again, the manufacturers have worked with the 
hospitals because they have a need to do that. If we wanted to 
replace your hip today, in the operating room they would open 
and have available for the surgeon several different closely 
related sizes, because they would not be able to know in 
advance which one would fit you. And rather than charge you for 
all three sizes if they opened them up, they would use the one 
that fit and then they would take the others back and re-
sterilize them and use them again. And we think this is a 
legitimate practice. It is one where the manufacturers work 
with the hospitals to provide instructions on how to do this. 
It is a different problem, I think, than the reuse of an 
already used single-use device.
    Mr. Pickering. Now in that context, has FDA reviewed the 
cleaning processes utilized in the reprocessing of medical 
devices, and if you have reviewed it, are you confident that 
the processes used are effective and safe?
    Mr. Feigal. Our first approach to this is to say that the 
cleaning and the re-sterilization and the refurbishing is 
device and model specific. So there is not a single standard or 
answer. Now, that said, there has been tremendous interest in 
the device manufacturing community and in the FDA to approve 
standards for things that are commonly done so that they do not 
have to be reinvented for every model and every device. And so 
that is one of the areas where we will be working with the 
people who do the cleaning to look at those standards. These 
are the same issues for reusable devices, and the majority of 
devices are reusable. And these kinds of issues are not new to 
us. The hospitals have been using the procedures on single-use 
devices that they have already found to work effectively for 
reusable devices.
    Mr. Pickering. And when do you plan to issue further 
guidelines on the cleaning process?
    Mr. Feigal. Well, the burden is actually on the 
manufacturers, on the hospitals, and the refurbishers to 
actually show to us that they have cleaning processes that are 
adequate. That is their burden to demonstrate in the 
application process, just like it is for an OEM who claims that 
they have a device that can be cleaned. The OEM has to show us 
the evidence that validates that their process can clean.
    Mr. Pickering. So, if the burden is on them, do they have 
to demonstrate that before they can reuse?
    Mr. Feigal. That is correct. As we roll out the enforcement 
strategy what we are saying is that these products, as we get 
to them in order of risk, the single-use product should no 
longer be cleaned until they have met the same application 
processes that would be required of an OEM.
    Mr. Pickering. Now, has FDA taken a position on what is the 
recommended life cycle for reprocessing of single-use devices?
    Mr. Feigal. Again, there would not be a single answer to 
that. It would vary on the device and on the model, and that is 
something to be determined by empiric data. There would not be 
a single answer for that.
    Mr. Pickering. And what empiric data do you have?
    Mr. Feigal. Well, the data has to come from the 
manufacturer. They are the ones that are claiming that they can 
take this single-use device and put it back into use and have 
it be used effectively. So, they need to develop the data in 
their application to us to show us that they can do that.
    Mr. Pickering. Are you telling the committee today that 
until that data is provided, that burden of proof is met, that 
the current practice of multiple use will not be allowed on a 
going forward basis?
    Mr. Feigal. That is the guidance. The guidance gives the 
timeframe for the types of devices and when the applications 
would be needed for those devices. And if those devices remain 
on the market, that is what our second guidance about the 
compliance timeframe is all about. We are asking in the 
simplest terms that the reprocessors provide the same kind of 
information that the manufacturers provide when they bring to 
market a multiple use device.
    Mr. Pickering. Mr. Chairman, I hope you forgive me for just 
a couple more questions. Now, there are three issues basically 
here. There is public health, public confidence, and in that 
confidence the right to know. Earlier this week I sent a letter 
to the FDA, what is the FDA's position on allowing patients to 
know if there is a device that is being reused, is there a 
simple way to provide that information to patients without some 
type of complex regulatory process and burden upon the 
providers and the doctors?
    Mr. Feigal. The issues you bring up are intertwined. On the 
one hand there is safe and effective use, and there are times 
when for a patient to really make a choice, they need to 
actually know what they are getting. And so there are cases, 
there are products, where the information that the patient is 
provided is explicitly provided in the product labeling, 
considered inherent in the safe and effective use of the 
product. There are other issues about what should your doctor 
tell you when they do surgery.
    Should they tell you the make and model of the machine? 
Should they tell you how long they have owned it? Should they 
tell you the last time it was repaired? Many of those things, I 
think, relate much more to what society feels is appropriate to 
know to be able to be medical consumers, and relate less to the 
product labeling responsibilities assigned to the FDA. I think 
where we would be enthusiastic about being involved is where 
the patient's consent is necessary for the safe and effective 
use of the product. So we would be happy to continue to 
participate in these discussions, but I think we would 
encourage you to really broaden the discussion to involve the 
medical practice community and others who really need to 
implement this. If it is something that is buried in the fine 
print on the product labels, which are usually attached to 
packaging which is thrown away when the package is opened, that 
is not going to do the patient much good. If it is the advice 
of Congress, if it is the demand of the public to know about 
these things, then you have to change the practice patterns of 
the physicians that provide informed consent for procedures.
    Mr. Pickering. Is the FDA planning to post that type of 
possible information as to possible risk of reuse or proper 
standards for reuse to create the public confidence and the 
public knowledge?
    Mr. Feigal. We have a Web site that is very actively used. 
It is mostly used by industry. But we do have consumer parts of 
it and there are some consumer products that generate a lot of 
interest in our Web sites. We are more than happy to spell out 
in consumer's terms the issues of these debates and our 
approaches and translate some of the regulatory language of our 
guidance for industry so that consumers can see our vantage 
point on this. I think that some of the broader issues about 
informed consent are things that involve other professional 
groups, so we would not be the only source, but we are 
certainly welcome to be a source.
    Mr. Pickering. Mr. Chairman, just one final question.
    Mr. Upton. I've heard that today.
    Mr. Pickering. And I guess this gets down to the crux of 
the issue. As I talked to a friend of mine who is a 
cardiologist, who actually takes a persons heart into his hands 
and uses many of these devices, he feels confident that they 
are safe and feels confident in his use of them. In talking 
with the manufacturers concerns are raised. Is this, in your 
opinion, driven by true health and safety concern and risk or 
is this more of an economic and cost and competitive issue 
among manufacturers?
    Mr. Feigal. Well, for the hospitals and the manufacturers 
and the physicians who are involved with this, I think the 
economics is a fact of life. It is actually not a factor that 
you have asked FDA to consider when we make approvals or take 
regulatory actions. And so we are bystanders on the economic 
issue. I think it is not an ``either/or'' question. It is both 
an economic and practice of medicine issue, and an issue that 
affects the safety and effectiveness of these products. You 
mentioned there needs to be confidence that products are well 
manufactured and will perform as expected, even if there is not 
a major safety problem. And that is actually in our minds the 
most common problem with reusables, the integrity of the 
manufacturing, not the explicit risk or safety to the patient.
    Mr. Pickering. Thank you Dr. Feigal. Thank you Mr. 
Chairman.
    Mr. Upton. Thank you. We are going to go to a second round. 
A couple of us have a couple of questions remaining. And I 
wanted to say to start off, too, Dr. Feigal, by thanking you 
for allowing a member of your staff to stay for the second 
panel and thus being able to address additional questions that 
we may have based on that panel. A couple of things. Not 
counting hospitals that might reprocess something on their own, 
do we know how many reprocessors there are across the country?
    Mr. Feigal. Yes. We probably do. I think we probably have 
identified the majority of them. We still get referrals. 
Sometimes if we visit one reprocessor he will be aware that we 
have not visited one of their competitors and they may add to 
our lists sometimes. But I think we actually do have pretty 
good knowledge. In fact, there are even reprocessors that have 
filed 510(k)s with us. So it is not that we are, you know, 
starting cold.
    Mr. Upton. What happens on liability on one of the devices 
or instruments or whatever it may be, that may fail or perhaps 
has been reprocessed? Historically what has been the case? Do 
they go after the OEM? Do they go after the reprocessor? Do 
they go after both? Have there been cases that have been used?
    Mr. Feigal. You are asking something that is really outside 
of FDA's expertise. We are actually only aware of a limited 
number of actions that relate to reuse. I think one of the 
difficulties for patients who think they have been injured by a 
device is that it is very difficult for them to identify 
whether the device was reused or not. Some times their 
physicians may not know because the devices look the same and 
they do not know if they are dealing with something that has 
been opened and re-sterilized, or if it has been reused before, 
or if it is brand new. So I think the whole scope of that we do 
not really know.
    Mr. Upton. Well, as we know in the physician data bank when 
there has been a judgment issued against a physician, that 
record is kept and available to hospitals and other providers. 
Is there such a log for devices that may fail or not?
    Mr. Feigal. Not in terms of liability. Actually our 
interests are broader than that. I am really out of my element 
talking about law, but I will try a little bit. Liability in 
medical malpractice relies on establishing negligence. We are 
interested in things that fail, whether there was negligence 
involved or not. So, manufacturers are required to report to us 
device failures that they know about. The voluntary system by 
health providers has tremendous under reporting. But if a 
manufacturer knows about something they have to tell us. When 
we inspect them, we look at their records. So we think that if 
the manufacturer knows about a device failure, whether it is 
going to be involved in a suit or not, we know about it. We are 
able to get those kinds of statistics.
    Mr. Upton. Would that same standard that is on the 
manufacturers then be under the regulations you have proposed 
be followed for the reprocessors as well or not?
    Mr. Feigal. Yes. The principle underlying all of this is 
that the same requirements would be applied.
    Mr. Upton. So, if this is reprocessed and it fails----
    Mr. Feigal. Right.
    Mr. Upton. [continuing] the reprocessor would have to file 
with you all----
    Mr. Feigal. That is right.
    Mr. Upton. [continuing] if your regulations are made in 
order?
    Mr. Feigal. That is right. Even if the reprocessor is a 
hospital.
    Mr. Upton. Right.
    Mr. Feigal. They would then have the kinds of mandatory 
responsibilities and if they have asserted to us, in an 
application that they know how to reprocess those, we would 
treat them like any other manufacturer.
    Mr. Upton. Good. Now, reading through your testimony that 
we received last night, I think that the answer to this is yes. 
Is the reprocessing of medical devices labeled for single-use 
without pre-market submissions a violation of the Food, Drug, 
and Cosmetic Act? It is a violation, is that not true? They 
just have not been enforced until these regulations are in 
place, is that right?
    Mr. Feigal. It would be a violation of the Act if the 
labeling of the product was false and misleading, or if the 
manufacturer was placing into commerce a product that did not 
have marketing clearance or marketing approval. That is why we 
say we do not need new authority. We already have the authority 
to require these.
    Mr. Upton. Great. And last as my light is going to light 
now, Mr. Stupak had to testify before another subcommittee and 
he will be back, but he asked me to ask you for him: please 
discuss exempt devices and how they are dealt with under the 
guidance for reprocessing.
    Mr. Feigal. Okay. Well, an exempt device is only exempt 
submitting a 510(k) application. They are not exempt from any 
of the other standards that establish the quality of devices: 
registration and listing, the device failure reporting, special 
controls, being subject to inspection. For exempt devices we 
have said the OEMs can manufacture and not get pre-market 
clearance. Our proposal says that those who remanufacture those 
products would also be exempt from the pre-market clearance. 
But that is all that they are exempt from.
    Now, someone might make the case that in fact the 
classification is not correct when you begin reusing certain 
types of devices. We have devices that are both single use and 
multiple use and in almost all cases they are in the same 
classification. In fact, I do not know of an exception. One of 
the things in this process of comment we will be looking at is, 
should that be the case, or are there cases where it is 
appropriate to exempt only the disposable product. If that is 
the case, that would apply as much to the OEMs as the 
reprocessor because we want the same standard of quality no 
matter who makes it.
    Mr. Upton. Thank you. Mr. Burr.
    Mr. Burr. Dr. Feigal, Med-Watch is an FDA voluntary program 
primarily for drugs.
    Mr. Feigal. Yes.
    Mr. Burr. It includes devices as well, doesn't it?
    Mr. Feigal. It includes devices, yes.
    Mr. Burr. Did I just hear you earlier to say voluntary 
programs do not work?
    Mr. Feigal. No. They have under reporting for a variety of 
reasons, and it is true in almost every country that uses them. 
But the under reporting does not mean that we do not get 
signals that are very useful to us to identify the problems. 
What the programs that are voluntary do not do is give us good 
numerators and denominators. So it is very hard for us to 
tell----
    Mr. Burr. So, are you an advocate of a continuation of Med-
Watch in its current form or would you be a proponent to change 
to a system that was more reliable on the indicator?
    Mr. Feigal. Well, I think Med-Watch in its current form is 
very useful and has identified problems with products that have 
resulted in actions.
    Mr. Burr. Is that for devices, or devices and drugs?
    Mr. Feigal. Devices and drugs.
    Mr. Burr. Let me ask you if I could. Do you believe that 
the legislation that guides FDA requires FDA to make sure that 
proper labeling follows specific products?
    Mr. Feigal. I'm sorry. Could you say that again?
    Mr. Burr. Do you believe that the legislation that guides 
FDA's work in fact requires FDA to make sure that proper 
labeling is assigned to all products?
    Mr. Feigal. Yes. Yes.
    Mr. Burr. Give me FDA's reason for allowing single-use 
devices to be reused and why as you as the head of the device 
area would spend so much time trying to figure out a process 
for single-use devices to be reused, given that one of the 
primary roles of the FDA is to make sure that the labeling is 
an accurate description of the use of the product?
    Mr. Feigal. Now, one of the fundamental questions is, if I 
own the device can't I do anything I want with it? That is sort 
of the off label drug question rephrased for devices. If I own 
that device I can't clean it and fix it up a little bit and use 
it again? I am now the owner. And our response is, the practice 
that has grown up in hospitals, and certainly third parties, of 
taking devices and trying to refurbish them, has actually 
turned them into, not owners of the device, but manufacturers. 
And that that is the reason that they now have to describe the 
integrity with which the device is manufactured and develop 
appropriate labeling, and adhere to the same regulations as any 
other manufacturer. Part of the reason that this process may 
look so tortuous is that we are aware that this is a process 
that probably cannot be stopped overnight, and that is probably 
a comment that you will hear debated by your next panel.
    Mr. Burr. But you would not consider that the labeling of a 
single-use device that could pass the test of reuse was 
mislabeled? You said in your opening statement, if I remember 
correctly.
    Mr. Feigal. Yes.
    Mr. Burr. Correct me if I am wrong, that many of the 
single-use devices today are configured in the same way with 
the same components as the multi use devices prior.
    Mr. Feigal. Yes.
    Mr. Burr. What, in your mind, distinguishes the difference 
between the multi use status that FDA agreed to and the single-
use status that FDA agreed to after the application was 
changed?
    Mr. Feigal. We evaluate the claims in the label from a 
specific manufacturer for a specific product and see if they 
have the evidence to support the claims. When it is re-
manufactured, actually the manufacturer changes. We are no 
longer dealing with the OEM and his label.
    Mr. Burr. Is it your interpretation then that liability 
would not extend back to the original equipment manufacturer, 
given that your----
    Mr. Feigal. I am not the person to ask about tort issues.
    Mr. Burr. But I am sure that the FDA has looked at that, 
haven't they?
    Mr. Feigal. Well, and actually liability is----
    Mr. Burr. I think there are some lawyers over there if I am 
not mistaken.
    Mr. Feigal. There are lawyers around here, but they are not 
tort lawyers. They write regulations and things like that. But 
I think this is definitely an issue you have identified for the 
community that reuses devices. I do not think it is really much 
of a factor in consideration of our work.
    Mr. Burr. What is the definition of FDA of an already used 
device?
    Mr. Feigal. That is a very good question because the 
variations that we have discussed of open but unused and any 
used device----
    Mr. Burr. If history is any indication there will be 
another director at some point in the future at FDA of the 
device area. What does the FDA have in place to guide them as 
far as this definition so that when they come in their 
interpretation is not an unsterile device that was in the OR in 
case it was needed.
    Mr. Feigal. Right. Well, I think the first principle in FDA 
labeling is that you should say what you know. And the original 
manufacturer said that this is a single-use device. It is their 
responsibility to define when the device has been used so it is 
not used again. So does that mean, for example, in the 
operating room when someone may have, with their glove on, 
handled a couple of different hip pins to pick the right one 
out, that is now a used hip pin or is that still in the open-
but-unused category which----
    Mr. Burr. Would it also be the original equipment 
manufacturer's responsibility when they file the initial filing 
to tell you if this could be reprocessed it could be used this 
many times based upon our clinical studies?
    Mr. Feigal. Yes. The type of use that they envision and the 
type of use that they are claiming is safe and effective has to 
be described. And actually we discuss these issues in the 
guidance that we have just released.
    Mr. Burr. And should the original manufacturer and FDA 
supply guidance to the reprocessors as it relates to the 
reprocessing of the device or sterilization?
    Mr. Feigal. Our stance is that the reprocessor is a new 
manufacturer and so there might be a business relationship 
between two manufacturers, but it is not required. The 
reprocessor is someone who is taking a disposed of device as 
their starting material and saying, ``I can build a safe and 
effective and well manufactured device out of this.'' And so it 
is not the OEM's responsibility to tell the reprocessor how to 
do this. If there are things which damage these delicate 
devices that are commonly encountered in hospitals, it is a 
little bit disingenuous for the OEMs to act like these things 
will never happen. What if something was opened-but-unused and 
the product is damaged by ethylene oxide? That normally would 
be used in the setting of remanufacturing but, you know, we 
would like to have some dialog with the OEMs about when is it 
appropriate for them to disclose that information in their 
labels.
    Mr. Burr. Well, I would--again, I commend you for your 
willingness to jump into what is a very, very difficult thing 
to figure out what the right balance is. I would encourage you 
to work with the OEM manufacturers, the reprocessors, the 
hospitals, to work out some of the areas that you pointed out 
are good questions. Because clearly I think we are going to 
continue to think of some questions that we have not thought of 
and I would encourage you also to focus on the future 
interpretation of others by what action you take and possibly 
what action Congress takes, because I think it does have an 
effect on the quality of health and the cost of health in the 
future. I thank the chairman. I yield back.
    Mr. Upton. Thank you. Mr. Bryant, do you have additional 
questions?
    Mr. Bryant. Mr. Chairman, I really don't. I would just--it 
is almost entertaining to hear this discussion, not that, you 
know, it is humorous or anything but we are just one giant 
circle and some of the questions that are asked, and, you know, 
is it a single-use item a single-use item, and reusing a 
single-use item, and who decides whether it is a single-use 
item, and then a new manufacturer taking that item and cleaning 
it and saying it is now my product. I suspect in the end it 
would be great to have some guidance from you, but it seems to 
me that is one of the questions we have to decide is, and I 
don't know.
    The FDA is probably not involved in making that decision as 
to whether or not this is really a single-use item. As you say, 
the OEM comes to you and you accept the labeling and if they 
say it is, it is. Question, why don't they put on there this 
can only be used one time and you do it otherwise you are 
subject to all kinds of problems. They don't want to do that, 
but I suspect in the end it is going to be up to the courts of 
law, the trial lawyers out there, the plaintiff's lawyers, to 
litigate this. And it is going to take a few big cases to sort 
things through. But there is tremendous potential of liability 
here among the reprocessor, the hospitals, and maybe even 
reaching back to--ingenious lawyers can reach back sometimes 
and find those original manufacturers, too. So, it is a 
complicated situation and I just again urge the FDA to move as 
quickly as you can to give us all some guidance and assistance 
in this. And thank you for your testimony.
    Mr. Upton. Ms. Eshoo, did you have additional questions?
    Ms. Eshoo. Yes. Thank you Mr. Chairman. I would like to go 
back to something, doctor, that you said just a few moments 
ago, and I think that you stated earlier in your responses to 
questions, and that is that the FDA considers reprocessors to 
be manufacturers, but your policies do not reflect this. You do 
not treat--if, in fact, you consider them to be manufacturers 
how do you apply the same policies that you told me earlier are 
applied? I think that there is a discrepancy here. And I would 
also like to ask you about enforcement. What exactly are FDA's 
enforcement measures that are brought to bear today? I mean, we 
could have all kinds of policies on the books. We know if they 
are not enforced then they are not worth the paper they are 
written on, so today what are your enforcement policies and 
give us examples of how you have a manifestation of the 
enforcement.
    Mr. Feigal. Well, one example that I mentioned earlier is 
that we have been inspecting reprocessors and we have issued 
them Warning Letters for the kinds of manufacturing problems 
that an OEM----
    Ms. Eshoo. Is this on the enforcement side?
    Mr. Feigal. Yes. On the enforcement side. And we have not 
treated those inspections as having any different standards 
than we would for any other type of manufacturer. There are 
many different levels of enforcement. Because we have had this 
policy of not regulating this area in the past, there is a 
period of time when we are going to find people who do not 
believe that they are regulated by us and are putting into 
commerce what we consider new devices and we will----
    Ms. Eshoo. And your new guidelines, does the enforcement 
change? Is it beefed up? Is it less? Is it----
    Mr. Feigal. The new guidelines takes the principle that the 
enforcement will be the same for a manufacturer, whether the 
manufacturer is a reprocessor or if it is an original equipment 
manufacturer. What the guideline does is that it gives people 
lead time to prepare for the change in policy, but it asks the 
manufacturers of high risk or high complexity devices by our 
definition to come into compliance more quickly. And that will 
mean having the same standards for applications and following 
all the same policies that we would expect of an original 
equipment manufacturer.
    Ms. Eshoo. So you are maintaining that your designation of 
a reprocessor as a manufacturer, as well as the OEMs that the 
policies that you have in place now, and the enforcement 
policies, are exactly the same as what your proposed guidelines 
are? That they are the same across the board?
    Mr. Feigal. Once they are fully implemented, it won't 
matter if a device is manufactured or a new manufacturer is 
remanufacturing it. That the same standards will apply.
    Ms. Eshoo. But see, I am confused, because I think that 
there is--it is very confusing to me whether you are referring 
to proposed guidelines and what you hope to do and what you 
hope to implement and/or what we have on the books today. Is it 
all the same? Is there enforcement across the board whether 
someone is an OEM or a reprocessor? Yes or no.
    Mr. Feigal. No. It is not because the----
    Ms. Eshoo. All right. Will there be consistency brought to 
both with the proposed guidelines?
    Mr. Feigal. Yes.
    Ms. Eshoo. As well as enforcement?
    Mr. Feigal. Yes.
    Ms. Eshoo. Across the board?
    Mr. Feigal. Yes.
    Ms. Eshoo. Not just in some areas?
    Mr. Feigal. Across the board and it will be phased in.
    Ms. Eshoo. You said earlier when I asked you about 
standards which is something about which I am talking about 
now. Today you only inspect the place where devices are 
processed. Is the place clean? Is the process a good one, is 
that correct?
    Mr. Feigal. These are GMP inspections. When we inspect a 
reprocessor, we look at him in the same way that we look at an 
original equipment manufacturer. The reprocessor, to us, is a 
different manufacturer than the OEM. They just have a different 
starting material.
    Ms. Eshoo. But you said you consider them both 
manufacturers.
    Mr. Feigal. That is right.
    Ms. Eshoo. So what is the difference in what you just said 
then or the piece that you just mentioned? How does it affect 
what you said previously?
    Mr. Feigal. The starting material that the manufacturer 
makes his product out of is different, but we treat them both 
as the same kind of manufacturer with a device that is 
classified as the same, with a device that has the same pre-
market requirements, with a device that has the same safety 
reporting requirements.
    Ms. Eshoo. Well, the reason that I am asking these probing 
questions is most frankly I do not think it is the same across 
the board. You are saying that it might be or that it will be 
if you get to implement your proposed regulations. But with new 
devices you require that all sorts of data be accumulated 
before they ever get to the patients, but that is not the case 
with the reprocessed pieces. So I do not think that there is a 
consistency, with all due respect. You are getting lots of 
notes on this so I must have----
    Mr. Feigal. Yes. I am.
    Ms. Eshoo. You know, by reusing the three tier risk system, 
the practical effect will be that enforcement, I do not think, 
will be the same across the board. FDA, I think, is sending a 
message to reprocessors that you are not going to enforce the 
same standards on them. And that may be your direction. I do 
not think it is good enough. Now, you talked about equipment 
that is the operating room earlier, but the equipment that you 
referred to is not being placed inside the patient's body. So I 
do think that there is a clear difference and that is why I 
think the standards really need to be much higher. So you may 
want to comment on this.
    Mr. Feigal. Let me be clear. Right now there are 
differences in the way they are treated because of the policy. 
The guidance that we have put forward are things which we 
intend to do. We are asking for comments. We have given the 
specific time table and told you when we intend to do them. We 
have done what Congress has consistently asked us to do with 
devices, and what the public has asked us to do, which is get 
to the highest risk things first. Whether something is a 
reprocessed device or an original device, it will have the same 
pre-market requirements. There will not be differences in 
requirements. The risk staging has more to do with how we phase 
in the change in policy, than it has to do with where we will 
be in 2 years, or 3 years, or whatever it takes to get there. 
There will be some differences in the types of applications 
because the companies building the same product are taking 
different paths to build it. There still will be the same 
standards, whether it is an original equipment manufacturer or 
a refurbisher.
    Ms. Eshoo. But reprocessors do not build products, do they?
    Mr. Feigal. Yes, they do.
    Ms. Eshoo. How?
    Mr. Feigal. They take a product that has been disposed of 
and----
    Ms. Eshoo. Do they reconstruct it?
    Mr. Feigal. They do things to it----
    Ms. Eshoo. They redesign it?
    Mr. Feigal. They have to understand----
    Ms. Eshoo. Or do they clean it for reuse?
    Mr. Feigal. They may do all of those things, or it may be a 
simple issue of recleaning, but once they take responsibility 
for remanufacturing a device, they are a manufacturer with the 
responsibility to explain all of those things: the design and 
controls, the performance standards, all of those things.
    Ms. Eshoo. This is in the new policy.
    Mr. Feigal. That is the new policy.
    Ms. Eshoo. The proposed policy.
    Mr. Feigal. The new policy is that they are no different 
than an OEM.
    Ms. Eshoo. That is not the case today?
    Mr. Feigal. That is not the case today, no. We have been 
very----
    Ms. Eshoo. Thank you. Mr. Chairman, I would like to ask a 
unanimous consent to place into the record a series of national 
articles that have been carried over a good deal of last year 
and some from this year about this issue. Many in national 
publications, grey sheets, etc., and I think it is information 
that is important to have as part of the record on this.
    Mr. Upton. Without objection.
    Ms. Eshoo. Thank you.
    [The information follows:]
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    Ms. Eshoo. Thank you Doctor.
    Mr. Burr. Mr. Chairman, could I ask unanimous consent for 
one additional question?
    Mr. Upton. Yes, you may.
    Mr. Burr. I just want to clarify one thing. If a hospital 
unpackages but does not use a sterilized device, is it your 
position that they are, in fact, a manufacturer when they re-
sterilize it for additional use?
    Mr. Feigal. It depends on how it is labeled. If the 
original equipment manufacturer provided instructions on how to 
re-sterilize, then they are using the device in one of the ways 
that it was intended to be used, which is to have it open and 
available but be able to close it back up and sterilize it. If 
the hospital is doing this for other types of products for 
which there are no instructions on how to sterilize, then we 
are back in the area of manufacturing. In general though, this 
is a practice that hospitals know very well how to do and it is 
part of routine practice, and this is one of the lower 
priorities on the risk scale for us to address this particular 
practice of repackaging products which have been opened.
    Mr. Upton. If the gentleman will yield just 1 second, I 
note on this particular device which I did not open, but 
somebody did maybe. I do see a warning. This device is intended 
for one time use only. Do not re-sterilize and/or reuse it as 
this can potentially result in a compromised device performance 
and the increased risk of inappropriate sterilization and cross 
contamination. But if that happened, they open this up and it 
goes in the trash if they do not use it.
    Mr. Burr. I guess my question would go a little deeper, 
given that the hospital did not repurchase it or resell it.
    Mr. Feigal. Right. No, that is right.
    Mr. Burr. The commerce question comes in and the question 
of your jurisdiction as well.
    Mr. Feigal. Yes, that is right.
    Ms. Burr. So, can you sort that out for me?
    Mr. Feigal. Well, that does get back to the issue of where 
do we get the definition of placing a device into trade. One of 
the factors that we have thought about is if the hospital is 
charging for it more than once, they are putting it back into 
trade, whether they are using something that they own or not. 
But it is a complex issue. The hospital oftentimes is acting as 
a third party for the physicians that practice there. And so 
they, in that sense, are much more like the third party 
reprocessor than they are the physician who owes the device who 
wants to modify it in some way and use it in his own practice.
    Ms. Burr. But clearly based upon what you have told me, 
there could be a situation where a device was never used, but 
it was unpacked, it needed to be re-sterilized, the 
manufacturer did not have re-sterilization instructions with 
it, no commerce took place, but they would still be considered 
a manufacturer when they repackaged it and reused it?
    Mr. Feigal. If this was something that was a very common 
practice, it would be a practice that we would say needs to 
come under some control, because in fact they do not know if 
they are damaging that product by trying to re-sterilize it. In 
most cases OEMs will work with hospitals to provide 
instructions when a product can be re-sterilized. And if they 
said it cannot be, I think that the hospitals are taking on the 
responsibilities of a manufacturer.
    Ms. Burr. The FDA does not currently ask for reporting of 
re-sterilized devices, do they?
    Mr. Feigal. No.
    Ms. Burr. Okay. Thank you Mr. Chairman.
    Mr. Upton. Thank you. Well, as you can tell Dr. Feigal, I 
was thinking maybe we ought to have a 2-day hearing. We 
appreciate your expertise and help certainly with our 
subcommittee. It has been a very good process for all of us. We 
look forward to seeing the regulations made permanent so that, 
in fact, we do have some enforceability that is out there. We 
appreciate your dialog with us, and we look forward to working 
with you in the future. Again we appreciate having a member of 
your staff remain to listen to the testimony from the next 
panel and to be able to respond to questions that may arise. 
You are formally excused. Thank you.
    Mr. Feigal. Thank you.
    Mr. Upton. Thank you.
    Okay. The second panel includes these individuals, Laurene 
West, R.N., Dr. Robert O'Holla, Vice President of Regulatory 
Affairs from Johnson & Johnson, Dr. Philip Grossman, Dr. John 
Fielder, Professor of Philosophy, Ethics, at Villanova 
University, Mr. Vern Feltner, President of Alliance Medical 
Corporation, Dr. Bruce Lindsay, Associate Professor of Medicine 
at the Washington University School of Medicine, Dr. Walter 
Maurer from the Cleveland Clinic on behalf of American Hospital 
Association, and Dr. Griffin Trotter, Center for Healthcare 
Ethics at Saint Louis University.
    I appreciate all of you being here this afternoon. As you 
may understand all of us are on multiple subcommittees. It 
seems like they are all meeting today. In addition to votes on 
the floor, and because this hearing has gone much longer than 
anticipated when we started, members scheduled are being 
telescoped so we will see a number of members coming in and 
out. We have a general rule that we would like you to limit 
your remarks to 5 minutes. As I am not real careful with the 
gavel, I will try to be a little more attentive to that clock. 
As you understood, I think, your testimony in its complete form 
is made already part of the record as earlier made under 
unanimous consent. As you may have also heard, it is our 
committee practice always to take testimony under oath. Do any 
of you have any objection to that? Seeing none, we also allow 
under committee rules the possibility of you being represented 
by counsel. Do any of you need counsel to represent you at your 
own expense? And last then, if you would rise and raise your 
right hand.
    [Witnesses sworn.]
    Mr. Upton. Okay. You are now under oath and we will start 
with Ms. West, if that is okay. Also for those behind you, 
particularly if you would make sure that you bring that 
microphone close to you, it would be helpful for all in the 
room. With the clock, a little warning light will go on with a 
minute to go, if that is okay. I can change that if you do not 
like that, but that is the way it will be. Ms. West, we 
recognize you.
    Ms. West. Thank you.
    Mr. Upton. Go ahead.

 STATEMENTS OF LAURENE WEST; ROBERT H. O'HOLLA, VICE PRESIDENT 
REGULATORY AFFAIRS, JOHNSON & JOHNSON; PHILIP GROSSMAN; JOHN H. 
FIELDER, PROFESSOR OF PHILOSOPHY, ETHICS CONSULTANT, VILLANOVA 
 UNIVERSITY; WALTER G. MAURER, CLEVELAND CLINIC FOUNDATION, ON 
    BEHALF OF AMERICAN HOSPITAL ASSOCIATION; VERN FELTNER, 
 PRESIDENT, ALLIANCE MEDICAL CORPORATION; C. GRIFFIN TROTTER, 
 CENTER FOR HEALTHCARE ETHICS; AND BRUCE D. LINDSAY, ASSOCIATE 
PROFESSOR OF MEDICINE, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE

    Ms. West. Mr. Chairman, members of the committee, I 
appreciate the opportunity of expressing my concerns this 
morning, actually this afternoon, sorry. I am here today not as 
a spokesperson, not as a lobbyist for any group that is paying 
me, but as a classic example of a patient who has suffered from 
the reuse of a single-use device. My perspective on this 
pandemic healthcare issue comes from not just being a patient, 
but also having been a registered nurse with a critical care 
certification and current licensure for 25 years.
    There are actually two ways that a single-use device can be 
used twice. One is if you have an incompetent staff member who 
does not follow sterile procedure and is using the device for 
the second time. And then second, as we have just talked about, 
the sterilization of a device, excuse me, autoclaving a device, 
perhaps, to make that single-use device into a multi use 
device. My personal example falls into category one which comes 
from an incompetent staff member not following sterile 
procedure. Just a little bit of history so that you will 
understand why I was in this position. In 1983 I was diagnosed 
with a tumor in the center of my brain and, in order to remove 
that tumor, I went through a procedure which is called a 
transsphenoidal hyphysectomy.
    I can describe that for you, but there are some people that 
perhaps would prefer not the clinical aspect of that. In order 
to get to that part of the brain the surgeons need to go 
through the bottom of the brain. So they went through my 
sphenoid sinus in order to do that. And while I was having that 
surgery there was a break in sterile technique. I was exposed 
to and infected by the bacteria known as staphylococcus aureus 
commonly known as staph. And because that infection was 
acquired during a hospital stay it is referred to as a 
nosocomial staph infection. And I have actually battled that 
infection for 17 years. As the purpose of this hearing is to 
describe the reuse of single-use devices, I am going to 
concentrate my testimony on an incident that occurred when I 
was ill in 1988.
    I had had two surgeries that year to remove infected bone 
from both my head and my facial structure in an effort to try 
to prevent Meningitis. Meningitis is where the infection is 
collected on the outside of your brain. The cultures that were 
taken of the bacteria in my head indicated that the bacteria 
had mutated to the point that I was no longer sensitive to any 
antibiotic other than one called Vancomycin which needs to be 
administered intravenously. So, I was admitted to the hospital 
and what is referred to as a central line was inserted. That 
goes into your antecubital vein, it is threaded up into your 
arm, and up into the superior venacava of my heart.
    For the first day I had a phenomenal nurse who followed 
sterile procedures. She changed the needles, she changed the 
tubing each time she hung the doses of Vancomycin. However, the 
next day I did not have such luck. The nurse who took care of 
me, as she took the needle out to end the dose, she put the 
needle on the table. My thought was well, you know, that is the 
end of the dose. The sterile procedure is that you would then 
hang a new bag, put new tubing, put a new needle on there. She 
did not do either, and before I realized what she had done she 
had picked the needle up off the bedside table, without any 
cover, not even wiping it off with an alcohol swab and then put 
that back into my central line which flowed directly back into 
my heart. Actually I would have been much better off had I just 
taken care of myself at home.
    My physician ordered blood cultures because we needed to 
know what additional bacteria that I was now exposed to. It is 
flashing red. Have I already gone 5 minutes?
    Mr. Upton. You have.
    Ms. West. Okay. I will make this very, very quick. In order 
to save my life, I went on a regime of three IV antibiotics. I 
have continued to suffer from that process of having had that 
device reused. I will skip over just very quickly that the 
reuse of a vital medical device can be a result of a bad habit, 
a result of not having appropriate quality assurance within a 
facility. However, every organization has a responsibility of 
maintaining a patient relationship that allows for a sterile 
procedure. As we are mutating bacteria year by year, the 
essentiality of sterilization is more, and more, and more 
important. As patient we deserve the right to be given 
treatment by trusted, trained professionals.
    Very quickly I will explain that. The implementation of the 
1996 Health Insurance Portability and Accountability Act known 
as HIPAA-96, that was intended to standardize and simplify 
administrative procedures for nurses, who are currently 
spending 50 percent of their time taking care of paperwork. So 
if there is proper implementation of the HIPAA legislation, 
then we then have nurses back on the floor who can monitor, and 
train, and certify and make sure that devices are not reused. 
Since I am over my time, I would be happy to answer any 
questions that you have. I appreciate the opportunity of 
sharing with you part of my story and hope that we can find a 
way so that all patients have access to quality care.
    [The prepared statement of Laurene West follows:]
                   Prepared Statement of Laurene West
    Mr. Chairman, members of the committee, my name is Laurene West. I 
would like to ask that my full statement be inserted into the record of 
this hearing.
    I am here today not as the spokesperson or lobbyist for any 
organization, nor for any group that is paying me to testify--but as a 
classic example of a patient suffering from the results of a re-used, 
single use biomedical device. My perspective on this pandemic 
healthcare issue is derived from being both a patient and a Registered 
Nurse with Critical Care Certification and Licensure for 25 years.
    There are two ways in which single-use devices can be re-used; 1) 
staff incompetence or failure to follow sterile procedures and perhaps 
inadequate training 2) cost containment but high risk procedures of 
autoclaving single-use devices to become multi-use devices.
    My personal example falls into category 1--staff incompetence or 
failure to follow sterile procedures and equally likely, inadequate 
training.
    In 1983 I was diagnosed with a tumor in the center of my brain. The 
tumor was surgically removed by a procedure called a Transsphenoidal 
Hyphysectomy. During my surgery there was a break in sterile technique 
and my brain was exposed to and infected by the bacteria staphylococcus 
aureus, or more commonly known as staph. Because this infection was 
acquired while in the hospital, it is referred to as a nosocomial staph 
infection.
    As the purpose of this hearing is to describe incidents directly 
related to the re-use of single use devices, my testimony will 
concentrate on an incident in 1988 where this common, hospital wide, 
cost saving practice nearly took my life.
    1988 was a rough year. I had two surgeries within three months 
trying to prevent meningitis--which is where the lining of the brain 
becomes infected. The infection in my head had traveled to my frontal 
sinus and the cultures revealed that the staph had mutated so that it 
was no longer sensitive to any antibiotic except Vancoymcin, which must 
be administered intravenously.
    I was admitted to the Hospital, a central line was inserted via my 
antecubital vein into the superior venacava of my heart. For my first 
day, I had a wonderful nurse who followed sterile procedure correctly, 
used only new IV tubing and needles as appropriate--and my temperature 
of 104 degrees began to decline. However, my next nurse, a foreign 
national, barely able to speak English, did not follow sterile 
procedure. When the current dose of Vancomycin had been infused, she 
took the needle out of the mainline and laid it on the bedside table. I 
assumed this was her way of reminding herself that she needed 
additional tubing and a new needle for the next dose. The correct 
procedure for administering the next dose would have been to hang the 
Vancomycin with new tubing and a new needle. However, she did neither. 
Before I realized what she was doing, she re-inserted the old needle 
with the old tubing into the mainline for that dose of the antibiotic. 
The damage was done--I had now been contaminated with additional 
bacteria from the table. Within 12 hours my temperature had spiked to 
108 degrees and I developed septicemia, meaning that the infection in 
my head had traveled to my blood system as well.
    I would have been better off taking care of myself at home.
    My physician, ordered blood cultures drawn so that he could 
determine if there were additional bacteria causing the increased 
temperature. However, my rapidly deteriorating condition caused my 
doctor to immediately start a regime of three IV antibiotics, each with 
exhaustive lists of negative side effects, to save my life.
    I was very lucky and after weeks of therapy, recovered from the 
sepsis and returned to my normal battle with just the routine staph 
infection.
    My case is only one of a vast undocumented number of similar if not 
worse life-threatening stories. Most patients entering the hospital or 
clinic do not understand what is happening to them and without a 
clinical background they do not know they need to be cautious. They go 
into a facility, trusting that they will receive the best possible care 
from trained and responsible professionals. They don't know the 
difference between a single-use or multi-use device.
    Earlier in my testimony I referred to two ways single use devices 
can be reused. I suffered from professional incompetence and the 
failure of an allegedly trained professional to follow appropriate 
procedures.
    The reuse of a biomedical device could simply be the result of bad 
habits not recognized during training and quality assurance review. A 
health care organization has constant follow-up and training 
responsibilities in every single patient relationship. With infection 
rates growing and bacteria being mutated to new forms that are no 
longer sensitive to existing antibiotics, the essentiality of 
sterilization is of the utmost importance for patient safety.
    The implementation of the 1996 Health Insurance Portability and 
Accountability Act, known as HIPAA 96', is intended to standardize and 
simplify administrative procedures, known as paperwork. Currently 
nurses are spending 50 percent of their shift time on these 
administrative procedures. Appropriate implementation of HIPAA 96' 
would allow for greater time spent in training, practice certification 
and supervision of licensed caregivers. Put nurses back on the floor 
taking care of patients rather than doing paperwork.
    Category 2, reuse of biomedical devices as a cost containment 
effort, is either sanctioned or not sanctioned by the health care 
organization. If the organization chooses to reuse these devices firmly 
labeled as single use, they are violating the implied sterilization 
warranty and putting patients at high risk of infection. This 
ultimately increases patients morbidity and mortality rates.
    This silent epidemic radiates throughout healthcare, from large 
acute care facilities to home health agencies and nursing homes--
regardless of the owner organization. I have shared with you my own 
story but can give you example after example of things that I have seen 
and heard from other healthcare professionals and from the 55 million 
patients I represented last year on the Year 2000 Project as the 
National Patient Advocate.

 Autoclaving IV tubing for second and third patient use.
 Autoclaving Pacemaker wires for use on additional patients
 Saving neonatal ambu-bags and pulse oximeters without being 
        autoclaved, to be given to 3rd world countries.
 Subclavian guidewires autoclaved to be used on additional 
        patients
 Suction catheters being used by multiple patients without any 
        cleansing process in-between patient contact.
    Most caregivers are not able to document cases of increased 
infection, morbidity or mortality from the re-use of single use devices 
as doing so would cause them to lose their jobs.
    Ladies and Gentlemen, healthcare must be driven by quality, 
compassion, honesty, and with respect for the rights and wishes of the 
individual. It must be provided by trained and competent staff.
    I offer my assistance in any way possible to this committee or any 
organization to help further awareness of this issue, to help better 
train hospital staff and make patients more enlightened consumers.
    I want to thank the members of the Committee for allowing me to 
testify today and will be happy to answer any questions you may have.

    Mr. Upton. Thank you very much.
    Mr. O'Holla?

                 TESTIMONY OF ROBERT H. O'HOLLA

    Mr. O'Holla. Good afternoon, Mr. Chairman. Thank you. 
Members of the committee, my name is Robert O'Holla, I am Vice 
President of Regulatory Affairs for the Medical and Diagnostic 
Group at Johnson & Johnson. I am also Chairman of the 
Association of Disposable Device Manufacturers, you have come 
to know as ADAM. Mr. Chairman, I would like to thank you and 
Mr. Bliley for raising the visibility of this important issue 
through this hearing and also by introducing a bill along with 
Congresswoman Eshoo on this issue.
    I am going to do my best to control my passion for the 
issue this afternoon. I have worked for approximately 30 years 
in the medical device industry, and I am seriously concerned 
that anyone would attempt to clean and reuse a medical device 
that was designed for use in a single patient and approved by 
FDA for only one use. Just as concerning, and I share the 
concern raised by this committee all morning, was the apparent 
disinterest on the part of FDA until very recently in this 
threat to the health and safety of U.S. patients. I have 
submitted my written testimony, but because my time is limited, 
today I would like to concentrate on just one aspect: The 
threat that reprocessed single-use devices present to quality 
healthcare for patients. The evidence for action is clear to 
me. There are reports of two patients who have been blinded in 
one eye, a premature baby whose foot was burned, increased 
pneumonia rates in children, and a 32 year old woman who we 
heard about earlier this morning who has a piece of metal 
lodged in her heart.
    In addition, ADAM members have retrieved approximately 
1,000 reprocessed devices from hospitals where they were 
awaiting use in patients. The results of the tests are 
chilling. Approximately 75 percent of the samples collected 
failed either due to the presence of blood and/or proteinaceous 
matter, bacterial contamination, functional failures, or 
defective packaging leading to non-sterile devices. And I 
brought some pictures along so you can have some appreciation 
for what we found. I would like to note that these are not 
unique pictures. These are representative of what we found. The 
first photograph shows a piece of proteinaceous material that 
was ejected from a reprocessed surgical clip applier when we 
fired it in the laboratory. This is a device that is used to 
close bleeding blood vessels. That piece of material is not 
actual size by the way. That is about a quarter inch to an 
eighth inch piece of material that would have been injected 
into the next patient. The interesting thing about this is that 
as we tried to fire the device further, there was so much 
tissue in the mechanism of this device that the device clogged 
and became nonfunctional.
    The second picture is in the anvil of a surgical stapler 
contaminated again with similar material. The next set of 
pictures we see a reused electrophysiology catheter that pulled 
apart while inserted in a second patient's heart making it 
difficult for the doctor to remove. Last is a photograph of 
another electrophysiology catheter. What we see is 
contamination with tissue residue. We found that this residue 
was indeed one that caused a marked increase in blood clot 
formation. In addition to all of this, FDA's own data indicate 
problems with the reuse of angioplasty catheters, 
electrophysiology catheters, and biopsy forceps. One FDA study 
revealed that the tiny tubes inside reprocessed angioplasty 
catheters were often kinked and clogged with blood and cleaning 
chemicals. Most disturbingly, some reprocessed balloons ended 
up being at least one size larger than they were supposed to 
be.
    Now, the proponents of reprocessing have said that they do 
not put patients at risk and they have no evidence that the 
practice is unsafe. Yet, by simple random sampling and without 
any trouble we found reused products that clearly increased the 
risk to patient's health and safety. A large portion of the 
devices we found were non-sterile. How many infections and more 
serious diseases such as Hepatitis-C and perhaps even HIV, have 
been spread to unknowing patients as a result of this practice? 
The sad answer to that question is, we do not know because 
nobody has been looking. There is a clear increased risk of 
disease transmission and functional failures. Is this an 
acceptable standard for medical device performance, or are we 
just inviting an increase in medical errors? It certainly is 
not the standard that FDA has applied to new medical devices 
for the last 24 years, and should not be the standard applied 
to reprocessed devices. It is time that FDA enforced the full 
requirements of the law so that the second, third, or sixth 
patient has the exact same level of FDA protection FDA 
oversight provides to devices used on the first patient. No 
other standard is acceptable. Thank you.
    [The prepared statement of Robert H. O'Holla follows:]
 Prepared Statement of Robert H. O'Holla, Vice President of Regulatory 
                       Affairs, Johnson & Johnson
    Good morning, Mr. Chairman and members of the Subcommittee. My name 
is Robert O'Holla and I am Vice President of Regulatory Affairs for the 
Medical Devices & Diagnostics Group at Johnson & Johnson. I am also 
Chairman of the Association of Disposable Device Manufacturers, a trade 
association of single use medical device manufacturers. Thank you for 
the opportunity to address this important patient health and safety 
issue. I have worked for 30 years in product development, quality 
assurance, microbiology and regulatory affairs. As a long time 
professional in this area, I cannot understand why anyone would believe 
it is acceptable to clean and reuse a delicate, complex medical device 
that was designed for use in a single patient and approved by FDA for 
only one use. Just as concerning is the apparent disinterest on the 
part of FDA until very recently in this threat to the health and safety 
of patients.
    FDA has said that it is now going to regulate the practice of 
reprocessing. I hope that means that FDA is now going to apply all of 
the provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act). 
No evidence of harm is needed before FDA can and should apply the law. 
The FDC Act and its implementing regulations establish a presumption 
that all medical devices are unsafe, and require that the safety and 
effectiveness of new or substantially modified devices be affirmatively 
demonstrated prior to their introduction into interstate commerce. 
Claiming that a single use device may be reused causes the device to be 
treated as a new device under FDA's regulatory scheme. Yet, for years 
FDA has chosen to ignore this clearly stated Congressional intent by 
allowing reprocessed single use devices to be used on patients without 
requiring or reviewing the necessary data to establish their safety and 
effectiveness.
Risk to Patients
    FDA is aware of reports of two patients who have been blinded in 
one eye, a premature baby whose foot was burned, a thirty-two year old 
woman with a piece of metal lodged in her heart, and increased rates of 
pneumonia in children.
    Nevertheless, FDA's first step in regulating reused devices was to 
improperly shift the burden by refusing to require that reprocessors 
demonstrate safety and effectiveness of their products, and suggesting 
instead that OEMs provide data regarding the risks associated with 
reprocessing. Despite this improper move, the original equipment 
manufacturer (OEM) industry expended substantial effort to test 
reprocessed single use devices. The data from that testing, all of 
which has been submitted to FDA, overwhelmingly demonstrates serious 
safety issues. Moreover, FDA's Office of Science and Technology (OST) 
simultaneously generated its own independent data confirming the risks 
of reusing certain single use devices.
    At least nineteen scientific studies involving approximately 1000 
individual devices have been submitted to FDA on this topic. These 
studies have been conducted by independent scientists, hospitals, OEMs 
and, as mentioned above, FDA's own laboratory personnel. Many of the 
devices used in these studies were obtained directly from hospital 
shelves where they were ``ready for use'' in seriously ill patients--
patients suffering from cancer or heart disease, and requiring major 
abdominal, cardiovascular or thoracic surgery.
    Devices studied included biopsy forceps, angioplasty balloon 
catheters, electrophysiology catheters, surgical trocars, staplers, 
papillotomes, and other general surgical instruments. Approximately 75% 
of the samples studied failed, either due to the presence of blood and/
or proteinaceous matter, bacterial contamination, non-functionality, or 
defective packaging. In each of seven studies of reprocessed biopsy 
forceps, a lack of sterility assurance was reported in over 45% of the 
samples tested. This particular failure was not unexpected. As recently 
as last October, FDA issued a warning letter to one of the largest 
commercial third-party reprocessors specifically citing the 
reprocessor's failure to adequately validate the sterilization process. 
These studies also found devices with mismatched parts, a scalpel blade 
designed to be blunt that was, instead, sharpened, a surgical stapler 
contaminated by a large piece of proteinaceous matter, and devices 
lacking warnings about latex content. These nineteen separate studies 
clearly demonstrate that reusing a single use device may seriously 
compromise the integrity and subsequent safety and efficacy of that 
device.
    To date, FDA has failed to make public any study reports 
summarizing OST's data. Nonetheless, public presentations by OST 
scientists clearly indicate that these findings include safety and 
effectiveness concerns with percutaneous transluminal coronary 
angioplasty (PTCA) catheters, electrophysiology catheters, and biopsy 
forceps. One presentation revealed PTCA catheters with non-patent 
lumens, crimped guidewire lumens, and plugged balloons or balloon 
channels. In some instances, cleaning chemicals and blood could not be 
removed from the device lumens. Some reprocessed PTCA balloons varied 
in size by more than 10% of the approved specifications. As a result, a 
cardiologist has no assurance he or she will get the particular balloon 
size intended for the patient.
    FDA has failed to acknowledge the demonstrated patient safety risks 
associated with reprocessing single use devices despite volumes of data 
to the contrary. Reprocessing amounts to a misuse of medical devices 
that can only add to the nation's preventable medical error rate. The 
agency's Congressional mandate to protect the public health will not be 
served by reversing the burden of proof and awaiting a proven public 
health disaster before taking action.
Requirements of the FDC Act
    The FDC Act requires that, prior to their introduction into 
interstate commerce, all new medical devices must be FDA-cleared or 
approved through the premarket notification (510(k)) or premarket 
approval (PMA) process. This process requires submission of data by the 
party that intends to market the device. For a single use device, the 
OEM demonstrates that the device is safe and effective for use on a 
single patient in a single procedure, and the device is then cleared/
approved for only that use. Under FDA's own rules, reprocessing 
significantly modifies a single use device by changing its intended use 
to multiple use, creating, in effect, a ``reusable'' device. FDA 
requires manufacturers of single use devices that wish to market those 
devices as reusable to submit a new 510(k) or PMA, including data to 
support the safety and effectiveness of the device for multiple use, 
prior to marketing the device for that new use.
    FDA agrees that reprocessors of single use devices are 
manufacturers under the FDC Act and its implementing regulations, and, 
as such, reprocessors are subject to the provisions of the FDC Act that 
require manufacturers to obtain clearance of a 510(k) or approval of a 
PMA. Despite this recognition, the agency clearly announced its 
intention to permit reprocessed single use devices to be marketed 
without its prior clearance/approval, and, to date, has subjected them 
only to some degree of post-market regulation. In a letter dated July 
9, 1999, FDA stated that, ``third-party reprocessing of devices labeled 
for single use is unlawful unless those engaged in this practice comply 
with all regulatory requirements for manufacturers, including premarket 
notification requirements.'' However, the agency then reversed itself 
by announcing in the same letter that ``FDA has exercised and will 
continue to exercise regulatory discretion for all premarket 
notification requirements.'' This unjustifiable use of enforcement 
discretion is perpetuated for many reprocessed single use devices under 
FDA's recently issued strategy for regulation of single use device 
reprocessing.
    The FDC Act requires pre-clearance of reprocessed single use 
devices by all device manufacturers, whether they are OEMs or 
reprocessors. The Medical Device Amendments of 1976 (MDA) were enacted 
for the purpose of implementing pre-market review of devices because 
Congress was concerned that post-marketing regulation of medical 
devices was inadequate to protect the public health. The design of the 
MDA is consistent with Congress' belief that post-market controls are 
insufficient to regulate medical devices. In today's world of 
increasingly complex medical devices and heightened concern over 
disease transmission, the regulatory discretion FDA has proposed to use 
under its new strategy, is inconsistent with Congress' intent. In 
enacting the MDA, Congress' goal was to protect patients from unsafe 
and ineffective devices, regardless of the identity of the device's 
manufacturer. As such, there is no justification for a patient to 
receive less protection from FDA merely because the device used for the 
patient's treatment is a reprocessed single use device rather than an 
FDA-cleared reusable device. FDA is, in effect, creating a de facto 
exemption from the premarket review requirements for most reprocessed 
single use devices `` and in doing so, is violating its Congressional 
mandate.
FDA's Disparate Treatment of OEMs and Reprocessors is Illogical
    FDA acknowledges that it has not regulated OEMs, third-party 
reprocessors, and health care facilities in the same manner with 
respect to single use devices. For example, in order to market a single 
use surgical stapler for use in multiple patients, an OEM must first 
obtain clearance of a 510(k) from FDA. A reprocessor that wishes to 
market that same stapler for use in multiple patients is currently free 
to do so without a 510(k). Not only is this dichotomy arbitrary, it is 
also illogical since only the OEM has full knowledge of the design 
criteria and performance specifications of the device and thus is in a 
far better position than the reprocessor to determine whether the 
device can be reused.
    In the FDA's November strategy, the agency lists the seven 
requirements of the FDC Act to which OEMs must adhere: 1) registration 
and listing; 2) premarket notification and approval requirements; 3) 
submission of adverse event reports under the Medical Device Reporting 
regulation; 4) manufacturing requirements under the Quality Systems 
Regulation ; 5) labeling requirements; 6) Medical Device Tracking; and 
7) Medical Device Corrections and Removals. Of these requirements, FDA 
acknowledges that reprocessors have only been subject to four 
``registration and listing, QSR, labeling requirements, and MDR 
reporting requirements. This unequal treatment has no justification in 
law.
    Moreover, this unequal treatment also seriously compromises public 
safety. Devices are being marketed that have not been demonstrated safe 
and effective as required by law. FDA is effecting a double standard 
that lowers the burden for reprocessors as compared to OEMs. The 
protection of U.S. patients requires that FDA regulate all 
manufacturers in the same manner, regardless of whether those 
manufacturers are deemed OEMs or reprocessors.
Conclusion
    FDA must quickly establish timelines for enforcement of the 510(k) 
and PMA requirements on all reprocessed single use devices. The FDC Act 
requires FDA to protect U.S. patients from unsafe and ineffective 
medical devices before they cause patient injury. Such injury has 
already been attributed to reprocessed single use medical devices. 
Proper regulation of these devices, including enforcement of the 
premarket submission requirements, will prevent further injury and 
protect patients.

    Mr. Upton. Thank you very much.
    Dr. Grossman?

                  TESTIMONY OF PHILIP GROSSMAN

    Mr. Grossman. Mr. Chairman, honorable committee members, 
and guests, good morning. My name is doctor----
    Mr. Upton. Good afternoon.
    Mr. Grossman. You are right. Good evening, actually. My 
name is Dr. Grossman. I am a practicing gastroenterologist in 
Miami, Florida, a Clinical Associate Professor of 
Gastroenterology, but I have spent my entire adult life as a 
patient advocate. I want to thank both Chairman Bliley and 
Upton for holding these hearings and for inviting me to 
participate. Like many of you I am somewhat heartened by the 
recent iteration of the FDA proposals because they address many 
of our prior concerns, but they certainly do not go far enough 
and in my opinion certainly do not get us there fast enough, 
and I think the time is clearly now to act. I find myself 
shaking my head in disbelief every day that this continues.
    In simple terms let me explain to you what this is about. 
Medicine has gone through an evolution to less invasive 
procedures. There have been devices that have been designed, 
created, and built to foster that improved healthcare and 
perform a specific task. They were not built to achieve the 
ability to reuse. They were built to achieve the ability to 
take better care of patients. What are the implications? They 
allow us to repair blocked coronary arteries without open heart 
surgery. They allow us to remove benign and malignant polyps 
without a laparotomy, and for the first time in our country 
they allow for a national initiative to prevent colon cancer 
using safe and effective techniques. But to achieve this 
ability their very construction is somewhat unique. They have 
sharp points, they have tightly coiled wires, and they have 
very, very narrow lumen to permit the flexibility and mobility 
required in many of these areas. This allows them to do the 
job, but does not necessarily allow them to be cleaned.
    Imagine being at home trying to clean the inside of a 
swizzle stick and then using it again. What are the 
consequences or the potential consequences of reuse? Infection, 
major concern. Lost function. If I take one of these devices in 
my hand to care for a patient and it fails in the middle of the 
procedure, it is not a question of dollars and give me another 
one. It may fail in a time and place that causes great harm to 
that patient. There is risk from chemical toxic injury from the 
reprocessing solution and finally, there is even a risk of 
misdiagnosis. There is a case I am familiar with where a 
patient underwent esophageal surgery for a diagnosis of 
esophageal cancer, but at surgery there was no cancer. It was 
believed that the tissue from which the diagnosis was made was 
residual tissue left inside the tiny cup in the biopsy forceps, 
and perhaps somebody could put a picture of the biopsy forceps 
up.
    In essence, if we permit what amounts to the recycling of 
medical waste, these consequences will confront us day in and 
day out. I implore you, do not be mislead by the proponents of 
reuse who tell you there are no complications, there are no 
problems, and there are no dead bodies. The reason is that 
nobody is counting, and if you do not go looking and if you do 
not count, you do not find it. There has never been a 
prospective study investigating patients before procedures, 
looking at their HIV status, their hepatitis status, and then 
bringing them back every month for a year to determine if, in 
fact, they have suffered a consequence. It is easy to say that 
it is not there. We are creating a potential generation with 
infectious time bombs. The incubation period for Hepatitis-C 
alone is over 6 months. These patients are not followed during 
that time. If you look at the biopsy forceps that is up there, 
you can start to see why these problems occur. I agree with the 
FDA that this is a high-risk device. My concern that the loop 
hole for exemption may allow it to escape and go beyond the 
protection that the law intended.
    I would like to comment on informed consent for a moment, 
and that is until the FDA actually embarks on device by device 
review and approval, there will be two standards of care in 
this country. I believe patients have a right to know. And if 
the people who think that this is so safe really believe it, I 
see no reason why they should not be bragging about it. In the 
last group, your healthcare workers, the unsung heros who are 
being exposed to unnecessary risk by handling these 
contaminated devices. My conclusion would be and my hope for 
this committee, the final answers may not be in, but if 
reasonable doubt exists and reasonable doubt does exist, we 
must err on the side of patient safety and patient well-being. 
I thank you for your attention and particularly thank you for 
your leadership.
    [The prepared statement of Philip Grossman follows:]
                 Prepared Statement of Philip Grossman
                             introduction:
    My name is Philip Grossman, MD., F.A.C.P., F.A.C.G., I am a 
practicing Gastroenterologist in Miami, Florida, and Clinical Associate 
Professor of Medicine and Gastroenterology at the University of Miami 
School of Medicine. I am submitting this written testimony to address 
the following subject not because of any titles, but primarily as a 
family man and a concerned citizen. I feel very strongly about this 
issue and have traveled from Florida to provide both written and oral 
testimony. I applaud your efforts to protect United States citizens.
                              the problem:
    The problem we are facing is the reuse of medical devices that were 
designed, manufactured, tested, packaged, and labeled for the sole 
purpose of a single use in a single patient. These are devices for 
which the very approval from the FDA is contingent upon information 
submitted, including the fact that these devices are to be disposed of 
after a single use. Reprocessing refers to the cleaning, packaging, and 
attempt at resterilization of a single-use medical device which was 
used on a patient for its intended purpose and which will then be used 
again on another patient.
    Some single-use medical devices, for example, biopsy forceps, are 
critical devices, which, according to the Spaulding Classification, are 
those which routinely break the mucus membrane, thereby coming into 
contact with sterile tissue or the vascular system. Critical devices 
carry a much higher level of risk when reused than do non-critical or 
semi-critical devices, which would include endoscopes--devices which in 
themselves have been associated with disease transmission even in the 
absence of sharp points and coiled wires. The core of this matter is 
not the paperwork, labeling, or the official box these devices fit 
into, although these factors are important as well. Rather, the core 
issue is the actual reuse of single-use devices in real, live people--
husbands and wives, parents and children, brothers and sister.
    The scope of this problem is broad. It encompasses a wide range of 
devices in multiple specialties and includes biopsy devices, cardiac 
catheters, and various access-related devices used in gastroenterology, 
urology, and cardiology, as well as other specialties. This issue has 
become increasingly controversial as more healthcare facilities 
consider reuse of single-use devices as an attempted means of cost 
containment. According to a survey published in 1997 by ECRI, a non-
profit health service research firm, approximately one-third of 
healthcare facilities reused medical devices labeled for single use, 
and 25% more were considering the practice (Costerton).
    I must be clear though that I am discussing used single use devices 
not single use devices that were opened prior to a procedure and then 
not used. An unused single use device presents less risk to the next 
patient. In a recent issue of OR Manager, 250 hospitals were surveyed 
on this topic. Of the devices that were being reprocessed, 80% of them 
were open but unused devices. Hospitals must look to the manufacturer's 
instructions to determine if these devices can be resterilized. These 
are not the devices that are being discussed here. I will focus my 
comments on the reuse of used single use devices.
                               overview:
Devices are designed for single use only
    No matter what the specialty--gastroenterology, cardiology, or 
urology--single-use devices are specifically designed from inception 
for safety and performance. Therefore, the very design structure did 
not take into account the need to access all the nooks and crannies in 
order to clean them. The research, development, and design of the 
structure focused on a safe, effective product to be used once. An 
analogy to this situation might be as follows: You are asked to design 
a car to take a family of two adults three blocks from their home. 
However, it is only later that you find out that this care needs to 
transport eight schoolchildren fifteen miles away. But the car is six 
seat belts short. As with the design of the car, the design and all of 
the safety features of a single-use device make is totally suitable for 
the purpose for which it was created but do not automatically apply 
when the rules are changed. That's what this problem is about.
    Proponents of reprocessing may maintain that reuse is safe and 
vital as a measure to reduce healthcare costs; however, a preliminary 
FDA study uncovered dozens of reports of infection, chemical injuries, 
and mechanical failures associated with reusing equipment designed to 
work just once. Although reprocessing single-use devices had been 
widespread abroad; France has prohibited such reuse, and other 
countries are looking at the issue.
Design features make cleaning/reprocessing a problem
    Single-use devices have a number of common features:

1. They tend to be very small and intricate.
2. They typically have complex wiring systems, such as diagnostic 
        wiring that carries an electronic signal for measurement, or 
        mechanical wiring that operates the working portion of the 
        device much like a remote control tweezer or remote control 
        cane.
3. Because many of these devices are used for the purpose of removing 
        pieces of tissue or altering tissue during a procedure, they 
        typically have sharp points and sharp edges.
    The problem is that the very structure just described that makes 
the device work so safely and effectively in its intended use is the 
same design that precludes the ability to access its nooks and crannies 
and that encourages human debris to get caught in tightly woven wires 
or on sharp points. In essence, the success of these devices is what 
makes them such a risk in terms of the inability to clean them for 
reuse. The basic tenet in the world of microbiology is: ``If you can't 
clean it, you can't sterilize it!!!''
Devices designed to be reusable differ from reprocessed single-use 
        devices
    Manufacturers are required to conduct additional testing for 
devices that are intended to be reusable. They must meet FDA criteria 
to validate that a device can be cleaned and resterilized multiple 
times. Data supporting reuse must be submitted to the FDA through the 
premarket notification process. FDA is not enforcing these same 
regulations against reprocessors of used single use devices.
    Many devices, whether labeled as single-use or reusable, may appear 
identical. However, the devices may not include the same materials or 
internal components. For a number of reasons, manufacturers may change 
the materials used in production. Changes in materials may not be 
obvious on visual inspection, but unless the devices is specifically 
labeled ``reusable,'' the new materials may not be able to withstand 
the heat or chemicals required for resterilization, particularly on a 
repetitive basis.
Fallacies of cost savings with reprocessing
    In an effort to control costs, some hospitals have taken the 
position: ``If a device costs $50 and it is used just once, it costs 
the full $50. If a devices costs $50 and is used ten times, it costs 
only $5 per use.'' The two fallacies of this position are:

1. It reduces human risk solely into dollars per session; and
2. There are very real costs associated with processing a device for a 
        second or subsequent use. Devices are either reprocessed in-
        house (at the hospital) or are outsourced to the new industry 
        of device reprocessors. Device reprocessors take the devices 
        from the hospital (much like dry cleaning) and later return 
        them, typically charging approximately 50% of the cost of a new 
        device. So, it's not an issue of $50 vs. $0. When you factor in 
        the cost of the reprocessor, as well as the hospital's cost of 
        labor in preliminary cleaning, nursing time, as well as plastic 
        bags, labeling, etc., the actual costs of reprocessing increase 
        significantly.
    Devices being reused that are not intended for that function are in 
fact being reused at risk to the patient--as a cost saving measure. 
Because of the very nature of these devices, well meaning people 
wanting to do a good job may still not be able to adequately make 
single-use devices safe and appropriate for the next person.
Cost of failure
    In addition to the issue of patient risk, there is a genuine cost, 
both medical and economic, to a device which now performs at less than 
the standard for which it was built. It may result in a delayed 
procedure, damage to other medical devices, for example, endoscopes, 
higher complications, and/or greater risk to the patient as well as the 
medical personnel. In fact, the entire economic issue may become 
lopsided beyond recognition when one actually weighs the economic cost 
of an injured patient whether due to infection or device failure, 
against the acquisition cost of single-use devices. It may take decades 
to break even following such an adverse event.
                         disease transmission:
Reports document disease transmission
    Extremely well documented reports and additional medical literature 
confirm that diseases that have been transmitted from patient to 
patient have been tied to improperly reprocessed medical scopes and 
devices. Two reports documented the transmission of tuberculosis and 
the transmission of hepatitis. Both of these studies were documented 
with DNA fingerprinting--that is, researchers were able to actually 
demonstrate that the exact DNA of the organism identified from patient 
#1 was also found in patient #2--on whom the same scope had been used. 
Scopes were implicated in these reports, and scopes do not have sharp 
points. If you take a tweezer-like device with a tiny spike in it and 
stab it into tissue, then reprocess the device and stab it into someone 
else's tissue, it does not take a leap of the imagination to understand 
why disease transmission is of great concern.
A fallacy: cleaned and sterilized equals safe
    Some argue that because a device is cleaned and sterilized, it is 
therefore safe. This view is faulty for the following reason: some 
devices are constructed in a way that make it literally impossible to 
properly clean. In order to clean in between wire segments, you would 
have to literally unravel the device. An analogy would be: If in order 
to get a pair of stretch pants properly cleaned, you have to remove the 
elastic before taking them to the cleaners, thus rendering them useless 
in the future.
    When devices are reprocessed, whether in a hospital or by outside 
contractors, there is a human chain of activity--that is, a series of 
human events where people perform a variety of tasks. Even with well 
meaning and competent people doing this task over and over, there is 
still a possibility for human error, which magnifies as the number of 
steps and number of people increase. When the task involved in the 
process is repetitive, tedious and arduous, the likelihood of human 
error along the way is further multiplied. Everyone agrees that any 
human error, whether from inadequate cleaning, scrubbing, or delay, 
makes it impossible to properly reprocess a device and may be the cause 
of disease transmission. Compare that to the patient lucky enough to be 
the recipient of a first-use device--where the device comes out of a 
manufacturing plant which is inspected and whose processes are 
regulated and monitored by the FDA, has an established Quality 
Assurance process, and complies with stringent published standards for 
microbiological testing. There is essentially no concern about the 
possibility of error association with a repetitive human chain because, 
compared to the alternative, the devices comes out assuredly sterile.
Devices may be pooled in reprocessing
    If a hospital farms out its devices, hospital personnel are 
supposed to do a preliminary cleaning. The devices are then placed in a 
bag, picked up by the reprocessor, taken offsite for reprocessing, and 
returned. It is not uncommon for reprocessors to return a similar but 
not identical device. For example: You're a reprocessor. I give you 
Catheter A from my hospital, and some time later you give me back a 
ready-to-use Catheter A that came from a general pool of Catheter As 
from various facilities. My staff, over whom I have control, may have 
done a great job with the preliminary cleaning of our Catheter A 
devices, but we got back someone else's catheters. Therefore our 
staff's diligence might not be benefiting our patients.
Bacteria can become trapped
    When human organic material--blood, stool, tissue, saliva--is 
allowed to stand and crust, it forms a type of biofilm. The problem is 
that, in many cases, devices sit for a period of time, waiting to be 
picked up. A hospital being busy or any number of factors can result in 
an initial delay in cleaning. This delay, as well as the possibility of 
inadequate cleaning, enables the debris to form a resin that literally 
seals in and therefore insulates the bacterial. (Picture the bacteria 
going into a ``bomb shelter'' and reemerging when ``the coast is 
clear.'') When the reprocessed device is returned to the hospital it 
has allegedly been sterilized by the reprocessor. However, the bacteria 
are not effected by the sterilization process because they've been 
ensconced in this insulating shell. The problem gets worse. When the 
reprocessed device is put into a patient, the shell, at body 
temperature, and in the presence of body fluids, starts to degrade, 
thereby releasing the bacteria into an innocent victim.
Devices are often used in contaminated areas of the body
    In addition, the actual nature of reprocessed single-use devices 
lends itself to disease transmission because: (a) the majority of 
devices are used in the vascular system or in a contaminated area such 
as the urological or gastrointestinal tract, and (b) most devices have 
sharp points. All of the above factors contribute to disease 
transmission in reprocessed devices and enormously raise the likelihood 
that this is not a safe device when used under these circumstances.
                            public awareness
    The reason the public is not up-in-arms about the use of 
reprocessed devices is that people don't know enough about this issue, 
which is why this hearing is so important. Reprocessing is not an issue 
of greedy manufacturers; it is an issue that the public, when informed, 
decries. The following data illustrate the issue of public awareness--
or lack thereof--and people's responses when they become aware.

1. In a study called The Medical Device Reuse Awareness Study for 
        Halsted Communications, conducted in October 1997, the 
        following question was posed to 501 participants from Los 
        Angeles, New York, Chicago, and Atlanta: How would you feel if 
        a device that by law was designed to be used once, was reused 
        on you or on someone you love? People responded as follows: 84% 
        stated they would be angry; 76% would demand an explanation; 
        69% would be frightened; and 59% would ask for a guarantee that 
        the person that the device was used on before was healthy. 
        Nineteen percent of the respondents from Los Angeles stated 
        that they would sue if they found out this happened.
2. Recently in Japan, a clinic initiated a policy in which patients 
        were told that there were two kinds of accessories they could 
        use in a procedure: single use or reprocessed. If they chose 
        the single-use device, however, they would have to pay an out-
        of-pocket premium. Everyone chose to pay the premium.
3. Some time ago the television show ``Dateline'' did a piece on the 
        practice of reusing some dental material--braces in particular. 
        Following this program, there was a huge outcry. Again, it was 
        a case of the public initially not knowing, but voicing their 
        displeasure when they found out.
4. Many studies, commissioned by original manufacturers, have been 
        conducted by independent sterility testing labs. In these 
        studies, researchers took random samples of reprocessed medical 
        devices sitting on shelves in hospitals--ready for use in 
        patients. The reprocessed devices were then sent to the 
        independent lab for testing. In all the studies, a large number 
        of devices were found to be contaminated with blood, body 
        fluids, tissue, cleaning chemicals and bacteria. These studies 
        represented real situations, not just a theoretical concept. It 
        was not a case of ``What do you think would be used?'' Rather 
        it was a case of what would have been used, since these devices 
        were right there on the shelf awaiting the next patient.
5. At a symposium during a meeting of the Society for Gastrointestinal 
        Nurses and Associates, Inc. (SGNA) held in 1998, nurses were 
        asked the following question: ``If you were a patient, what 
        would you want used on you: single-use or reprocessed 
        devices?'' Unanimously, they did not want reprocessed devices. 
        Since then, the SGNA as an organization has published a 
        position paper speaking out against the practice of 
        reprocessing. It states, ``In the absence of clear regulatory 
        guidelines for reuse of single-use devices, based on current 
        scientifically based literature, and taking into consideration 
        concerns for patient safety and ethical practice, the Society 
        of Gastroenterology Nurses and Associates, Inc. supports the 
        position that critical medical devices labeled for single-use 
        should not be reused.''
                    informed consent and liability:
    The outgrowth of the practice of reprocessing single-use devices 
raises the issues of informed consent and liability. I believe that:

1. Ultimately the physician or physicians using the devices bear a 
        significant liability. They are the guardian of the patient. If 
        physicians have knowledge that the device handed to them in any 
        way might cause harm, they have accepted some responsibility.
2. If a hospital makes a choice to take a legally labeled single-use 
        device and use it contrary to the manufacturer's instructions, 
        the hospital also bears responsibility.
The patient's right to know
    This also raises a question as to what the patient has the right to 
know and do. Based on the above, it is my belief that, in addition to 
telling the patient of the risks and benefits, potential complications, 
and the names(s) of the physician(s), there should also be informed 
consent. It would state: ``Devices that we use have been previously 
used in other patients. Those patients may have had infectious 
diseases, including AIDS and hepatitis. These devices are used contrary 
to manufacturer' instruction.'' The patient would then have the 
opportunity to say, ``Yes, I understand; go ahead and use the 
reprocessed device.'' This, however, is obviously not being done. I 
believe the practice of reprocessing of single-use devices is a 
significant enough deviation that does warrant truly informed consent.
Why is information withheld?
    Before conducting a procedure, I don't hesitate to tell my patients 
that they have a one in ``x'' risk of perforation, the possibility of 
hemorrhage, or even death. Clearly, it is not atypical to advise 
patients of potentially serious or even possibly fatal events 
associated with procedures. So why is it that we hide information about 
the risks of reprocessed devices? The answer is that physicians and 
hospitals are comfortable saying, ``The procedure we're doing is the 
best available for your condition, while recognizing that no procedure 
is perfect. Here is the scientific information to show why, given the 
risk/benefit ratio, it is in your best interest.'' That is different 
from trying to hide the fact that ``We paid $50 for a single-use, 
disposable device, but by reusing it over and over, we will save the 
hospital money.''
    It is as though physicians and hospitals are not informing people 
about using reprocessed devices and are not asking for consent because 
they don't want people to know. If they are unwilling to ask for 
informed consent, does that not tell the whole story?
Do patients get equal treatment?
    A patient might rightfully question, ``Why do I go through life 
living so carefully and avoiding risky behavior, then you expose me to 
the risky behavior of someone else without telling me that the 
motivation is to save money for the institution?'' Or, ``Why does 
patient #1 get the benefit of a sterile, first-use device with no risk 
of disease transmission while I, patient #2, get a reprocessed 
device?'' There would be no justifiable answer.
                             in conclusion:
    I have never in my own profession or in related specialties heard a 
physician or hospital say, ``I think reprocessed single-use devices are 
better.'' The only justification is that ``it helps control costs and I 
think it's OK.'' Ardent supporters may say that they have conducted 
many procedures safely with reprocessed single-use devices without 
hearing about resulting deaths or diseases. But, you can't take a 
device apart to ensure that it's sterile, and therefore, one doesn't 
really know. We need to be open enough to state that we have seen 
tremendous microbiological studies, including DNA fingerprinting, that 
confirm that reprocessed devices can transmit disease. If we err on 
this position, we should do so on the side of public protection. I 
don't think the public is best served by waiting to form public policy 
until enough victims are amassed.
    You will hear from many people who will offer their legal, 
microbiological, and engineering perspectives. The real message you 
need to take away from me in my professional, life-long role as a 
patient advocate is that, while not dismissing the hospital or its 
association's role as the patient advocate, it is perhaps the physician 
who has the major advocacy role and who ultimately drives the decision.
    I understand cost containment, I am not a naive physician saying 
that cost doesn't matter. In today's healthcare climate, we all must be 
mindful of cost in order to be able to continue to deliver healthcare 
to the populace. In fact, I currently sit on the board of directors of 
a hospital and constantly deal with cost containment. However, 
understanding the need to control health care costs and making 
decisions for which current information tells us that our decisions may 
be injurious to the patient, are hopefully--and should be--mutually 
exclusive.
    In closing, I'd like you to ask yourselves this question: Would you 
want your loved ones who had the misfortune of being ill to be in the 
care of a doctor or a hospital where you sat in the waiting room and 
not only needed to worry about the disease that has afflicted them, but 
also had to worry about the safety of the very device used to try to 
bring about their wellness?

    Mr. Upton. Thank you for your final answer.
    Dr. Fielder?

                  TESTIMONY OF JOHN H. FIELDER

    Mr. Fielder. Mr. Chairman, I am John Fielder. I am a 
professor of Philosophy at Villanova University and I am here 
not representing any group.
    Risk is the probability of harm times the severity of harm. 
We know that the severity of harm, potential harm is very 
great. Hepatitis C, tuberculosis, and other diseases. What we 
do not know is how large the probability of that harm is, 
however, even if you have a low probability of harm, if the 
severity of harm is high, you have a significant risk. Now, the 
ethics of risk are clear and they are well established, both in 
ethics and law. It is the patient's right to be informed of the 
risk, informed of the benefits, the alternatives to treatment, 
and to give consent. These principles are based on the 
fundamental idea that persons are in charge of their lives and 
it is the job of healthcare professionals to guide them in 
making those decisions. Most patients are not informed that 
they are being treated with devices that pose additional risk 
to them over a single-use device.
    Last fall I prudently got a flu shot, went down to the 
infirmary at Villanova and they shot me, but I had to sign a 
consent form first that told me the dangers, the benefits, and 
the alternatives. So I signed it and I got my shot. And I was 
thinking as I was walking back that if it is appropriate for me 
to sign a consent form to get a flu shot like millions of other 
Americans, I would sure like to sign a consent form if somebody 
was going to put one of these things that had been in somebody 
else into my body and to bite off a piece of me to bring back 
for a sample. It is enlightening and constructive to try to 
construct a consent form for a patient who is going to be 
treated with a reused device. First the risk. Okay. We have 
talked about the risks, we know that there is a potential of 
transmission of disease, of functional degradation, and so 
forth.
    But what exactly are the benefits here to the patient? See, 
this is where we hit the ethical brick wall. The patient is 
getting no benefit by being treated with a reprocessed device. 
They are getting additional risk, but they are not getting any 
additional benefit. Now, you will be told that the savings from 
these reprocessed device will be put back into patient services 
and life will be better for patients and hospitals. This may be 
true. But it is also true that money might go into the pockets 
of investors or for-profit hospitals as well. Also, it seems to 
me if this is a great benefit, put it down, let patients decide 
if they want that benefit based on the risk that the device 
poses.
    I think the use of reprocessed devices in a present form is 
really a kind of vast medical experiment that we are doing. We 
do not really know the outcomes of using these extensively, we 
do not really know how much disease is being transmitted, and 
we are doing it without people's knowledge and consent. And 
that is wrong. We should not be doing that. A couple of other 
items. Fairness. I am pleased that the FDA is moving in the 
direction to make the regulatory burden for the original 
equipment manufacturers and the reprocessors more or less 
equal. That seems to be appropriate. It is simply unfair to ask 
one group to go through a complicated song and dance to get 
their device approved and not the others. Another item I am 
concerned about is labeling. Many times physicians do not know 
that they are using a reprocessed device. They do not open it 
in the operating room. Somebody else does and hands it to them. 
So when they get the device, it says Cortis, or Boston 
Scientific, or whatever, and they will think they are using an 
original device. I think that is unfair to the original 
equipment manufacturers because that is no longer their device 
once it is reprocessed. And I would urge FDA and perhaps this 
committee if it is appropriate, to make sure that this 
information about the device is on the device so that people 
who are using it can tell, and so that patients who may be 
damaged can use that if they want to sue for damages.
    Finally, as in all things, money is a big issue here. I 
know that hospitals are under tremendous financial pressure. 
Some of it from the Government, from HCFA and Medicare, some of 
it from insurers. One of the reasons this kind of problem pops 
up was that it is very hard to treat people in hospitals and 
make money and to stay afloat. I am very concerned that we 
create a system where hospitals start looking for places that 
are ethically questionable to save money. I would much rather 
have a system where they could do their work and have adequate 
resources to do it, and not have to consider this kind of 
practice. Thank you Mr. Chairman, I appreciate your holding 
hearings on this important topic.
    [The prepared statement of John H. Fielder follows:]
      Prepared Statement of John H. Fielder, Villanova University
Introduction
    The patient is the ethical center of health care. All who 
participate in patient care, directly or indirectly, are ethically 
obligated to provide adequate and appropriate care to patients and to 
safeguard their right to make informed health care decisions. Patients 
are ill, vulnerable, dependent, and usually ignorant of the nature of 
their illnesses, their treatment options, and what they mean for them. 
As a result, they require a greater degree of help and protection than 
persons who are not ill.
    Almost all health care procedures involve some risk to the patient. 
It is a long-standing tradition in ethics and law that patients have 
the right to decide what risks to take, and health care professionals 
have the obligation to inform them of the risks and benefits of 
alternative treatments, including nontreatment.\1\ Patients are in 
charge of their lives, not doctors. The greater the risk, the greater 
the patient protection that is needed. Formal biomedical research must 
meet extensive requirements concerning maximizing benefits while 
minimizing risks, independent review, and informed consent.\2\ The 
concept of informed consent embodies the ethical principles of patient 
autonomy and provider beneficence.
---------------------------------------------------------------------------
    \1\ Beauchamp, Tom, and Childress, James, Principles of Biomedical 
Ethics, Fourth Edition (1994), Oxford University Press, New York.
    \2\ Faden, Ruth, and Beauchamp, Tom, A History and Theory of 
Informed Consent (1986), Oxford University Press, New York.
---------------------------------------------------------------------------
Risk
    From the patients' point of view, the primary question concerns the 
risks posed by the reuse of medical devices approved by FDA only for a 
single use. The devices in question are those that pose the greatest 
risk to patients. No one worries about the reuse of single-use 
compression sleeves or bedpans. It is the complex devices like cardiac 
catheters, biopsy forceps, and similar devices that raise the most 
serious questions of risk. These devices enter the patient's blood 
stream, intestines, and major organs where disease organisms reside. 
They also have tiny passages for guide wires which may be difficult to 
clean and resterilize.
    It is important to distinguish the two factors that are used to 
determine risk. Risk is the product of the probability of harm and the 
severity of harm. Thus, high risk could result from the high 
probability of moderate harm as well as the low probability of very 
serious harm. In assessing risk we must look at both the seriousness of 
the potential harms as well as the likelihood of their occurrence.
    In addition, we need to distinguish two kinds of harms that may 
result from treatment with a reused single-use device. First, diseases 
may be transmitted from previous patients to the patient being treated 
through inadequate cleaning and resterilization. Second, devices may 
have their functional characteristics changed as a result of cleaning, 
so that patients may be injured or be given less than optimal 
treatment. Thus we need to look at the probability and severity of harm 
regarding both functional changes and disease transmission.
    From my study of reuse of single-use devices, the following facts 
emerge:

 We know that studies of reprocessed single-use devices by FDA 
        and others show that some devices have debris left in them and 
        are contaminated with fungi, bacteria, or viruses. A study of 
        Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon 
        catheters found that some clean easily while others seemed to 
        regularly get clogged. About half the samples grew organisms in 
        the middle sections.\3\ Other studies report residual organic 
        debris that cannot be adequately eliminated.\4\ Company-
        sponsored studies, some by independent laboratories, confirm 
        these results.\5\
---------------------------------------------------------------------------
    \3\ Merritt, Katherine, Hitchins, Vicki, Woods, Terry, and Brown, 
Stanley, ``Re-Use of Devices: Cleaning Issues,'' presentation at the 
Association for Medical Instrumentation/FDA Conference, The Reuse of 
Single-Use Devices: Practice, Patient Safety, and Regulation, Crystal 
City, VA, May 6, 1999. This information was taken from a public 
presentation; FDA has not made a report of this study publicly 
available.
    \4\ Yang M, Deng X, Zhang Z, Julien M, Pelletier F, Desaulniers D, 
Cossette R, Teijeira FJ, Laroche G, Guidoin R, ``Are intraaortic 
balloons suitable for Reuse? A survey of 112 used intraaortic 
balloons.'' 1997 Artificial Organs 21(2) 121-130.
    \5\ Two of the most extensive were conducted by Ethicon Endo-
Surgery, a Johnson and Johnson Company, ``Evaluation of Reprocessed 
Ethicon Endo-Surgery, Inc. Single-Use Medical Devices,'' (1998) Ethicon 
Endo-Surgery, Cinncinnati, OH, and Muradali, Kumaree, ``Report on Re-
furbished Single Use Devices,'' Cordis, a Johnson and Johnson Company, 
Miami Lakes, FL.
---------------------------------------------------------------------------
 We know that reprocessing devices can result in functional 
        changes. Another FDA study of PTCA balloon catheters found that 
        there were changes of up to 10% in balloon diameter after 
        reprocessing. Reprocessed balloons were also stickier that new 
        ones. The effects of cleaning agents on the various plastics 
        used in devices is materials-specific.\6\ The company-sponsored 
        study (see note 5) also found function changes in the devices 
        they studied.
---------------------------------------------------------------------------
    \6\ Brown, Stanley, Merritt, Katherine, Hitchins, Vicki, and Woods, 
Terry, ``Effect of Use and Simulated Reuse on Materials and PTCA 
Balloons and Catheters,'' presentation at the Association for Medical 
Instrumentation/FDA Conference, The Reuse of Single-Use Devices: 
Practice, Patient Safety, and Regulation, Crystal City, VA, May 6, 
1999. This information was taken from a public presentation; FDA has 
not made a report of this study publicly available.
---------------------------------------------------------------------------
 We know that devices approved for reprocessing have been 
        responsible for the transmission of TB and hepatitis C during 
        bronchoscopy and colonoscopy because of improper cleaning and 
        sterilization.\7\
---------------------------------------------------------------------------
    \7\ Bronowicki JP, Venard V, Botte C, Monhoven N, Gatin I, Chone L, 
Hudziak H, Rhin B, Delanoe C, LeFaou A, Bigard MA, and Gaucher P, 
``Patient-to-Patient transmission of Hepatitis C Virus During 
Colonoscopy,'' New England Journal of Medicine (1997) July 24; 337(4): 
237-40. Michele TM, Cronin WA, Graham NM, Dwyer DM, Pope DS, Harrington 
S, Chaisson RE, Bishai WR, ``Transmission of Mycobacterium Tuberculosis 
by a Fiberoptic Bronchoscope. Identification by DNA Fingerprinting,'' 
Journal of the American Medical Association (1997) Oct. 1; 
278(13):1093-5.
---------------------------------------------------------------------------
 We know that reprocessed devices can also transmit diseases. 
        Sixty percent of pediatric patients treated with reused 
        tracheostomy tubes contracted pneumonia compared to 25% treated 
        with new ones.\8\ We do not know if other diseases, 
        particularly hepatitis C, are being transmitted because no 
        studies have screened patients before treatment and tested them 
        later. A report by a well-regarded independent organization 
        concluded that ``there is no clear evidence that reuse of 
        single-use medical devices is either safe or unsafe for 
        patients.'' \9\
---------------------------------------------------------------------------
    \8\ Bahng, Susanna, VanHaln, Sonja, Nelson, Virgina, Hurvits, 
Edward, Roloff, Dietrich, Grady, Elizabeth, Lewis, Cathy, ``Parental 
Report of Pediatric Tracheostomy Care,'' Archives of Physical Medicine 
and Rehabilitation, (1998) Vol. 79; 1367-9.
    \9\ ECRI Special Report, Reuse of Single-Use Devices: Making 
Informed Decisions (1996). ECRI, Plymouth Meeting, PA., p. 1.
---------------------------------------------------------------------------
 We know that reprocessed devices have failed and injured 
        patients. A patient undergoing cardiac catheterization for 
        coronary angiography reported a sudden loss of vision in his 
        right eye. The procedure was stopped and an examination of the 
        eye revealed a green crystalline foreign body within the 
        central retinal artery on the optic nerve head. The catheter, 
        approved only for a single use, was reautoclaved, making it 
        more friable. A fragment had broken off and traveled to the 
        central retinal artery, occluding blood flow. Treatment of the 
        injury was unsuccessful and the patient was left with only 
        light perception in his right eye.\10\ In another case the tip 
        of a reused cardiac catheter broke off and lodged in a 
        patient's atrium.\11\
---------------------------------------------------------------------------
    \10\ Hallermann D, Singh G. ``Iatrogenic central retinal artery 
embolization: a complication of cardiac catheterization.'' Annals of 
Opthalmology 1984; 16:1025-27.
    \11\ MedWatch report, 3/18/99. MedWatch is a voluntary reporting 
system of FDA.
---------------------------------------------------------------------------
 We know that a few studies in peer-reviewed journals show that 
        single-use and reprocessed devices have similar rates of in-
        hospital adverse events. One study in this literature is a 
        double-blind, randomized control trial of 1,033 procedures, of 
        which 753 were reused PTCA balloon catheters. They found slight 
        differences in serious adverse complication rates, urgent 
        coronary artery bypass surgery, and abrupt vessel closure.\12\
---------------------------------------------------------------------------
    \12\ Mak, Koon-Hou, Eisenberg, Mark, Plante, Sylvain, Strauss, 
Bradley, Arheart, Kristopher, and Topol, Eric, ``Absence of Increased 
In-Hospital Complications with Reused Balloon Catheters,'' The American 
Journal of Cardiology (1996) Vol. 78; 717-9.
---------------------------------------------------------------------------
    Several conclusions can be drawn from these facts.
Changes in Functional Characteristics
    Severity of Harm: Reprocessed devices can fail and cause serious 
injuries. Other changes in functional characteristics can result in 
difficulties in treatment that may result in injuries or additional 
exposure to risk.
    Probability of Harm: There are only a few reports in the literature 
of patients being harmed by failure of these devices, but it is likely 
that device failures are underreported. Also, physicians may not 
recognize problems caused by reprocessing. The probability of in-
hospital adverse events does not appear to be high, but more studies 
need to be done to confirm this.
    This analysis suggests that the probability of harm from functional 
failure is likely to be low, although more good scientific evidence is 
needed to establish this with reasonable certainty. I conclude that 
patients who are treated with reprocessed single-use devices are being 
subjected to a low risk of failure to function adequately.
Transmission of Disease
    Severity of Harm: Reprocessed devices have the potential to 
transmit deadly diseases; thus the severity of harm is high.
    Probability of Harm: The probability of transmission of disease is 
unknown but is certainly greater than zero. It also varies with the 
type, brand, and model of device.
    The real risk is not in functional failure but in the transmission 
of disease. The severity of harm is great from TB and hepatitis C, and 
we simply do not know much about the probability of this happening with 
reprocessed single-use devices. We do know that improper cleaning and 
resterilizing of used devices can transmit these diseases, and we know 
that there is no manufacturer-developed and FDA-approved protocol for 
cleaning them. Even if this is a low probability of harm, the severity 
of the consequences creates a significant risk for patients.
Informed Consent
    In cases where patients are exposed to a significant risk, ethics 
requires that they be informed of the benefits of treatment, the risks, 
and the alternatives. This is true even for common, low risk 
procedures. Last October I got a flu shot at the Villanova University 
Health Center. Vaccines have a small probability of triggering an 
immune reaction that can cause serious illness or death. Because of 
this I was asked to read and sign a consent form that informed me of 
the benefits of the injection, the risks, and alternatives. The form is 
appended to this document.
    Since patients treated with reprocessed single use devices are also 
exposed to a significant risk, it is enlightening to construct a 
consent form for this procedure. Imagine that you are being asked to 
consent to the use of a reprocessed device in your treatment instead of 
an otherwise identical new, single-use device.
    The form would have to state that the potential harms include the 
possibility of transmission of TB and hepatitis C, very serious 
diseases, and possible functional changes or failures. While some 
studies suggest that the probability of these events occurring is low, 
we do not really know how likely they are.
    What are the benefits? None to you, the patient, only to the 
hospital's finances. Note that the consent form may also have to 
include the fact that the hospital has a significant financial interest 
in treating patients with reprocessed devices.\13\
---------------------------------------------------------------------------
    \13\ Moore v. Regents of the University of California, 51 Cal. 3d 
120 (1990)
---------------------------------------------------------------------------
    What are the alternatives? Besides nontreatment and any other less 
invasive procedures, you could be treated with a new device at no extra 
cost to you and avoid these potential complications. In effect, you are 
being asked to take significant risks in your treatment for no 
corresponding benefit to you but to contribute to the financial health 
of the hospital.
    To see how this works in practice, consider two patients, in 403A 
and 403B, both scheduled for cardiac catheterization. The patient in 
403A will be treated with a new, single-use device and will have no 
risk of the infection being transmitted by the catheter, nor will that 
patient or the physician have to worry about any functional changes 
from previous uses. In contrast, the patient in 403B is put at risk, 
without any corresponding therapeutic benefit, and without the 
patient's knowledge or consent. This is simply ethically unacceptable. 
You cannot put people at risk without their informed consent.
Patient Benefit
    Proponents of reuse sometimes argue that savings will be passed on 
to patients in the form of more and better services, but this is a weak 
argument. First, in for-profit hospitals those savings will, in part, 
be returned to investors as dividends. Second, it is not guaranteed 
that any savings will directly affect the patients taking the risk, 
because savings may well be applied to other hospital service areas. 
Third, patients being treated with a reprocessed device may get some 
indirect benefit from previous savings generated by reuse, but none 
from their treatment with a reprocessed device. Fourth, if these are 
patients' benefits, no matter how remote, shouldn't they have the right 
to decide where they should be spent? The fact of the matter is that it 
is the hospitals who benefit, and that benefit may have some indirect 
beneficial impact on patient care. But this does not alter the fact 
that any beneficial impact that accrues to a particular patient is 
greatly out of proportion to the risks being taken.
Medical Experimentation
    There are further ethical anomalies in the reuse of single-use 
devices. When you take your flu shot, the probability of harm is 
reasonably well established. When you are treated with a reprocessed 
device, there are substantial unknowns, especially concerning disease 
transmission. Consequently, the use of reprocessed devices is a form of 
experimental treatment, providing an even stronger claim for the 
traditional ethical protections, particularly informed consent.
        The adequacy of consent to a pure experiment of to experimental 
        treatment raises more issues than consent to an established 
        therapy simply because less is known about the risks involved 
        in an experimental procedure . . . Therefore a prospective 
        subject must be aware that little is known about the possible 
        risks and consequences . . .\14\
---------------------------------------------------------------------------
    \14\ Woltjen, Maria ``Regulation of Informed Consent to Human 
Experimentation,'' Loyola University of Chicago Law Journal, Vol. 17 
(1986), p. 313.
---------------------------------------------------------------------------
    In the absence of adequate scientific evidence to establish the 
probability of harm, particularly the transmission of disease, and in 
the absence of FDA-approved, device-specific protocols for cleaning, 
resterilizing and number of permitted uses, the continued use of 
reprocessed medical devices is a large, ongoing medical experiment, but 
one that lacks even the rudimentary protections to patients, 
particularly the requirements that risk be proportional to patient 
benefit and informed consent.
    This raises further questions about the ethical responsibilities of 
all who participate in this practice--hospitals, health care 
professionals, and reprocessors. Because the use of reprocessed medical 
devices is an unethical form of medical experimentation, then the 
hospitals, physicians, and other health care professionals who take 
part in it are also not meeting their obligations to put patient 
interests first and to uphold their right to informed consent.
Other Ethical Issues
    Regulatory Fairness: Risk and patient protection are the primary 
ethical issues, but there are others that need to be mentioned. 
Original equipment manufacturers (OEM's) who wish to market a reusable 
device must submit a validated protocol to FDA for approval. The 
protocol must include scientific evidence to show that it can be 
properly cleaned and resterilized, the effect of cleaning an 
resterilization on the materials, functionality, and safety of the 
device, and the number of times it can be reprocessed without loss of 
safety and effectiveness. No such regulatory burden falls on the 
reprocessor, who must, at most, meet good manufacturing and quality 
control standards. This is an unequal burden for which there is no 
adequate justification. Thus the present arrangements are unfair to 
OEM's. However, FDA has recently taken significant steps to bring 
reprocessed devices under greater regulatory scrutiny.
    Labeling: Reprocessed devices still bear the name of the OEM on the 
device, but in a real sense it is no longer theirs, since they can no 
longer vouch for their safety and effectiveness. Unless there is clear 
information in the labeling of the reprocessed device, there is the 
misleading suggestion that the device has the assurance of quality, 
safety, and effectiveness associated with the OEM, or that any failure 
is to be attributed to the OEM.
    OEM's and Reprocessors: Are OEM's unethical for failing to produce 
reusable catheters? Critics have charged that what were once reusable 
devices were simply relabeled for single use. Is this practice wrong? 
The FDA does not have the authority to determine what products 
companies may develop or what they charge for them. It is a basic 
principle of our economic system that producers have a right to decide 
what products they wish to market as long as they meet all legal and 
regulatory requirements. Unless there is some strong reason to think 
otherwise, OEM's and reprocessors are not ethically obligated to make 
or withhold particular products.
Conclusion
    Hospitals are under severe financial pressure from payers, 
including Medicare and HCFA. They are, understandably, looking for ways 
to cut costs and using reprocessed devices is one of them. However, 
this practice is, at present, ethically unacceptable because of the 
severity of potential harm to patients, the lack of knowledge about the 
probability of disease transmission, and the absence of device-specific 
FDA standards for cleaning and resterilizing. It amounts to an 
extensive medical experiment without patient benefit, knowledge, or 
consent.
    It may be useful to end with the observation that it is the problem 
of costs that is driving the issue of reuse of single-use medical 
devices. The present arrangements encourage ethically questionable 
arrangements because of the pressure to cut costs of services.

    Mr. Upton. Thank you very much.
    Dr. Maurer, welcome.

                  TESTIMONY OF WALTER G. MAURER

    Mr. Maurer. Thank you. Mr. Chairman, members of the 
committee, I am Dr. Walter Maurer, Director of Quality 
Management at the Cleveland Clinic Foundation in Cleveland, 
Ohio. I am here today on behalf of the American hospital 
Association. In addition to being Board Certified and 
practicing in both the areas of internal medicine and 
anesthesiology, I serve as Medical Director of the Office of 
Quality Management. With approximately 50,000 surgeries and 
more than 1.5 million outpatient visits yearly, it is my 
responsibility to guide and direct our quality management team 
in ensuring the highest level of patient care is provided. I 
also chair the Quality Council, the Safety Coordinating 
Committee, and the Joint Commission Preparation Team.
    The term reuse and reprocess can encompass numerous 
scenarios and they take place in multiple locations: In 
hospitals, ambulatory surgical centers, and physician offices. 
Some hospitals utilize the services of third party reprocessors 
while others reprocess within their own facilities. In some 
cases, the device never touches a patient. For example, almost 
every day at the Cleveland Clinic we have a surgery cancelled 
or postponed, sometimes after the operating room has been 
prepped for the procedure. That preparation may include 
assembling customized procedure trays that contain many open 
single-use devices, such as needles, scalpels, and syringes. I 
have with me here today what we term our total hip pack. This 
total hip pack costs us $236. I just spent $236. This is 
medical trash. Right now this is all thrown away. This is gone.
    Another common scenario is the use of a low risk device, 
one that does not penetrate a sterile tissue plane or mucus 
membrane during use, but may simply contact the patient's skin. 
For instance, the device put on a patient's leg to promote 
circulation comprised largely of plastic and fitting like a 
sleeve over a patient's leg. Hospitals routinely clean, 
sterilize, inspect, and repackage these types of devices. 
Ironically the most controversial reprocessing practice is 
probably the least common for hospitals, that of cleaning, 
sterilizing, and repackaging a single-use, critical device 
after it has been used on a patient. With constrained 
healthcare resources and a heightened commitment to the 
environment, reprocessing does makes sense.
    I need only reiterate the slogans we now teach our 
children, the three Rs of reduce, reuse, and recycle. AHA 
members are committed to being better stewards of the 
environment by pledging to reduce, not increase waste. The AHA 
strongly supports the FDA's plan to develop a research program 
to help bridge the data gap between the perceived and actual 
safety risks associated with the reuse of single-use devices. 
We must move away from anecdotal reports although they are 
important to look at. Research should be directed at more 
complex or high-risk devices and be peer reviewed and published 
for credibility. This will provide device specific scientific 
evidence regarding patient safety. We applaud the FDA's plan to 
develop consensus standards for the reprocessing of single-use 
devices. The FDA should include all stakeholders, 
manufacturers, third party reprocessors, healthcare facilities, 
physicians, and members of the public in developing the 
consensus standards.
    At the Cleveland Clinic, for example, our cardiology 
electrophysiology laboratory reprocesses diagnostic heart 
catheters. These are solid tubes without hollow lumens. Each 
catheter is limited to five uses. First it is thoroughly 
cleaned by professionals in sterile processing. It is then 
tested after each and every use for electrical and mechanical 
safety and function and only then re-sterilized. Each year 
standard operating procedures are reviewed and patient outcomes 
are assessed. The sterilization practices are regularly 
reviewed and staff competency assessed. Since 1993 our lab has 
had a continuous quality improvement project on any infections 
caused by any procedures done in that lab. Infection cases are 
then reviewed with the Infectious Disease Department.
    Additional oversight is provided through existing Federal 
and State agencies charged with ensuring safe quality patient 
care. We must restore the meaning to the term single-use. 
Original equipment manufacturers have little to no incentive to 
label their devices as reusable, and, in fact, have financial 
incentives to self-designate devices as single-use. In the last 
2 years we have observed products that have been historically 
labeled as reusable arriving with the single-use label with no 
observable change in the product. These are orthopedic saw 
blades. Stainless steel. There are no small lumens in these. 
This is reusable. This is not. The ones that we have started to 
use reprocessors of, I found out, are marked when they come 
back. So we know which ones are reusable and how many times 
they have been reused.
    The FDA should begin to regulate the use of single-use only 
labels and require manufacturers to both justify labeling a 
device as single-use and provide scientific data specifying any 
re-sterilization or reprocessing techniques that may compromise 
the integrity of the device. In conclusion, Mr. Chairman, 
patient safety is the first and foremost concern of all 
hospitals and health systems. The AHA believes that the FDA's 
proposed strategy on the reuse of single-use devices represents 
a thoughtful approach to a complex issue. And we are pleased 
that the FDA has been consulting with front-line caregivers and 
other experts in its effort to make the standards even more 
meaningful. We further believe that the additional legislation 
is unnecessary at this time and would only undermine the 
progress that the FDA has already made. We welcome the 
opportunity to work with the FDA to ensure the best practices 
are universally used. Thank you.
    [The prepared statement of Walter G. Maurer follows:]
 Prepared Statement of Walter Maurer, Cleveland Clinic Foundation, on 
              Behalf of the American Hospital Association
    Mr. Chairman, I am Walter Maurer, M.D., director of quality 
management at the Cleveland Clinic Foundation in Cleveland, Ohio. I am 
here today on behalf of the American Hospital Association's (AHA) 
nearly 5,000 hospital, health system, network, and other health care 
provider members. We are pleased to have the opportunity to testify on 
the long-standing practice of reprocessing medical devices.
    The Cleveland Clinic Foundation, founded in 1921, integrates 
clinical and hospital care with research and education in a private, 
non-profit group practice. Last year at the Cleveland Clinic and 
Cleveland Clinic Florida, more than 850 physicians representing 100 
medical specialties and subspecialties provided care for more than 1 
million outpatient visits and close to 50,000 hospital admissions.
    I have spent most of my career as a private practice internal 
medicine specialist and anesthesiologist at the Cleveland Clinic with a 
focus on outpatient, pediatric, and ear, nose and throat anesthesia. I 
also have been involved in resident education, quality assurance and 
preoperative testing. Currently, I serve as the medical director of the 
Office of Quality Management. The role encompasses the hospital, its 
ambulatory settings including community health centers, and a long-term 
care facility. With approximately 50,000 surgeries and more than 1.5 
million outpatient visits yearly, it is my responsibility to guide and 
direct our quality management team in ensuring the highest level of 
patient care is provided. I also chair the Quality Council, the Safety 
Coordinating Committee and the Joint Commission Preparation Team.
                               background
    The term ``reuse'' and ``reprocess'' can encompass numerous 
scenarios, and they take place in multiple locations, in hospitals, 
ambulatory surgical centers and physician offices. Some hospitals 
utilize the services of third-party reprocessors while others reprocess 
within their own facilities. In some cases, the device never touches a 
patient. For example, almost every day at the Cleveland Clinic we have 
a surgery cancelled or postponed, sometimes after the operating room 
has been prepped for the procedure. That preparation may include 
assembling customized procedure trays that contain many open single-use 
devices (SUDs), such as needles, scalpels, sponges and syringes. What 
becomes of these devices when the surgery is cancelled? Most of it 
would be unfortunately wasted as ``medical trash'', but because of 
increased environmental concerns and cost reduction initiatives, we 
have found that we can safely sterilize, inspect and repackage many 
devices for later use.
    In another scenario, often a manufacturer will ship SUDs to 
hospitals with separate sterilization instructions, if the manufacturer 
is experiencing a period of high demand and has not had time to 
sterilize the SUDs prior to shipment. Hospitals sterilize, inspect and 
repackage these devices too.
    Another common scenario is the reuse of a non-critical device-one 
that does not penetrate a sterile tissue plane or mucus membrane during 
use, but may contact the patient's skin. For instance, a sequential 
compression device, which is used on the patient's leg to promote 
circulation and avoid deep vein thrombosis, is comprised largely of 
plastics and fits like a sleeve over a patient's leg. Hospitals 
routinely sterilize, inspect and repackage these types of devices.
    Ironically, the most discussed reprocessing practice is probably 
the least common for hospitals: that of cleaning, sterilizing and 
repackaging a single-use, critical device after it has been used on a 
patient so it can be used again on another patient.
                        reprocessing makes sense
    Many medical products can be safely reused. The AHA is unaware of 
any evidence to demonstrate a problem with reprocessed SUDs. With 
constrained health care resources and a heightened commitment to the 
environment, reprocessing makes sense. I need only reiterated the 
slogans we now teach our children--that's the three R's--reduce, reuse, 
and recycle. AHA members are committed to being better stewards of the 
environment by pledging to reduce, not increase waste. In 1998, the AHA 
and the Environmental Protection Agency initiated a joint-partnership 
to reduce hospitals' total waste volume by 50 percent by 2010. 
Responsible waste management and recent cost reduction initiatives have 
resulted in the discovery that hospitals can safely sterilize, inspect, 
and repackage many devices for later use.
    The AHA is encouraged by the Food and Drug Administration's (FDA) 
decision to provide guidance in this area to ensure and enhance patient 
safety, which is the first and foremost concern of AHA members. AHA 
members have a great deal of experience with reprocessed medical 
devices and have been working closely with the FDA as it refines its 
strategy. We believe that the agency's Proposed Strategy represents a 
thoughtful approach to a complex issue; it both echoes and furthers the 
goals of patient safety, which we share.
    The potential for device malfunctions, patient injuries, or 
infections related to the reprocessing and reuse of single-use devices 
is a matter of great concern to hospitals and health systems. The AHA 
strongly supports the FDA's plan to develop a research program to help 
bridge the data gap between the perceived and actual safety risks 
associated with reuse of SUDs. Such research should be directed at the 
more complex or highrisk devices and be peer reviewed and published for 
credibility. This will provide device-specific scientific evidence 
regarding patient safety.
    The AHA also is encouraged by the FDA's proposal to categorize SUDs 
into risk categories, and we agree that the level of regulation for a 
device correspond to the level of risk to a patient.
    Furthermore, the AHA applauds the FDA's plan to develop consensus 
standards for the reprocessing of SUDs. These kinds of standards would 
go a long way toward addressing the safety, and effectiveness of 
reprocessing. The FDA should use a ``community best practices'' 
approach for low-risk devices and a more formal FDA interdisciplinary 
advisory panel for high-risk devices. The FDA should include all 
stakeholders--manufacturers, third-party reprocessors, health care 
facilities, physicians and members of the public--in developing the 
consensus standards.
                       oversight of reprocessing
    Hospitals are subject to significant regulatory and accreditation 
oversight by entities such as the Health Care Financing Administration, 
the Joint Commission on Accreditation of Healthcare Organizations 
(JCAHO), state licensing authorities, and other county and city 
agencies, particularly with respect to patient safety and quality of 
care. By contrast, only one outside source--the FDA, regulates 
manufacturers and third-party reprocessors.
    Hospital reprocessing activities are marked by a high degree of 
physician involvement, supervision and control. In many cases, a multi-
disciplinary committee, such as the infection control committee, 
consisting of clinical staff (physicians and nurses) and operational 
staff (sterile processing, risk management, and materials management) 
oversees the reprocessing activities of health care facilities. This 
committee monitors reprocessing quality assurance and improvement 
activities, recommends strategies for improving performance, and 
reports such findings and recommendations to the facility's performance 
improvement oversight committee, medical staff and governing body.
    Through its membership, activities and reporting structure, this 
type of multi-disciplinary committee meets the requirements of numerous 
JCAHO standards, including those for surveillance, prevention and 
control of infection, etc. Naturally, medical professionals and the 
health care facilities in which they practice have as their primary 
mission quality patient care, and have in place standards, policies and 
procedures for reprocessing.
    At the Cleveland Clinic, for example, our cardiology 
electrophysiology laboratory reprocesses both non-lumen diagnostic 
electrophysiology catheters and non-lumen radiofrequency ablation 
catheters. Each catheter is used five times or less. It is tested after 
each use for electrical and mechanical safety and function, and then 
resterilized. Each year, standard operating procedures are reviewed and 
patient outcomes are assessed. The sterilization practices are 
regularly reviewed and staff competency assessed. Since 1993 our lab 
has had a continuous quality improvement project on any infections 
caused by any procedures done in the lab. Infection cases are then 
reviewed with the Infectious Disease Department.
    Reprocessing standards, policies and procedures, in conjunction 
with the quality improvement program, are designed specifically to 
protect the well-being of hospital patients. Existing nonFDA regulatory 
oversight, which the AHA believes includes the components necessary to 
address and satisfy the FDA's concerns in this area, has resulted in 
the development of these processes.
    For instance, JCAHO, during its announced and unannounced surveys, 
focuses heavily on patient safety. In addition to visiting patient care 
and reprocessing areas to observe infection control practices, JCAHO 
reviews the minutes of the infection control committee, the medical 
staff executive committee, the performance improvement oversight 
committee and the governing body. The inspectors look for evidence of 
sufficient reporting of performance improvement information and for 
action on performance improvement recommendations. Failure to 
adequately demonstrate compliance in these areas would result in 
substantial findings of noncompliance for the facility.
               restore meaning to the term ``single use''
    Original equipment manufacturers have little incentive to label 
devices as reusable, and, in fact, have financial incentives to self-
designate devices as ``single use.'' Manufacturers appear to use the 
term ``single use only'' as part of their labeling without justifying 
whether, in fact, the device can be safely reprocessed for subsequent 
use. In the last two years, we have observed products that have been 
historically labeled as reusable, arriving with the ``single use only'' 
label with no observable change in the product.
    We must ensure that the label ``single use only'' is meaningful and 
not simply an attempt to increase device sales. Currently, device 
manufacturers determine whether a device is labeled ``single use.'' 
However, the FDA should begin to regulate the use of the ``single use 
only'' label and require manufacturers to both justify labeling a 
device as ``single use'' and provide scientific data specifying any 
resterilization or reprocessing techniques that compromise the 
integrity of the device. Manufacturers are the repository for data on 
the functional specifications of their devices and know the most about 
the ability of their devices to hold up to repeated cleanings and 
sterilizations. They should share that information with those of us who 
use the devices, and be actively involved in developing consensus 
standards.
          opened but unused devices deserve special treatment
    As discussed earlier, it is common practice for hospitals to 
reprocess open, but unused, SUDs. Many SUDs are routinely opened prior 
to use and are assembled as part of customized procedure trays that 
contain several devices. Sterile processing professionals assemble, 
wrap and sterilize these trays, which may consist of single-use and 
disposable items. It is essential that hospitals be permitted to open 
singleuse devices, combine them with other devices as needed for each 
medical procedure, and resterilize the entire tray. The creation of 
these trays in advance of surgeries and other procedures is designed to 
avoid delays in the surgical suite, create efficiencies, and prevent 
subsequent infection during the procedure. Treating this process as a 
``reprocessing'' activity impedes these efforts.
    As I stated earlier, any regulation should reflect the relative 
risk of the device involved. Reprocessed devices that have been opened, 
but not used on a patient, do not need to be part of the FDA's 
guidance. Resterilization and repackaging of such devices pose 
virtually no risk for patients.
    There are three general areas of risk associated with reprocessing: 
1. contamination of the device, if it is not properly cleaned and 
sterilized, could lead to infection; 2. the cleaning and/or 
sterilization process could harm the integrity of the device; and 3. 
the repeated use of the device in subsequent procedures could harm the 
integrity of the device.
    With respect to unused devices, the third risk is eliminated 
entirely. A major component of the first risk, patient 
crosscontamination, is also eliminated. The only possible risks, 
therefore, are whether the device can be adequately resterilized and if 
the process of resterilization somehow harms the device. Hospitals have 
a great deal of experience in sterilization of medical devices as 
sterilization is routinely performed on many types of devices. In fact, 
as mentioned earlier, it is not uncommon for manufacturers to ship SUDs 
to hospitals with separate sterilization instructions. Therefore, many 
providers suspect that the ``single use only'' label and ``do not 
resterilize'' instructions are not based on reliable scientific 
evidence.
                               conclusion
    Mr. Chairman, as we have already noted, patient safety is the first 
and foremost concern of all hospitals and health systems. The AHA 
believes that the FDA's proposed strategy on the reuse of SUDs 
represents a thoughtful approach to a complex issue, and we are pleased 
that the FDA has been consulting with front-line caregivers and other 
experts in its effort to make the standards even more meaningful. This 
is an important step towards the goal of assuring patient safety. For 
the sake of all concerned, we commend the FDA's efforts to move 
forward, with all deliberate speed, to finalize its strategy. We 
further believe that additional legislation is unnecessary at this time 
and would only undermine the progress that FDA has already made towards 
developing a balanced and reasonable regulatory structure. We welcome 
the opportunity to work with the FDA to ensure best practices are 
universally used.

    Mr. Upton. Thank you very much.
    Mr. Feltner?

                    TESTIMONY OF VERN FELTNER

    Mr. Feltner. Good afternoon. The Association of Medical 
Device Reprocessors appreciates the opportunity to present 
testimony regarding the reprocessing of medical devices labeled 
as single-use. My name is Vern Feltner. I am President of 
Alliance Medical Corporation. We are a member of AMDR. AMDR is 
a trade association representing the legal and regulatory 
interests of third party reprocessors of medical devices 
labeled as single-use. It is estimated that AMDR members 
perform approximately 80 percent of the third party 
reprocessing done in the United States. AMDR is not here today 
seeking exemption from regulation and oversight. In fact, just 
to the contrary. AMDR believes that a strong, rational, FDA 
regulatory regime is critical to ensuring the safety of 
reprocessed devices. FDA currently imposes a number of 
regulatory controls on third-party reprocessors, and membership 
in AMDR requires compliance with all applicable FDA 
requirements. In AMDR's view, protecting the patient must be of 
the highest priority, and accordingly FDA regulation of 
reprocessing must be based on demonstrated patient safety risk 
and not on hypothetical risk designed to provoke public alarm.
    Unfortunately much of the opposition of reprocessing comes 
from original device manufacturers who view reprocessing as an 
economic threat, and who stand to reap enormous financial gains 
by eliminating reprocessing as an option for hospitals. Their 
strategy has been to portray reprocessing as unsafe, but the 
facts simply do not support their claim. The truth is that the 
safety record of reprocessing is excellent. As you will hear, 
reprocessing enjoys the support of major hospital and physician 
groups, and the safety of reprocessing has been demonstrated in 
numerous peer review studies and scientific studies. AMDR 
companies, themselves, have reprocessed over 9 million devices 
with very few problems. In order to ensure the safety of their 
devices, AMDR members adhere to several important safety 
principles, including testing every single device before it is 
returned to the hospital that requested that reprocess.
    The reality is that proper reprocessing of certain medical 
devices labeled for single-use is absolutely safe. 
Manufacturers label devices as single-use, not because FDA 
requires a single-use designation, but because the manufacturer 
chooses that label. And what we have seen again and again is a 
single-use label being used for economic reasons as a way to 
sell more devices, and not out of a concern for patient safety. 
Hospitals that discard devices that could easily be 
reprocessed, are wasting resources that could be directed 
toward improvement in patient access and medical technology.
    Mr. Chairman, as I listened to the testimony being given I 
would like to take the rest of my short period of time and set 
the record straight on a couple issues that I believe are very 
important. First, there seems to be a gross impression that the 
industry is not regulated. Nothing could be farther from the 
truth. Reprocessors must comply with FDA QSRs just like 
manufacturers. The fact is that FDA does not regulate all 
medical companies in exactly the same way. There is a whole 
industry known as device servicers and refurbishers. FDA 
considers these companies to be manufacturers, but pre-market 
review and compliance with QSRs are not required. Second, an 
issue I believe that is most important and certainly of highest 
concern to everyone here and that is patient safety.
    This is a hard one to say, but there have been documents 
distributed, even to members of this committee that at best are 
misleading and disingenuous. At worst blatant untruths. There 
have been articles commissioned and published insinuating that 
multitudes of patient injuries due to the use of reprocessed 
devices are labeled as single-use, and that patient safety lies 
in using only the new devices. Facts are stubborn things, and 
the facts expose the disingenuous nature of these accusations. 
Public records solidly promote the efficacy and safety of 
commercially reprocessed devices. As a matter of comparison 
between AMDR companies and just four device manufacturers, the 
four that happen to be so strongly fighting our industry, the 
facts state this. In the reporting period from January 1997 to 
March 1999, 27 months, there were three medical device reports 
filed concerning devices reprocessed by AMDR companies. In the 
same reporting period for just these four device manufacturers, 
there were in excess of 16,000 medical device reports filed, 
11,827 product malfunctions reported, 2,508 patient injuries 
recorded, and a very unfortunate number of 163 deaths 
associated with the new products. Now, everyone knows that the 
delivery of healthcare is not risk free. Not for one moment am 
I suggesting that any of these companies market inherently 
unsafe products. These are good companies, good histories, made 
up on the most part of good and caring people. But the facts 
remain that in the 12 year history of the reprocessing 
industry, there shows an excellent record, whether you judge it 
on its own or whether you compare it to the OEM industry 
segment. I thank you for your time.
    [The prepared statement of Vern Feltner follows:]
  Prepared Statement of the Association of Medical Device Reprocessors
    The Association of Medical Device Reprocessors (AMDR) appreciates 
the opportunity to present testimony regarding the reprocessing of 
medical devices labeled for single-use. My name is Vern Feltner, and I 
am President of Alliance Medical Corporation. AMDR is a trade 
association representing the legal and regulatory interests of third-
party reprocessors of medical devices labeled for single-use. It is 
estimated that AMDR members perform approximately 80 percent of the 
third-party reprocessing done in the United States. Members of AMDR 
serve a nationwide customer base of hospitals and outpatient surgery 
centers, and reprocess a limited set of devices in several clinical 
areas, including perioperative, cardiology, orthopedics, patient floor, 
and respiratory therapy. AMDR companies contract with hospitals in all 
50 states, and reprocessing takes place in many of the elite hospitals 
of our nation.1 AMDR companies very likely work with 
hospitals in the districts of many Subcommittee members.
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    \1\ See ``America's Best Hospitals,'' U.S. News & World Report, 
July 19, 1999, at 61.
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    AMDR is not here today seeking exemption from regulation and 
oversight. To the contrary, AMDR and the reprocessing industry can only 
survive in a clear, rational regulatory scheme. It is important, 
however, that any regulatory scheme be based on demonstrated public 
safety risks and not on hypothetical risks designed to provoke public 
alarm. This industry is made up of people who are doctors, nurses, 
parents, husbands, and wives. Our families are the very ones on whom 
reprocessed devices will be used. If there was truly a question of 
increased risk to patients and, therefore, to our families, we would 
not be in this business. The hospitals we serve are populated by 
doctors who live and work under the Hypocratic Oath, which is based 
upon the premise that patient safety must come first. In fact, the 
reprocessing industry came to be as a direct result of doctors who saw 
the need for reprocessing. Yes, we are a business, and yes, hospitals 
have bottom-lines, but that does not mean that our motives are suspect 
or that reprocessed devices are inherently unsafe. All businesses have 
bottom lines. AMDR members stand committed to complying with all Food 
and Drug Administration (FDA) requirements applicable to third-party 
reprocessing. It is in AMDR's best interest to ensure that reprocessing 
is a safe, rationally regulated practice that hospitals can utilize to 
conserve health care resources without compromising patient care.
                       i. history and background
    Over Two Decades of Successful Reprocessing. From the recent press 
and congressional interest, one might believe that reprocessing of 
medical devices labeled for single-use is new, uncharted territory. One 
might also assume that reprocessing is a haphazard practice applied 
indiscriminately to a garden variety of medical devices. In fact, these 
assumptions are entirely false. The reprocessing of certain medical 
devices labeled for single-use has taken place for over two decades. 
The American Hospital Association (AHA) calls reprocessing of ``single-
use'' devices ``a safe and standard medical practice'' that hospitals 
have used ``for years with excellent success.'' The American College of 
Cardiology wrote to Congress that ``there are cardiovascular 
specialists who have been using reprocessed catheters in their labs for 
more than 20 years and cannot cite a single instance where a 
reprocessed catheter has broke[n] or caused infection.'' And the Mayo 
Clinic states that ``for more than 20 years, the catheters used in 
electrophysiology procedures have been reprocessed at Mayo and have 
continued to function normally without any evidence of infection.'' 
2
---------------------------------------------------------------------------
    \2\ See Attachment A for these letters.
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    Hospitals originally began to reprocess for two reasons: 1) certain 
devices initially labeled ``reusable'' were switched to ``single-use'' 
without any structural change in the device; and 2) doctors and nurses 
recognized the inherent waste in discarding certain devices after one 
use. The single-use designation is not based on a determination by FDA. 
To the contrary, the single-use label is chosen by the original 
equipment manufacturers (OEMs), and, for many devices, the single-use 
designation is a marketing decision, not a safety decision. AMDR 
believes that much of the attack on the reprocessing industry is also 
based on marketing concerns, not true safety concerns. The math is 
easy--the more devices that are reprocessed, the fewer brand-new 
devices are purchased, and that much less money is made by 
manufacturers.
    Making the Decision to Reprocess. Hospitals do not reach the 
decision to reprocess lightly. Rather, they rely on committees made up 
of physicians, nurses, sterile processing professionals, infection 
control specialists, risk managers, and hospital lawyers to determine 
whether a specific device can and should be reprocessed. At each AMDR 
company, the specific devices are carefully scrutinized in order to 
determine whether they can be safely and effectively reprocessed. 
Because of this rigorous selection process utilized by hospitals and 
third-party reprocessors, only a small percentage of the thousands of 
medical devices used by hospitals are actually reprocessed.
       ii. third-party reprocessing is an fda-regulated industry
    In the past, manufacturers have claimed that third-party 
reprocessing is an ``unregulated'' industry. The fact is that third-
party reprocessors are currently required to comply with a number of 
FDA regulatory requirements, the most significant of which is the 
Quality System Regulation. The Quality System Regulation is an 
extensive set of quality assurance provisions governing every aspect of 
a reprocessor's operations, including production and process controls, 
process validation, control of non-conforming product, and finished 
device acceptance. Pursuant to these Quality System Regulation 
requirements, third-party reprocessors must: (1) control and monitor 
production processes to ensure that a device conforms to its 
specifications; (2) validate with a high degree of assurance that their 
reprocessing processes ensure that specified requirements are met; and 
(3) establish and maintain procedures for reprocessed device acceptance 
to ensure that each production run, lot, or batch meets acceptance 
criteria. See 21 C.F.R. Part 820. In other words, reprocessors must 
document that they have developed comprehensive systems to assure that 
a reprocessed device is clean, sterile, and able to perform its 
originally intended clinical function. The functional testing step of 
reprocessing differs significantly from the testing performed by device 
manufacturers: AMDR companies functionally test every single 
reprocessed device before sending it back to a hospital, whereas device 
manufacturers test only a small sampling of their finished devices.
    Third-party reprocessors must make all required Quality System 
Regulation information and data available for FDA inspection 
3, and firms that fail to comply with these requirements are 
subject to agency enforcement action. In addition to complying with 
Quality System Regulation requirements, third-party reprocessors also 
are required to: (1) register with the agency; (2) comply with FDA 
labeling controls; (3) and adhere to Medical Device Reporting (MDR) 
regulation requirements. Pursuant to MDR requirements, third-party 
reprocessors must report to FDA certain device malfunctions and device-
related patient adverse events.
---------------------------------------------------------------------------
    \3\ All AMDR companies have been inspected by FDA in the last 12 
months.
---------------------------------------------------------------------------
    AMDR members reprocess three broad categories of medical devices 
labeled for single-use: 1) opened devices that have never been used; 2) 
unopened devices whose expiration date has passed; and 3) previously 
utilized devices. All three of these categories are reprocessed in 
compliance with the rigorous quality assurance requirements contained 
in FDA's Quality System Regulation.
    iii. the manufacturers' allegations are based on one overriding 
                           concern: economics
    Manufacturers Want to Erect Economic and Regulatory Barriers to 
Market Competition. In AMDR's view, there exists little, if any, 
factual basis for the vast majority of objections to third-party 
reprocessing. The major medical device manufacturers have embarked on a 
crusade at the federal and state level to eliminate third-party 
reprocessing. This is not a surprise. Hospitals are fully aware that 
the ``single-use'' label on a medical device does not necessarily mean 
that it should be discarded after one use. As the AHA noted, ``In our 
view, the real issue is not whether reuse is appropriate, but whether 
the single-use label is a complete and accurate representation of the 
device.'' 4 For hospitals, proper reprocessing offers a way 
to maintain the highest quality patient care, while also achieving 
significant cost savings.
---------------------------------------------------------------------------
    \4\ See Attachment A.
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    Reprocessed Devices are More Affordable, and Market Competition 
Exerts Downward Pressure on the Price of New Devices. It is clear that 
third-party reprocessing represents a potentially formidable economic 
threat to manufacturers. A future where hospitals no longer needlessly 
discard certain devices labeled for single-use could, ultimately, mean 
a future of lower profits for manufacturers. The fact is that 
reprocessing has already had a substantial impact on the sales and 
profits of device manufacturers. Indeed, every time a hospital chooses 
to reprocess a device rather than purchase a new device, that means a 
lost sale for manufacturers. In addition, in an effort to persuade 
their customers not to reprocess, manufacturers have lowered the price 
of their devices. Lower prices generally mean lower profits.
    The experience of one hospital that utilizes third-party 
reprocessing services is particularly telling. EP Technologies, Inc., a 
division of Boston Scientific Corporation, informed the hospital that 
it
        would be willing to supply [the hospital] with new catheters at 
        the price of each returned catheter, if I (the hospital's Chief 
        of Infection Control Service) would stop reprocessing . . . 
        Being dumbfounded with this offer for cutting the price in half 
        for each new catheter, I immediately asked her (the E.P. 
        Technologies representative) where her integrity was with 
        keeping the price so high all this time? She had no 
        answers.5
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    \5\ Letter from Dana Gruber, Chief, Infection Control Service, 
Brooke Army Medical Center, to William B. Stoermer, Jr., Executive Vice 
President, Alliance Medical Corporation (December 29, 1999). See 
Attachment B.
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Not surprisingly, the device manufacturers fail to acknowledge that 
their opposition to third-party reprocessing is rooted in economics. 
Rather, they repeatedly assert that their primary motivation is patient 
safety. While emotionally appealing, the manufacturers' professed 
interest in patient safety is disingenuous at best, misleading at 
worst. As set out below, third-party reprocessing is a safe, federally-
regulated industry. When performed properly, third-party reprocessing 
poses no threat to patient safety.
A. Manufacturers Frequently Designate a Device As ``Single-Use'' For 
        Economic Reasons, Rather Than Out Of Concern For Patient Safety
    FDA does not require manufacturers to designate certain devices as 
``single-use'' only. There are no FDA regulations or formal standards 
distinguishing the quality or functionality of reusable devices from 
single-use devices. The discretion to label a device as single-use lies 
solely with the device manufacturer.
    The ``Single-Use'' Label Provides Little Indication of the 
Product's Useful Life. The device manufacturers have repeatedly 
contended that devices labeled for single-use must be discarded after 
one use because they are manufactured in such a way that makes reuse 
prohibitive. As a practical matter, however, it is nearly impossible to 
manufacture a medical device for ``one use and only one use.'' For 
example, a surgical instrument labeled for single-use does not ``wear 
out'' simply because it was used in a surgical case that took three 
hours rather than two hours. Likewise, it is absurd to suggest that if 
a scissor labeled for single-use is utilized to snip only once in a 
surgical case, then its entire useful life has been exhausted. In 
reality, a manufacturer's ``single-use'' designation on a medical 
device provides little indication of the product's useful life. The 
``single-use'' designation more often than not reflects a 
manufacturer's decision to market a product that will lead to a 
needless waste of scarce health care resources. The key issue should be 
the device's functionality. If a device labeled for single-use can be 
properly cleaned, packaged, and sterilized without negatively affecting 
its functionality, it can, and should, be used again.
    Evidence that manufacturers often designate devices as single-use 
for economic reasons, rather than out of a concern for patient safety, 
is abundant. For example, the December 11, 1998, episode of NBC's 
``Dateline'' exposed Johnson & Johnson's practice of labeling as 
``single-use'' contact lenses 6 that were virtually 
identical to the lenses that the company had been marketing as 
reusable. Thus, consumers were needlessly discarding lenses after one 
use. When asked why it had designated the lenses as single-use, Johnson 
& Johnson stated: ``If we had changed the label and marketed for 
general use, then we couldn't advertise and create this single-use, 
daily disposable category. We made that decision because we felt it was 
a good business decision to do it that way.'' 7
---------------------------------------------------------------------------
    \6\ AMDR members do not reprocess contact lenses.
    \7\ Transcript of December 11, 1998, Dateline episode at 5 
(emphasis added).
---------------------------------------------------------------------------
    Another example is a letter written by USCI Cardiology & Radiology 
Products (USCI) to a hospital explaining that, although USCI had 
decided to change the label on a particular device from reusable to 
single-use, it had made no structural changes to the device. 
Specifically, USCI stated: ``[O]ur manufacturing processes of Woven 
Dacron Intracardiac Electrodes have not changed. These electrodes are 
made with the same materials and in the same manner they have been in 
the past.'' 8 In another example, Microvasive, a division of 
Boston Scientific Corporation, advised hospitals that, although 
Microvasive's hemostatic probes are labeled for single-use only, they 
may be reused under certain circumstances. Specifically, the 
Microvasive notice states: ``BICAP' Hemostatic Probes are 
recommended for single-use only. However, this recommendation does not 
prohibit reuse under certain specific conditions . . .'' 9
---------------------------------------------------------------------------
    \8\ See Attachment C.
    \9\ See Attachment D.
---------------------------------------------------------------------------
    In light of the above evidence, the manufacturers' protestations 
that the single-use designation on a device is never arbitrary, and 
that ``economics must be subordinate to this concern for proper 
health'' 10 ring hollow. The reality is that some devices 
that carry a single-use label are suitable for reprocessing, and many 
are not. Every product--whether it is labeled ``single-use'' or 
``reusable''-- must be assessed individually to determine whether it 
can be cleaned, packaged, and sterilized without impairing 
functionality. Hospitals, and their doctors and nurses, should not be 
forced to needlessly discard devices labeled for single-use that could 
be safely reprocessed. Hospitals should be free to redirect their 
limited resources where they are truly needed--toward improvements in 
patient access and medical care.
---------------------------------------------------------------------------
    \10\ Josephine Torrente, President, Association of Disposable 
Device Manufacturers, testimony to Illinois State Board of Health Board 
Meeting and Public Hearing Regarding the Reprocessing of Medical 
Devices Labeled for Single-Use, December 10, 1998.
---------------------------------------------------------------------------
B. When Done Properly, Third-Party Reprocessing Is Safe
    The most frequently levied allegation in the manufacturers' arsenal 
of scare tactics is that third-party reprocessing is unsafe. There 
simply is no factual basis for this claim. The manufacturers cling 
desperately to this argument as a way to disguise what is, for them, an 
economic issue. The facts are as follows: AMDR member companies have 
collectively reprocessed over 9 million devices labeled for single-use 
with very few problems.
    Indeed, FDA itself recently stated that it ``has been unable to 
find clear evidence of adverse patient outcomes associated with the 
reuse of a single-use device from any source.'' 11 
Similarly, a physician with the Centers for Disease Control and 
Prevention remarked that he ``would just be absolutely amazed if 
[reprocessing] is a major health problem and the [leading hospitals] 
have failed to realize it.'' 12
---------------------------------------------------------------------------
    \11\ Letter from David W. Feigal, Director, Center for Devices and 
Radiological Health, FDA, to Larry R. Pilot, McKenna & Cuneo. See 
Attachment E.
    \12\ Lauran Neergaard, Debate on Reuse of Medical Devices, 
Associated Press, August 13, 1999.
---------------------------------------------------------------------------
1. The Safety Record Of Reprocessed Devices Is Excellent--As 
        Demonstrated By The Handful Of MDRs And As Compared To The OEM 
        Record
    Based on FDA's own database of device-related patient adverse 
events, the safety record of reprocessing is excellent. Pursuant to the 
agency's MDR regulation, hospitals must notify FDA when they learn that 
a device may have caused or contributed to a patient death or serious 
injury. 21 C.F.R. Sec. 803.30. Every year, FDA receives over 100,000 
MDR reports. Significantly, there have been only a handful of MDR 
reports associated with reprocessed devices. Indeed, FDA itself 
recently remarked that the number of MDR reports involving reprocessed 
devices is ``tiny'' compared with other problems.13 
Furthermore, the incidents reported in the few MDRs involving 
reprocessed devices are identical to problems that have occurred in new 
devices. Thus, it is not at all clear that these incidents were caused 
by reprocessing.14
---------------------------------------------------------------------------
    \13\ Device & Diagnostics Letter, Vol. 26, No. 48 (Dec. 17, 1999) 
at 1.
    \14\ As one example, an MDR report was submitted to FDA concerning 
a reprocessed electrophysiology (EP) catheter whose tip became 
detached. MDR Report Number 1062310-1999-00001. See Attachment F. 
However, the identical incident has been reported for new EP catheters. 
MDR Report Numbers 4501350000-1995-0088 and 6000087-1998-00002. See 
Attachment G.
---------------------------------------------------------------------------
    There are Thousands of MDR Reports on Brand New Devices Each Year. 
The OEMs have made much noise about the handful of MDRs on reprocessed 
devices. Attached to my testimony is a chart of some of the MDRs for 
the few companies leading the attack on reprocessing. From January 1997 
to March 1999, a 27-month period, Boston Scientific companies had a 
total of 2,396 MDRs. This number includes 874 injuries and 50 deaths. 
Johnson & Johnson companies had 11,327 MDRs, including 1,239 injuries 
and 58 deaths. Mallinckrodt companies had 1,755 MDRs, including 90 
injuries and 47 deaths. Tyco companies had 552 MDRs, including 305 
injuries and 8 deaths.15
---------------------------------------------------------------------------
    \15\ See Attachment H.
---------------------------------------------------------------------------
    As you can see, there are numerous examples of medical devices 
causing patient injury during their first use. For example, a 1994 
outbreak of post-surgical infections has been attributed to bacteria-
contaminated sutures manufactured by Ethicon, Inc. (Ethicon), a 
division of Johnson & Johnson. The contamination allegedly resulted 
from a malfunction in Ethicon's sterilization system.16 
Ethicon ultimately recalled 3.6 million packages of 
sutures.17 As another example, FDA recently found that an 
improperly functioning coronary stent system manufactured by Boston 
Scientific Corporation had caused 26 patient injuries, and may have 
been a factor in the death of one individual. Boston Scientific 
Corporation is engaged in a recall of the defective 
stents.18 We cite these examples to show that the use of 
medical devices is not and will likely never be 100% problem-free. That 
said, the reprocessing industry believes that having one injury is 
still one injury too many, and we will continue to strive to make our 
services as safe as possible.
---------------------------------------------------------------------------
    \16\ See, e.g., Lance Williams, ``Common thread in illnesses: 
sutures lawsuits blame postsurgical infections on a single source,'' 
San Francisco Examiner (Feb. 21, 1999); Lance Williams, ``Patients 
wounded by infections across the country, lives have been torn by post-
op complications,'' San Francisco Examiner (Feb. 21, 1999); Lance 
Williams, ``How suture maker kept lid on infection suits despite 
recall, Ethicon said product was harmless,'' San Francisco Examiner 
(Feb. 22, 1999); Lance Williams, ``Patients who suffered,'' San 
Francisco Examiner (Feb. 22, 1999).
    \17\ See, e.g., FDA Enforcement Reports 94-43 & 95-08.
    \18\ See, e.g., Ronald Rosenberg, ``Boston Scientific, FDA spar 
over stent,'' The Boston Globe (October 10, 1998).
---------------------------------------------------------------------------
2. The Warning Letters Received By Certain Third-Party Reprocessors Do 
        Not Constitute Evidence That Third-Party Reprocessing Is Unsafe
    The device manufacturers also cite FDA Warning Letters received by 
certain third-party reprocessors as evidence that third-party 
reprocessing is unsafe. Once again, the manufacturers are not applying 
their own logic to themselves. While it is true that some third-party 
reprocessors have been issued FDA Warning Letters, most, if not all 
manufacturers have also received FDA Warning Letters. Indeed, FDA often 
issues Warning Letters to device manufacturers.19
---------------------------------------------------------------------------
    \19\ FDA's Center for Devices and Radiological Health issued 303 
Warning Letters in 1999. See www.fda.gov/foi/warning.htm and 
Thompson.com, an FDA Warning Letter Monitor.
---------------------------------------------------------------------------
    By way of background, a Warning Letter is based upon an FDA 
inspector's inspectional observations and is not independently 
verifiable by a court or other impartial finder of fact. A Warning 
Letter is informal and advisory, and constitutes only an FDA 
communication that the Agency considers a violation to 
exist.20 Typically, the company in question addresses the 
concerns raised in the Warning Letter, and FDA re-inspects the facility 
to ensure that any necessary changes have been made.21
---------------------------------------------------------------------------
    \20\ See Regulatory Procedures Manual at Ch. 4; FDA Office of 
Regulatory Affairs Warning Letter Reference Guide (October 4, 1994) at 
p.14.
    \21\ As an example, we are including an FDA letter issued to an 
AMDR member company indicating that, in FDA's view, the concerns raised 
in the Agency's Warning Letter had been adequately addressed. See 
Attachment I.
---------------------------------------------------------------------------
    By failing to frame FDA Warning Letters in their proper 
perspective, and by choosing not to disclose that manufacturers 
themselves often receive Warning Letters, the manufacturers clearly 
hope to create the impression that FDA has singled out third-party 
reprocessors for some sort of special scrutiny. This is not the case. 
Actually, a discussion of our receipt of Warning Letters helps prove 
our case--that reprocessors are subject to FDA oversight, that 
oversight is active even as we sit here. Also, what is important is 
that the Warning Letter recipient take the appropriate steps to address 
the agency's concerns. While AMDR members have full confidence in the 
safety and efficacy of their operations, they recognize that there is 
always room for improvement, and they welcome FDA's input in this 
regard. But, if the suggestion that receipt of Warning Letters means 
that reprocessed devices are inherently unsafe, then brand new devices 
should also be considered inherently unsafe. We do not believe this 
line of thinking is logical and urge the manufacturers to be consistent 
in their application of the facts.
3. A Substantial Body Of Peer-Reviewed Scientific Literature 
        Demonstrates The Safety Of Reprocessing
    Physician and hospital groups have articulated strong support for 
reprocessing. There is also a significant body of independent, peer-
reviewed scientific literature confirming the medical community's 
confidence in the safety of reprocessing devices labeled as single-use. 
Indeed, studies demonstrating the safety and efficacy of reprocessing 
have been published in a number of highly esteemed medical journals, 
including Gastrointestinal Endoscopy, The American Journal of 
Gastroenterology, Journal of the American College of Cardiology, 
Journal of Thoracic Cardiovascular Surgery, Pacing and Clinical 
Electrophysiology (PACE), American Journal of Cardiology, Medical 
Journal of Australia, Canadian Journal of Surgery, and Canadian Journal 
of Cardiology.22
---------------------------------------------------------------------------
    \22\ See Attachment J for a bibliography and summary of these 
studies.
---------------------------------------------------------------------------
    As one example, Dr. Richard Kozarek, Chief of Gastroenterology at 
the Virginia Mason Medical Center in Seattle, Washington, and former 
President of the American Society for Gastrointestinal Endoscopy, has 
conducted a number of independent studies demonstrating the reusability 
of certain endoscopic accessories. In the area of sphincterotomes 
labeled as single-use, for instance, Dr. Kozarek found that ``[d]ouble 
channel sphincterotomes marketed as one-time-use items can be reused 
safely when properly cleaned.'' 23 Likewise, with respect to 
argon beam plasma coagulation (APC) probes labeled for single-use, Dr. 
Kozarek concluded:
---------------------------------------------------------------------------
    \23\ R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., T.J. Ball, M.D., 
J.J. Brandabur, M.D., ``Reuse of disposable sphincterotomes for 
diagnostic and therapeutic ERCP; a one-year prospective study.'' 
Gastrointestinal Endoscopy, Vol. 49 (1999) at 39.
---------------------------------------------------------------------------
        The combination of manual cleaning and ETO sterilization 
        consistently cleaned APC probes. Ninety percent of the probes 
        showed no sign of physical deterioration and 100% maintained 
        their electrical activity after 10 uses. APC probes can 
        potentially be safely and effectively reused up to 10 times, 
        and a significant procedural savings is possible with reuse.'' 
        24
---------------------------------------------------------------------------
    \24\ S.K. Roach, R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., and 
S.E. Sumida, Ph.D., ``In Vitro Evaluation of Integrity and 
Sterilization of Single-Use Argon Beam Plasma Coagulation Probes,'' The 
American Journal of Gastroenterology, Vol. 94 (1999) at 139.
---------------------------------------------------------------------------
    As another example, Dr. Edward V. Platia, a nationally recognized 
electrophysiologist at the Washington Hospital Center in Washington, 
D.C., conducted an extensive multi-center study of the reuse of 
electrophysiology (EP) catheters, involving 14,640 EP cases and 48,075 
catheter uses. Dr. Platia concluded that:
        the sterilization and reuse of non-lumen, woven Dacron pacing 
        catheters is safe, and does not appear to result in any 
        increase in the risk of infection. The catheters are 
        sufficiently durable to allow them to be reused well in excess 
        of five times. One-time use of such catheters appears to be an 
        unnecessary and expensive policy.25
---------------------------------------------------------------------------
    \25\ E.V. Platia, M.D., S. O'Donoghue, ``Reuse of Pacing Catheters: 
a Survey of Safety and Efficacy,'' PACE, Vol. 11 (Sept. 1988) at 1280.
---------------------------------------------------------------------------
    What is, perhaps, most striking about the rigorous body of 
scientific evidence supporting the safety and efficacy of reprocessed 
devices is its dramatically superior quality, as compared to the 
``studies'' offered by the OEMs that oppose reprocessing. Indeed, most 
of the ``scientific evidence'' submitted by the opponents of 
reprocessing should be disregarded, as: (i) much of it was conducted by 
the OEMs themselves, rather than independent entities, and, as such, is 
tainted by the OEMs' clear economic incentive to portray reprocessing 
in a negative light; and (ii) much of it is plagued by fundamental 
scientific deficiencies, such as lack of an adequate sample size, and, 
as a result, cannot serve as a basis for any conclusions about the 
safety of reprocessed devices.
4. Tracking And Tracing Systems For Reprocessed Devices Help Ensure 
        Accountability And Safety
    Third-party reprocessing is not conducted in a black hole where no 
one is accountable. There are several steps taken to ensure appropriate 
tracking and tracing of each device. Once a hospital makes a 
determination that a specific type of device can be reprocessed, AMDR 
members pick up a batch of the devices from the hospital, reprocess 
those devices, and return the same devices to the hospital. AMDR 
members also ensure that there are numerous ways to determine whether a 
device was reprocessed and to identify who the reprocessor was. For 
example, some reprocessors employ bar code tracking systems, which 
allow devices to be tracked back to the reprocessor. Likewise, some 
reprocessors provide hospitals with ``peel-off'' labels, which can be 
placed in a patient's record to identify where the device was 
reprocessed. Therefore, it is quite easy for a doctor and a hospital to 
know if a reprocessed device was used and to identify who the third-
party reprocessor was.
5. Proper Reprocessing Does Not Require Access To The Manufacturer's 
        Specifications
    One the most misleading arguments made by the manufacturers is that 
third-party reprocessors are incapable of safely reprocessing devices 
labeled for single-use because they lack access to the original 
manufacturer's specifications. The assertion that the manufacturer's 
specifications are required to reprocess most devices is misleading.
    Access to manufacturers' specifications is unnecessary because 
third-party reprocessors employ a variety of techniques to equip 
themselves with intimate knowledge about the workings of every device 
they reprocess. For example, in addition to utilizing every publicly 
available source of product-related information, e.g., product 
labeling, marketing materials, AMDR members also use independent 
laboratories to ``reverse engineer'' certain devices. In addition, AMDR 
member companies are engaged in an ongoing dialogue with the clinical 
users themselves, i.e., the hospitals and physicians, in order to 
understand the performance requirements for each device they reprocess.
    More importantly, AMDR member companies have developed validated 
protocols to ensure that every device they reprocess is safe and 
effective for its intended use. If an AMDR member lacks sufficient 
information about a device in order to safely reprocess it, then that 
device will not be reprocessed. Furthermore, as described above, AMDR 
members--unlike manufacturers--perform functionality testing on every 
single device that they reprocess. Thus, the manufacturers' argument 
that access to the original specifications is necessary to safely 
reprocess devices labeled for single-use is without merit. Indeed, if 
the manufacturers were correct in this claim--and they are not--it 
certainly is difficult to understand why so many hospitals and doctors' 
groups have endorsed the use of reprocessing.
iv. the manufacturers' call for ``informed consent'' is simply another 
                    prong of their economic argument
    As part of their campaign to create an ``aura'' of suspicion around 
third-party reprocessing, the manufacturers argue that the very doctors 
committed to treating and curing the sick are keeping patients ``in the 
dark'' about the alleged hazards of third-party reprocessing. Indeed, 
the manufacturers advocate vociferously for mandatory ``informed 
consent'' regarding the use of reprocessed devices.
    Although dressed up in the garb of patient safety, the 
manufacturers' informed consent argument is merely another prong of 
their economic agenda. Medical ethicists state that the objective of 
informed consent is to arm patients with sufficient information to make 
a prudent judgment about their medical care. If a physician believes 
that the use of a certain device or procedure will increase a patient's 
risk, then the physician should disclose this to the patient. Properly 
done, third-party reprocessing presents no additional risk to patients. 
Because properly reprocessed devices are as safe and effective as new 
devices, there is no ethical basis for requiring informed consent 
before the use of reprocessed devices.
    Should There be Informed Consent for New Devices? It is striking 
that, although they push vigorously for informed consent with respect 
to the reprocessing of devices labeled for single-use, the 
manufacturers conspicuously avoid the obvious implications of their own 
argument. According to the manufacturers' thinking, a physician should 
tell a patient before using any device that has been the subject of an 
MDR report, Warning Letter, or recall. Similarly, it seems only logical 
that the manufacturers would demand informed consent with respect to 
the ``second use'' of devices that are labeled reusable. The 
manufacturers do not make these arguments because they realize that 
informed consent regarding MDR reports, Warning Letters, and recalls 
would be detrimental to their own economic interests.
                             v. conclusion
    As we have demonstrated, when performed properly third-party 
reprocessing is safe. Third-party reprocessors are required to comply 
with a host of FDA requirements. Hospitals that take advantage of the 
benefits of third-party reprocessing can maintain the highest quality 
patient care, while also achieving significant cost savings. Resources 
saved through third-party reprocessing can be redirected toward 
improvements in patient access and medical technology. We believe that 
patient safety is of utmost concern, but health care cost containment 
is also of extreme importance. In this age of rising health care costs, 
reprocessing is one of the few technologies that offers a solution.
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    Mr. Upton. Thank you.
    Dr. Trotter?

                 TESTIMONY OF C. GRIFFIN TROTTER

    Mr. Trotter. Thank you. I am Griffin Trotter. I am an 
Assistant Professor of Ethics and an Assistant Professor of 
Surgery at Saint Louis University, Sciences Center. As a matter 
of record, I am not representing any particular organization 
and have not received an honorarium for this appearance. 
However, the Association of Medical Device Reprocessors has 
covered my travel and my lodging expenses. As an emergency 
physician and medical ethicist, my expertise is in general 
ethical and clinical considerations. I am not an expert in the 
reprocessing of medical devices, and hence will confine my 
comments about safety issues to general remarks concerning 
clinical risks and the moral requirement for informed consent.
    In clinical medicine, healthcare providers are morally 
obliged to disclose significant risks pertaining to any 
treatment, test, or procedure that they have recommended or 
intend to undertake. Determining which risks count as 
significant for the purposes of disclosure is an important 
clinical challenge that is widely addressed by the use of a 
material risks standard. Risks are material when they are 
likely to be relevant to the decisions of reasonable patients. 
When risks are very remote, disclosure is not required and, in 
fact, may even detract from informed consent by inducing 
unreasonable fears. Physicians or other clinicians are 
generally the individuals who bear the task of disclosing 
risks. However, in an age of managed care, many decisions 
governing the practice of medicine and its attendant risks, are 
determined at an institutional level. In such instances, the 
moral obligation for obtaining informed consent may shift away 
from the individual clinician to the institutional provider.
    For example, an institution that reprocesses the contents 
of its suture kits may have a moral responsibility to inform 
clients of thispractice, if, indeed, it was determined that the 
use of these kits poses a significant risk. One problem is that 
it is not clear whether the material risk standard applies or 
even makes sense at this level. Informed consent in this 
context pertains not so much to decisions about specific 
treatments or procedures, but to patient's decisions about 
whether or not they want to subscribe to a given healthcare 
plan. The likely risk pertaining to the use of a reprocessed 
single-use medical device will vary depending on the nature of 
the device, the previous use of the device, the reprocessing 
method, and the proposed manner in which the device will be 
reused. These variations, along with the aforementioned 
intricacies that pertain to the material risk standard, make it 
very difficult to articulate a uniformed requirement for 
informed consent. However, if standards for reprocessing 
medical devices are sufficiently rigorous to ensure that these 
devices may be used safely, then there is no more requirement 
for informed consent.
    My opinion is that if the use of reprocessed single-use 
medical devices is not safe, then these devices simply should 
not be used. Ensuring that the devices are safe is a far better 
strategy than legislating burdensome requirements for informed 
consent that would amount to one more bureaucratic obstacle to 
the provision of a swift, efficient, and effective response to 
our patients' needs. Thank you.
    [The prepared statement of C. Griffin Trotter follows:]
   Prepared Statement of C. Griffin Trotter, Center for Health Care 
                     Ethics, Saint Louis University
                                summary
    In clinical medicine, health care providers are morally obliged to 
disclose significant risks pertaining to any treatment, test or 
procedure that they have recommended or intend to undertake. The 
determination of which risks count as ``significant'' for the purposes 
of disclosure is an important clinical challenge that is widely 
addressed by the use of a ``material risks'' standard. Risks are 
material when they are likely to be relevant to the decisions of 
reasonable patients. Physicians or other clinicians generally disclose 
these risks. However, in some cases it may be more appropriate if 
institutions obtain informed consent. If use of reprocessed single-use 
medical devices was shown to be risky, then hospitals or other 
corporate providers who systematically use these devices have a moral 
obligation to inform their clients of this practice. On the other hand, 
when risks are very remote, disclosure is not required and, in fact, 
may even detract from informed consent by inducing unreasonable fears.
    The likely risks pertaining to the use of a reprocessed single-use 
medical device will vary, depending on the nature of the device, the 
previous use of the device, the reprocessing method and the proposed 
manner in which the device will be reused. These variations make it 
difficult to articulate a uniform requirement for informed consent. 
However, if standards for reprocessing medical devices are sufficiently 
rigorous to ensure that these devices may be used safely, then there is 
no moral requirement for informed consent.
    In assessing the relevant scientific data pertaining to the reuse 
of single-use devices, objective sources (such as the FDA and the CDC) 
are preferred over other sources (such as original equipment 
manufacturers, reprocessors and even the news media) that have 
important financial interests hinging on the interpretation of this 
data.
    Health care policy concerning the use of reprocessed single-use 
devices should be guided by the Principle of Subsidiarity, which 
implies that regulatory authority and action should be concentrated at 
the lowest hierarchical level of government where there is sufficient 
competence. This principle points, once again, to the importance of 
garnering advice from important regulatory agencies such as the FDA.
                           written statement
    Mr. Slobodin has asked me to testify about safety and policy issues 
associated with the use of reprocessed single-use medical devices 
(abbreviated ``RSUDs'' in subsequent text). As a physician and medical 
ethicist, my expertise is in general ethical and clinical 
considerations that may pertain to the use of these devices. I am not 
an expert in the reprocessing of medical devices and, hence, will 
confine my comments about safety issues to general remarks concerning 
clinical risks and the moral requirement for informed consent.
    Valid informed consent consists of three elements: disclosure, 
understanding and voluntariness. Disclosure involves the relay of 
relevant information (risks, anticipated benefits, costs and 
alternatives) about recommended medical interventions to medical 
decision-makers (i.e., patients or patients' proxies). Understanding 
involves the ability of medical decision-makers to grasp the disclosed 
medical information and to deliberate about choices in a manner that 
integrates this information with the patient's goals and values. 
Voluntariness is freedom from undue constraint. Undue constraints 
include various forms of coercion, as well as emotional and social 
constraints that hinder reasonable decisions.
    If the proposed use of a RSUD bodes a significant risk, then this 
risk should be disclosed to patients. Various standards for what ought 
to count as a ``significant risk,'' requiring disclosure, have been 
offered. In a landmark 1972 U.S. Circuit Court decision, Judge 
Spotswood G. Robinson articulated the ``material risk'' standard. 
According to this standard (which is now widely accepted) all material 
risks should be disclosed. A risk is material ``when a reasonable 
person, in what the physician knows or should know to be the patient's 
position, would be likely to attach significance to the risk or cluster 
of risks in deciding whether or not to forgo the proposed therapy.'' 
Robinson held that serious complications that occurred in less than 1% 
of cases were generally not material risks.
    Robinson's 1% standard probably does not apply for risks that could 
be easily avoided. Hence, even a 0.2% additional risk posed through the 
use of reprocessed medical devices may be material if the complications 
in question are serious and new devices are readily available and 
affordable. The rationale for requiring a higher standard of disclosure 
in such instances would be that the risks are clinically unnecessary. 
Where to draw the line for disclosing such risks is debatable, and our 
ultimate decision will of necessity be somewhat arbitrary (just as the 
standards of statistical significance that we use in estimating risk 
are themselves somewhat arbitrary).
    Saving money is not an adequate reason for foregoing disclosure, 
unless there is an agreement (tacit or explicit) between patient and 
provider that the provider may pursue cost savings whenever the risks 
do not exceed a certain (more generous) threshold. The degree to which 
such tacit understandings operate in a managed care environment is 
debatable. Physicians and/or corporate health care providers often are 
not expected or required to disclose risks that may pertain when they 
employ cost-saving medical technologies or protocols that are less than 
the best available. For instance, hospitals with a policy of not 
providing pelvic ultrasounds after radiologists' office hours are not 
required to post a warning on the emergency department doorway that 
announces this policy to patients. As another example, physicians 
generally are not expected to disclose whether the lab is measuring 
cardiac enzymes by the traditional chromatography method or with the 
newer, more effective mass spectrometry method. As a practicing 
clinician and patient advocate, I am more worried about these practices 
than I am about not disclosing the use of reprocessed medical devices, 
since I believe the potential risks are generally less serious in the 
latter instance.
    If it is determined that risks of using reprocessed medical devices 
are minimal, then the process of trying to disclose these risks could 
actually hinder the integrity of informed consent by promoting 
irrational concerns (thus constraining understanding and 
voluntariness). Two pitfalls pertain.
    1. Patients do not generally reason statistically. Even when a risk 
is statistically very remote, most patients will assume that if you 
mention it, then it is a clinically significant risk. I often 
illustrate this point to medical students by noting that if one pointed 
out the known risks of taking a bath (e.g., possible traumatic brain 
hemorrhage, drowning, and broken bones), then most patients unfamiliar 
with the process of bathing would refuse the procedure outright, even 
if you explained that the cumulative serious risks were less than one 
in fifty thousand.
    2. Patients often maintain un-warranted superstitions about the 
hazards of contact with others' bodies. Members of the media who hope 
to turn the use of reprocessed medical devices into a high-profile 
health care scandal have used these superstitions as emotional 
leverage. Magic Johnson's decision to quit professional basketball is 
an example of how concern about the transmission of AIDS is sometimes 
overwrought. Even health care workers tend to be irrational about the 
issue of AIDS transmission. A number of health professionals have 
expressed concern about occupational AIDS transmission and hope that 
their occupational risks can be minimized through the development of an 
effective AIDS vaccine. However, many of these same health care 
professionals have failed to obtain immunization against hepatitis B, 
despite data showing that the occupational risk of dying from hepatitis 
B is far greater than it is for AIDS.
    In an age of managed care, issues about the context of informed 
consent emerge. Often, decisions governing the practice of medicine--
and its attendant risks--are determined at an institutional level. In 
such instances, the moral obligation for obtaining informed consent may 
shift away from the individual clinician to the institutional provider. 
For example, an institution that reprocesses the contents of its suture 
kits may bear a moral responsibility for informing clients of this 
practice (if it was determined that the use of these kits poses a 
significant risk). One problem is that it is not clear whether or not 
the material risk standard applies, or even makes sense, at this level. 
Informed consent, in this context, pertains not so much to decisions 
about specific treatments or procedures, but to patients' decisions 
about whether or not they want to subscribe to a given health care 
plan.
    Several public policy implications follow from these considerations 
about informed consent. First, the problem of determining the risks of 
using RSUDs is crucial. The likely risks pertaining to the use of a 
reprocessed single-use medical device will vary, depending on the 
nature of the device, the previous use of the device, the reprocessing 
method and the proposed manner in which the device will be reused. 
These variations make it difficult to articulate a uniform requirement 
for informed consent.
    Second, if standards for reprocessing medical devices are 
sufficiently rigorous to ensure that these devices may be used safely, 
then there is no moral requirement for informed consent. One exception 
might be in unusual cases where patients could be expected to have 
religious or other doctrinal objections to any reuse of specific 
devices. But this sort of consideration applies to any device, drug or 
procedure, and is best handled at a clinical level rather than through 
government regulations. If significant dangers pertain despite adequate 
regulation, then informed consent may be morally obligatory. It will be 
important to ensure that the standards of disclosure in such cases are 
neither too rigorous nor too lax. Overly rigorous requirements would 
result in irrational fears based on the disclosure of clinically 
insignificant risks. It is also likely that overly rigorous disclosure 
requirements would place a bureaucratic obligation on clinicians that 
would impede patient care. Overly lax requirements would result in 
violations of the moral requirement for informed consent--in effect, 
exposing patients unwittingly to dangers that reasonable persons might 
not approve.
    Third, regulatory requirements for informed consent for the use of 
RSUDs should be responsive to the context in which specific RSUDs are 
employed. In some instances, consent should be obtained by clinicians, 
in other instances the obligation should lie with hospitals or other 
corporate providers.
    There are also ethical issues that pertain--apart from the 
Principle of Informed Consent--to the proper interpretation of risks 
and to the proper level of government intervention. If the risks of 
using various RSUDs are to be interpreted accurately, it is important 
that we obtain the best possible scientific data. Objective sources 
(such as the FDA) are to be preferred over sources that have important 
financial interests that hinge on the interpretation of this data. Even 
the news media is suspect in this regard, since they are exposed to 
financial incentives to find newsworthy scandals that will arouse an 
emotional response from the general public. Hence, they will be prone 
to exaggerate the dangers of RSUD use and to rely on anecdotal reports 
of untoward effects.
    Finally, health care policy concerning informed consent for the use 
of RSUDs should be guided by the Principle of Subsidiarity, which 
implies that regulatory authority should be concentrated at the lowest 
hierarchical level where there is sufficient competence. This 
consideration enhances the rationale for looking to the FDA for input 
and guidance about risks and about necessary policy adjustments. 
Assuming that the FDA is properly motivated to represent patients' 
safety interests, the cumulative training and expertise of FDA 
officials is an important asset that should be maximally utilized.
    I suspect, when all is said and done, that it will not be possible 
to articulate and legislate a uniform standard for obtaining informed 
consent for the use of RSUDs that is more effective or useful than 
general legal standards that already pertain in clinical medicine. A 
more promising avenue would be to rely on the enforcement of effective 
safety regulations, which would render informed consent into a moot 
issue. The best available scientific evidence should guide the 
development of safety standards. This hearing attests to the serious 
efforts that are being taken in order to garner such evidence.

    Mr. Upton. You get a bonus.
    Mr. Lindsay?

                  TESTIMONY OF BRUCE D. LINDSAY

    Mr. Lindsay. Mr. Chairman and members of the subcommittee, 
I am Dr. Bruce Lindsay, a cardiologist and a member of the 
American College of Cardiology and the North American Society 
of Electrophysiology. And these organizations represent about 
24,000 board certified cardiologist in the United States. I 
thank you for the opportunity to testify about the safety and 
efficacy of reusing electrophysiology catheters in patients who 
undergo procedures for the diagnosis and treatment of heart 
rhythm disorders. I have about 15 years of experience in 
electrophysiology and I direct the Cardiac Electrophysiology 
Laboratory at Washington University in St. Louis, where more 
than 1,500 diagnostic and therapeutic procedures are performed 
each year. In all my years of practice I have never encountered 
a complication related to the reuse of an electrophysiology 
catheter.
    Furthermore, in my conversations with professional 
colleagues at other major medical institutions, I have never 
heard any of them describe this problem. I would like to 
emphasize that neither I nor the organizations that I represent 
have any direct or indirect financial interest in the reuse of 
electrophysiology catheters. Our position is rooted in 
scientific evidence and puts concern for patient safety as its 
first priority. The standard electrophysiology catheters that 
we use have several electrodes used for recording electrical 
signals. They cost about $500 each. In fact, some of the newer 
and more advanced catheters cost $2,000 or $3,000 each. The 
cost of a reprocessed catheter is generally about half the cost 
of a new catheter. The first electrophysiology procedures were 
performed more than 30 years ago. Experience over the years has 
shown that electrophysiology catheters are durable and can be 
re-sterilized for reuse. The obvious motives were to reduce 
costs and eliminate waste. Clearly there are ethical, medical, 
and legal reasons for physicians to avoid any practices that we 
feel would add material risk to a procedure.
    Sometimes several catheters are tried during a procedure 
before an optimal catheter is identified. Sometimes a catheter, 
whether it is new or reprocessed, does not have the right 
configuration to reach a specific target in the heart, or may 
become less maneuverable over a period of time. You can see how 
the cost of a procedure would escalate if we had to take 
catheters out and reuse them, meaning try other catheters and 
change the models that we are using. The costs begin to add up. 
Medicare and other third-party payers do not increase their 
reimbursement irrespective of whether we use one catheters, 
three catheters, or six catheters. Reprocessing is a way to 
help reduce the fiscal implications of using several catheters 
during a single procedure. I must point out that there are 
studies that have evaluated the safety of reusing 
electrophysiology catheters, and these studies have involved 
more than 15,000 patients. And in these studies the sterility 
of reprocessed catheters was not a concern, nor was the 
incidence of infection increased. Moreover, several studies 
have demonstrated that the catheters are durable enough to be 
reused in excess of five times. The conclusions from these 
studies are that the catheters appear to be stable for reuse, 
that this can be done provided that they are carefully examined 
and that the quality assurance standards are observed. It is an 
expensive policy to preclude reuse of these catheters.
    You are also aware that adverse events stemming from the 
reuse of medical devices are reported to the FDA. We have 
already heard today that some of these reports involve not just 
reprocessed catheters, but new catheters. So I think it is 
appropriate to emphasize that despite the reuse of hundreds of 
thousands of catheters, only a few instances have been cited in 
which they have proved to be faulty. We conclude that the risk 
to patients associated with reusing electrophysiology catheters 
is very, very small relative to the overall risk of the 
procedure. The risk, in fact, is so low that it is difficult to 
quantify. Policies that prohibit the reuse of electrophysiology 
catheters will not have an appreciable impact on risk, but they 
will most certainly increase costs. In a major medical center, 
the cost for example just of reusing electrophysiology 
catheters, the savings from that are in the range of $250,000 
to $400,000. Both the American College of Cardiology and the 
North American Society of Pacing and Electrophysiology are 
working with the FDA to refine additional risk adjusted 
standards that can be applied to reprocessing medical devices 
and to clarify the criteria for single-use labels. We urge 
Congress to defer to the FDA is it perfects a regulatory 
strategy for the reuse of medical devices that is based on 
science and emphasizes the public safety as a first priority. 
Mr. Chairman, I appreciate the opportunity to speak before the 
committee. Thank you.
    [The prepared statement of Bruce D. Lindsay follows:]
 Prepared Statement of Bruce Lindsay, Associate Professor of Medicine, 
   Director, Clinical EP Laboratory, Washington University School of 
       Medicine, on Behalf of the American College of Cardiology
                              introduction
    Mr. Chairman and members of the subcommittee, I am Dr. Bruce 
Lindsay, a cardiologist and member of both the American College of 
Cardiology (ACC) and the North American Society of Pacing and 
Electrophysiology (NASPE). I thank you for the opportunity to testify 
before you today about the safety and efficacy of reusing 
electrophysiology (EP) catheters in patients who undergo EP studies for 
the diagnosis or treatment of heart rhythm disorders.
    Over the past several months there has been much discussion, and 
unfortunately much factual distortion, about the reuse of certain 
medical devices. My testimony pertains to the reuse of EP catheters and 
is based on more than 15 years of experience in the field of clinical 
EP. I direct the cardiac electrophysiology laboratory at Washington 
University in St. Louis, where more than 1,500 diagnostic and 
therapeutic procedures are performed each year. During all these years, 
I have never encountered a complication related to the reuse of an EP 
catheter. Moreover, in my conversations with professional colleagues at 
other major medical centers, I have never heard any of them describe 
this problem.
    The ACC and NASPE share several common objectives that promote 
optimal patient care, research, and education. These organizations also 
provide leadership in the development of standards and guidelines and 
the formulation of health care policy. The interest of these two 
organizations in the medical reuse debate grows out of concern for 
patient safety and the promotion of quality cardiovascular care for 
patients. Neither I, nor the organizations that I am representing 
today, have any direct or indirect financial interest in the reuse of 
EP catheters. The involvement of the ACC and NASPE in this issue is 
rooted in scientific evidence. The ACC and NASPE have been working with 
the Food and Drug Administration (FDA) and believe that it has also 
taken an approach to the issue of medical device reuse that is based in 
science out of concern for patient safety.
Electrophysiology Procedures
    Clinical cardiac EP studies are performed to diagnose and treat 
abnormal heart rhythms referred to as arrhythmias. Typically, three to 
six catheters are used during these procedures. Each catheter 
incorporates four to 20 platinum electrodes to record electrical 
signals or pace the heart. The standard EP catheters are solid 
nonluminal designs, which means they do not have a hollow inner core. 
Some catheters have special mechanisms used to deflect the tip to help 
guide the catheter to a specific target. Catheters with these 
deflection mechanisms are often used to deliver radiofrequency energy--
a high frequency electrical current--to destroy a small amount of 
tissue on the lining of the heart that has been identified as the cause 
of a patient's abnormal heart rhythm. This curative technique is 
referred to as an arrhythmia ablation procedure.
    The cost of catheters used to perform EP studies varies depending 
on the number of electrodes, steering mechanisms, or materials used for 
the particular model. Diagnostic catheters range in cost from $100 to 
more than $1,000. Deflectable catheters used for ablation of abnormal 
heart rhythms generally cost $400 to $800. Some advanced designs that 
provide feedback about the position and orientation of the catheter 
cost $2,000 to $3,000.
    The first EP procedures were performed more than 30 years ago. The 
early experience showed that EP catheters were quite durable and could 
be sterilized for reuse, as has been the practice for many surgical 
instruments. The obvious motives were to reduce cost and eliminate the 
waste of catheters that could be reused without compromising patient 
safety. The physicians who perform these studies have no direct or 
indirect personal financial incentives to reuse catheters, and there 
are ethical, medical, and legal reasons to avoid any practices that 
would add material risk to EP studies. The cost of medical supplies is 
the responsibility of the hospital where the procedure is performed; 
however, physicians often consider it their responsibility to work with 
hospitals to make efficient use of supplies and reduce operating costs.
    Arrhythmia ablation procedures typically take three to five hours 
to perform. In order to advance the EP catheters to the heart, tube-
like sheaths are inserted into the arteries and veins to provide 
vascular access for EP catheters. The catheters are then inserted 
through the sheaths and advanced to the heart. The sheaths allow 
cardiovascular specialists to remove, exchange, or reinsert the EP 
catheters as needed during the procedure. Sometimes catheters--new or 
reprocessed--must be exchanged because they do not have the necessary 
configuration to reach a specific target in the heart, or because they 
have become less maneuverable during the course of the procedure. 
Sometimes several catheters are tried during a procedure before the 
optimal catheter is identified. Reprocessing allows the flexibility to 
use several catheters during an EP study safely and free of fiscal 
concerns.
    In some cases the catheter is easily positioned at the target site 
and is subjected to very little manipulation. In more difficult cases a 
catheter may be removed and reinserted several times during the course 
of a procedure and is subjected to considerably more stress when 
extensive efforts are required to reach the target. Because the 
stresses that can be imposed on an individual catheter can vary 
considerably during a study, EP catheters are manufactured to be very 
durable. It is their durability which makes them reprocessable. 
Regardless of the amount of stress imposed on a catheter during a 
study, each one is carefully evaluated by the reprocessor to determine 
whether it is suitable for reuse.
    The number of catheters used during an EP study can have a 
substantial impact on the cost of performing the study, but it does not 
change the level of reimbursement from Medicare or other insurance 
companies. When the cost of catheters exceeds the level of 
reimbursement, hospitals bear the loss.
Review of Published Clinical Studies
    There are studies, all of which have been published in peer-
reviewed scientific medical journals, which have evaluated the safety 
of reusing catheters for EP studies. All have found no evidence that 
the sterility of reprocessed catheters is a concern or that the 
incidence of infection is increased. The results of four clinical 
studies are summarized:
    1. The results of a study of 12 medical centers were published in 
the medical journal Pacing and Clinical Electrophysiology in 1988. The 
study looked at the safety of reusing catheters. The incidence of 
infection related to a total of 14,640 EP procedures involving 48,075 
catheter uses was reported. At three centers, catheters were 
automatically discarded after a single use. These centers carried out 
1,245 EP procedures using 3,125 catheters. At the other nine centers, 
catheters were sterilized for reuse. There were 13,395 procedures using 
44,950 catheters in the reuse group. The incidence of bacteremia (blood 
borne infection) and superficial skin infection at the site of catheter 
insertion is shown below.

           Table 1: Incidence of Infection During EP Studies.
------------------------------------------------------------------------
                                                             Superficial
                     Group                       Bacteremia      Skin
------------------------------------------------------------------------
Single Use Catheters..........................    1 (0.03%)    1 (0.03%)
  1,245 studies
  3,125 catheters
Reused Catheters..............................   8 (0.018%)   1 (0.002%)
  13,395 studies
  44,950 catheters
------------------------------------------------------------------------

    The authors of the study concluded that sterilization and reuse of 
the catheters employed in this study did not result in any increase in 
the risk of infection. They felt the catheters were sufficiently 
durable to be reused well in excess of five times, and that one-time 
use of such catheters appeared to be a medically unnecessary and 
expensive policy to adopt.
    2. Similar results in a prospective study were published in the 
Journal of the American College of Cardiology in 1987. The study 
evaluated catheter reuse over a five-year period during which 178 
catheters were used 1,576 times for 847 EP procedures. Detailed records 
of catheter testing and use were maintained. No complications were 
encountered during the study period. All reused catheters functioned 
for cardiac pacing and recording of cardiac electrical signals. 
Surveillance cultures and biologic indicators revealed that adequate 
sterilization procedures were used. The authors concluded that EP 
catheters may be safely reused provided a thorough cleaning, testing 
and record-keeping system is instituted. They also concluded that the 
practice of reusing catheters would result in substantial cost savings 
to hospitals.
    3. The studies mentioned above were conducted in patients 
undergoing diagnostic EP studies before the advent of deflectable 
catheters and arrhythmia ablation procedures. A study published in the 
Journal of the American College of Cardiology in 1993 prospectively 
investigated the time course of electrical, physical and mechanical 
changes in ablation catheters to determine the affect of reuse on 
safety and efficacy. The study included 69 ablation catheters made by a 
single manufacturer that were used in 336 procedures. Testing of 
physical integrity consisted of visual and stereoscopic (X30 
magnification) examination of handle function, catheter shaft and the 
deflectable tip. Specific attention was paid to the ablation electrode 
attachment to the catheter shaft, and the ablation tip electrode was 
scrutinized for pitting. The electrical integrity of the catheters was 
measured by electrical resistance from the handle connector to the 
recording rings and to the tip electrode. Deflection and torque 
measurements were made to assess mechanical integrity.
    During the course of this study 36 catheters (52 percent) were 
rejected at some point because of mechanical or electrical failure. 
Eighteen catheters were repeatedly sterilized and eleven of the 
catheters were used 10 or more times. The most common reasons for 
catheter rejection were tip electrode glue separation after an average 
of 4.3 uses and loss of deflection after an average of five uses. 
Electrical discontinuity was observed after an average of 10 uses. 
There was no significant decrease in catheter torquing ability that 
determines the steering responsiveness of the catheter. The medical 
records of 140 patients who had arrhythymia ablation procedures in this 
study revealed only one case (0.7 percent) of local infection at the 
insertion site that was treated effectively by antibiotics. There were 
no other complications.
    The authors of the study concluded that the catheter model used in 
this study could be reused an average of five times. They recommended 
that after each use catheters be carefully examined under magnification 
with special attention to the tip electrode. They also recommended that 
the catheters be tested for deflection and electrical integrity after 
each use.
    4. Another study published in the American Journal of Cardiology in 
1994 looked at the effects of reprocessing on mechanical integrity, 
sterility, and chemical residuals. The study was part of an internal 
quality review process conducted by a hospital to establish and 
validate an institutional policy for reuse. A total of 12 commercially 
available catheters from two manufacturers were analyzed. Eleven of the 
catheters were randomly selected from the catheter inventory of the 
clinical EP laboratory after being used one to four times. They were 
manually cleaned, repackaged, and gas sterilized with ethylene oxide. 
To assess the sterility of reused catheters, three were cut into two-
inch segments, placed in bacterial culture media, and incubated for 
five days. Six of the catheters were analyzed for chemical residuals 
after gas sterilization. Two catheters were examined for evidence of 
component failure. Visual inspection and microscopy were used to 
determine mechanical integrity of the catheter surface, and x-ray 
inspection was performed to assess interior structures.
    The results showed no bacterial growth detected on any of the 
cultures. which indicated that reprocessed EP catheters are effectively 
sterilized. The chemical analysis demonstrated that the concentrations 
of ethylene oxide detected in extraction liquid exceeded standards 
established by the FDA. Microscopic examination of reprocessed 
catheters demonstrated inconsequential metal and fiber particulates on 
the catheter surface and at some electrode-catheter interfaces. The 
shaft of the catheters and the electrodes remained intact. There was no 
evidence of electrical discontinuity, and the integrity of internal 
structures was confirmed by x-ray inspection.
    The authors concluded that, with sterilization techniques 
frequently used by hospitals, the potential for chemical residual 
contamination might exist after sterilization with ethylene oxide. 
Based on these results the hospital changed its policy to single use. 
It should be noted that the hospital subsequently resumed multiple use 
of catheters that were reprocessed by a commercial vendor whose 
chemical residuals after reprocessing met FDA standards.
Medical Device Reports
    Medical Device Reports (MDRs) submitted to the FDA contain 
information about three cases involving EP catheters. One case involved 
a reprocessed catheter. The other two occurred with new single-use 
catheters. It is appropriate to emphasize that despite the reuse of 
hundreds of thousands of catheters, only one MDR has been submitted to 
the FDA that involved a reused catheter. The reports are summarized 
below:

 A new deflectable ablation catheter was being positioned in 
        the right atrium when the catheter tip was noted to be detached 
        and wedged in the coronary sinus. The patient was observed 
        overnight and discharged the following day without any reported 
        symptoms.
 A small fragment of the distal tip in proximity to the 
        electrode side of a new catheter broke away and the fragment 
        could not be located. Further details are not available.
 A reprocessed orthogonal EP catheter was used without incident 
        until it was removed from the heart. The physician felt some 
        resistance during removal of the catheter. A subsequent x-ray 
        showed a small electrode fragment lodged in the wall of the 
        right atrium. It was presumed that a single platinum electrode 
        mounted on the surface of the catheter might have been 
        compromised during reprocessing. The surgical consultant 
        decided that removal of the fragment was not indicated and the 
        patient remained free of symptoms.
Impact of Reuse Policies on Physicians, Hospitals, and Patients
    Most EP laboratories are staffed and administered by hospital 
employees. The cost of supplies and maintenance for EP laboratories is 
also paid from hospital budgets. The physicians' motive to reuse EP 
catheters has arisen from their experience that the catheters are 
durable and can be safely used for several procedures without posing an 
increased risk to the patient. As such, it would be a waste to discard 
EP catheters after a single use.
    The risk to patients associated with reusing EP catheters is 
inconsequential relative to the overall risk of these procedures. The 
risk is, in fact, so low that it is difficult to quantify. Policies 
that prohibit the reuse of EP catheters will not have an appreciable 
impact on the risks of these procedures, but they will certainly 
increase the costs.
    The cost savings realized by hospitals that reuse EP catheters 
depend on the volume of procedures and whether catheters are 
reprocessed internally or through a commercial reprocessing company. As 
a general rule, reprocessing companies charge 50 percent of the 
original cost of the catheter each time the catheter is reprocessed. 
Allowing for an 85 to 90 percent pass rate for each reprocessing cycle 
for a maximum of six uses per catheter (resterilized a maximum of five 
times), hospitals can reduce their catheter costs by about 35 percent. 
At large medical centers these measures may lead to cost savings in the 
range of $250,000 to $400,000. At smaller medical centers the total 
savings would be substantially less, but for both large and small 
hospitals this practice is a significant cost-reducing measure at a 
time of escalating costs and declining reimbursement.
Development of Policies For Reuse of Medical Devices
    The FDA has proposed a strategy to address the reuse of medical 
devices currently labeled for single use. This policy was developed in 
response to the concern that a device's performance, safety, 
specifications, or intended use might be compromised during 
reprocessing procedures. The policy would be applicable to both 
commercial reprocessors and hospitals that engage in these activities. 
The FDA's strategy categorizes levels of risk presented by reprocessing 
and reusing single-use devices. Factors that would influence the risk 
category of a specific device include the complexity of procedures 
associated with reprocessing, the actual and potential risk for 
infection should the device be reused, and the quality and extent of 
published data on reprocessing for that device. The agency would 
consider ``high-risk'' devices to be products that may pose significant 
public heath risk to patients and users after reprocessing. It is 
anticipated that the FDA would enforce all of the agency's regulatory 
requirements, including premarket requirements, for high-risk devices. 
The FDA has indicated that it would also enforce applicable premarket 
requirements for ``moderate-risk'' devices to ensure that the 
reprocessed device remains as safe and effective as a device that has 
never been used.
    The FDA is examining the criteria used to label a device as 
``single-use.'' The new policy would potentially clarify or justify 
manufacturers' need for ``single-use'' labels.
    The FDA has also questioned the need for informed consent when it 
is anticipated that reprocessed devices might be used during a 
procedure.
Summary
    The ACC and NASPE support the position that reuse of EP catheters 
is a safe and cost-effective practice provided that these devices are 
meticulously cleaned, sterilized, and inspected in accordance with 
accepted standards of practice. Both organizations are working with the 
FDA to refine additional risk adjusted standards that can be applied to 
reprocessing medical devices and to clarify the criteria for single-use 
labels. We urge Congress to defer to the FDA as it perfects a 
regulatory strategy for the reuse of medical devices that is based on 
science and emphasizes public safety as the first priority. We firmly 
believe that no further congressional action is required at this time.

    Mr. Upton. Well, thank you all very much for your testimony 
and as folks could tell we wanted a diverse range of opinions 
and we got them. I compliment the staff, Mr. Ford and Mr. 
Slobodin. A couple of things. This is an enormously complex 
issue and Dr. Ganske, as an example, will be able to come back 
to discuss. He is one of the physicians that serves on this 
subcommittee. I know that the FDA regulations that they put out 
for comment only really came out this week. There has been a 
lot of talk about them in recent days, weeks. And Ms. Eshoo's 
bill has been out there for a little while as well.
    I am wondering if any of you at the table have actually 
looked at the regulations that came out earlier this week, and 
might make some comment or indicate whether you are going to 
comment on them. And if so, maybe give us an advance in terms 
of where you think they are strong enough, where you think they 
may be too weak. Or maybe you do not think we need them at all 
or whether this is exactly the right direction that we are 
going to head. And I will just start, Mr. Lindsay. And if you 
have not had a chance to see them, I certainly understand. We 
understand. I appreciate your comments maybe in writing at some 
point if you, in fact, you do make those comments known.
    Mr. Lindsay. I just received the documents yesterday and 
was taking care of patients until late in the day, so I have 
not reviewed them. But I have spoken to people at the FDA this 
week, and we have talked about some of the common ground that 
as a professional organization we feel that we have with the 
FDA in trying to address this problem. Physicians have no 
reason to use devices that are unsafe. It just makes our lives 
miserable and it is not why we went into medicine. Our interest 
is in protecting patients and in trying to help them, and we 
would like to work with the FDA to tackle this in a responsible 
way.
    Mr. Upton. So, you do not have a verdict yet whether or not 
it is the right course?
    Mr. Lindsay. From what I have read I think that it is a 
workable solution and one that will protect the public 
interest. I think it is one that would prohibit the recycling 
of certain devices that are not safe to reuse. I think it would 
permit the reuse of devices that can be safely reprocessed, and 
I think that is a reasonable approach to take.
    Mr. Upton. Dr. Trotter?
    Mr. Trotter. I too have not been able to review the written 
revisions by the FDA. I do think that it is important that we 
focus on the FDA recommendations. One of the things I 
appreciate about all the attention that was given to the FDA 
today is I consider them to be a relatively objective source. I 
think some of the other parties involved on both sides may have 
financial conflicts of interests that could implicitly or 
explicitly affect their testimony. I think there is less of 
that then on the FDA.
    Mr. Upton. You want to stay on the topic. The clock is 
ticking on me, too.
    Mr. Trotter. Okay.
    Mr. Upton. Mr. Feltner.
    Mr. Feltner. Yes. It is AMDR's view that FDA regulation of 
reprocessing is necessary, critical to ensuring the safety of 
reprocessed devices, and the patients. We believe that the 
current FDA regulatory regime which emphasizes compliance with 
QSRs is well-suited to meeting public health. We do not really 
believe that the pre-market review scheme proposed is 
necessary, but if there is a reason, and there is an 
assessment, and there are relevant facts that determine a pre-
market review is necessary, we support it and we are willing to 
work and look forward to working with FDA on any path that it 
chooses.
    Mr. Upton. Dr. Maurer, and actually before you answer, I 
would just like to know what the difference was. You showed 
those saw blades that you said were recyclable. What was the 
other device that looked like a----
    Mr. Maurer. Both of these are saw blades.
    Mr. Upton. Oh, they are? Okay. I did not see the other end 
of it.
    Mr. Maurer. It has been coming for years and years.
    Mr. Upton. You had it covered up with your thumb.
    Mr. Maurer. And it shows up on our door----
    Mr. Upton. I just saw the wrench.
    Mr. Maurer. [continuing] you could be paralyzed. Same 
blade.
    Mr. Upton. Okay. Okay. I just saw the wrench at the other 
end when you----
    Mr. Maurer. Put it with the other saws.
    Mr. Upton. So that is--all right. All right. Go ahead and 
answer the----
    Mr. Maurer. Well again, we have not had much time to look 
at it. I looked at it briefly. I think the major thing that 
comes out of it, just on a cursory review, is it's got to be 
the same across the board. I think when you first read it, it 
looks like it is directed purely at hospitals and reprocessors. 
We have free standing inventory, surgery centers, we have 
physician offices, we have a lot of people that are going to 
reuse these devices, and it has got to be a level playing field 
or we are going to have patient problems.
    Mr. Upton. Do you all at the Cleveland Clinic, actually 
keep track then of the number of times that things are 
reprocessed?
    Mr. Maurer. Absolutely. You would have to be or we would 
not be able to limit it to five and those that come back from 
the reprocessor have a mark on them. Half of the ones we sent 
out, they threw away because after they looked at them they 
felt they were unacceptable and we do not get charged for that 
when they throw them away.
    Mr. Upton. Dr. Fielder.
    Mr. Fielder. I very much like the direction that the FDA is 
moving. I did have a chance to look at the documents, but not 
terribly carefully. One of the things that, from an ethical 
standpoint, is important about their proposal is that they are 
going to have patient assurance that these devices can be 
cleaned and sterilized that is based upon an objective third 
party review rather than simply on what the manufacturers say, 
or on GMPs and quality assurance. And that is very important 
for patients.
    Mr. Upton. Dr. Grossman.
    Mr. Grossman. Yes. I'm sorry. I have had a chance to review 
them and have four specific areas. First, I think they are very 
commendable in that they do level the playing field and for the 
first time will force the production of reliable data, and that 
should be commended. Some of the specific devices, I think, 
probably should be in higher categories and I think that will 
probably evolve under their scheme up. The exemption issue 
concerns me because the very biopsy device I showed, although I 
am not an attorney, clearly, the reason for it in the past 
would be to allow similar devices. But in fact, if it would 
allow that kind of device with a sharp point to skate through 
and bypass the safeguards, clearly that would need to be 
tightened up. My last comment is again, the plea. This issue 
has been alive for longer than today. My concern is I start to 
see 6 months to 12 months to 18 months, a notice period. I do 
not know how much more it could be tightened, but that would 
clearly be a plea.
    Mr. Upton. Mr. O'Holla?
    Mr. O'Holla. Yes. I have also had an opportunity to read 
them in between everything else I was doing this week, and I 
think FDA has come a long way, certainly from where they were 
18 months ago. Certainly where they were even in November, and 
I would like to thank this committee and its members because I 
think it is a result of the attention you have paid to that 
issue that has caused some of that movement. I do, however, 
think there is one problem area where we need to talk with FDA 
a little more, and that is the area of exemptions raised by Dr. 
Grossman. The exemptions currently for medical devices did not 
take into consideration the risks associated with reuse and 
cleaning. I think, therefore, those exemptions should not stand 
for a prolonged period of time. We are going to have to figure 
out how can we deal with that issue and make sense out of the 
scheme. But I think we are headed in the right direction. I 
think the nice part is, nobody has to believe me and nobody has 
to believe them. We will have a referee.
    Mr. Upton. Ms. West.
    Ms. West. I think the recommendation certainly show 
progress. My concern is that it does not cover staff 
incompetence and question how they would be able to implement 
that without having someone on the floor continually for 
quality assurance.
    Mr. Upton. Thank you. Mr. Stupak, you ready or do you want 
me to come back to you?
    Mr. Stupak. Thank you Mr. Chairman. Dr. Lindsay, if the FDA 
is going to set a standard for a number of times the device is 
reused, how do you establish this number? Is there a community 
or an acceptable medical practice standard for a device 
established by ACC or NASPE or would it vary from hospital to 
hospital? Would the standard include a level of device 
integrity below which the catheter is discarded? How do you 
track and account for the number of times that the individual 
catheter has been reused? What happens if the numbers exceed 
it? I know there are a lot of questions there, but I am just 
trying to get it on the record.
    Mr. Lindsay. First of all the tracking is easy in that any 
catheter that is reused has a tag on it. It is a serial number 
and it is tracked by the reprocessor. So that there are limits 
that are set on that. Many hospitals with regard to 
electrophysiology catheters have set a limit of five reuses 
based on some information that is available from the 
literature. In some cases catheters in these studies have been 
used 10 or 15 times, but we do not want to push it to its limit 
because at that point I think you could have a greater risk for 
a breakdown. But certainly somewhere in the maximum of five 
seems reasonable. Now, having said that let me make it clear 
that not all catheters make it to five.
    Each cycle, at least with our reprocessor, each cycle about 
80 percent, 85 percent of the catheters will make it through 
that cycle and the others do not. They do not make the cut. So, 
I think that the criteria that are used has to be the same at 
each hospital or at each reprocessor. We cannot have divergent 
criteria.
    Mr. Stupak. So whether a catheter makes the cut, that is up 
to the reprocessor?
    Mr. Lindsay. That depends on the inspection and the testing 
that is done. So they examine it for nicks and electrical 
integrity, things that might potentially compromise it. Now, 
the other part of that question is that as catheter designs 
evolve, and the catheters we use today are different than they 
were say 10 or 15 years ago. It may be that with the newer 
designs, some of the designs will not be suitable for 
reprocessing. They may have sensors in them that would preclude 
reprocessing. We have that, for example, for some of the 
catheters that cost $2,000 or $3,000. They have sensors built 
into them that cannot be reprocessed. In other cases they may 
have mechanisms that may not lend themselves to reprocessing. 
So I think that one of the challenges before us is to identify 
these catheters, to look at their mechanisms, to look at the 
materials that they are made of, and decide whether they can 
safely be reprocessed and used in patients in such a way that 
nobody has any question whatsoever about the integrity of that 
product.
    Mr. Stupak. Thank you. Dr. Maurer, in keeping with that 
same line of thought, in your testimony you talked about the 
fact there is a five time use limit for reprocessed non-
aluminum diagnostic electrophysiology catheters. Would you 
outline for the committee how the clinic tracks the five times 
use to assure that is not exceeded? What mechanisms are in 
place that you use? Should it be accidentally exceeded? And is 
this a model for tracking limited reuse utilized on a hospital 
wide basis?
    Mr. Maurer. Well, it is important to understand there is 
very little of this done. I mean, more sterile processing and 
so forth, I mean, 99.9 percent is with reusables. Scissors and 
clamps in ORs. So we are not, you know, just striking out on 
this.
    Mr. Stupak. True.
    Mr. Maurer. This is a very small amount. I would echo what 
Dr. Lindsay says. We follow the same things. These are 
nationally published studies that are peer reviewed and have 
been around for years. We track them by serial numbers, there 
is a log kept, we have continuous quality improvement and 
statistical process control that is applied to these entire 
departments, not just in the reprocessing of catheters. It 
looks at all their infections, and all staff competency, and 
the review that has to occur on a regular basis. We are 
required to do this for Joint Commission. Believe me, when they 
come they bare down on this and if there is any problem, there 
is a root cause analysis done by us before Joint Commission 
does come and we have to show them that root cause analysis. So 
it is very stringent. I mean, you have got to understand, we 
physicians do not get any money from this. Can you imagine what 
it takes for us to grab a reprocessed device. We require that 
there be good quality control before we touch that and stick it 
in a patient.
    Mr. Stupak. Sure, but then a question I asked earlier about 
DRGs. I mean, DRGs source will only pay so much for a 
procedure. Now, if I can use a reprocessed catheter I am going 
to save some money, and the pressure on the hospitals, and 
clinics, and everyone else to keep within that amount, I mean, 
you know, we talk about these things, but there is also a 
responsibility here for the rest of us up on this side of the 
dias when we start putting on these standards or what we are 
saying has to be done. DRGs limited amount payment leads to 
this reuse.
    Mr. Maurer. Yes. We charge less, and we so note that in the 
record that it is a reused device. I do.
    Mr. Stupak. But if it is a DRG, I mean, you get paid the 
same for the DRG whether you use reprocessed or not.
    Mr. Maurer. That's true. That's true. But that charging 
less than when the DRG gets reevaluated by HCFA they will note 
that. And if it has become a standard thing that everyone 
reprocesses it, then they feel within their rights in terms of 
being budget neutral to cut back on that where they want to 
give money elsewhere.
    Mr. Stupak. I do not have any more for now.
    Mr. Upton. You are out of time.
    Mr. Stupak. Okay. Thanks.
    Mr. Upton. We are going to have another round though, I 
promise. Mr. Bryant.
    Mr. Bryant. Thank you Mr. Chairman. Dr. Trotter, on the 
issue of informed consent I kind of, first of all I want to 
apologize for being late. We have been in a prescription drug 
meeting right next door, and I missed, I think, the first four 
or five panelists testimony. But I did come in and Dr. Trotter 
you had mentioned something in your testimony about informed 
consent and when it would be appropriate. And as I recall it 
was based on, I think, the degree of risk involved, that being 
determined by I assume a physician, would determine whether or 
not the patient ought to be informed. And if I hear what you 
are saying that overall the gist of your testimony is that for 
a reprocessed medical equipment there should not be an informed 
consent by the patient?
    Mr. Trotter. That would be the end result that I would 
recommend. My opinion was that we ought to ensure that these 
reprocessed single-use devices are safe, safe enough so that 
there would not be a significant risk, and therefore informed 
consent would be a moot point.
    Mr. Bryant. And how do you do that? How do you ensure that 
they are that safe? You as a physician cannot do it, can you?
    Mr. Trotter. No. No, I cannot do it as a physician. I did 
read H.R. 3148 and I noticed though that many of the devices 
that I use I guess I count as the reprocessor. For instance, a 
stethoscope would count as a critical Class I device since I 
put it in unsterile areas of the body like the oscula and the 
inframamillary fold every time I examine a patient. So if 
something like a stethoscope, if that sort of risk was 
something where we required informed consent, then I guess, you 
know, I would need to be more involved in that sort of manner. 
But in fact, the specific requirements for ensuring the safety 
of some of these more complicated devices are far beyond my 
scope.
    Mr. Bryant. Yes. That should be at least the FDA's 
responsibilities?
    Mr. Trotter. Yes.
    Mr. Bryant. Okay. Dr. Lindsay, on reviewing some of the 
information here I find that the Association for Operating Room 
Nurses has developed a different policy from the one you 
expressed and the one that is endorsed by your American College 
of Cardiology and that is that in essence that unless the 
hospital can demonstrate the patient's safety and the medical 
devices effectiveness and integrity are not compromised, that 
reprocessing is not recommended by that Operating Room Nurses' 
Association. Do you have any comments on that?
    Mr. Lindsay. I think some of this may reflect the different 
types of devices that are reused. The American College of 
Cardiology and NASPE are not advocating that all devices be 
reused, and some of it may depend on what kind of things they 
come in contact with. That is a different group than nurses, 
for example, that work in cardiac catheterization and 
electrophysiology laboratories. I do not know that a lot of 
these devices clearly should not be used. I think there are 
some things in gastroenterology that probably should not be 
reused. And there may be some areas in cardiology that we have 
touched on today that they should not be reused. But that is 
what we have to examine carefully.
    Mr. Bryant. I would like to just throw this question open 
to anyone who would like to answer. I think some of you have 
touched on this already in other questions, but my question 
would be what more, beyond these two letters that the FDA has 
sent out, what more can they do now to advise and instruct or 
anything else the FDA can do to help ensure the safety of 
patients in this area of using reprocessed, I almost said 
repossessed, reprocessed medical equipment.
    Mr. Upton. You are thinking of NAPA auto parts.
    Mr. Bryant. We were talking about body parts a minute ago. 
Yes, doctor.
    Mr. Maurer. Well, I think they have already done quite a 
bit. I have looked at their conferences that many on this 
committee have attended and given their views to, and they have 
taken views from everyone. I just think they need to continue 
to collect data, now that it is time to get the studies of 
large groups of patients that are peer reviewed and published, 
that have the chance of appropriate criticism of the design of 
the study and the results, and we get the data out in the open 
and let the public know that we are doing our job at looking at 
this on a scientific basis.
    Mr. Upton. Very quickly, one more.
    Mr. O'Holla?
    Mr. O'Holla. Yes. I think the FDA has done a great job in 
getting everybody's comments together and looking at the 
available data. You know, peer review is not the standard that 
FDA uses to establish safety and efficacy. I think it is time 
for FDA to act. They have already said that this is a device by 
device decision. The big studies are not necessary to make the 
device decisions. They need to act. They may need to act more 
quickly than they have published this week and start looking at 
the applications that show the particular device that the 
surgeon is grabbing tomorrow is safe.
    Mr. Bryant. Anyone else? I thought I saw a hand go up. 
Okay. Well, thank you very much, and I yield back the balance 
of my time.
    Mr. Upton. Thank you. I wish all members were able to spend 
the time like you have, Ms. Eshoo. Maybe you should think about 
getting off one of those other subcommittees and we will find a 
vacancy over here.
    Ms. Eshoo. There are several people here that would not 
want me to.
    Mr. Upton. Go ahead.
    Ms. Eshoo. Thank you very much, Mr. Chairman. I want to 
make a couple of observations before I ask questions of this 
very distinguished panel. A few barbs have been thrown around 
that the effort underway to take an even closer look at 
reprocessing, what that means relative to the public health and 
whether we have policies in place that speak to the best of 
what we could do. These are all very legitimate questions that 
are being asked. And I think that the, I know that the intent 
here, my intent of submitting the legislation was not to favor 
one group or another. Now, around here, you know, you punch the 
pillow, you put a dent in it, but there is always something 
else that pops up. I remember going back to FDA reform where 
medical device manufacturers were not happy with what I placed 
on the table because it was very stringent and it did not 
always meet with what they wanted to do. There were some people 
involved in that debate that wanted to destroy the FDA. They 
did not want an FDA around. Now today I hear so many 
complimentary things said about the FDA and I welcome that.
    I think it is important to the American people, and I 
reminded my colleagues during that debate that if they were to 
say otherwise they were frightening the American people. The 
American people want an Agency that is going to be a top 
watchdog that will step between whatever interests are out 
there and their interests. I think today by the questions that 
have been asked by my colleagues on both sides of the aisle, 
that you have all figured out that we are here for the public 
interest. So, you know, always in all of these issues someone's 
ox seems to be gored or the perception is that. I am here for 
the public interest and I think everyone here on the committee 
is as well. So I would hope that you would keep that in mind. I 
really want to work with everyone.
    I really believe that the reason that all of these proposed 
guidelines were bragged about today, and I think it is terrific 
that they have proposed guidelines, is because we have pushed, 
and pushed, and pushed. That is what my colleagues and I are 
supposed to do. Because every 2 years our constituents hold us 
responsible for what we have done or have not done. So I think 
it is a very important background for each one of the people 
that comprise this very distinguished panel. Just one more 
observation, and that is in all of the research we did before 
we ever thought of writing legislation, yes each side has some 
studies, but the FDA does not on behalf of the public which 
raises another question. Of course an organization is going to 
bring information forward that is going to be favorable to what 
they do. I would be all over you, questioning you, why you had 
not done that. But the fact of the matter is, is that the 
public agency that is supposed to be guarding the best 
interests of the public health has not done that. Nor do the 
regulations, so to speak, or the guidelines, or whatever they 
have in place do not bring that about.
    That is a big, deep, dark hole as far as I am concerned 
because we have to have a public yardstick by which we measure 
these things. I think it is important for organizations to do 
it. Certainly I will take that into consideration, but I want 
you to know that I think that at the top the absence of that 
kind of information, I think, is somewhat alarming and we need 
to do something about that. Now, I would like to go to Dr. 
Maurer, thank you for being here representing the American 
Hospital Association. I am very familiar with the Joint 
Commission standards because I chaired a hospital board of 
directors. So I know what those standards are, but I also know 
that as someone at this end of the table said that there really 
is a patchwork quilt throughout the country of what some 
hospitals may do, what some other hospitals may not. My 
question to you is do you pass the savings on of the reuse of a 
single-use device onto the patient or to Medicare?
    Mr. Maurer. Well, like I said we charge less. It all 
depends on whether the patient----
    Ms. Eshoo. Where does the savings go though? Does it go to 
the patient or does it go--if it is a HCFA issue----
    Mr. Maurer. Whoever is paying the bill. If Medicare is 
paying the bill on a Medicare patient, the savings goes to 
Medicare.
    Ms. Eshoo. Then it goes to Medicare.
    Mr. Maurer. If the patient does not pay anything, we cannot 
impart savings to him.
    Ms. Eshoo. If it is a private insurance, do you pass it up 
to the private insurers?
    Mr. Maurer. Yes. Yes. The charge is made.
    Ms. Eshoo. You do? And that is a consistent standard across 
the country or is it just where you are?
    Mr. Maurer. That I do not know. I can only speak for what I 
do.
    Ms. Eshoo. All right.
    Mr. Maurer. And what my hospital does.
    Ms. Eshoo. Well, I think the committee members need to keep 
that in mind. In your testimony you said, to go with the FDA's 
proposed guidelines, you have not read them thoroughly, but you 
said we do not need the bill. Have you read the bill?
    Mr. Maurer. I have read the bill.
    Ms. Eshoo. All right. Now, if you have not read the others 
and you compare and contrast the two, how can you come to that 
conclusion? I mean, I have said to the American Hospital 
Association, California Hospital Association, I stand ready to 
work with you. So it is a little disturbing to me because you 
have been my partner in so many things, and I have a deep 
regard for what you do and fought very hard, by the way, for 
the BBA refinements to take place because hospitals were really 
getting it across the country. Why would you say in your 
testimony not having read one, but read the other, to go with 
the one that you really have not read but disregard the one 
that you had.
    Mr. Maurer. No. What I meant was, I have read the bill. I 
think the bill actually does exactly what you said it did. It 
is a wake-up call. This needs to be looked at. But all the bill 
can do is one thing. The FDA has a continuous regulatory 
process which they are putting in place. Which conceptually as 
we have heard today I fully agree with. In a cursory review of 
what I got less than 12 hours ago I have some concerns, but 
that is the regulatory process which will go on and on years 
and years after you and I are doing something else.
    Ms. Eshoo. Well, good laws do too as well.
    Mr. Maurer. Exactly.
    Ms. Eshoo. So thank you very much. To--let's see who it 
was. I do not have a name. Is it Dr. Trotter? I think if you 
read page four again of the bill's language, it really applies 
to devices that are inserted into the body. And to take that, 
to pull that out of context I think is, well, I mean as the 
author of the legislation I can say it is somewhat unfair. If 
we need to go back and say that in a better way we will do 
that. But it was never intended, you know. I am a legislator, I 
am a politician. I do not consider myself a fool. I simply 
would not do that legislatively, because it is not necessary. 
So I just want to correct that.
    Let me ask one more question and that is to Mr. O'Holla, 
and I want to thank you. Even though I am not asking all of you 
questions, I would like to thank you all for what you have 
brought forward today. In your view should any single-use 
device be reprocessed without a 510(k)? This has gone on back 
and forth today and, you know, I think that I would like to 
have this set down for the record. For instance, if a new 
device is exempt, it is all around these exemptions and the 
consistency. Now, I heard Dr. Feigal say that under the 
proposed guidelines that there would be total consistency, and 
yet I do not hear a consistency of comments from the varying 
views that are a part of this panel in agreement that there 
will be consistency. So would you comment on that where a new 
device is exempt from pre-market requirements, should not the 
reprocessed one be exempt as well?
    Let me just add a little asterisk to this. For those of you 
that cannot stand what I am doing, you must think that I am 
regulation happy. I am not. But I do think and if anyone ever 
wanted to go back and track this and we have talked about 
tracking today, in all of the years of my public service, both 
in County government and now here in the House of 
Representatives, there are two places where I think, regardless 
of what level of government we are at, that we have to have 
absolutely the highest standards when it comes to public safety 
and when it comes to public health. People cannot do these 
things for themselves. They simply cannot. They are reliant 
upon either very sound regulations and laws that are put into 
place. So, would you comment on this.
    Mr. O'Holla. I am glad you asked that question, because I 
also got confused this morning, but I have worked it out in my 
mind and I hope I can clarify it for the members here. There 
are exemptions for new devices in two categories. There are 
exemptions for the disposable devices, and there are exemptions 
for reusable devices. For certain kinds of devices both of 
those are lumped together. So we have three different kinds. If 
a disposable device has been exempted, it has never been taken 
into consideration the risks associated with the reuse of that 
disposable device. That exemption does not address those risks 
and should not hold. If an exemption holds for a reusable 
device, it has been exempted based upon the fact that the 
device was designed to be reusable. It still does not take into 
consideration the risks associated with reusing a single-use 
device. So, my comment to the committee would be, be very 
careful about these exemptions. They have not taken the risks 
into consideration. They should not stand.
    Ms. Eshoo. Thank you.
    Mr. O'Holla. Does that help?
    Ms. Eshoo. It does help. Thank you.
    Mr. O'Holla. Okay.
    Ms. Eshoo. It is clarifying and it is an important part of 
the record. Thank you to all of you and to Mr. Chairman.
    Mr. Upton. Thank you. I have got a number of questions left 
and I know Mr. Stupak is back and so I would expect the same as 
well. What is the number of single-use devices that are 
reprocessed about, percentage wise? Mr. O'Holla? Mr. Maurer, at 
the Cleveland Clinic?
    Mr. Maurer. I can comment at our institution. We have just 
done a recent review of that. It is very hard to give an exact 
percentage, but of all devices that go through sterile 
processing, and that is what we are talking about. I think, you 
know, Ms. Eshoo's comment is: Let us get away from this reuse 
of single-use devices. We are talking about sterile processing 
of devices, period. It is less than 1 percent, maybe even less 
than \1/10\th of a percent.
    Mr. Upton. Mr. Feltner?
    Mr. Feltner. Yes. Overall it is very small. In fact, on the 
list that FDA published of commonly reprocessed devices, AMDR 
members do not do half of them.
    Mr. Upton. Well, that is my other question. In fact, I was 
going to ask Dr. Maurer, you know, as I look at--and you are a 
terrific witness. The Cleveland Clinic is up at the very top, 
so we are glad that you are here and I know my hospitals of 
Michigan are very good as well, and I am anxious to see exactly 
what they are doing. But of the devices that you watch over, 
how many of them will be sent out to one of the AMDR member 
versus what you do in-house?
    Mr. Maurer. Most of the reprocessing is in-house. When it 
gets down to a critical device, the saw blades like I showed 
you, we send out. Now, the electrophysiology catheters, what if 
you were better at that. They are contained within the 
department of electrophysiology, there are trained people 
there, we have looked at them, we have continuous process 
control upon them. You have got to remember in terms of sterile 
processing, hospitals have done that ever since they opened 
their doors hundreds of years ago and, you know, Halsted 
decided that things should be sterile. That we should wear 
gloves. Hospitals do that, they are professionals in that. The 
people are trained. You cannot walk into those areas unless you 
are supposed to be there.
    Mr. Upton. And Mr. Feltner, as your organization brings 
things in, and obviously some things fail, what percentage of 
that? I mean, obviously if the average of----
    Mr. Feltner. It varies by product as you--I mean, saw 
blades, for instance. I mean, you cannot drop one and break it 
generally, but other products you could. So I would say we have 
some products as high as 60 percent rejection. Other products 
as low as 10 percent rejection. But I think there is something 
here that I am not comfortable that we are all speaking in the 
same language, because here is the thing.
    Mr. Upton. I know there are a lots of oranges and apples 
here.
    Mr. Feltner. Yes. One thing though that is very important 
that we have common language on. I am hearing a lot of concern 
that these devices that we are talking about I could not 
possibly think of having a device put in my body that was in 
the body of a previous person. Well, then you better never go 
to a hospital because every procedure that I have ever seen, 
someplace in that procedure is a product, whether it is 
reprocessed, or reusable, or new, that has been used on another 
patient. So what we are really saying is oops, I did not mean 
to say that I meant to say if it is single-use.
    Mr. Upton. Well, this happened. Yes.
    Mr. Feltner. Now, what we are saying then is we have two 
different standards of sterility. We have two different 
standards of cleanliness. One for a product marked single-use, 
and one for a product marked reusable. Well, that does not make 
any sense because the standard for validating the sterility of 
either product is the same. So, I think we have to look at 
this. Once a product is out of the package it has to meet the 
same standard. We were talking about which one would be exempt. 
The example just talked about. One of Dr. Maurer's saw blades 
would be exempt and one would not. Why? Because the 
manufacturer chose to label one single-use. It just so happened 
he sold the same one as reusable last week. Which one do you 
exempt?
    Mr. Upton. When an AMDR member rejects a product, is there 
some reporting of that? Do they go back to the OEM?
    Mr. Feltner. We manifest everything that we must turn that 
into medical waste or hazardous waste.
    Mr. Upton. Right. Right. But do you report back to the 
original manufacturer or to the FDA?
    Mr. Feltner. Oh, yes. Sure. Well, not back to the 
manufacturer. No. We report back to the hospital who sent it to 
us. See, that is another thing I want to make sure we 
understand. Hospitals who send products to us only get their 
products back. These are never owned by us. We do not sell 
products.
    Mr. Upton. Right. I understand.
    Mr. Feltner. So when they send us 50 saw blades and we 
reject five, they know that. We send them back and say we 
rejected five of these. We are shipping you 45 back.
    Mr. Upton. Well, what happens with devices that are used on 
someone with a disease like Hepatitis or HIV, what happens to 
those--are those automatically out of the stream? Are they 
reprocessed still? What type of----
    Mr. Maurer. Well, I can tell you, we have a policy in terms 
of sterilization that is the same for everything, because you 
do not know who has the Hepatitis.
    Mr. Upton. Right.
    Mr. Maurer. It was spoke about here that it may take 6 
months to develop.
    Mr. Upton. But what if you do know that somebody has that? 
What if you do know that somebody has HIV, are any of those 
products that might have been used in that individual's body? 
Are they still processed with maybe more care? I mean, what 
happens?
    Mr. Maurer. The processing is the same. The processing will 
kill HIV. It has got to because you do not know if they have 
it. It has got to. Now, to be frank, when I am in an operating 
room and I know the patient has got HIV, yes. I double glove 
and, you know, obviously that is just normal. But we cannot 
rely on that, so our processing has to be enough to kill that 
bug, no matter if we knew it or not.
    Mr. Upton. As I go back to, and I am going to use, you 
know, one of Mr. O'Holla's, I guess it is the lower picture 
there which is the tip of a catheter, is that what that is?
    Mr. O'Holla. Ablation catheter, yes.
    Mr. Upton. Ablation residue, and I presume that this device 
that you came back to get had been reprocessed, right?
    Mr. O'Holla. Yes, it had.
    Mr. Upton. So it was not perfect.
    Mr. O'Holla. That is right.
    Mr. Upton. And if that individual whose residue is still 
there, in fact, had HIV or something else infection like that, 
it would be more than trouble?
    Mr. O'Holla. I would think so.
    Mr. Maurer. Two things. You have got to look at what the 
process is that delivered that to the physician. You know, it 
is probably not a good process. You also have to remember that 
residue does not always equal infection as was shown in some of 
the studies.
    Mr. O'Holla. Right.
    Mr. Maurer. Now, it is yucky. I agree and it should not be 
there and I would not want it in me. Okay. Absolutely. But you 
have got to look at the process. That is a good quality 
control. If that is coming out, the process needs to be looked 
at. The process needs to be improved, but do not throw out the 
baby with the bath water. We are not going to throw out 
reprocessing because the process is bad. That is where the data 
needs to come from, from the FDA, and that the processes are 
certified as not producing that product.
    Mr. Upton. Well, I guess as us novices sit up here on this 
dais, we want something that is going to work so that that does 
not happen.
    Mr. Maurer. That is true.
    Mr. Upton. And we want some good housekeeping seal or 
something along those lines to ensure the safety to the 
patients, as well as to the hospital workers that are using 
those particular products. My time has expired here so I guess 
I go to Mr. Stupak.
    Mr. Stupak. Thank you Mr. Chairman. Dr. Fielder, in 
delineating patient alternatives, you used the example of 
offering a patient the choice between a used or reprocessed SUD 
with no difference in the cost to the patient. Would it follow 
then that a patient should be offered the same choice in a 
situation of two brand new devices, or one that costs the 
hospital less and at a smaller potential risk?
    Mr. Fielder. If I was a patient and they came at me and I 
had a choice between a new single-use device and a reprocessed 
one, I would take the new one, sure.
    Mr. Stupak. Sure. But I am saying should they be offered 
that choice?
    Mr. Fielder. Yes, they should.
    Mr. Stupak. Okay.
    Mr. Fielder. Because it is an alternative treatment.
    Mr. Stupak. But on two new ones, where one would cost less, 
both new, if there is one cost----
    Mr. Fielder. If there is no significant difference in risk, 
then that is the choice of the physician and the hospital. In 
the case of reprocessed devices, there is a significant risk. 
That crud that you see on the ablation catheter could be 
Hepatitis C that you are going to put into somebody else, so 
that is a risk. We do not know how high the risk is, but it is 
a risk.
    Mr. Stupak. If you have two new devices, brand new, and the 
question assumes a small potential risk with using one or the 
other, the patient should be made aware of that, right?
    Mr. Fielder. Not necessarily. I mean, there has to be some 
kind of, I mean, there is some risk in everything.
    Mr. Stupak. Sure.
    Mr. Fielder. And there is some level, as Dr. Trotter was 
saying, that the Courts have used the idea that material risk, 
is this something that the patient would want to know as part 
of his or her decision to have this treatment? So there is a 
kind of floor or level beyond which the risks are so remote 
that that does not really matter and people need not to be 
informed. They need to be informed if this is part of their 
decision in their lives and in their healthcare. And I think 
the fact that we do not have a well controlled cleaning and 
sterilization process that has been approved by FDA, means that 
there is a significant risk that people ought to know about so 
they can decide if they want to go along.
    Mr. Upton. Mr. Feltner?
    Mr. Feltner. Yes. That is not entirely correct because all 
of the processes in commercial reprocessing are validated and 
the FDA has standards for sterilization validation. Now, if we 
ask or have the doctor get patient consent for every product 
that has been used, are we going to get patient consent for 
every reusable product? Every product has a life. We just do 
not happen to know what it is. I have seen $4,000 instruments 
sold as reusable break on the first case. They were not meant 
to be disposable. They just happened to be that time. So we 
never know. Well, we say oh, take this out of circulation 
because next time it is going to break. We do not know that. So 
all of these products that are being reprocessed should they 
have patient consent as well?
    Mr. Stupak. Well, should a patient be asked their consent 
on whether they want a new one or reprocessed one?
    Mr. Feltner. If we do that we will run out of money by 7 
this evening.
    Mr. Maurer. Let me explain a little bit about patient 
consent because I do it every day. Every day I do anesthesia on 
somebody, I have to consent that patient. Okay. These people 
are very nervous. They are coming in for surgery on their 
bodies. Okay. What they want is quality care delivered to them 
in a safe environment. That is all our jobs here is to make 
sure that the regulatory, that the laws, that the FDA, that the 
licensing to be a physician, is done properly. Okay. I consent 
them for the serious parts of their procedure that they need to 
consent to. Okay. I tell you, to shirk our duties and think 
that somehow the consent issue is the primary one and that is 
going to solve this, is not going to work. Okay. We should 
consent patients. We should inform them, but when the risk is 
very low, and that is the thing that we are arguing here on 
either side, is how high is the risk. When the risk is very low 
and that risk is documented by valid data, then let us not 
confuse the issue with consent.
    Ms. West. Excuse me. I want to know if there is a reused 
device going to be put into my body. I have suffered for 17 
years because a C-arm was reused when they originally did the 
surgery on my head. And whether we run out of money or not, 
then we need to find another way to do that. But as a patient, 
I want to know if I am being given a reused or a clean device. 
And then in addition to that, I need to ask to be excused as I 
am supposed to be over at the Senate at 3 and I apologize for 
this, but my opinion is that I want to know. And I have many 
years of experience because I was not told, I was not given the 
option and everybody should be given the option.
    Mr. Stupak. Dr. Maurer, if I may, just a point of 
clarification on a question and answer with Ms. Eshoo. Maybe I 
misunderstood it. But I understand that, Ms. West, you can go. 
Right, Mr. Chairman, she can go?
    Mr. Upton. Yes.
    Mr. Stupak. I understand that the Cleveland Clinic passes 
along savings of reprocessing to the government and the 
patient, but where does the Cleveland Clinic reduce cost by 
reprocessing? I got the impression that there was a reduced 
cost that was passed on to the patient and the Government, so 
where does the Cleveland Clinic reduce the cost by 
reprocessing?
    Mr. Maurer. Well, if you reduce the cost and you deliver 
the same quality, you increase your value. And that is 
reflected in your market share because you then, the patients 
come to you more because you are delivering better value. So 
that is where the advantage is.
    Mr. Stupak. Okay. So it is not, that is value to the 
Cleveland Clinic then?
    Mr. Maurer. That is right. Now in some instances, in terms 
of going out in the marketplace and then negotiating a managed 
care contract, if we can do it at a lower cost, we offer a 
lower managed care contract, as long as we deliver the same 
quality and can certify that quality to the people that are 
paying us, and we get the contract.
    Mr. Stupak. Okay.
    Mr. Upton. Dr. Ganske.
    Mr. Ganske. Thanks Mr. Chairman. I want to go back to a 
question I asked Dr. Feigal, and it looks to me like we have a 
cardiologist on this panel, and I apologize for not being here 
earlier, but I had some other meetings I had to be at. We have 
somebody from the reprocessors, and the manufacturers. And now 
Dr. Maurer, are you representing the American Hospital 
Association?
    Mr. Maurer. I have been asked to come here on their behalf, 
yes.
    Mr. Ganske. Okay. Let us go to this situation where we have 
a catheter used for balloon angioplasty to crack open a 
stenosis in a coronary artery. That little balloon, you know, 
is made of an inflatable material. It is manufactured, in my 
understanding to under a certain pressure go to a certain size, 
there are different techniques for sterilization, one of which 
though is a heat sterilization. The other would be a gas, but 
then you are also dependent on very meticulous cleansing, 
manual cleansing. I want to know specifically, does this panel 
think that the average hospital, I am not saying some hospitals 
cannot, but the average hospital, can they re-sterilize those 
catheters, and I am not talking about the reprocessors. I will 
get to that in a minute. But the average hospital, can they re-
sterilizing that balloon catheter, with a proper 
sophistication, to be able to certify that after multiple uses 
this catheter is up to par.
    Mr. Maurer. Well, I can tell you that I cannot comment 
nationally, and I do not have the data on it, but in my hands, 
when I open a Swan-Ganz catheter with a balloon on it, even if 
I do not put it into the patient it goes in the trash. We do 
not even re-sterilize those that are open and not used because 
we have that concern.
    Mr. Ganske. So it is a Swan-Ganz?
    Mr. Maurer. Well, it has got a balloon on it. That is what 
I have in my hands.
    Mr. Ganske. All right. I am talking about are balloon 
angioplasty catheters reuse?
    Mr. Maurer. We do not reuse those at the Cleveland Clinic, 
no.
    Mr. Ganske. Are they reused, do you think they are reused 
anywhere?
    Mr. Maurer. You can ask our cardiologist.
    Mr. Ganske. Yes.
    Mr. Lindsay. I'm Dr. Lindsay. There are some hospitals that 
reuse these catheters. My hospital does not, and I have some 
reservations about whether the data would support reusing 
those. I think there are some of these devices that probably 
should not be used. And I think as the FDA looks at them, that 
is one of the devices that I have questions about.
    Mr. Ganske. Mr. Feltner, what would your response on that 
be?
    Mr. Feltner. Some AMDR members reprocess balloon catheters, 
and when they do they use FDA published guidelines that assure 
bio-compatibility and physical testing. One company I know that 
is an AMDR member, they tested over 8,000 balloon catheters 
before they ever shipped their first one back to the hospital. 
And I am told now that they have processed over 3,000 without 
an incident. This----
    Mr. Ganske. Does this require some special type of 
technology and expertise to do that?
    Mr. Feltner. Oh, yes. It will require special technology, 
special equipment, but I think here what we are really getting 
to though----
    Mr. Ganske. Let me just ask you.
    Mr. Feltner. Yes.
    Mr. Ganske. Do you think the average hospital has that type 
of technology or equipment to do?
    Mr. Feltner. I would not think, and I use the word think, I 
would not think that today many hospitals would have all that 
equipment, but this is where we really need to zero in on the 
answer here. And the answer is process. Validation. I am aware 
of a major institution reprocessing in-house pace makers from 
cadavers. Now, that sends a little hair up my back when I first 
heard that and I heard no. If the process is right, if the 
cleaning is validated, if the sterilization is validated, and 
the functional testing is to a standard that could be 
validated, the process is good. Now, many companies may chose, 
or many hospitals may chose not to reprocess a product simply 
because of our litigious society. There are certain products 
that maybe the risk of a legal problem is greater than the 
possible return of the market.
    Mr. Ganske. Okay. Well, let me just follow this. I want an 
answer from everyone on the panel on this. Is the panel in 
consensus that at least for some types of single-use products 
that the re-sterilization should be done, not by hospitals, but 
only by certifiable reprocessors?
    Mr. Maurer. The hospitals could get certified if they had 
enough volume to get all the same equipment.
    Mr. Ganske. Okay. But they would have to go through a--that 
for some types of single-use products they ought to go through 
FDA certification process. Is there any disagreement with that 
on this panel?
    Mr. Grossman. I would disagree because I think that the FDA 
themselves are saying that what they are going to finally focus 
on is the data that not what the process might have led to, but 
what actually happened. Because that is the burden they put 
when these products are originally created. The Office of 
Science and Technology recently did a study they presented 
publicly in May looking at the kind of catheters to which you 
refer. Took them from Walter Reed instead of discarding them in 
the garbage and performed functional testing and showed that 
they were a disaster. They were a disaster. The balloons 
changed compliance, changed shape, became sticky, so I think 
since----
    Mr. Ganske. So, you are agreeing with me?
    Mr. Grossman. Well, I am saying I do not think the process 
will protect it by saying you have handled it well. I think the 
FDA then needs to actually go to the device and say now that it 
has been processed, we are going to say that it is safe and 
effective just like we did when it was new.
    Mr. Ganske. Well, right. I am assuming that if it is 
processed----
    Mr. Grossman. Oh, okay.
    Mr. Ganske. That if it is processed that the process 
certification says that it works, not that you can just have a 
sterile one--but now it inflates to 3 millimeters instead of 
2.5. Okay.
    Mr. Grossman. Yes.
    Mr. Ganske. So, at least the entire panel is in consensus 
that there are probably some sophisticated devices that are in 
use that it would be inappropriate for a hospital to be 
reprocessing and sterilizing themselves unless they have some 
extraordinary reprocessing/processing capability, and that 
these are items that could be identified by the FDA. Is that 
fair?
    Mr. Maurer. It out to be a functional definition. I worry 
about location because things change over time. You know, so I 
think it is a functional definition. If you cannot meet the 
standard, then you should not be doing it no matter who you 
are.
    Mr. Ganske. Yes.
    Mr. O'Holla. Congressman Ganske, I do not know if FDA can 
actually identify those a priority. I know that FDA can make a 
judgment about those if the person who wanted to do the act 
came to FDA and said I am going to reprocess this particular 
device this way and here is the data that shows it is safe and 
effective. I think they can evaluate that. I think you may be 
asking them to do an impossible task to identify a priority 
which devices can and cannot be done, because they do not know 
what people will be doing to them.
    Mr. Ganske. Okay. Let me get to my second question. And you 
know, pictures like this are disturbing to all of us, but 
matters of thoroughness, of cleansing can vary between let's 
say hospitals and professional reprocessors. Is there anyone 
that would disagree with that?
    Mr. Maurer. Well, I think it can vary hospital to hospital. 
It can vary reprocessor to reprocessor.
    Mr. Ganske. Right. But how many reprocessors are there in 
the country?
    Ms. Eshoo. They do not know.
    Mr. Feltner. I cannot really say. I hear some stories that 
are amazing. I do not know if they are--somebody said there are 
23. If there are, I do not know who they are. There are three 
major processors that are members of AMDR. I think that as FDA 
implements the proposed guidelines, they would all have to 
register, and then we would definitely know who they were. We 
have cooperated with FDA in giving them all the companies that 
we know of.
    Mr. Ganske. Well, are were talking about less than 20?
    Mr. Feltner. Oh, yes. Yes. Yes.
    Mr. Ganske. Okay. And how many hospitals are there in the 
country?
    Mr. Feltner. Six thousand, roughly.
    Mr. Ganske. It would be a lot easier to oversee whether 
less than 20 reprocessors are doing their job properly than to 
be thinking about looking at, for single-use devices, 
particularly the ones that can be identified as problematic, 
6,000 hospitals. Does not that seem reasonable?
    Mr. Maurer. On the surface, yes. Okay. But you have got to 
watch because, you know, hospitals have very good sterile 
processing departments and quality control systems in place, 
and those are well set up. They are supervised by Joint 
Commission and State health boards, and it is not just the FDA 
that is getting in on this. You know, processing and sterile 
processing has been around for years.
    Mr. Ganske. I understand. I am a surgeon. I have worked 
with instruments all my life.
    Mr. Maurer. You know what I am talking about. We have got 
to look at those ones which are borderline, and we do not have 
the data on, and if they require functionally specialized 
techniques and the hospital cannot deliver that specialized 
technique, then a specialized person needs to do it. And if 
that is a reprocessor, then so be it.
    Mr. Ganske. I agree. Thank you. Thank you Mr. Chairman.
    Mr. Upton. Thank you. Ms. Eshoo, do you have additional 
questions?
    Ms. Eshoo. Yes. Mr. Chairman, I would like to make a 
request and that is that if Dr. Maurer for the committee's 
record could submit to us copies of the hospital's billings 
that show the rates that are billed to HCFA when a reused 
device is used versus the other. Because I think it will show, 
you know, it is a demonstration and an example of the billing. 
And I also think that when we look at these things that are 
submitted for the record that we understand that while you may 
be doing that at your hospital, we do not know what is 
happening at others.
    Mr. Maurer. We can do that.
    [The following was received for the record:]
    [GRAPHIC] [TIFF OMITTED] T2970.074
    
    Ms. Eshoo. And I think that this patchwork quilt of issues 
has really been nailed down with me today. That we have some 
reprocessors that are absolutely terrific. The gentlemen that 
represents them as a trade association cannot tell us how many 
there are in the country. We do not know how many hospitals 
adhere to the high standards that Dr. Maurer has talked about, 
nor do we have information and data that has been collected by 
the FDA, not the associations and the groups around all of 
this. They simply have not tracked and collected the data that 
we could weigh and measure in a hearing like this. So, it is a 
patchwork quilt. I think that there are some problems out 
there. We do not know in the reuse of these devices if, in 
fact, the record that we know about anecdotally is the best 
record of all. I mean, maybe that is the perfect good news. It 
is not perfect, but there is a lot of good news in it because 
people with legitimacy can say well, we do not have that many 
problems in the country. But do we really know that? So I think 
that this hearing was designed, or really offered us, what 
Congressional investigation and oversight is really meant to 
be. It has answered some questions, it has raised others, and 
because of each one of you I think that we are going to move on 
and keep examining this, at least I will. So thank you very 
much. And thank you again, Mr. Chairman, for allowing me to be 
here today and for the legislative courtesies that have been 
extended to me, and your patience as well. Thank you.
    Mr. Upton. Thank you. Again, I appreciate all of your 
testimony and your answers. We would be most interested in the 
future as you comment back to the FDA with regard to the 
regulations that they put out. You have done a fine job today 
and you are formerly now excused. Thank you.
    [Whereupon, at 2:58 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]
    [Additional material submitted for the record follows:]
            Prepared Statement of National Consumers League
    The National Consumers League is a national, nonprofit consumer 
advocacy organization founded in 1899 to represent consumers in the 
marketplace and workplace. NCL commends the Subcommittee on Oversight 
and Investigations for holding this hearing. As you examine the complex 
issue of medical device reprocessing, we want to bring to your 
attention important consumer implications of this issue.
    NCL believes that Congress must do all that it can to assure that 
the Food and Drug Administration is doing its job to protect public 
health. We believe that the Commerce Committee is moving in the right 
direction as it investigates and oversees FDA's regulation of medical 
device reprocessing. The safety of medical device reprocessing must be 
the overriding concern of Congress, the FDA, hospitals, and physicians. 
Clearly, no amount of health care cost savings can be justified if 
safety is compromised.
    In our view, the medical device reprocessing debate concerns two 
very different interests: the interests of consumers who expect safe 
health care practices and the interests of the medical device 
manufacturers who are working very hard to eliminate competition.
    First and foremost are the interests of consumers. Through 
appropriate regulation, FDA must assure that medical device 
reprocessing is safe. Consumers must have confidence that when a 
reprocessed medical device is used in a procedure, it will perform as 
safely and effectively as it would on its first use. Consumers should 
be assured that they will not experience an infection or health 
complication because a device was reprocessed.
    Once it is determined, through sound science, that medical device 
reprocessing can be safely performed and is adequately regulated, then 
and only then should the cost savings that such a practice provides be 
considered. Faced with overwhelming cost pressures, hospitals are 
increasingly reducing staff and scaling back on the procedures they 
will perform. For many consumers, the result has been lower quality and 
less affordable health care. Measures that can help control health care 
costs must be encouraged but should never be considered if patient care 
is compromised.
    As you know, medical device reprocessing is a practice aimed at 
reducing costs associated with medical devices labeled as ``single 
use'' or ``disposable'' by the manufacturer. We understand that many 
hospitals have been reprocessing ``single use'' devices for years and 
that a number of hospital and physician groups have sent letters to 
Congress expressing confidence in the safety and effectiveness of 
reprocessed devices.
    FDA has a strong tradition of protecting the public health based on 
sound science. As FDA reviews its regulatory approach for medical 
device reprocessing, we expect the agency to continue this tradition. 
Even though there has not been any significant evidence of a public 
health hazard to date, FDA should be thorough and vigilant in its 
regulation of device reprocessing and should take a strong regulatory 
posture that is systematic, based on science and based on risk. If 
effectively enforced, FDA's current regulatory regime affords consumers 
appropriate protection. FDA's Quality System Regulation, which governs 
the reprocessing of medical devices by third parties, is similar to 
good manufacturing practice regulations and sets forth requirements 
designed to assure that reprocessed medical devices are clean, sterile, 
and functional. Through inspection, FDA must assure compliance with all 
of the QSR requirements, including process validation, acceptance 
activities, internal audits, personnel training, storage, and complaint 
handling. By requiring those engaged in the reprocessing of medical 
devices to withstand the scrutiny of FDA inspection, consumers can have 
assurance that reprocessed medical devices are clean, sterile, and 
functional.
    We understand that FDA is reviewing its policy to require premarket 
review of reprocessed medical devices. To date, the agency has not 
believed premarket review is necessary to protect the public health. If 
risk warrants premarket review for certain device reprocessing, FDA 
should require it. NCL also believes consumers deserve more information 
about the risks and benefits with all health practices, including 
procedures that involve using all devices. FDA should work with 
consumer and patient advocates to ensure that the messages patients 
receive are accurate and thorough. To that end, statutory requirements 
for informed consent--in consumer friendly language to assure that the 
consumer understands--should be more broadly applied so that consumers 
may assess the relative risks of a procedure or a particular device. 
The FDA should require that all significant risks trigger an informed 
consent requirement. In this way, consumers will receive relevant 
information, communicated both orally and in writing in consumer 
friendly language, and the information that they receive will be put in 
the proper context with respect to their own health care regimen.
    As mentioned, the issue of medical device reprocessing touches on 
two different interests: the interests of consumers and the interests 
of the medical device manufacturers. As the Subcommittee studies the 
safety of medical device reprocessing, we urge you to take note of the 
strong opposition to reprocessing voiced by the manufacturers of 
``single use'' devices. You should be aware that the term ``single 
use'' is a term that is chosen by the manufacturer of the device; it is 
not required by the FDA. There is a clear economic incentive to label 
devices as ``single use'' in order to sell more devices.
    As Congress considers the issue of medical device reprocessing, it 
should make sure that FDA has a sound science-based regulatory 
procedure for medical device reprocessing in place that will protect 
the public health and assure consumers that the devices used for their 
health care are safe and effective.

                                
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