[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




 
MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY 
                           SINGLE-USE DEVICES

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

                                HEARING

                               before the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 26, 2006

                               __________

                           Serial No. 109-190

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
                      http://www.house.gov/reform


                                 ______

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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
JON C. PORTER, Nevada                C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas                BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia        ELEANOR HOLMES NORTON, District of 
PATRICK T. McHENRY, North Carolina       Columbia
CHARLES W. DENT, Pennsylvania                    ------
VIRGINIA FOXX, North Carolina        BERNARD SANDERS, Vermont 
JEAN SCHMIDT, Ohio                       (Independent)
BRIAN P. BILBRAY, California

                      David Marin, Staff Director
                Lawrence Halloran, Deputy Staff Director
                         Benjamin Chance, Clerk
                         Michael Galindo, Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on september 26, 2006...............................     1
Statement of:
    Selvey, Don, senior vice president, regulatory affairs and 
      quality assurance, Ascent Healthcare Solutions, Inc.; 
      Dennis J. Toussaint, director, regulatory affairs, 
      Sterilmed, Inc.; and Stephen J. Ubl, president and CEO, 
      Advanced Medical Technology Association....................    39
        Selvey, Don..............................................    39
        Toussaint, Dennis J......................................    56
        Ubl, Stephen J...........................................    73
    Schultz, Dr. Daniel G., Director, Center for Devices and 
      Radiological Health, Food and Drug Administration..........    13
Letters, statements, etc., submitted for the record by:
    Davis, Chairman Tom, a Representative in Congress from the 
      State of Virginia, prepared statement of...................     4
    Schultz, Dr. Daniel G., Director, Center for Devices and 
      Radiological Health, Food and Drug Administration, prepared 
      statement of...............................................    17
    Selvey, Don, senior vice president, regulatory affairs and 
      quality assurance, Ascent Healthcare Solutions, Inc., 
      prepared statement of......................................    41
    Toussaint, Dennis J., director, regulatory affairs, 
      Sterilmed, Inc., prepared statement of.....................    58
    Towns, Hon. Edolphus, a Representative in Congress from the 
      State of New York, prepared statement of...................    92
    Ubl, Stephen J., president and CEO, Advanced Medical 
      Technology Association, prepared statement of..............    75
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................     8


MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY 
                           SINGLE-USE DEVICES

                              ----------                              


                      TUESDAY, SEPTEMBER 26, 2006,

                          House of Representatives,
                            Committee on Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:40 a.m., in 
room 2157, Rayburn House Office Building, Hon. Tom Davis 
(chairman of the committee) presiding.
    Present: Representatives Tom Davis, Mica, Gutknecht, 
Porter, Foxx, Schmidt, Waxman, Owens, Towns, Cummings, 
Kucinich, and Norton.
    Staff present: David Marin, staff director; Larry Halloran, 
deputy staff director; Keith Ausbrook, chief counsel; A. Brooke 
Bennett, counsel; Susie Schulte, professional staff member; 
Michael Galindo and Benjamin Chance, clerks; Karen Lightfoot, 
minority communications director/senior policy advisor; Stephen 
Cha, minority professional staff member; Sarah Despres, 
minority counsel; Early Green, minority chief clerk; and Jean 
Gosa, minority assistant clerk.
    Chairman Tom Davis. I apologize for being a couple of 
minutes late. I want to welcome everybody to today's hearing on 
the Food and Drug Administration's regulation of reprocessed 
single-use devices.
    The purpose of this hearing is to assess FDA's oversight of 
the reprocessing industry and determine what, if any, 
additional measures are needed to assure reprocessed SUDs are 
effective and safe. FDA is responsible for approving these 
devices. Manufacturers choose to submit applications for 
single-use only designation as opposed to multi-use 
designation. FDA, however, allows reprocessed SUDs to be 
marketed if they are substantially equivalent to the original 
device.
    Many of you may not be aware that several commonly used 
medical devices are cleaned and resterilized to be used by 
hospitals more than once. Devices such as catheters, biopsy 
forceps, and surgical tools are often designated for one-time 
use, but hospitals routinely pay to have them reprocessed to 
cut costs and reduce medical waste. For example, new biopsy 
forceps can cost $60, yet reused forceps can cost as little as 
$15. Savings from use of reprocessed devices can be 
significant.
    Original device manufacturers have said, however, they 
cannot guarantee the safety of SUDs once they are reprocessed 
and reused. Reprocessors contend there is no sufficient or 
credible evidence to indicate the use of reprocessed medical 
devices is riskier than the use of new ones. Hospitals may save 
overhead costs, but what is the cost of patient's health? That 
is just one of the many questions we are going to ask today.
    The committee's interest began with a series of articles in 
the Washington Post that reported many instances of patient 
injury associated with the use of defective and unsterile 
reprocessed devices. Mr. Waxman and I wrote to the FDA, asking 
for information on device safety regulations and the adequacy 
of adverse event data. The FDA responded that the data in hand 
did not establish a clear causal link between reprocessed 
devices and subsequent adverse health effects, but we need to 
know whether that is because the reprocessed devices are safe 
or because MedWatch, the adverse event monitoring system, is 
too passive or insensitive to capture subtle but potentially 
deadly trends.
    Today's hearing will question whether FDA's current 
MedWatch reporting system can accurately capture adverse events 
resulting from reprocessed devices. We will ask FDA how new 
labeling requirements under the Medical Device User Fee and 
Modernization Act are working to help improve the MedWatch 
system. Effective last month, reprocessed devices are required 
to be stamped or tagged with a label indicating they have been 
reprocessed. Previously, only the packaging was required to 
identify the device was reprocessed, and most doctors were 
unaware devices were reprocessed as packaging is often removed 
prior to use in the operating room.
    Now look, I realize some of our witnesses will say it is 
too early to clearly determine what impact the new labeling 
requirement will have on adverse event reporting, and that is 
OK. Today's hearing will not be the committee's final look at 
the issue.
    Mr. Waxman and I have asked GAO to update its June 2000 
report on SUDs. GAO's initial report found little harm from 
reuse but recommended additional oversight by the FDA. Because 
FDA regulation of the industry has increased significantly 
since 2000, the committee asked GAO to specifically examine the 
safety of SUD reprocessing, the adequacy of FDA's oversight, 
and how reprocessed SUDs compare to original devices. GAO has 
accepted this request, but they have not yet initiated work.
    Before we move to our first panel, I am going to express my 
disappointment in the original device manufacturing industry. 
We have no device makers testifying today because they 
preferred to speak through their trade association, AdvaMed. 
Specifically, C.R. Bard, a company from Murray Hill, NJ, was 
invited to testify, but they declined to appear. We would have 
preferred to have direct testimony from companies so they would 
be able to provide specific examples and commentary regarding 
their specific devices. Despite the committee's disappointment 
with the lack of original device manufacturer witnesses, we 
will continue our discussions with those companies.
    We have the reprocessors represented by SterilMed and 
Ascent Healthcare Solutions, the two largest companies in the 
business, ready to testify today, and I want to thank them for 
appearing.
    I look forward to your testimony from both panels on this 
important issue.
    [The prepared statement of Chairman Tom Davis follows:]

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    Chairman Tom Davis. I would now recognize Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman for holding today's 
hearing on the safety of reprocessed medical devices.
    FDA's oversight of medical devices is an important issue 
that does not get sufficient attention. Medical devices can be 
as critical to a patient's care as the drugs they are 
prescribed. There are devices that keep the heart beating, to 
measure the level of oxygen in blood, to deliver pain 
medication, and to test blood pressure. When devices fail, 
there can be very serious consequences including death.
    Today's hearing is focused on the risks of reprocessed 
medical devices, but the safety risks posed by medical devices 
are by no means limited to reprocessed devices. One example is 
the recent manufacturing defects in brand new implantable 
cardiac defibrillators. These are devices that are implanted 
into people with heart problems and that can save a person's 
life by shocking a nonfunctioning heart back into rhythm. Even 
after one major manufacturer of defibrillators learned that 
some of its devices were flawed, the company did not inform 
physicians or the public, and the faulty defibrillators 
continued to be surgically implanted.
    Eventually, there was an after the fact recall, but by this 
time, the faulty defibrillators had already been implanted and 
patients were put into the position of having to live with 
defibrillators that could fail or undergoing another surgery to 
have them replaced. That is a terrible position for anyone to 
be in.
    In recent years, there has been a concerted effort to 
strengthen FDA regulation of reprocessed devices. A series of 
congressional hearings and a GAO investigation showed that this 
was an area that needed more regulation. FDA then asserted its 
jurisdiction over device reprocessors, subjecting them to the 
same standards as other device manufacturers, and in 2002 and 
in 2005, Congress imposed additional requirements on the 
manufacturers. The last of the new rules for reprocessed 
devices went into effect in August. As a result, we no longer 
have a regulatory scheme that allows devices to be cleaned and 
reused with no oversight. Under the law, reprocessed devices 
are actually more tightly regulated now than their single-use 
counterparts.
    I understand that the original equipment manufacturers do 
not like reprocessing. They have an economic concern about this 
practice. The practice of reprocessing cuts into their profits 
and often forces them to lower their prices to stay 
competitive. Their agenda, however, should not be our agenda.
    The safety concerns with reprocessed devices have to be 
understood within the broader context of device safety. Under 
the FDA's current regulatory scheme for reprocessed devices, 
FDA assures us that a reprocessed device will meet the same 
exact standards as the original device. It must be just as 
strong and just as sterile as it was the first time it was 
used. So, as we question FDA's ability to assure that 
reprocessed devices are safe and effective, as we should, we 
must recognize that we are, in effect, questioning FDA's 
ability to ensure that all devices are safe and effective.
    We will hear today that FDA is not devoting enough 
resources to enforcing the requirements that apply to 
reprocessed devices. I share these concerns.
    I want to learn how the new regulations for manufacturers 
of reprocessed devices are being implemented, and I hope we 
will do everything we can to urge FDA to be more effective 
bringing enforcement actions for violations of the regulations 
governing reprocessed devices. But we must recognize that FDA's 
failure to protect the public extends beyond reprocessed 
devices. The reality is that FDA is also not doing a good job 
protecting Americans from the dangers of new devices, and it is 
the original devices, not reprocessed ones, that cause the 
largest number of deaths and injuries.
    I issued a report in June that revealed that FDA 
enforcement actions have declined significantly under the Bush 
administration. Among FDA's regulatory centers, the Center for 
Devices and Radiological Health saw the biggest decline in 
enforcement with a 65 percent drop in the number of warning 
letters it issued from 2000 to 2005. This report made clear 
that in the last 5 years, FDA has chosen to ignore the advice 
of its own staff, has taken far fewer enforcement actions than 
in previous years, and has left the industry to police itself.
    In order to put the issue of reprocessed medical devices 
into the broader context of device safety, I requested that Dr. 
Peter Lurie from Public Citizen be invited to testify. For 
reasons that I do not understand, my request was denied. Dr. 
Lurie is a consumer advocate with no financial stake in this 
issue. He would have provided an important public health 
perspective to today's hearing, and it is unfortunate he was 
not allowed to participate.
    Americans rely on the FDA to make sure that the foods they 
eat, the drugs they take, and the devices that they need are 
safe and effective. Unfortunately, recent tragedies like the 
faulty defibrillators have shaken consumers' confidence that 
FDA is effectively fulfilling this role.
    I look forward to learning from our witnesses today steps 
we can take to strengthen FDA's oversight of all medical 
devices so that we can have this faith restored. I thank the 
witnesses for coming.
    Thank you, Mr. Chairman.
    [The prepared statement of Hon. Henry A. Waxman follows:]

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    Chairman Tom Davis. Thank you.
    Any other Members wish to make opening statements?
    Mrs. Schmidt.
    Mrs. Schmidt. Thank you, Mr. Chairman. I will be brief. I 
really appreciate the opportunity to have this hearing today. I 
first became aware of the issue of using reprocessed single-use 
medical devices in my own district with people that had 
concerns over the fact that patients may not know these devices 
are being used, doctors may not know that these devices are 
being used, and the quality of them being reprocessed.
    I look forward to an insightful debate on this issue. The 
concern and the bottom line that I have is that when a patient 
seeks medical treatment that the best care is being provided, 
the safest care is being provided, and that the patient 
understands that when a reused device is going to be used, that 
they know the ramifications of that.
    I thank you very much for the opportunity to learn more 
about this.
    Chairman Tom Davis. Thank you very much.
    Any other Members wish to make opening statements?
    If not, we will proceed to our first panel. We have Dr. 
Daniel Schultz, the Director of the Center for Devices and 
Radiological at the Food and Drug Administration.
    Dr. Schultz, thank you for being here. Why don't you just 
remain standing, and I will swear you in.
    [Witness sworn.]
    Chairman Tom Davis. Thank you.
    You have a light in front of you that turns orange after 4 
minutes, red after 5. Your entire statement is part of the 
record, and questions will be based on your entire written 
statement. Thanks for being with us.

   STATEMENT OF DR. DANIEL G. SCHULTZ, DIRECTOR, CENTER FOR 
 DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION

    Dr. Schultz. Good morning, Mr. Chairman, members of the 
committee.
    My name is Dan Schultz. I am Director of the Center for 
Devices and Radiological Health at the Food and Drug 
Administration. The safety of medical devices is of utmost 
importance to the agency, and I appreciate the opportunity to 
discuss the safety and effectiveness and manufacturing quality 
of reprocessed single-use devices or SUDs.
    My written testimony includes an overview of our regulatory 
authority for medical devices. FDA classifies medical devices 
into Class I, II, and III, based on risk, Class III being the 
highest risk. Currently, only Class I and II single-use device 
types have been cleared by FDA for reprocessing.
    Let me provide some background on the regulation of 
reprocessed devices. In August 2000, FDA issued guidance 
enforcement priorities for single-use devices reprocessed by 
third parties in hospitals. Again, this was prior to any 
specific legislation on this issue. It was based on a series of 
meetings that we held and input from stakeholders, which 
suggested that there was interest in having closer regulation 
on this topic.
    This guidance set forth FDA's priorities for enforcing pre-
market submission and post-market requirements for 
manufacturers who wish to market reprocessed SUDs. The guidance 
document stated that any third party and hospital reprocessor 
should comply with requirements pertaining to registration and 
listing, medical device reporting, medical device tracking, 
medical device corrections and removals, the quality system 
regulation, labeling, and pre-market submission. Essentially, 
at that time, reprocessors were placed on the same regulatory 
framework as the OEMs.
    Prior to issuance of this guidance, reprocessors were not 
consistently held accountable to any of these requirements. In 
2002, with enactment of MDUFMA, Congress mandated a number of 
new requirements for SUD reprocessors including, for certain 
SUDs, the pre-market submission of data that exceeded the 
requirements for OEMs. Certain reprocessed SUD types that 
present the greatest potential risk of infection and inadequate 
performance following reprocessing and that were previously 
exempt from pre-market submission were no longer exempt.
    MDUFMA also created a new type of pre-market submission 
called a pre-market report for Class III reprocessed SUDs that 
otherwise would have required a pre-market approval 
application. MDUFMA also required a change to FDA's MedWatch 
voluntary and mandatory reporting forms to identify adverse 
events involving reprocessed SUDs. As of August 1, 2006, MDUFMA 
also requires reprocessed SUDs to bear the name, abbreviation, 
symbol of the reprocessor, either on the device itself, on an 
attachment, or a detachable label.
    Under the FD&C Act, before introducing a device to market, 
manufacturers must submit a notification of 510(k) and obtain 
FDA clearance unless the device has been exempted. MDUFMA 
required FDA to identify previously exempt device types that, 
if processed as an SUD, would now require 510(k) submission 
including the submission of validation data. In addition, 
MDUFMA required the FDA identify SUDs already subject to 510(k) 
pre-market requirements but that would now also require the 
submission of validation data. Validation data include cleaning 
and sterilization and functional performance data demonstrating 
that each SUD will remain substantially equivalent to its 
predicate after the maximum number of times the device is 
intended to be reprocessed.
    On June 1, 2004, FDA issued Guidance for Industry and FDA 
Staff, MDUFMA 2002, Validation Data in Pre-market Notification 
for Reprocessed Single-Use Medical Devices. This document 
describes the types of validation data that FDA expects to be 
submitted on cleaning, sterilization, and functional 
performance, the timeframe for FDA's review of these 
submissions, and what actions the agency intends to take if it 
finds a reprocessed SUD to be not substantially equivalent.
    As of September 2006, FDA has received 200 pre-market 
notification submissions for reprocessed SUDs, each covering 
from a single to as many as several hundred device models. 
Approximately 67 percent have been cleared by the agency. The 
remaining were not cleared for reasons such as inadequate 
validation data, lack of necessary information from the 
reprocessor, withdrawal of the application, or lack of response 
to FDA's request for data. Just to give you some perspective on 
this and put it in context, of the total number of 510(k)'s 
that we received, approximately 88 percent of all those are 
cleared.
    Inspections serve as a bridge between pre and post-market 
activities. On the average, FDA has conducted inspections of 
reprocessor firms once every 2 years, a rate considerably 
higher than the one in every 4 years for OEMs. All known 
reprocessing firms have been inspected within the last 2 years. 
FDA continues to evaluate newly registered firms to confirm 
whether they are performing SUD reprocessing and updates its 
inspectional plan as required.
    Post-market; post-market monitoring of device-related 
adverse events and product problems is accomplished through the 
MDR system. MDR reports include deaths, serious injury, and 
device malfunctions. Healthcare facilities are required to 
report deaths suspected to be device-related to both FDA and 
the manufacturer/reprocessor and serious injuries to the 
manufacturer/reprocessor. FDA also receives voluntary reports 
generally from healthcare professionals through its MedWatch 
reporting system. CDRH receives approximately 200,000 device-
related adverse event reports per year.
    Can I continue? Oh, sorry.
    As you know, on January 24, 2006, I and others briefed the 
committee staff about SUD reprocessing. We searched our 
Manufacturer and User Facility Device Experience data base for 
reports from October 22, 2003, which is when the MDUFMA 
legislation went into effect, to December 13, 2005, that were 
coded as adverse events associated with reprocessed SUDs. 
Analysis of these reports did not disclose a clear link between 
a reprocessed SUD and subsequent patient injury or death.
    In July 2006, the agency updated the search to include all 
reports between October 2003, and July 2006. FDA has received a 
total of 434 reports and, of these, approximately 65 reports 
involved or were suspected to involve reprocessed SUDs. These 
AEs may be associated with reprocessing. They may also be 
associated with the medical condition of the patient, the 
medical procedure, or other confounding factors. We are seeing 
that the same types of adverse events reported to be associated 
with the use of SUDs are similar for new, non-reprocessed 
devices.
    To learn more about how reprocessing was actually occurring 
from a user standpoint, we conducted a survey under our Medical 
Product Device Safety Network or MedSun. FDA's MedSun is 
comprised of over 350 hospitals that identify and report device 
problems, and this is a more active surveillance system as 
opposed to the MAUDE system which is a much more passive 
system. Representatives from more than 50 of these facilities 
provided feedback on their experience with reprocessed SUDs to 
FDA staff. In general, participants had a favorable view of 
reprocessed SUDs. There were no reports with specific problems 
with SUD-related infections, and participants did not report a 
greater concern with mechanical problems associated with 
reprocessed SUDs compared to non-reprocessed SUDs.
    I would like to emphasize, however, that one of the 
statements, and there was some variability in terms of the 
comments that we got, but one of the statements that was clear 
and was totally consistent was the idea that it was, that they 
found it necessary and desirable for FDA to have a strong 
oversight over this process.
    The agency continues to review and assess the practice of 
reprocessing SUDs. I have some specifics in my written summary.
    Just yesterday, FDA published rules amending certain 
classification regulations for reprocessed SUDs formerly exempt 
from pre-market, those previously subjected to pre-market 
notification, and for which validation data are now necessary 
in a 510(k). These amendments will help reprocessors and other 
stakeholders to know which devices are being reprocessed and 
allow them to submit the data that they need to demonstrate 
that their device is substantially equivalent.
    We have also recently updated our Web site. We have also 
recently initiated a dedicated post-market team to look 
specifically at the adverse events associated with 
reprocessing, and we continue to update our inspection plan to 
make sure that we are inspecting all of the reprocessors on a 
regular basis.
    Available data show that certain--and I emphasize the word, 
certain--SUDs can be reprocessed with a reasonable assurance of 
safety and effectiveness. FDA believes that reprocessed SUDs, 
that meet FDA's regulatory requirements are as safe and 
effective as their predicate. The law and regulations in place 
are designed to protect the public health by assuring that 
reprocessing is based on sound science. We continue to monitor 
the performance of these devices and to assess and refine our 
ability to regulate them appropriately.
    Mr. Chairman, I apologize for running over. Thank you again 
for the opportunity to address this important topic.
    [The prepared statement of Dr. Schultz follows:]

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    Chairman Tom Davis. Thank you very much.
    I am going to start the questioning with Mr. Gutknecht.
    Mr. Gutknecht. Mr. Chairman, I don't have a question so 
much as a comment.
    I am delighted the FDA is taking some of these issues 
seriously, but I just want to make sure that we don't overstate 
the danger here. I just don't want consumers to believe that 
there is real risk.
    In your professional judgment, how many American consumers 
have been injured by some of these reused technologies?
    Dr. Schultz. I wish I could give you an exact count; I 
can't.
    Again, we have looked at all of the reports that have been 
submitted to us, most of the reports, and we were given 
specific authority to designate those reports as whether they 
are reprocessed or non-reprocessed. Unfortunately, a lot of 
those reports were incorrectly designated. When we looked at 
them specifically one by one, of those that remained, there 
certainly are some that could have been associated with 
reprocessing, but based on the data and actually the in-depth 
analysis of those individual reports, as I said, it is very 
difficult to precisely, precisely define which ones were, in 
fact, associated with the reprocessing versus the device or the 
overall procedure. I apologize for not being able to give you a 
more specific answer, but that is the honest answer of what we 
currently know.
    Mr. Gutknecht. My point really is, Mr. Chairman and 
Members, I think we have to put this in some context. The 
unfortunate fact is that somewhere between 6,000 and 10,000 
Americans die every year in hospitals as a result of either 
getting the wrong medication or an infection which they 
actually caught while they were in the hospital. In the very 
rare circumstance of that infection, did that have anything to 
do with a reprocessed medical device?
    I think it is important we have this hearing, Mr. Chairman, 
but I think we have to put it in context. No. 1, we don't have 
very good data, and second, the data that we do have doesn't 
suggest that American consumers, American patients are at any 
undue risk because of the reprocessing of medical devices.
    I know in talking to some of the healthcare people in my 
district and in the State, they do want to use these because 
they can see significant savings rather than having to buy all 
new equipment. If it were up to the device manufacturers, there 
would be no reprocessing at all.
    So the only thing I would say--and I want to thank you for 
your testimony--is that the evidence here is pretty scant that 
there is real harm being done to American consumers by this 
technology.
    I yield back.
    Chairman Tom Davis. Thank you very much.
    Mr. Waxman.
    Mr. Waxman. Thank you, Dr. Schultz, for your presentation.
    As I mentioned in my opening comments, I didn't really want 
to restrict my comments to reprocessed devices alone because in 
some ways there is a blur between the two. I do want to ask you 
about what your office is doing regarding device safety 
generally.
    I mentioned in my opening comments the cardiac 
defibrillators made by Guidant. The New York Times broke the 
story about the Guidant pacemakers. There was little movement 
by your agency to look further into the company, despite 
reports of short circuits for years preceding this effort. Your 
agency, in fact, knew about these problems for years before the 
New York Times story. Can you explain your agency's delay in 
action?
    Dr. Schultz. Yes, we have looked at that very carefully, 
Mr. Waxman, because obviously it was an issue that concerned us 
a lot as well.
    One of the things that we have done over the course of the 
last year is to look at all the different ways that we get 
input regarding medical devices, and I think what we found is 
that we get input from a lot of different sources. We get input 
from patient reports. We get input from inspections. We get 
input from reports that manufacturers are required to submit as 
part of their routine post-market reporting, especially on PMA 
devices. I think one of the things that we have found is that 
it is very difficult sometimes to, what I call, connect the 
dots and to be able to put together the information, the 
patient report information, the inspectional information, and 
the updated manufacturing information.
    Mr. Waxman. Notwithstanding that, obviously you have to 
connect the dots before you do something, but I guess one of 
the sources of information is reading the newspaper because 
they seemed to come up with a story that connected the story in 
advance of the FDA.
    I wonder if this is part of the problem. FDA's enforcement 
actions have declined under the Bush administration. In fact, 
your Center on Devices had the greatest drop with 65 percent 
fewer warning letters in 2005 than in 2000. How can you explain 
such a sharp dropoff in enforcement during a time of increasing 
problems in devices such as implantable pacemakers and 
defibrillators?
    Dr. Schultz. Well, I am not sure that, I am not sure I 
would characterize it as increasing problems, and in terms of 
the 65 percent number, I don't have that number in front of me, 
but I certainly would take you, that that is, in fact, the 
number. I think that one of the things that we have been asked 
to do is to make sure that the warning letters that we do send 
out are consistent and are reviewed at higher levels to make 
sure that they are, in fact, consistent so that we are not 
sending warning letters to some companies as opposed to other 
companies.
    Other than that, I can tell you that the people that I work 
with and the people that are in my center are constantly 
looking at problems related to manufacturing and submitting 
appropriate, what I consider to be appropriate action items to 
deal with those problems. Sometimes they are warning letters. 
Sometimes they may be so-called untitled letters where we feel 
that some of those corrections can be made in other ways. 
Sometimes they are injunctions. Sometimes they are seizures.
    Mr. Waxman. Have you ever had your staff recommend 
enforcement action and then send it up to other higher levels 
than the FDA and have it turned it down?
    Dr. Schultz. I am sure that there are instances where 
warning letters have gone through different layers of review 
and have not gone forward. I can't tell you specifically.
    Mr. Waxman. Maybe you can get us some information for the 
record.
    Dr. Schultz. We can do that. We can do that.
    Mr. Waxman. MDUFMA required FDA to develop a list of 
reprocessed devices for which companies would be required to 
submit supplemental validation data. Can you walk us through 
the process FDA used to select the devices on that list?
    Dr. Schultz. Sure; basically, we used sort of a dual 
approach. One was using the so-called Spaulding criteria where 
we looked at the inherent risk of that particular type of 
device in terms of what part of the body it came in contact 
with. Under those criteria, there are certain types of devices 
that touch normally sterile parts of the body, for instance, 
the inside of the abdominal cavity or the chest cavity; there 
are other what is called semi-critical devices which touch 
mucosal surfaces such as the inside of the gastrointestinal 
tract or the inside of the respiratory tract; and then there 
are low risk devices which basically come in contact with 
intact skin.
    So we looked at that. We sort of used that as a starting 
point, and then we also looked at the device itself. There are 
some devices that are relatively simple and straightforward in 
terms of how they could be cleaned and how they could be 
sterilized, and we tried to gauge the complexity of the device 
and how difficult it would be to reprocess in conjunction with 
the criticality of how the device was being used.
    So we combined those two sets of criteria and came up with 
a list of what we thought were the most important, the most 
urgent to regulate, and then sort of worked our way down from 
there.
    Mr. Waxman. Thank you.
    Thank you, Mr. Chairman.
    Chairman Tom Davis. Thank you.
    Mrs. Schmidt.
    Mrs. Schmidt. Thank you, Mr. Chairman. I have a few 
questions.
    I think the first and the most basic that I have is I have 
a little trouble with if something is designed for single use, 
how can it be reprocessed too for dual use?
    Let me give you an analogy. In auto racing, there is a 
difference between drag cars and cars that go around and around 
on a track. Drag cars' engines are built for a single use, a 
single time, and then they get rebuilt. They are not built to 
go more than once. If these devices are being built to go one 
time, how can they be reprocessed and be safe?
    Dr. Schultz. OK; I am not an expert on car racing, but what 
I would tell you is when we look at any product, whether it be 
a reprocessed product or a non-reprocessed product, we don't 
make a decision sort of before the fact as to whether or not 
that particular product can or can't be used in that particular 
manner. What we do is we say, OK, you want to do this. You want 
to label your product to be used in such a way. You must 
provide us with the data that shows that, in fact, that can 
happen safely and effectively.
    You are right; I think in some cases, there are single-use 
devices that cannot and should not be reprocessed. But what we 
have found in terms of our own review process, not what 
somebody tells us or doesn't tell us but in terms of our own 
review process is that, in fact, some devices--again, I tried 
to be careful in my testimony that certain devices, we believe, 
can be reprocessed safely and effectively--that some devices, 
in fact, can be used more than once if they are properly 
reprocessed. And we clear those devices if, and only if, the 
manufacturer, in this case, reprocessor, provides us with data 
to demonstrate that is, in fact, the case and they have to tell 
us, in fact, how often the device can be reprocessed safely.
    Mrs. Schmidt. Mr. Chairman, may I have two more questions?
    Chairman Tom Davis. Yes, go ahead.
    Mrs. Schmidt. Thank you.
    The second one I have is on the labeling of the devices.
    Dr. Schultz. Right.
    Mrs. Schmidt. Last winter, I had the opportunity to 
actually review some of these devices, and it would be very, 
very hard for anyone including a physician to figure out 
whether the device was new or reprocessed because, in some 
cases, there is just a little teeny dot on the instrument to 
note that it is a reprocessed instrument.
    Dr. Schultz. Right.
    Mrs. Schmidt. What kind of labeling do you have in place?
    Dr. Schultz. The new statute with regards to device 
labeling, as was mentioned in some of the opening comments, 
went into effect on August 6th. I think there was a recognition 
by Congress that there needed to be a clearer designation of 
those devices that are reprocessed versus those devices that 
are, in fact, being used for the first time, and that was 
something that needed to be done. That was part of the MDUFSA 
legislation, and that legislation went into effect as of August 
of this year. So, in terms of what was done, I can tell you 
that we did, in fact, that those requirements did go into 
effect. In terms of the outcome, what effect, and how 
successful that will be in terms of alleviating some of the 
concerns that you have heard, I think we will have to just wait 
and see what happens.
    Mrs. Schmidt. A followup, sir; what kind of label? What 
does this label look like that is one of these devices now?
    Dr. Schultz. It really depends on the device itself. This 
is a problem with labeling in general. Some devices can have 
relatively large, prominent labels if they are large devices. 
Some devices, the labeling is, by definition, based on the size 
of the device, fairly small. In those cases, there are 
exceptions where the label can actually be an attachment to the 
device as opposed to actually being imbedded in the device 
itself.
    So, again, I think what we are trying to do is take sort of 
a common sense approach to this to make sure that the labeling 
actually is legible and is of a size that people can actually 
see it and understand who the device manufacturer is for that 
particular device.
    Mrs. Schmidt. One final question, if I may; you said in 
your testimony that there is a savings aspect to this. Can you 
give me an indication of what the cost savings to reuse the 
device per procedure?
    Dr. Schultz. I think what I said was that in our talking to 
the user hospitals, that they expressed a benefit in terms of 
cost savings. We, at FDA, do not look at cost as one of our 
criteria regarding whether we clear or don't clear devices for 
market. We simply look at whether the device meets the criteria 
for safety and effectiveness.
    Mrs. Schmidt. Thank you, sir.
    Chairman Tom Davis. Mr. Towns.
    Mr. Towns. Thank you very much, Mr. Chairman, and thank you 
for holding this hearing.
    Dr. Schultz, do you think that the patient has the right to 
know that this is being reused or that they have the right to 
refuse the treatment with the reprocessed if they know it? What 
is your position on that?
    Dr. Schultz. Well, in terms of our authority, we clear 
devices based on the data that is provided to us, and once a 
device is clear for marketing, it is designated as a legally 
marketed product. So we don't discriminate between devices that 
are reprocessed versus those that are not reprocessed, just as 
if we don't discriminate between various models and various 
different product types.
    So I guess I am not trying to avoid your question. I think 
it is a good question.
    Mr. Towns. You are not answering it; you know that.
    Dr. Schultz. Well, I guess what I am saying is that my best 
understanding, is that our authority does not extend to 
deciding whether or not patients should be informed about 
reprocessing or lack of reprocessing. Our authority is to make 
sure that the devices, in fact, are as safe and effective as 
the original devices.
    Mr. Towns. The testimony here is very conflicting, of 
course. Do you feel that maybe an independent group should 
analyze and evaluate this because when you listen or read the 
testimony here, one person is saying it is great, it is no 
problem, and another is saying it is not. Do you think that 
maybe we should have some independent person to evaluate all of 
this?
    Dr. Schultz. Congressman, if I may, I would like to believe 
that we do, in fact, function as that independent person 
because frankly whether or not a device is reprocessed or 
whether it is an original device, I and my staff have one 
concern and one concern only, which is will that device perform 
as intended and will it provide a benefit to the patient in 
whom it is being used. So I can't speak to whether there ought 
to be another independent body looking at these questions, but 
I can tell you that is how we look at that.
    Mr. Towns. The question is: Do all hospitals report to you 
and indicate to you that there is a problem, if there is one, 
all hospitals?
    Dr. Schultz. All hospitals are required to report problems, 
and that, as I mentioned, that is under the passive reporting 
system that we have, the so-called MDR system. In addition to 
that, I mentioned that we actually, on our own initiative, 
instituted a survey of some of our MedSun facilities to try to 
get a better handle on just the kind of question that you are 
asking. Are there concerns? What are the concerns? Do people 
think that this is a good process, a bad process?
    Again, the responses were mixed. The responses, basically, 
people said no matter what the evidence shows or doesn't show, 
they do not believe that they should be using reprocessed 
devices. Even within hospitals, what we found was that there 
were some doctors, some parts of the hospitals, some, whether 
it is G.I. or cardiac may decide we will or won't allow the use 
of reprocessed devices. So there was a fair amount of 
variability.
    What, again, was a clear message to us was we had a 
responsibility to clearly identify those devices that have gone 
through our review process and let the hospitals know which 
ones have gone through the review process, which ones haven't, 
and inform them so that they can make up their own minds.
    Mr. Towns. Let me ask were you able to identify which types 
of hospitals traditionally use the reprocessed? Is it rural 
hospitals, inner city hospitals? Were you able to establish a 
pattern as to who would use this the most?
    Dr. Schultz. To the best of my knowledge, we haven't done 
that kind of analysis. My impression was, in participating in 
some of those focus group discussions, that they were hospitals 
of various sizes and various locations and, in fact, the MedSun 
program is designed specifically to include different size and 
different locality types of facilities. But I don't have a 
specific answer to your question.
    Mr. Towns. Let me just raise, Mr. Chairman, one more 
question.
    Chairman Tom Davis. Sure.
    Mr. Towns. I think it was raised earlier on the other end.
    Do you think it is appropriate for the FDA to approve a 
device as a single-use device and then turn around and approve 
the same device after reprocessing? Should new standards or 
regulations be put into place to set a standard for what is 
labeled as approved for a single use?
    In other words, I just sort of have a little problem with 
that. If you approve it as a single-use and then you come back, 
don't you feel uncomfortable with that process?
    Dr. Schultz. I feel that we need to look at these devices 
individually. As I said before, some of these devices, in fact, 
are labeled for single-use and cannot and should not be 
reprocessed. Others that have gone through our full evaluation 
process, and if you are interested, I can provide you some 
examples of what that evaluation is actually like because that 
may be sort of helpful in terms of understanding the kind of 
rigor that goes into those evaluations. I have confidence based 
on what I know our reviewers are doing and what kind of 
requirements they are setting up, that those devices that go 
through our full review process and full inspectional process 
are, in fact, going to perform as intended.
    Mr. Towns. With permission of the chairman, I would 
appreciate it if he would submit that.
    Chairman Tom Davis. OK; if you could try to get that to us, 
that would be helpful.
    Dr. Schultz. The specific example; sure.
    Mr. Towns. OK; thank you very much.
    Chairman Tom Davis. Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Dr. Schultz, thank you for your testimony. It has been very 
enlightening.
    I just want to go back. Who usually makes the application, 
a reprocessing company?
    Dr. Schultz. Yes, yes.
    Mr. Cummings. Basically, other than a hospital perhaps 
reporting something to you, that is how these things come to 
issue, is that right? In other words, is there any other way?
    The reprocessing company says we think this is something 
that can be reprocessed. You hear about a problem from a 
medical establishment.
    Dr. Schultz. Correct.
    Mr. Cummings. Is there any other way that it would come to 
your attention?
    Dr. Schultz. We hear about problems from the reprocessors 
who get reported back to them, from other parties who get 
reports submitted to them, and from individual hospitals and 
practitioners.
    Mr. Cummings. Let us rewind.
    Dr. Schultz. Yes.
    Mr. Cummings. So, in other words, you may approve a device 
for reprocessing.
    Dr. Schultz. Correct.
    Mr. Cummings. The reprocessor then discovers that someone 
is having a problem with the device.
    Dr. Schultz. Correct.
    Mr. Cummings. The reprocessor then has a duty to notify 
you.
    Dr. Schultz. That is correct.
    Mr. Cummings. When the reprocessor notifies you, what 
happens then?
    Dr. Schultz. We look at those reports, decide if there is a 
pattern, like we do with other adverse event reports, and then 
take appropriate action if, in fact, we see a pattern where a 
particular type of device is causing a particular type of 
problem.
    Mr. Cummings. Have we seen that happen?
    Dr. Schultz. We haven't.
    Mr. Cummings. We have not yet.
    Dr. Schultz. That is, part of the dilemma is that, again, 
we see a lot of reports. I mentioned we have seen over 400 
reports of reprocessed devices. We see about 200,000 reports of 
all devices. And thus far, thus far--and we continue to look--
thus far, we have not seen a specific pattern that would 
require us to take a certain action.
    Mr. Cummings. Now, let me ask you this. You said something 
that I found very, very enlightening and interesting. You said 
one of the things that you are most concerned about is making 
sure that the reprocessed device--I am not trying to put words 
in your mouth, so correct me--is just as good as or just as 
safe as the original, is that correct?
    Dr. Schultz. That is correct.
    Mr. Cummings. Now, it is my understanding that you had 
6,500 deaths associated with not reprocessed but original 
devices, is that correct, over the last few years?
    Dr. Schultz. That is the number that I heard quoted. I 
would have to go back and confirm that, but that is the number 
that I heard quoted.
    Mr. Cummings. Well, would you say there are thousands?
    Dr. Schultz. Again, you know, one of the things when we 
talk about deaths associated with devices, I think we have to 
be extremely careful, just as when we talk about deaths and 
adverse events associated with reprocessed devices. I think the 
same holds true, in general, about looking at those reports 
critically to see whether or not the incident in which a device 
was used was actually, the problem was actually caused by the 
device or not caused by the device. Again, I don't mean to sort 
of over-complicate this, but I----
    Mr. Cummings. Doctor, you are not over-complicating. I 
understand it. I used to practice medical malpractice, so I 
understand.
    Dr. Schultz. OK.
    Mr. Cummings. There are all kinds of reasons.
    Dr. Schultz. Correct.
    Mr. Cummings. When you are talking about the human body, 
this very strong but very delicate machine, almost anything can 
happen. So it is hard sometimes--I understand what you are 
saying--to actually pinpoint something to the machine, I mean 
to the device.
    Dr. Schultz. That is correct.
    Mr. Cummings. All right.
    Let us go back very quickly and just talk about the 
criteria. Once you get that application, what is the criteria? 
Is it strength?
    I know you talked about the different parts of the body 
that it might touch. Tell me about how that--I see my time is 
running out--or which part of the body it touches. I want you 
to talk about strength of the instrument or whatever. I want 
you to talk about exactly what goes into the process.
    And one last thing, is there a situation where something 
may be approved to, say, use it three times? Then the 
reprocessor says, look, I can do something to this, and you 
will be able to use it 10 times.
    Can you just incorporate that all in your answer, please?
    Dr. Schultz. Let me try to work backward so that I try to 
cover all those. In terms of the number of times, again, the 
reprocessor has the option of defining how many times they 
believe the device can be safely reprocessed. When we do our 
review, we look at that number that they are proposing, and we 
ask a very simple question. Do you have the data to support the 
claim that you are making in terms of how many times that 
device can be used?
    That means that during the review process, we require that 
testing be done to show that the device can be used, cleaned, 
sterilized if necessary, and that appropriate functional 
testing--strength testing, bend testing, whatever type of 
mechanical testing our engineers tell us is appropriate for 
that particular use--that testing, in fact, either confirmed or 
didn't confirm that number of uses is appropriate. Then we will 
go back to the manufacturer and say, you have shown us or you 
haven't shown us that, in fact, that device can be used that 
many times.
    Your other question, I think was describe sort of how the 
review process is done. That would take a little bit longer, 
but let me say that, in general, we use the same set of 
criteria that we use for any other device, which is that we 
focus on those aspects of the device that relate to the way in 
which the device is being used. So if we are talking about a 
biopsy forceps, we will be looking very, very carefully at how 
the jaws open and close. Is it still able to capture the amount 
of tissue that is necessary to make a diagnosis? Is it able to 
bend around whatever curves it needs to bend around to get to 
the location that it needs to get to in order to perform 
optimally? Those would be the kinds of questions in addition 
to: Can it be cleaned, can it be disinfected in order to be 
able to be used safely?
    I don't know if that answers your question.
    Mr. Cummings. Thank you very much.
    Chairman Tom Davis. Thank you.
    Has FDA ever been able to establish a clear causal link 
between reprocessed devices and subsequent adverse health 
effects?
    Dr. Schultz. In general terms?
    Chairman Tom Davis. In general.
    Dr. Schultz. No.
    Chairman Tom Davis. MedWatch is the adverse event 
monitoring system, do you think it works well or do you think 
it is too passive or insensitive to capture the subtle trends?
    Dr. Schultz. I think it is. I think the short answer to 
your question, Mr. Chairman, is that we are looking very hard 
at the MedWatch system right now for reprocessing in particular 
as well as in general to see what MedWatch does well and what 
it doesn't do well. And I will tell you that MedWatch has been 
extremely useful in terms of allowing us to pick up signals. It 
has not been that useful in terms of helping us to analyze 
those signals and actually come to answer the kind of question 
you are asking, which is why.
    You gave us the MedSun program in 1995, I believe, in 
FDAMA, that allowed us to have a more active system where we 
can actually go out and ask questions and try to get specific 
data from various hospitals.
    I think that the MedWatch system, it needs to be improved. 
We need to do some updating in terms of getting electronic 
reports is one thing that I think would be extremely helpful, 
which would hopefully make the reports a little more consistent 
and also allow us to input those reports more quickly. But I 
think that we need to be realistic in terms of what a passive 
surveillance system can provide and what needs to be provided 
through a more active surveillance system or through ongoing 
studies.
    Chairman Tom Davis. In its written testimony, AdvaMed 
describes two adverse events reports that relate to FDA in 
2004. These reports involve malfunction of a reprocessed heart 
positioner and a reprocessed endoscopic vein harvester. Did the 
FDA act on these reports?
    Dr. Schultz. The heart positioner, that question came up as 
to whether or not that particular type of device should fall 
under the unexempt provision and whether we should be 
regulating those. Subsequent to that, we did, in fact, include 
that type of device as part of the review process which, again, 
required the additional validation data.
    I can't give you a specific answer for the other one, but I 
certainly will go back and look at it.
    Chairman Tom Davis. If you can go back and check.
    Dr. Schultz. Yes, sir.
    Chairman Tom Davis. FDA, were they able to establish a 
causal link between the reprocessing and the adverse health 
effect in that?
    Dr. Schultz. I don't; again, the information that I got was 
from the MDR reports and is what I gave you.
    Chairman Tom Davis. Well, let me ask you this. Does FDA 
require tracking procedures or are the reprocessing companies 
required to develop those procedures as part of its validation 
of data requirements?
    Dr. Schultz. Could you be more specific when you talk about 
tracking?
    Chairman Tom Davis. You track the device. You track 
individual devices.
    Dr. Schultz. These; my best understanding, and I am going 
to go back and confirm this, is these do not fall under what we 
normally consider to be tracked devices which are usually 
things like pacemakers and other sort of immediately 
lifesaving, sustaining devices.
    Chairman Tom Davis. Well, then what happens when a device 
is recalled by an original device manufacturer? Does the FDA 
ensure that reprocessed devices are withdrawn from the market, 
or is it hard to track?
    Dr. Schultz. Yes, I mean these devices are considered 
individually.
    Chairman Tom Davis. Some are and some aren't is basically 
the answer. I guess that is where the debate lies.
    Dr. Schultz. I am sorry?
    Chairman Tom Davis. I guess that is where the debate is, 
reuse, where it can be dangerous and where it can't, and what 
should be tracked and what shouldn't and how we get into this.
    Thank you very much.
    I think we will take a 2-minute recess while we move our 
next panel up.
    Doctor, thank you. You owe us a couple answers, but I 
appreciate your patience.
    Dr. Schultz. Thank you very much.
    [Recess.]
    Chairman Tom Davis. The hearing will reconvene.
    We are going to now move to our second panel. We have Mr. 
Don Selvey, the senior vice president of Ascent Healthcare 
Solutions; Dennis Toussaint, the director of regulatory 
affairs, SterilMed; and Stephen Ubl, the president and CEO of 
Advanced Medical Technology Association.
    It is our policy that we swear you in.
    [Witnesses sworn.]
    Chairman Tom Davis. Thank you.
    Please be seated. I think you know the rules.
    Mr. Selvey, we will start with you, and we will move 
straight on down and then try to get to questions. Again, your 
entire statement is in the record. With most of your 
statements, we think we know where we want to go on this, so 
you can keep it within 5. If you really want or if you need 
extra time, take it, but I would like to keep them within 5 
minutes, if we can, and then we will move on to questions. 
Thanks for being with us.

  STATEMENTS OF DON SELVEY, SENIOR VICE PRESIDENT, REGULATORY 
  AFFAIRS AND QUALITY ASSURANCE, ASCENT HEALTHCARE SOLUTIONS, 
   INC.; DENNIS J. TOUSSAINT, DIRECTOR, REGULATORY AFFAIRS, 
    STERILMED, INC.; AND STEPHEN J. UBL, PRESIDENT AND CEO, 
            ADVANCED MEDICAL TECHNOLOGY ASSOCIATION

                    STATEMENT OF DON SELVEY

    Mr. Selvey. Thank you, Mr. Chairman, members of the 
committee.
    I am Don Selvey, the senior vice president for regulatory 
affairs and quality assurance at Ascent Healthcare Solutions, 
the Nation's largest reprocessor of single-use medical devices. 
Although I have more than 16 years experience in the medical 
device industry, I am an epidemiologist by training. Prior to 
my service in the medical device industry, I spent over a 
decade as a public health professional in Arizona, originally 
as a registered sanitarian and then as head of Infectious 
Disease/Epidemiology and later as Head of the Environmental 
Epidemiology program.
    Ascent Healthcare Soultions, headquartered in Phoenix, AZ, 
employs 800 persons throughout the country. Our customer base 
consists of approximately 1,600 hospital and surgery centers in 
the United States, including most of those facilities annually 
recognized by the U.S. News and World Report as the top 
hospitals in America.
    We only reprocess low or moderate risk medical devices such 
as compression sleeves, electrophysiology catheters, and 
orthopedic tools. We do not reprocess high risk medical devices 
such as implantables or devices which come into contact with 
the central nervous system or the brain. In fact, we estimate 
that we are able to reprocess only 1 to 2 percent of devices 
labeled for single use.
    The emergence of reprocessing in the United States is 
rooted in the meaning of the single-use label itself. Contrary 
to what one might think, the single-use label is not an FDA 
requirement. In fact, FDA does not require any device to carry 
a single-use label. Instead, single-use is a designation the 
original equipment manufacturer [OEM], chooses, and that choice 
is sometimes made in an effort to sell more devices, not for 
patient safety reasons. The truth is that a manufacturer could 
label an operating table as being for single use if the OEM 
believed it could persuade a hospital to throw the table out 
after one use.
    To show you some of these single-use devices, I brought 
along some external fixation devices and some surgical tools. 
This, for example, is a clamp. This is a clamp. We are happy to 
pass those around, if you like. Here is a surgical saw blade 
made of stainless steel. These are the types of single-use 
devices we are talking about.
    Chairman Tom Davis. I am going to let somebody bring these 
up, and we will pass them around.
    Mr. Selvey. About two decades ago, some OEMs began to 
change the label on certain medical devices from reusable to 
single-use, in some cases, without any significant structural 
changes in the device that would preclude safe reuse. With this 
change in labeling, it became evident to many hospitals that 
the single-use label does not necessarily mean only single use 
and that certain devices designated by the original 
manufacturer as single-use can, in fact, be safely reprocessed. 
Further evidence that the single-use label does not always mean 
a device can only be used one time is the fact that some 
original manufacturers reprocess their own single-use devices. 
In fact, some manufacturers partner with third parties to 
reprocess devices that manufacturer has labeled as single-use.
    Today, reprocessing of devices originally labeled for 
single-use is standard practice in the Nation's top hospitals. 
Hospitals simply cannot afford to throw out devices that can be 
safely reprocessed. These dollars are better spent on 
purchasing new medical technology and preserving nursing staff. 
The savings generated by reprocessing can be significant. A 
2000 GAO report found that for one device alone, the 
electrophysiology catheter, individual hospitals are saving 
between $200,000 and $1 million annually as a result of 
reprocessing.
    As the reprocessing industry has grown, so too has the 
strident opposition from the original manufacturers who see 
reprocessing as an increasing economic threat. The threat is 
two-fold. First, reprocessed devices are, on average, about 
half the cost of the original devices. Therefore, many 
hospitals choose to use reprocessed devices rather than 
purchase new ones. This means lower sales for original device 
manufacturers. Second, the very existence of reprocessing has 
resulted in a decrease in the price of certain new devices. 
Lower prices mean lower prices.
    Ascent hopes that this hearing today will make clear that 
the third party reprocessing in the United States is safe and 
that it is highly regulated. In fact, reprocessors are more 
stringently regulated than the original equipment industry. 
Specifically, reprocessors are required to submit validation 
data in our pre-market submission while the manufacturers have 
no such requirement. Second, certain devices that require pre-
market submission for the reprocess device have no requirement 
for the original version of that device. And third, unlike 
OEMs, we reprocessors are required to place an identifying mark 
on the device itself, not simply on the label.
    Reprocessors provide a valuable service to this country's 
hospitals, a service that helps hospitals survive in an era of 
spiraling healthcare costs. Additional regulation at either the 
Federal or State level is not only unnecessary but also, 
because it would limit the ability of hospitals to use 
reprocessed devices, would do a disservice to America's 
hospitals and patients.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Selvey follows:]

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    Chairman Tom Davis. Thank you very much.
    Mr. Toussaint.

                STATEMENT OF DENNIS J. TOUSSAINT

    Mr. Toussaint. Thank you, Mr. Chairman.
    My name is Dennis Toussaint, and I am the director of 
regulatory affairs at SterilMed. I have been in the medical 
device industry for approximately 18 years. Most recently, my 
work has been at SterilMed.
    SterilMed was founded in 1997 and is a leading provider of 
reprocessing and repair services designed to help hospitals and 
other healthcare organizations generate substantial cost 
savings through better utilization of medical devices. As a 
medical device reprocessor, SterilMed cleans, tests, packages, 
and sterilizes previously used devices that were originally 
labeled for single use only. During a time of rapidly rising 
healthcare costs, SterilMed helps its hospital partners free up 
critical financial resources that can be devoted to improving 
their delivery of medical services while maintaining the 
highest possible quality of patient care at the same time.
    At SterilMed, I am responsible for ensuring the company's 
compliance with all reprocessing-related Federal, State, and 
local regulations. In particular, it is my responsibility to 
ensure compliance with the Federal Food, Drug, and Cosmetic Act 
and all medical device-related regulations of the Food and Drug 
Administration. As my colleague, Don Selvey, has just 
explained, reprocessors are subject to more stringent FDA 
regulations than OEMs are.
    SterilMed currently has more than 800 full-time and part-
time employees throughout the country. We provide reprocessing 
services to approximately 1,400 healthcare facilities 
throughout the United States and Canada. We reprocess 
approximately 2 million devices per year. In that context, 
SterilMed currently saves hospitals over $40 million per year 
in device expenditures.
    The safety record for reprocessed medical devices is 
nothing short of outstanding. Of the tens of thousands of 
patient adverse event reports that FDA receives through its 
medical device reporting program [MDR] program, only a very 
small percentage concern reprocessed single-use devices, and 
the few problems that have occurred with reprocessed single-use 
devices appear to be quite similar to the types of problems 
associated with new devices. Indeed, in a recent letter from 
FDA to Chairman Davis regarding MDR reports filed since October 
2003, to December 2005, the FDA stated expressly that it did 
not identify any adverse events that were actually related to 
the reprocessing of the SUD.
    A significant body of professional and scientific 
literature, much of it from peer review journals, further 
supports the conclusion that some single-use devices can safely 
be reprocessed. A GAO report confirms the existence of these 
studies. Because of the reprocessing industry's exemplary 
record of safety, informed hospitals and physicians support the 
practice of reprocessing. The GAO interviewed hospital 
infection control practitioners, risk management executives, 
and patient safety experts and found that they all reported 
that proper reprocessing does not pose a risk to patient 
health.
    Hospitals demand all rigorous safety standards be adhered 
to by third party reprocessors. Indeed, SterilMed tests or 
inspects every reprocessed device before it is sent out to a 
hospital, and this is the practice of the industry as a whole. 
This is in contrast to OEMs who we understand typically test 
only a small sampling of devices. The result is that some 
hospitals say they prefer using reprocessed devices over 
original devices because they know that each reprocessed device 
has been individually scrutinized.
    America's finest medical facilities use reprocessed medical 
devices, including 13 of the 14 institutions ranked by U.S. 
News and World Report in 2006 as the Nation's Honor Roll of 
Hospitals. These institutions include Massachusetts General, 
Brigham and Women's University Hospital, the Mayo Clinic, the 
Cleveland Clinic, and Johns Hopkins University. It simply makes 
no sense that these institutions would put their patients at 
risk in order to save money. To the contrary, these facilities 
use reprocessed devices because they have studied the issue 
thoroughly and have determined that reprocessing is both safe 
and cost-effective.
    Mr. Chairman, that concludes my testimony. I look forward 
to responding to any further questions you might have regarding 
these issues.
    [The prepared statement of Mr. Toussaint follows:]

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    Chairman Tom Davis. Thank you very much.
    Mr. Ubl.

                  STATEMENT OF STEPHEN J. UBL

    Mr. Ubl. Good morning, I would like to thank you, Mr. 
Chairman, and other members of the committee for holding this 
hearing today.
    AdvaMed is the world's largest trade association 
representing medical technology manufacturers. Our member 
companies produce the medical devices, diagnostic products, and 
health information systems that are transforming healthcare 
through earlier disease detection, less invasive procedures, 
and more effective treatments.
    I would like to open this morning by clarifying the basic 
distinction between devices sold by original equipment 
manufacturers, our members, and those by reprocessors. Devices 
that our manufacturers sell must be safe and effective. Based 
on their design and the data submitted, FDA clears devices 
designed for one-time use only as well as other devices 
designed for multiple use. Reprocessors, by contrast, take a 
device that has been cleared as safe and effective by the FDA 
for only one use and, after reprocessing, sell it to be used 
again.
    There are four primary messages I would like to leave with 
the committee about reuse of medical devices.
    First, reprocessing a medical device that is designed to be 
used once is inherently risky. It is difficult to clean and 
sterilize extremely small and structurally complex devices. 
Blood, mucous, and fecal material can accumulate during use in 
areas that are very difficult to access and clean. In addition, 
there can be debilitating effects from initial use, cleaning, 
and resterilization on the physical properties of the device. 
Materials can become brittle, sticky, or deformed.
    Let me illustrate these points with an example, and I think 
somebody will bring this to the dais for the Members to review. 
This is one of the technologies that was mentioned in earlier 
testimony. It is an EP catheter, electrophysiology catheter, 
and this technology is threaded through the groin of a patient, 
up into the heart to map the heart's electrical impulses in 
various parts of the heart to detect abnormalities.
    This device has to be rigid enough, stiff enough to 
actually be threaded up into the heart, yet it has to be 
flexible enough to make sure that it doesn't puncture the 
artery and it has to be flexible enough to go through the 
twists and turns of the artery. It also has to be sterile so as 
not to introduce potential infection, and it has to be 
sensitive enough so that when it gets to the heart, it can 
accurately take readings from the heart.
    Every one of those properties can be negatively affected by 
reuse. Failure to completely clean and sterilize the device can 
potentially transfer blood-borne diseases from one patient to 
another. Cleaning and sterilization and use itself can affect 
the device's flexibility, durability, and sensitivity. No one 
should want a device used on a second, third, or fourth patient 
unless there is an ironclad assurance that it is literally as 
good as new after it is reprocessed.
    That leads to me to my second point. A reprocessed device 
should be held to the same rigorous standard of safety and 
effectiveness that FDA applies to original devices.
    Third, the recently enacted legislative and regulatory 
framework for reprocessed devices is a significant improvement. 
However, in our view, the public is still not adequately 
protected because only a limited number of reprocessed devices 
have been subjected to FDA review. FDA directives require that 
reprocessors submit validation data for only 68 or 228 device 
types.
    Yet in 50 percent of those cases, the reprocessed device 
was found to be not substantially equivalent to the original 
device or the reprocessor voluntarily withdrew the product due 
to lack of adequate validation data. A 50 percent failure rate 
is intolerable for any industry, but it is especially 
intolerable when it occurs with a device designed to diagnose, 
treat, and cure patients. AdvaMed urges FDA to review 
validation data for all reprocessed single-use devices.
    Fourth, we support the strengthened reporting and branding 
provisions in MDUFSA. However, it is still too early to draw 
conclusions as to whether these changes will adequately improve 
the identification reporting of adverse events associated with 
reprocessed devices. As has been mentioned earlier, the new 
labeling provision only went into effect in August. Prior to 
that date, providers had little ability to identify whether or 
not an adverse event was due to a device that had been 
reprocessed or one that was not.
    In closing, if appropriate regulations means some products 
will continue to be reprocessed because the practice is 
supported by appropriate validation data, that is acceptable. 
If appropriate regulation of reprocessing means some of these 
products can no longer be reprocessed, then patient safety will 
benefit from that decision.
    We look forward to working with the Congress and FDA to 
make the promise of MDUFMA a safe reality for millions of 
patients. Thank you for the opportunity to address the 
committee on this important patient safety issue. I look 
forward to answering any questions the committee might have.
    [The prepared statement of Mr. Ubl follows:]

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    Chairman Tom Davis. Thank you.
    Mr. Selvey and Mr. Toussaint, let me just start.
    Mr. Selvey, one of the challenges of reprocessing, it seems 
to me, has to be the changes to technology and designs. How do 
you keep up with the evolving technology and designs when you 
are not privy to trade secret information?
    Mr. Selvey. Mr. Chairman, if I may?
    Chairman Tom Davis. Yes.
    Mr. Selvey. There are a couple of things that we can do to 
keep up with the changing in design. First off, if the design 
change by the original manufacturer is significant, they are 
required under law to notify the FDA. That becomes public 
information. We can monitor that and, in fact, we become aware 
of that.
    Chairman Tom Davis. You can then decide if you want to buy 
something new at that point to make the decision?
    Mr. Selvey. Correct.
    The other part would be the change that is made by the 
original manufacturer that is not a significant change; we 
would pick that up through our routine monitoring of the 
devices. Periodically, we will do revalidation of the process 
but even beyond that, we will do periodic things like materials 
testing, analysis of the devices, just to make sure that there 
hasn't been a relatively insignificant change that has not been 
reported to the Food and Drug Administration and therefore not 
made public.
    Chairman Tom Davis. I don't know how I ask this. I guess I 
just ask this in a generic sense. How many times can one of the 
single-use devices be reprocessed before it becomes unusable? 
Does it just depend?
    I gather you have a way to look at that and decide if it is 
usable or not. How do you decide?
    Mr. Selvey. Mr. Chairman, there are a couple of factors 
that go into it. Yes, every device does have a finite number of 
reprocessing cycles. Typically, for the devices that we 
reprocess, it is going to be somewhere between one and five 
cycles. The average is about three. We are going to base that 
on the studies that we do in order to validate our ability to 
clean and test and resterilize the device.
    There is also a certain amount of, what I refer to as, the 
law of diminishing return. Typically, these devices are 
rejected out at about a 20 percent rate. That is, when they 
come into us, for whatever reason, about one in five devices is 
not fit to go through the process. Therefore, it is in our best 
interest to look very carefully at whether we are going to get 
more than five cycles out of the device, just based on that 
diminishing; typically three times, usually based, well, always 
based on the validation studies that we have.
    Mr. Ubl. Mr. Chairman, may I comment on that question?
    Chairman Tom Davis. You may.
    Mr. Ubl. I think it is very, very difficult for 
reprocessors to keep up with those changes. Let me just give 
you example. This was mentioned earlier. FDA allows 
reprocessors to submit in bundles, sometimes covering multiple 
manufacturers in the same device in the hundreds. FDA would 
never allow original manufacturers to submit and bundle their 
applications in that fashion. So I think it is extremely 
difficult to essentially assert that these types of products 
have the same degree of sameness, if you will, and keep up with 
the rapid incremental changes in technology.
    Chairman Tom Davis. Mr. Selvey asserts that the 
reprocessing is highly regulated and probably more stringently 
regulated than the original equipment industry, and you seem to 
contradict that.
    Mr. Ubl. Yes, I am absolutely baffled by that assertion. 
Our information suggests that, in fact, they have a much lower 
bar, and part of that is the bundled submission that I 
mentioned but, in addition, the quality systems regulation, 
pre-clinical testing of individual components, which they 
obviously can't do because they don't have the proprietary 
information. There is a whole range of FDA regulatory 
authorities that apply much more acutely to original 
manufacturers than they do to reprocessors.
    Chairman Tom Davis. Why don't you guys reprocess your own 
stuff?
    Mr. Toussaint. Mr. Chairman.
    Chairman Tom Davis. I will give you a chance to answer in a 
second.
    Why don't your own people, your own member companies ever 
partner with a reprocessor to refurbish their own devices?
    Mr. Ubl. Why don't they? Because they don't----
    Chairman Tom Davis. Yes; is it because you make more on 
selling new stuff?
    Mr. Ubl. Well, they fundamentally don't believe that a 
reprocessed device is their device. It is a different product, 
and they really question the premise of whether these 
technologies can be safely reprocessed.
    I have to go back to the comment that was made that this is 
about money. Reprocessing single-use devices are less than 5 
percent of all device sales, 5 percent. So the assertion that 
this all about economics is ludicrous, absolutely ludicrous.
    Chairman Tom Davis. But obviously, if you can get this 
device to work well, I don't know why you wouldn't want to do 
something that costs less. They are getting squeezed every 
which way for health costs. If you can reprocess a device and 
use it cheaper, why wouldn't you?
    Mr. Ubl. Absolutely, and we do it all the time. Let me just 
clarify that FDA approves single-use devices and multiple use 
devices. Our members make both. Our members are trying to be 
responsive to what the patient needs are and what the hospital 
and provider needs are. So for example, a trocar is a 
technology that used to be made in stainless steel and is now 
made in plastic due to the customer demanding ease of use and 
disposability. So there is a tension in the marketplace, and we 
are trying to be as responsive as possible to providers.
    Chairman Tom Davis. But you would admit that if the 
reprocessors and the FDA can guarantee patient safety, you 
don't have a problem with reprocessing.
    Mr. Ubl. We believe that the biggest problem is that a 
large number of devices don't come under the FDA purview. Dr. 
Schultz actually mentioned two adverse events that we reported 
to the FDA that were not being regulated by the FDA's 
reprocessing authority.
    Chairman Tom Davis. But conceptually, if the FDA regulated 
them, even if they made them be single-event pieces, if they 
can use them and it is safe, you don't have a problem.
    Mr. Ubl. Conceptually, yes; I mean I think we might have 
some issues around bundling and some of the mechanics of how it 
is done.
    Chairman Tom Davis. You are saying if they can assure the 
safety, you don't have a problem; OK.
    Mr. Selvey, do you want to comment, or Mr. Toussaint?
    Mr. Toussaint. Mr. Chairman, I really need to respond to 
Mr. Ubl's comment about bundling. I am not sure where he is 
getting this, his information, but there is an FDA guidance on 
bundling that does apply to, not only to reprocessor but OEMs, 
and in that guidance document, it states specifically that it 
is appropriate for manufacturers to bundle devices among 
generic types of devices, and it defines very specifically what 
a generic type of device is. It is appropriate. It further 
states that it is appropriate to bundle devices when the 
differences do not reflect any changes in safety or 
effectiveness of the devices. So bundling is an appropriate 
practice.
    When we do choose to bundle, we do it very carefully, and 
we scrutinize it very carefully. When Mr. Ubl says that 
hundreds of devices are not tested, that is simply not correct.
    Chairman Tom Davis. Every time there is an adverse 
incident, it just hurts your industry, right?
    Mr. Toussaint. I am sorry, what?
    Chairman Tom Davis. Every time there is an adverse incident 
with one of these devices, it just hurts your marketability and 
profitability, doesn't it?
    Mr. Toussaint. Yes, I would say.
    Chairman Tom Davis. So, of course, OK.
    Mr. Toussaint. Yes. When we choose to bundle devices, 
however, it is not that we choose one device out of, say, 50 
devices to test. Within the bundling, within bundling a family, 
for instance, all devices are tested, and that way, during the 
review process, if the FDA would choose to analyze each device 
separately, statistically and otherwise, they could do so.
    So in effect, it would become a separate submission. So 
bundling is a means to increase the efficiency of FDA review, 
and it allows FDA to look at devices individually along with 
the family of devices, the generic type of family devices they 
belong to.
    Chairman Tom Davis. How do you feel about the level of FDA 
regulation? Do you think it is about right at this point? Do 
you think you are under-regulated or over-regulated?
    Mr. Toussaint. Are you speaking to me, Mr. Chairman?
    Chairman Tom Davis. I am. I am going to ask all three of 
you that.
    Mr. Toussaint. About the entire MDUFMA regulation, I think 
it is entirely over-regulated. I think many of these devices 
that require additional validation were previously cleared in 
the year 2000 or even prior to that and contain much of the 
data that submissions contain today, and I believe this is 
simply that the requirements that are required today of SVS 
submissions are a result of the pressure put on OEMs, so we are 
not allowed to process devices.
    Chairman Tom Davis. Mr. Ubl, you don't agree with that?
    Mr. Ubl. I absolutely don't agree. I think the practice is 
under-regulated. Again, FDA only regulates 68 types of 
technologies out of a possible 228. AdvaMed has provided to the 
FDA two types of technologies that have had adverse events 
associated with them. They, in turn, have extended their 
regulatory umbrella to those types of technologies. We wonder 
how many other technologies are out there that are at risk to 
patients.
    I know for my family, I certainly wouldn't want to trust a 
reprocessor to tell me how many uses.
    Chairman Tom Davis. Well, let me ask you another question. 
Do you think the OEMs are too regulated or not regulated 
enough?
    Mr. Ubl. I think there are appropriate regulations of 
original manufacturers.
    Chairman Tom Davis. OK.
    Mr. Toussaint. Mr. Chairman, I really need to respond to 
one other comment from Mr. Ubl.
    Chairman Tom Davis. Now, I am going to get to Mr. 
Gutknecht. Sure, we will let you respond. Let me give Mr. 
Gutknecht 10 minutes. Go ahead.
    Mr. Gutknecht. Well, I just want one real quick question. 
If this is so dangerous, you, both Mr. Selvey and Mr. 
Toussaint, your product liability or your liability insurance 
must be just sky-high.
    Mr. Selvey. Mr. Gutknecht, that is an important 
distinction. We do carry liability insurance, in fact, at the 
same level or an even higher level than some of the original 
manufacturers. Although we are not trying to compete with the 
manufacturers, we are trying to make our hospital customers 
very comfortable with our level of coverage. The reality is 
that despite having reprocessed something on the order of 15 
million devices since our inception, we have never been sued by 
a patient, by a hospital, claiming that we produced an adverse 
event in a patient. In a litigious society, I think maybe that 
says something.
    Mr. Toussaint. I don't know what our insurance rates are at 
SterilMed, but I can say the same thing that Mr. Selvey has 
said, and that is that we have never been sued by a hospital, a 
patient, or had any other litigious event occur against our 
company.
    Mr. Gutknecht. So it is fair to say that both your 
insurance companies and your customers are satisfied with the 
quality of the products that you are putting out there.
    Mr. Ubl. Can I comment on that, Congressman?
    In some ways, reprocessing is flying under the radar. The 
reason there haven't been suits by patients or by providers is 
because, as has been mentioned by FDA and in my testimony, 
there is not adequate branding so that practitioners and 
patients even know that a reprocessed device is being used. So, 
until we have well-established branding, tracking, reporting, 
and so forth, we are not going to know what the true impact is.
    Mr. Gutknecht. Well, with all due respect, I have heard 
those siren songs before about drugs coming in from Canada, and 
the evidence is that a whole lot more Americans die every year 
from drugs that are purchased in the United States.
    Mr. Ubl. This is very different than a pill, Congressman. 
This is coming in contact with blood, tissue, and even the 
heart.
    Mr. Gutknecht. I understand, and I will reclaim my time, 
thank you.
    The point really is if this was as dangerous as some would 
have us believe, we would have massive lawsuits and, more 
importantly, the market for these devices, in my judgment, 
would dry up. I have talked to some of my hospital people. I 
have talked to some of my doctors about this very issue, and 
their general view is this is much ado about very little.
    I yield back my time.
    Chairman Tom Davis. Mrs. Schmidt.
    Mrs. Schmidt. Thank you, Mr. Chairman.
    I have a couple of questions for the panel. The first 
regards the bundling. I am very concerned about the bundling 
because I don't think it allows the FDA to have a clear review 
of each and every device. Would you be amenable? Frankly, I am 
not concerned about the ease of the FDA doing their job. The 
point is we have to have FDA doing the right job.
    Would any of you be adverse to not allowing the bundling 
and to force the FDA to look at each and every application on 
its own merit without bundling these devices?
    Mr. Selvey. Mrs. Schmidt, may I take a crack at that?
    Bundling is a prime example of much ado about nothing. As 
Mr. Toussaint has said, there is an FDA guidance on bundling 
for both OEMs and for reprocessors.
    But there is a very practical aspect here. When we put 
together a 510(k) and it goes to a reviewer who is not used to 
seeing bundled submissions, they have not been trained in 
bundled submissions, honestly, the reviewer doesn't know what 
to do with a bundled submission. We do not put together bundled 
submissions. I am not sure what Mr. Ubl is complaining about, 
but aside from some of the very early submission that we did 
back in the year 2000 that caused much heartburn and grief 
among the reviewers at the FDA, we stopped bundling. We haven't 
bundled a submission in a very long time.
    So to answer your question very directly, we would have no 
issue at all with doing away with bundling. It simply is not an 
issue for us in this industry.
    Mrs. Schmidt. In the matter of time, could I have a yes or 
no from either one of you because I have another question?
    Mr. Ubl. I am delighted to hear that response. The only 
comment that I would make is it is important for the committee 
to understand we are not just talking about a family of 
technologies made by one manufacturer. What they are bundling 
is across manufacturers making a similar product which is why 
it is so disturbing to us.
    Mr. Toussaint. Mr. Chairman, why that statement is somewhat 
incorrect is after each family, even though we bundle across 
families, for each family we provide separate validation data 
on that family. So each family is tested independently. Whether 
they are bundled together in a single submission or in multiple 
submissions, they still undergo the same review process.
    Mrs. Schmidt. Mr. Chairman, another question; one of my 
other concerns is the ability for the patient to know whether 
they are getting an original product or a reused product. Would 
any of you; just a yes or no answer with no comment, be in 
agreement that in the future, if it is a reused product, the 
patient will know up-front that it is going to be used, yes or 
no?
    Mr. Selvey. No.
    Mr. Toussaint. No.
    Mr. Cummings. Yes, we would support patient informed 
consent.
    Mrs. Schmidt. OK, thank you very much.
    Mr. Toussaint. Mr. Chairman.
    Chairman Tom Davis. Yes, go ahead.
    Mr. Toussaint. I have another comment I feel I must address 
by Mr. Ubl, and that was his comment regarding the 50 percent 
rate as being totally unobjectionable as devices not being safe 
enough and effective. I am not sure where that rate comes from, 
but I believe it is a total distortion of facts. I believe that 
rate comes from the fact that when reprocessors originally had 
to submit SVSes on a number of products, we received a number 
of NFC determinations or requests for additional information. 
This in no way implied that the devices were not safe and 
effective.
    In fact, let me read to you a quote from an FDA colleague 
about this matter. Larry Spears, the Deputy Director of the 
Office of Compliance at the FDA Center for Devices and 
Radiological Health stated that any reference to the specific 
devices that can no longer be legally marketed as being 
dangerous or unsafe is incorrect. Although some devices were 
found through review by our Office of Device Evaluation to be 
non-substantially equivalent to a previously marketed device, 
this does not mean they are unsafe or ineffective.
    Mr. Ubl. Mr. Chairman.
    Mr. Toussaint. When you receive an NFC letter, that is a 
request by FDA that you need to submit further information, 
further validation data, or other information. It does not mean 
that the devices at that point cannot be deemed substantially 
equivalent. During that period of time, many SVS submissions 
were submitted to FDA, and FDA was working through the process 
as well as the manufacturer. So it is not unexpected that we 
would receive NFC letters and FDA would be, would send out such 
letters and ask for additional information.
    There are other factors that relate to that 50 percent 
figure. It may be simply that the manufacturer chose not, after 
receiving such a letter, decided, chose not to provide that 
additional information because it was too, not feasibly cost-
effective.
    Mr. Ubl. I promise to be really quick, Mr. Chairman, but 
let us just look at FDA's testimony to this committee. They say 
33 percent of the time when the reprocessor submits their 
application, it was not substantially equivalent. That means it 
is taken off the shelf. I will grant you that it seems like 
approval rates have improved since we have been using the 50 
percent rate, but a third of the time, they are submitting 
applications that are not meeting the test by FDA. This, to us, 
tells us that not only should they be looking at the devices 
they are looking at now but the additional types of 
technologies that are currently under FDA's purview.
    Chairman Tom Davis. All right; anything else?
    Mr. Toussaint. No; I would just like to respond to that 
comment as well.
    Chairman Tom Davis. Go ahead and get going. Go ahead.
    Mr. Toussaint. Just that the 33 percent simply means that 
we need to provide additional validation data. It doesn't mean 
the devices are not substantially equivalent, nor does it mean 
that----
    Mr. Ubl. Does it mean they are off the shelf?
    Chairman Tom Davis. Is this stuff properly categorized so 
you know how many times it has been used, just for the record, 
as you keep it, or do you just examine it and say, yes, this 
looks good?
    Mr. Toussaint. I am sorry. I didn't understand the 
question.
    Chairman Tom Davis. Every time you reuse a medical device, 
is it logged in that this is the third time or the fourth time 
or the second time it has been used, or do you just kind of 
look at it and decide if it meets criteria or not?
    Mr. Toussaint. I would say we generally look at it and 
decide if it meets criteria.
    Chairman Tom Davis. So it is not necessarily logged in, and 
you have that record of how many times it is has been used?
    Mr. Toussaint. Well, we certainly have. You are talking 
about specific devices?
    Chairman Tom Davis. Yes.
    Mr. Toussaint. Certainly, we have a record of how many 
times a device has been used.
    Chairman Tom Davis. Anything else?
    We are going to vote, and I want to let the panel go.
    This is to be continued. Obviously, we don't have a 
consensus here, but I appreciate everybody's testimony and 
being able to make the case. The committee will continue to 
look at this further.
    Thank you.
    [Whereupon, at 12:17 p.m., the committee was adjourned.]
    [The prepared statement of Hon. Edolphus Towns follows:]

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