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



 
           Y2K AND MEDICAL DEVICES: SCREENING FOR THE Y2K BUG

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

                             JOINT HEARING

                               before the

                            SUBCOMMITTEES ON
                         HEALTH AND ENVIRONMENT

                                  and

                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 25, 1999

                               __________

                           Serial No. 106-25

                               __________

            Printed for the use of the Committee on Commerce


                                


                      U.S. GOVERNMENT PRINTING OFFICE
 57-443CC                    WASHINGTON : 1999
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                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

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

                   James E. Derderian, Chief of Staff
                   James D. Barnette, General Counsel
      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                 Subcommittee on Health and Environment

                  MICHAEL BILIRAKIS, Florida, Chairman

FRED UPTON, Michigan                 SHERROD BROWN, Ohio
CLIFF STEARNS, Florida               HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 PETER DEUTSCH, Florida
RICHARD BURR, North Carolina         BART STUPAK, Michigan
BRIAN P. BILBRAY, California         GENE GREEN, Texas
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia             THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma              LOIS CAPPS, California
  Vice Chairman                      RALPH M. HALL, Texas
RICK LAZIO, New York                 EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona             JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING,         (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)



              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

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

                                 (iii)



                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Hubbard, William K., Acting Deputy Commissioner for Policy, 
      accompanied by Thomas Shope, Special Assistant to the 
      Director, Office of Science and Technology Center for 
      Devices and Radiological Health, Food and Drug 
      Administration.............................................    13
    Nunn, John C., Vice President for Patient Care Services, 
      Henry Ford Hospital, on behalf of the American Hospital 
      Association................................................    63
    Smith, Kent T., Global Project Manager, Baxter Healthcare 
      Corporation, on behalf of the Health Industry Manufacturers 
      Association................................................    52
    Willemssen, Joel C., Director, Civil Agencies Information 
      Systems Accounting and Information Management Division, 
      General Accounting Office..................................    20
    Williams, Noel Brown, Senior Vice President, Columbia HCA 
      Health Care Corporation, on behalf of the Federation of 
      American Health Systems; accompanied by Don Workman, 
      Columbia HCA Health Care Corporation.......................    59

                                  (v)



           Y2K AND MEDICAL DEVICES: SCREENING FOR THE Y2K BUG

                              ----------                              


                         TUESDAY, MAY 25, 1999

              House of Representatives,    
                         Committee on Commerce,    
                Subcommittee on Health and Environment,    
      and the Subcommittee on Oversight and Investigations,
                                                    Washington, DC.
    The subcommittees met, pursuant to notice, at 10:10 a.m., 
in room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman, Subcommittee on Health and the 
Environment) and Hon. Fred Upton (chairman, Subcommittee on 
Oversight and Investigations) presiding.
    Members present Subcommittee on Health and Environment: 
Representatives Bilirakis, Upton, Sterans, Burr, Bilbray, 
Ganske, Bryant, Bliley (ex officio), and Brown.
    Members present Subcommittee on Oversight and 
Investigations: Representatives Upton, Burr, Bilbray, Ganske, 
Blunt, Bryant, Bliley (ex officio), Klink, and McCarthy.
    Staff present: Lori Wall, majority counsel; John Manthei, 
majority counsel; Michael Flood, legislative clerk; Chris 
Knauer, minority professional staff member, and John Ford, 
minority counsel.
    Mr. Bilirakis. The hearing will come to order. Good 
morning.
    I am pleased that our two subcommittees, the Health and 
Environment Subcommittee and the Oversight and Investigations 
Subcommittee under Mr. Upton, have convened today to ensure, or 
at least to try to help to ensure, that healthcare delivery is 
not interrupted by the Y2K computer problem.
    Specifically, we want to guarantee that medical devices 
using computer software will function properly after the 1st of 
January of the year 2000. Any failure, by any device, caused by 
the Y2K problem is one failure too many; I am sure we all agree 
with that. There is no room for error because human lives are 
at risk.
    Today, we will hear what steps have been taken by the Food 
and Drug Administration, the medical device industry, and 
individual hospitals on medical device Y2K compliance.
    Medical devices play a critical role in the daily delivery 
of healthcare, and can range from basic thermometers to more 
complex devices such as electrocardiograms and infusion pumps. 
Certainly, if devices that utilize computer software fail to 
operate, or give improper readings, patients all over the 
country, and indeed the world, may be put at an unnecessary 
risk.
    The FDA has testified before Congress on this subject over 
the last couple of years. Unfortunately, in some instances, the 
FDA has not had positive news to report. Today, I look forward 
to hearing the progress that the agency has made toward 
addressing this very pressing health concern.
    The General Accounting Office will offer additional 
testimony on the FDA's efforts. In particular, the GAO will 
provide Congress with recommendations on its thorough audit of 
FDA's activities and the Y2K problem.
    With respect to our second panel, we will hear about the 
steps individual hospitals and medical device manufacturers are 
taking to address the unique challenges resulting from the Y2K 
problem. Only the medical device manufacturers have complete 
access to a device's design, operating details, and 
manufacturing parameters. Therefore, their testimony is 
particularly important.
    We look forward to hearing about the steps that the 
industry is taking to guarantee the safety of patients. With 
respect to the hospital industry witnesses, we are interested 
in specific examples of initiatives being undertaken to provide 
hospitals with the most up-to-date information and products.
    On behalf of Mr. Upton and myself, I would like to welcome 
all of our witnesses and thank them for taking time out of 
their very busy schedules to join us this morning, and we all 
look forward to hearing your testimony. Mr. Bliley, the 
chairman of the full committee, for an opening statement.
    [The prepared statement of Hon. Michael Bilirakis follows:]
Prepared Statement of Hon. Michael Bilirakis, Chairman, Subcommittee on 
                         Health and Environment
    Mr. Chairman, I am pleased that we have convened our two 
Subcommittees today to ensure that health care delivery is not 
interrupted by the Y2K computer problem.
    Specifically, we want to guarantee that medical devices using 
computer software will function properly after January 1, 2000. Any 
failure, by any device, caused by the Y2K problem, is one failure too 
many. There is no room for error because human lives are at risk.
    Today, we will hear what steps have been taken by the Food and Drug 
Administration, the medical device industry, and individual hospitals 
on medical device Y2K compliance.
    Medical devices play a critical role in the daily delivery of 
health care, and, can range from basic thermometers to more complex 
devices such as electrocardiograms and infusion pumps. Certainly, if 
devices that utilize computer software fail to operate, or give 
improper readings, patients all over the country, and indeed the world, 
may be put at an unnecessary risk.
    The FDA has testified before Congress on this subject over the last 
couple of years--unfortunately, in some instances, the FDA has not had 
positive news to report. Today, I look forward to hearing the progress 
the Agency has made toward addressing this pressing health concern. The 
General Accounting Office will offer additional testimony on the FDA's 
efforts. In particular, the GAO will provide Congress with 
recommendations on its thorough audit of FDA's activities on the Y2K 
problem.
    With respect to our second panel, we will hear about the steps 
individual hospitals and medical device manufacturers are taking to 
address the unique challenges resulting from the Y2K problem. Only the 
medical device manufacturers have complete access to a device's design, 
operating details, and manufacturing parameters, therefore, their 
testimony is particularly important.
    I look forward to hearing about the steps that the industry has 
taken to guarantee the safety of patients. With respect to the hospital 
industry witnesses, I am interested in specific examples of initiatives 
being undertaken to provide hospitals with the most up to date 
information on products.
    Finally, I want to welcome all of our witnesses and thank them for 
taking time out of their busy schedules to join us this morning. I look 
forward to hearing your testimony.

    Chairman Bliley. Thank you, Mr. Chairman.
    Several months ago, this committee began an in-depth look 
at the healthcare industry and its efforts to become ready for 
the year 2000. Letters were sent to the Health Care Financing 
Administration and healthcare associations representing 
Medicare contractors and Medicare providers, asking them about 
their progress in becoming year 2000 ready, or Y2K compliant.
    Over the past year, this committee has received regular 
updates on the progress of the Department of Health and Human 
Services and what progress they have made in addressing their 
Y2K problems. Just last month, this committee held a hearing on 
the Y2K problem as it relates to billing and financial systems.
    However, the issue of Y2K readiness includes not only 
billing and financial services, but also products associated 
with healthcare delivery, such as medical devices.
    Today, we will hear about how medical devices and 
biomedical equipment are in terms of Y2K readiness. Medical 
devices are critical to medical treatment and research in both 
Federal as well as private sector healthcare facilities. Any 
equipment that performs a date or time calculation is 
potentially susceptible to the Y2K bug.
    Since 1997, the Food and Drug Administration of FDA, as 
well as the Veterans' Health Administration, and others, have 
attempted to collect information from manufacturers of medical 
equipment regarding any Y2K problem a device or piece of 
equipment may have. A data base clearinghouse was established 
that would allow providers to find out whether a particular 
piece of equipment was Y2K compliant.
    Since this process began over 2 years ago, progress has 
been made. Unfortunately, there are still device manufacturers 
who have not responded to repeated requests from the FDA to 
provide information on the Y2K status of their equipment. 
Therefore, Medicare providers are often left wondering whether 
or not their equipment will be safe as we enter the new year.
    I hope this hearing will allow us to gain a better insight 
into the process that medical device manufacturers, Medicare 
providers, and FDA have undertaken in order to ensure that 
medical devices and equipment will be Y2K compliant. The health 
and safety of Medicare patients is of the utmost importance.
    I would like to welcome all our panelists here today and 
thank you all for coming and testifying before us. Mr. 
Chairman, thank you.
    Mr. Bilirakis. Thank you, Mr. Chairman. Mr. Klink.
    Mr. Klink. Thank you, Mr. Chairman, for having this hearing 
today.
    This hearing is about whether medical devices we use in the 
everyday practice of medicine are Y2K compliant and, if not, 
what corrective actions we must take to make them so.
    In short, today's hearing has both good news and bad news. 
The goods news is that today, we now have much more information 
on the Y2K problem and how it may affect certain medical 
devices than we had only a couple of months ago. The bad news, 
though, is that we still have a significant amount of 
information to gather and much more work ahead of us, and the 
clock and the calendar are running out on us.
    Here is what we know so far about the biomedical side of 
the Y2K problem: Within the past several months, thanks to the 
help of the GAO, the FDA finally created a single, Internet-
accessible clearinghouse, so that providers could determine the 
status of their existing inventories of medical equipment. To 
complete this data base, the FDA identified about 2,300 
companies that they believe might have a Y2K problem, and so 
should be part of this data base.
    The FDA then sent letters to, and attempted to contact 
directly, as many as of the 2,300 potentially susceptible 
companies as they could locate. Most of those responded to the 
FDA in one form or another. But, about 200, for reasons 
unknown, have yet to respond.
    In discussions with the FDA and industry officials, 
committee staff were told that none of the non-reporting 200 
companies appear to be major equipment manufacturers; that is, 
that they make medical equipment that could be life-threatening 
if a Y2K problem exists.
    FDA reported, in fact, that many of the companies may have 
merged with others and, thus, may no longer exist, or may 
really never have existed at all, and were placed in error on 
the original list. Nevertheless, I would ask the FDA and the 
device industry to continue to identify all of the companies on 
this list, to try to determine with certainty that we are not, 
somehow, missing any companies that may be making critical 
equipment.
    Of those that did report to the FDA's data base, some seem 
to have few, or no, Y2K-related equipment problems, while 
others have reported that some of their devices are affected by 
the date change. For example, while a number of the original 
2,300 companies reported that none of their products were Y2K-
susceptible, and thus, the FDA did not have to worry about 
their status, about 300 companies have reported that about 1000 
biomedical devices that they collectively manufacture do have a 
Y2K problem.
    Still another group, rather than listing information in the 
FDA data base, has opted instead to link to each of their own 
websites, where their equipment status can be identified. This 
group of about 400 companies will most certainly report at 
least some equipment requiring a Y2K fix.
    What does this all mean? I believe that the group of 
approximately 300 companies reporting about 1000 problems, and 
the approximately 400 companies linking the FDA clearinghouse 
to their own websites, must be the major focus of these 
subcommittees' attention. What we can determine is that there 
exists a rather sizable group of companies, and thus devices, 
that do have Y2K problems. What we have not yet determined, 
however, is the exact nature of this equipment and how it may 
affect the healthcare delivery system of our Nation.
    Quite simply, Mr. Chairman, we have begun to collect decent 
Y2K data, but I don't think we have made full use of it. I 
believe that this committee must work with the FDA and the GAO 
and the device industry to make further sense of this data. We 
presently know only that there are at least some Y2K problems 
affecting some medical devices. We must go beyond this general 
statement and place this problem into context. At a minimum, I 
would like to know, No. 1, the nature of the equipment being 
reported as having Y2K problems; No. 2, how the problem could 
affect each piece of equipment, and No. 3, exactly how, and 
when, the problem will be dispositioned by the manufacturer. 
This is very achievable, I believe, in the limited months 
remaining before the year's end.
    So, Mr. Chairman, I don't think the sky is falling 
regarding the Y2K safety of biomedical equipment but, 
nevertheless, I am not fully comfortable with the present 
status of this industry. In order to fully gain public 
confidence, I think we must go further and truly attempt to 
assess existing data to determine what areas are fully safe and 
where we need to pay additional attention.
    Let me conclude by saying that I will split the difference 
between my good friends from GAO and what they have recommended 
and what the FDA has approved, or has proposed.
    Frankly, I don't think there is enough time or the 
technical resources available at the FDA to undertake the kind 
of verification measures the GAO advocates. Quite simply, I 
don't believe the FDA is equipped to systematically review all 
of the Y2K assessments made by the device manufacturers 
reporting to the FDA's data base. Nevertheless, I do welcome at 
least some additional checks on behalf of the FDA, particularly 
in those areas where a serious Y2K problem has been identified 
in a medical device that could cause life-threatening failure.
    Scrutiny in such areas cannot be overdone, and I am willing 
to work with our friends at both the GAO and the FDA and the 
device industry itself to reach some accommodating measures.
    So, Mr. Chairman, we have made significant progress in 
these areas, but we have much more work ahead of us in the few 
months ahead. I look forward to working with you and other 
members of this committee and the witnesses before us today to 
continue our efforts.
    I would just like to mention my friend, Mr. Upton, and I 
have been discussing, and I just bring this up publicly, we 
also have grave interest, as technology moves forward, talking 
about computers, and we would like subcommittee chairman 
Bilirakis to work with us also, it has come to our attention 
about the difficulties, right now, in reining in the sale of 
some pharmaceutical problems over computers, some of them 
without prescriptions, some of them being sold that are drugs 
that are illegal in this country. We have talked about it, and 
we want to bring you into that conversation. It is something 
that both the majority and the minority have great interest in, 
and we would like to be able also to pursue this together at 
some future time, Mr. Chairman. With that, I yield back.
    [The prepared statement of Hon. Ron Klink follows:]
Prepared Statement of Hon. Ron Klink, a Representative in Congress from 
                       the State of Pennsylvania
    Thank you Mr. Chairman for having this hearing.
    Today's hearing is about whether the medical devices we use in the 
everyday practice of medicine are Y2K compliant, and if not, what 
corrective actions we must take to make them so. In short, today's 
hearing has both good news and bad news: the good news is that today, 
we now have much more information on the Y2K problem and how it may 
affect certain medical devices than we had only a few months ago. The 
bad news is that we still have a significant amount of information to 
gather, and much more work ahead of us.
    Here is what we know so far about the biomedical side of the Y2K 
problem:
    Within the past several months, thanks to the help of the GAO, the 
FDA finally created a single Internet-accessible clearinghouse, so that 
providers could determine the status of their existing inventories of 
medical equipment.
    To complete this database, the FDA identified about 2,300 companies 
that they believed might have a Y2K problem, and so should be part of 
this database. FDA sent letters to, and attempted to contact directly, 
as many of the 2,300 potentially susceptible companies as it could 
find. Most of these responded back to the FDA in one form or another. 
Nevertheless, approximately 200, (for reasons unknown) have yet to 
respond.
    In discussions with FDA and industry officials, Committee staff 
were told that none of the non-reporting 200 companies appear to be 
major equipment manufacturers that make medical equipment that could be 
life threatening if a Y2K problem exists. FDA reported, in fact, that 
many of the companies may have merged with others and thus no longer 
exist or may have never existed at all and were placed in error on the 
original list.
    Nevertheless, I would ask that the FDA, and the device industry 
continue to try to identify all of the companies on this list to 
determine with certainty that we are not somehow missing any companies 
that may make critical equipment.
    Of those that did report to FDA's database, some seem to have few 
or no Y2K-related equipment problems while others have reported that 
some of their devices are affected by the data change.
    For example, while a number of the original 2,300 companies 
reported that none of their products were Y2K susceptible, and thus the 
FDA did not have to worry about their status, about 300 companies have 
reported that about 1,000 biomedical devices they collectively 
manufacture, have a Y2K problem. Still another group, rather than 
listing information in FDA's database has opted instead to link to each 
of their own websites where their equipment's status can be identified. 
This group of about 400 companies will, with almost certainty, report 
at least some equipment requiring a Y2K fix.
    What does this all mean, Mr. Chairman?
    I believe that the group of approximately 300 companies reporting 
about 1,000 problems, and the approximately 400 companies linking the 
FDA clearinghouse to their own websites, must be the major focus of our 
attention. What we can determine is that there exists a rather sizeable 
group of companies, and thus devices, that have a Y2K problem. What we 
have not yet determined, however, is the exact nature of this equipment 
and how it may affect the health care delivery system.
    Quite simply, Mr. Chairman, we've begun to collect decent Y2K data, 
but I don't think we've made full use of it.
    Mr. Chairman, I believe that this Committee must work with the FDA, 
the GAO, and the device industry, to make further sense of this data. 
We presently know only that there are at least some Y2K problems 
affecting some medical devices. We must go beyond this general 
statement and place this problem into context. At a minimum, I would 
like to know: (1) the nature of the equipment being reported as having 
a Y2K problem; (2) how the problem could affect each piece of 
equipment, and (3) exactly how and when the problem will be 
dispositioned by the manufacturer.
    This is very achievable in the limited months remaining before the 
year's end.
    Mr. Chairman, I don't think the sky is falling regarding the Y2K 
safety of biomedical equipment. Nevertheless, I'm not fully comfortable 
with the present status of this industry. In order to fully gain public 
confidence, I think we must go further, and truly attempt to assess 
existing data to determine what areas are fully safe, and where we need 
to pay additional attention.
    Finally, let me conclude by saying that I will split the difference 
between what my good friends from GAO have recommended, and what the 
FDA has proposed. Frankly, I don't think there's enough time, nor the 
technical resources available at the FDA to undertake the kinds of 
verification measures the GAO advocates. Quite simply, I don't believe 
the FDA is equipped to systematically review all of the Y2K assessments 
made by the device manufacturers reporting to FDA's database. 
Nevertheless, I do welcome at least some additional checks on behalf of 
the FDA, particularly in those areas where a serious Y2K problem has 
been identified in a medical device that could cause a life threatening 
failure. Scrutiny in such areas cannot be overdone and I am willing to 
work with my friends at the GAO, the FDA, and the device industry 
itself, to reach some accommodating measure.
    Mr. Chairman, we've made significant progress in this area, but we 
have much more work ahead of us. I look forward to working with you, 
the other members of this Committee, and our witnesses before us today 
to continue our efforts.
    With that, I yield back.

    Mr. Bilirakis. Thank you. Mr. Upton.
    Mr. Upton. Thank you, Mr. Chairman. I would ask unanimous 
consent that my lengthy opening statement be made part of the 
record.
    Mr. Bilirakis. With unanimous consent, all the lengthy 
opening statements of the members of the two subcommittees will 
be made a part of the record.
    Mr. Upton. I would just like to add that I appreciate this 
hearing by both of our two subcommittees and it stems from an 
earlier hearing that we had about a month ago with regard to 
billing within the health community and the Y2K problem.
    This is a daunting task. In fact, a number of hospitals 
across the country are spending perhaps as much as $1 million 
to comply, to make sure that things work when the calendar page 
turns.
    Since FDA's clearinghouse began in 1998, they have heard 
from some 4000 manufacturers regarding compliance, but there 
are still hundreds that they have not heard from. As we all 
know, there is no room for error. I recently spent the day with 
one of my hospitals in Berrien County, Michigan, and looked at 
virtually every sector of what they do to provide good 
healthcare in our region. I can remember well a visit to the 
renal dialysis facility where virtually every single one of the 
booths was occupied. In fact, they said that they are occupied 
for the complete day, 24 hours a day, 6 days a week, providing 
assistance for folks, and there was no room even for visitors 
to come in from other parts of the country that might be 
visiting friends or families in our part of the State. If they 
had a reason, or need, for renal dialysis, the answer would be 
no.
    With that type of occupancy, it is pretty clear that we 
have to make sure that these machines and other devices work 
within the hospitals and to try and get a better gauge of that.
    I appreciate the hearing today and look forward to the 
testimony from the witnesses, and I yield back the balance of 
my time.
    [The prepared statement of Hon. Fred Upton follows:]
   Prepared Statement of Hon. Fred Upton, Chairman, Subcommittee on 
                      Oversight and Investigations
    Today, the Subcommittee on Oversight and Investigations and the 
Subcommittee on Health and the Environment are holding a joint hearing 
on the issue of the Year 2000 problem as it relates to medical devices. 
Over the past several months, the Committee on Commerce has undertaken 
an extensive review of the progress the Health Care Financing 
Administration, or H-C-F-A, its Medicare contractors and its hospitals, 
nursing homes, doctors and other providers have made in becoming Y-2-K 
compliant. Last month, these two subcommittees held a hearing on the Y-
2-K status of Medicare providers and their billing and financial 
systems.
    Today, our hearing will focus on the status of medical devices. 
Medical devices and equipment, such as cardiac monitoring systems, 
cardiac defibrillators and x-ray machines, are critical to providing 
health care treatment in a variety of health care settings. These 
devices have the potential to adversely affect patient safety if they 
perform any type of date or time calculation. The degree of risk 
increases significantly if the machine is a critical care of life 
support device.
    Several weeks ago, the importance of ensuring that medical devices 
and equipment are Y-2-K compliant really came home to me in a powerful 
way. I toured a renal dialysis unit in St. Joseph/Benton Harbor, 
Michigan, my home community, with a population of about 50,000. The 
dialysis center operates 6 days a week, 24 hours a day, at full 
capacity. It was during that visit that I learned that there was no 
room for visitors to use this facility. Obviously, should this unit and 
others in other communities across the nation fail to operate properly 
on January 1, 2000, lives would be put in serious jeopardy.
    I have been talking with hospitals in my Congressional district 
about their Y-2-K efforts to ensure that their medical devices and 
equipment are compliant, and I have learned a lot. First, the magnitude 
of the effort is daunting. All of the hospitals inventoried their 
devices as an initial step--one hospital system had 8000; another 5000. 
The direct costs of reviewing critical devices and upgrading or 
replacing those which are not compliant are also significant--$\1/2\ to 
$1.0 million.
    As a second step, each hospital contacted device manufacturers for 
information on the device's Y-2-K compliance. All reported that 
initially, they often had difficulty getting information, particularly 
from smaller manufacturers. However, all have seen improvement and 
greater cooperation in meeting the challenges of Y-2-K, particularly 
with the creation of the FDA's central data base.
    In 1997, the Food and Drug Administration, or F-D-A, began 
collecting data from device manufacturers regarding the Y-2-K 
compliance status of their devices. After several letters and a small 
response rate from manufacturers, the F-D-A joined in partnership with 
the Veterans Health Administration, the Department of Defense and the 
Health Industry Manufacturers Association, to assemble a single 
database clearinghouse. The goal of the clearinghouse was to provide a 
centralized source of information on the Y-2-K compliance status of 
biomedical equipment in the United States.
    Since F-D-A's data clearinghouse began in September of 1998, they 
have heard from 4,116 manufacturers regarding the compliance status of 
their equipment. They are still awaiting information from another 232 
manufacturers. Since F-D-A began its database, the flow of information 
has increased significantly. However, the F-D-A has stated that they 
are in no way ensuring that the information displayed on their 
clearinghouse is accurate or complete. In other words, the 
clearinghouse serves as a central point for data, but not a guarantee 
by the F-D-A that the data provided is accurate or complete.
    While information regarding medical devices continues to increase, 
recent surveys conducted show that Medicare providers are still 
expressing concern over the compliance status of their equipment. I 
hope this hearing will demonstrate the need for all manufacturers to 
release information to providers regarding the Y-2-K status of their 
devices and equipment. It is crucial at the turn of the century that 
service to Medicare beneficiaries is uninterrupted and patient safety 
is not jeopardized.
    I would like to welcome all of our panels here today to testify. 
Thank you all for coming and appearing before us today.

    Mr. Bilirakis. I thank the chairman. Mr. Brown.
    Mr. Brown. Thank you, Mr. Bilirakis.
    I would also ask to enter to my written statement into the 
record.
    I just have a couple of comments that are a bit off the 
subject but I have not really heard much said during this whole 
Y2K debate and I find it interesting that in our much vaunted 
private sector in this country, where all wisdom begins and 
ends, that all of the computer geniuses, in all of the large 
companies that bought computer systems in the last 20 to 30 
years, really did not anticipate this whole Y2K problem.
    That companies that made billions of dollars, computer 
executives that are worth hundreds of millions, billions of 
dollars, in some cases, that companies where the purchasing 
agents, and the vice presidents in charge of putting in these 
computers, and buying these computers, made these purchases 
without really anticipating what was going to happen in the 
year 2000.
    If that had been a government decision we would see 
newspaper article after newspaper article criticizing big 
government and telling us how government does nothing right in 
this country, but since it was the much vaunted private sector 
we have not really seen those kinds of newspaper articles.
    I would imagine that that computer company executives that 
created this problem, and did not foresee this problem until 
not very many years ago, still got their bonuses and I would 
imagine large companies that have had this, that bought these 
computer systems and that installed them and did not warn their 
CEOs about the Y2K problem until only a small number of years 
ago still got their bonuses and were still doing very well, 
thank you.
    I just think it is important that as this country has 
begun, in the last small number of years, to deal with Y2K, and 
this Congress has been involved, that we are aware of some of 
the history of this and we are aware that this problem is one 
that has cost us so much money and has cost us so much time in 
this Congress, and in the private sector, and the public sector 
all over in dealing with it.
    So, I thank the Chair and yield back the balance of my 
time.
    [The prepared statement of Hon. Sherrod Brown follows:]
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress 
                         from the State of Ohio
    Thank you, Mr. Chairman. I'm pleased to participate in our second 
joint hearing on Y2K issues, and I thank our distinguished panelists 
for joining us.
    Today's hearing is important from a number of perspectives: to the 
extent the Year 2000 transition disrupts medical devices and the 
production and distribution systems supporting them, health care 
access, quality and continuity could all be affected.
    According to FDA, there are more than 100,000 medical devices, 
equipment ranging from tongue depressors to MRIs.
    Fortunately, the great majority of these devices are not date-
dependent, and medical device manufacturers have been working hard to 
ensure that the production and distribution systems around these 
devices experience no disruption as we transition into the next 
century.
    I commend FDA, which has worked with the Department of Veterans 
Affairs, the Department of Defense and the Health Industry 
Manufacturers' Association to develop a clearinghouse for compliance 
information.
    One of the areas I hope today's witnesses will address involves 
devices made by manufacturers who are no longer in business or who have 
otherwise refused or have been unable to reply to FDA's request for 
information. How do we ensure that there will be no harm done to 
patients or disruption in the delivery of care?
    I understand the response rate to FDA's clearinghouse information 
request was strong--about 90%--but that some 399 device manufacturers 
have not provided FDA any information.
    I hope our witnesses also touch on areas we didn't explore during 
the last hearing, including the implications of the Y2K transition for 
non-hospital providers and their patients--areas such as home health 
care and setting such as skilled nursing facilities and community 
health clinics.
    Today's hearing will provide valuable information in our continuing 
examination of Y2K transition issues. I look forward to hearing your 
comments.

    Mr. Bilirakis. I thank the gentleman. Let's see, do we have 
an order here? Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. Good morning.
    I want to thank you and Chairman Upton, as well as Mr. 
Brown and Mr. Klink, for holding this second hearing on the Y2K 
bug and its potential effects on medical care.
    As we are all aware, the clock is ticking. The countdown 
continues to January 1, 2000. To be frank, I am concerned about 
what is going on and what is going to happen with my friends, 
relatives, and constituents who will need medical care at that 
time. Will we be prepared?
    For some people, the answer to that question will mean the 
difference between life and death. For that reason, I am 
looking forward to the hearing today and the testimony that we 
will hear about the efforts of the manufacturers, and 
healthcare providers, and those in government, to assess the 
Y2K compliance of medical devices.
    I sincerely hope that the news is encouraging, and taking 
leave of my prepared statement just briefly, for those of you 
who are prepared to testify, I would also like to hear 
testimony about the potential liability issues out there. I 
know in the Judiciary Committee we have looked at a Y2K 
liability bill that, in fact, has been passed out of the House 
of Representatives. And when it will be signed into law, I 
don't know, but I have talked to some people in the medical 
industry, particularly about the services in terms of their 
potential exposure as to whether or not medical devices, 
whether they take the assurance of the manufacturer, that it is 
going to work. Should they, themselves, test it independently 
of that and would they then incur liability for doing that 
testing?
    There are lots of intriguing issues, and I realize that you 
did not come to testify specifically about that, but if you 
have any statements that you would like to make public on the 
potential impact of liability, I certainly would welcome those.
    I would like to take a moment to welcome one of the 
witnesses who will appear on the second panel, and I want to 
particularly welcome her, Ms. Noel Brown Williams, of Columbia 
HCA Healthcare Corporation, who is here this morning 
representing the Federation of American Health Systems. I am 
particularly pleased she is here because we have two hospitals 
in my district from the Columbia system. One of those serves 
the good people of Cheatham County. It is the Cheatham Medical 
Center in Ashland City in Cheatham County, and the Horizon 
Medical Center in Dickson, and I am very interested and pleased 
with the progress that Columbia HCA hospitals have made, and 
will continue to make, to ensure that patient care is not 
compromised as we reach the turn of the century.
    Again, Mr. Chairman, I want to thank all the witnesses for 
their testimony and you for having this hearing, and I would 
yield back.
    Mr. Bilirakis. I thank the gentleman. Mr. Burr, for an 
opening statement.
    Mr. Burr. Thank you, Mr. Chairman. I will be brief.
    I want to take this opportunity to thank all of the 
witnesses who are here today.
    A couple of the areas I want to concentrate on are the 
distinction between urban and rural. Do we have the same 
assurances with some of the rural facilities that their 
equipment is as up-to-date, even though it may be much older 
than equipment that we currently asked manufacturers about?
    Another area of concern is, whose responsibility is it for 
the end-to-end testing, if it is needed, for this equipment? 
And, could this equipment be interconnected with other devices 
where end-to-end testing becomes extremely important as to who 
goes first?
    I think that, Mr. Chairman, we all share the same common 
goal, that is, to give America the assurance that healthcare 
will go on uninterrupted. I have every reason to believe that 
we have very capable people working on this, and the 
clearinghouse certainly has produced good work.
    We are reliant on manufacturers to share with us their 
information as it relates to the Y2K problem. I remind all of 
us that, just 6 months ago, most people thought that Y2K was a 
spot remover. The reality is that we have all had a very steep 
learning curve, but these agencies and this Congress must 
assure the American people that their healthcare will be of the 
same quality, and uninterrupted, as we head into the new 
millennium.
    I hope that we are further down that road when we complete 
this hearing. I yield back.
    Mr. Bilirakis. I thank the gentleman. Mr. Bilbray for an 
opening statement. Dr. Ganske.
    Mr. Ganske. Thank you, Mr. Chairman, for holding this 
hearing. I think this is an important hearing, and I want to 
build on the remarks that Congressman Bryant made related to 
liability.
    Last week, the House passed a liability relief for Silicon 
Valley and for manufacturers. I voted against that bill because 
I had some concerns, particularly for the users of those 
products, many of whom are represented today whose patients are 
going to be on ventilators, life-support, run with computer 
chips.
    Vern Ehlers tried to get an amendment made an order for 
that bill that basically would have restricted the liability 
relief for products made after 1995. That was not made an 
order.
    I sincerely hope that, when that Y2K liability bill comes 
back from the Senate and from conference, that we take into 
account the fact that, within that liability bill that we 
passed, there is a 90-day moratorium on legal redress for 
products that are not working because of their Y2K computer 
chips. I mean, I don't think that a patient on a ventilator has 
90 days.
    I think the message should be to the manufacturers and to 
the software Silicon Valley folks that we are not going to give 
you liability relief. You know, we have about 8 months to get 
this fixed, and there are going to be a lot of patients that 
potentially could be harmed if we don't fix this Y2K problem.
    So, I believe that we need to pass more wise legislation on 
Y2K than what we have looked at so far in the House, and I will 
also be interested, like Congressman Bryant, in comments from 
members of the panels today on this issue.
    Thank you very much.
    Mr. Bilirakis. I thank the gentleman.
    [Additional statements submitted for the record follow:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress 
                       from the State of Florida
    I want to thank Chairman Bilirakis and Chairman Upton for holding 
this important hearing today.
    I believe we would all like to be assured that all medical devices 
will be Y2K compliant.
    What many people may not realize is that computer software is 
frequently imbedded as a component of devices. For example, software 
contained on a microchip to control a devices operation could deeply 
impact individuals who rely upon their pacemakers, ventilators and 
other life saving equipment for survival.
    There is also the question of non-embedded software which is 
usually operated on a personal computer. This would involve such 
equipment as MRI's, Sonograms, X-rays, and CAT scans to name a few.
    There are those who say there is too much hype about the Y2K 
problem and that we don't need to worry. I disagree and look forward to 
hearing from our distinguished panels about what they have done to 
prevent any possible future catastrophes from occurring.
    As Chairman of the VA Subcommittee on Health, I noted Mr. Hubbards' 
comments about the Department of Veterans Affairs testimony before the 
VA Subcommittee on Oversight and Investigations indicating they had 
been assured by manufacturers that all the critical care devices are 
expected to be in compliance by the year 2000. This is good news for 
our nation's veterans. I was also pleased to learn about the 
partnership between the VA and the FDA to develop a single data 
clearinghouse for biomedical equipment year 2000 status information.
    I also look forward to hearing Mr. Noel Williams' testimony since 
several hospitals in my district are Columbia Health Care facilities. 
In fact, Ocala Regional Medical Center is in my home town. The other 
two HCA facilities are Putnam Community Hospital and Orange Park 
Medical Center. It is very reassuring to know that Columbia/HCA began 
planning for the Y2K problem back in 1996. Their efforts are to be 
commended and should serve as a role model for those in the public and 
private sectors that are not yet fully in compliance.
                                 ______
                                 
Prepared Statement of Hon. Karen McCarthy, a Representative in Congress 
                       from the State of Missouri
    Thank you Mr. Chairman. Today we are discussing the issue of 
medical device Y2K compliance. We must ensure that medical devices that 
are date sensitive are Y2K compliant, so that patients depending on 
these devices are not adversely affected when the new year begins. I 
would like to thank the witnesses who are testifying today. I look 
forward to hearing your ideas about how to bring all medical devices 
into Y2K compliance.
    Many people do not realize the serious nature of the Y2K problem. 
Dates are important to the functionality of many medical devices that 
contain internal computer chips. Basically, anything that is electronic 
is at risk for noncompliance. For example, in a Kansas City Star 
article on May 23, 1999, Dr. Andrew V. Kauftnan, a Kansas City 
neurosurgeon explains the importance of Y2K compliance for the gamma 
knife. The gamma knife is a device used to treat brain tumors. A 
computer chip in the knife determines the length of radioactive 
exposure to the brain that is needed. Dr. Kaufman states, ``It has to 
be perfect. We don't want to undertreat, because if we do, we are 
inadequately treating the condition. Were we to overtreat, we run the 
risk of brain injury or other complications such as brain swelling.'' 
Fortunately, preliminary tests have shown this device to be Y2K 
compliant, but more tests will be conducted in the next 60 days to be 
certain.
    The costs associated with bringing medical devices into Y2K 
compliance are high, and could be an insurmountable burden for smaller 
hospitals. For example, Health Midwest of Missouri expects to spend 10 
million dollars to check 21,000 biomedical devices. Because of these 
high costs and also because of the potential crises that could arise as 
a result of the failure of medical devices, we must explore contingency 
plans for this issue. I look forward to hearing more about such 
contingency plans as we continue this discussion.
    I am eager to work with our witnesses and with my colleagues to 
find a solution that will protect our nation's patients and provide a 
fiscally responsible solution for the medical providers. Thank you. I 
yield back the balance of my time.
                                 ______
                                 
  Prepared Statement of Hon. Lois Capps, a Representative in Congress 
                      from the State of California
    Mr. Chairman, thank you for holding this important hearing to gain 
insight on the Y2K compliance of medical devices. These devices, such 
as cardiac defibrillators, pacemakers, and cardiac monitoring systems, 
are all computer-run, and thus are subject to the Y2K bug. It is 
imperative that we take a proactive stance on this matter.
    The importance of this hearing is clear. Millions of people rely on 
medical devices everyday, and the consequences of these machines not 
working on January 1, 2000 would be devastating.
    Pursuant to the Federal Food and Drug Act, it is the responsibility 
of the FDA to ensure the safety and effectiveness of medical devices in 
the marketplace. I know the FDA has tried, through various mail 
campaigns and the Federal Year 2000 Biomedical Clearinghouse, to do 
this as thoroughly as possible. However, the FDA heard back from less 
than 10% of those doctors who were mailed these questionnaires, and the 
success of the clearinghouse is so far indeterminate. It is clear that 
there is much to be done.
    I am eager to hear from our witnesses today, to see how we can all 
work together to make sure the medical community is properly prepared 
for the Year 2000. Again, I thank you, Mr. Chairman, for holding this 
hearing, and I look forward to working with you.
    Thank you.

    Mr. Bilirakis. The Chair will now call for the first panel: 
the Honorable William Hubbard, Acting Deputy Commissioner for 
Policy with the U.S. Food and Drug Administration; Dr. Thomas 
Shope, Special Assistant to the Director, Office of Science and 
Technology Center for Devices and Radiological Health, U.S. 
Food and Drug Administration, and Mr. Joel C. Willemssen, 
Director, Civil Agencies Information Systems, Accounting and 
Information Management Division of the General Accounting 
Office.
    The Chair now yields to his co-Chair, Mr. Upton.
    Mr. Upton. Thank you. Panel, we have a longstanding 
tradition in the Oversight and Investigations Subcommittee of 
our witnesses being sworn under oath. Do any of you have any 
objection to that, or problem with that?
    [All witnesses shake head indicating no.]
    And we also provide, under House rules, if you desire to 
have counsel. Do you need to have a counsel for your questions?
    [All witnesses shake head indicating no.]
    If not, if you would stand and raise your right hand?
    [Witnesses sworn.]
    I yield back to the chairman. Thank you.
    Mr. Bilirakis. I thank the chairman. Each of you is now 
under oath. I am going to set the clock at 5 minutes. 
Obviously, your written statement is a part of the record, and 
we would hope you would complement it in your oral remarks. I 
am going to set the 5-minute clock, but, obviously, if it takes 
a little longer for you to get your message across, I want you 
to feel free to do so. Let us see, I guess we will call on Mr. 
Hubbard first.

TESTIMONY OF WILLIAM K. HUBBARD, ACTING DEPUTY COMMISSIONER FOR 
 POLICY, ACCOMPANIED BY THOMAS SHOPE, SPECIAL ASSISTANT TO THE 
 DIRECTOR, OFFICE OF SCIENCE AND TECHNOLOGY CENTER FOR DEVICES 
AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION; AND JOEL 
  C. WILLEMSSEN, DIRECTOR, CIVIL AGENCIES INFORMATION SYSTEMS 
    ACCOUNTING AND INFORMATION MANAGEMENT DIVISION, GENERAL 
                       ACCOUNTING OFFICE

    Mr. Hubbard. Thank you, Mr. Chairman. As you said, Mr. 
Chairman, we have a written statement which I will not read 
today.
    Let me first mention that I have Dr. Thomas Shope, from our 
Center for Devices, and expert legal help with me today. He is 
an expert in this matter.
    What I will do, Mr. Chairman, is briefly give you some 
sense of the many things that we have done in the FDA on this 
issue thus far. We have sent a number of letters to the 
industry giving them advice and advising them of what they need 
to do on the worry about this problem, to make sure that their 
products are Y2K compliant. We have given written guidance to 
the industry that spells out certain procedures that they need 
to follow. Our field staff has asked the right questions; we 
have inspected device firms, and we believe we are helping in 
that way. We have done a substantial amount of outreach to the 
industry, Mr. Chairman, with press contacts and speeches and 
meetings and mailings and articles and lots of other things to 
make sure that the industry and hospitals know what to look for 
here.
    We have developed a rapid response plan so, as the year 
progresses, if there are problems with these devices, our field 
force and our headquarters' specialists will be able to jump in 
right away. As a matter of fact, that program will be staffed 
on a 24-hour basis beginning in the fall.
    We have developed, as you know, a biomedical equipment 
clearinghouse, a website, which initially listed all of the 
non-compliant medical devices, and now is attempting to list on 
that website compliant devices, so that the public, the 
hospitals, the physicians, and others will be able to access it 
readily.
    We have worked with the VA and the hospitals to help 
identify critical devices that, if they fail, would be a 
problem. We have tried to identify those devices that might 
present a high risk to patients if they were not compliant and 
fail for that reason. We are pursuing those most vigorously.
    All of these activities, Mr. Chairman, have led us to a 
fairly high degree of confidence that no serious problems exist 
from medical devices and that, as the year progresses, and we 
go into the first of the year, there won't be a problem.
    Nevertheless, Mr. Chairman, our colleagues at the GAO have 
recommended that we take an additional step, the auditing of 
manufacturers' records, demonstrating that they have verified 
that no problem will exist and that a fix has been properly 
implemented, if a problem did exist for a given device.
    The GAO believes that this additional step will provide 
assurance to the agency, hospitals, and the public that certain 
potentially high-risk devices will function properly at the 
turn of the century. We, of course, respect that view and have 
the clue that such a program could, feasibly, be constructed. 
We believe somewhere over 300 firms make these so-called 
potentially high-risk devices, the sort of devices that, if 
they failed, could cause serious injury to patients.
    So, we propose to begin in June an audit program that would 
have contractors, hired by the FDA, specialists in this area, 
go to manufacturers and review their records and ascertain 
that, in fact, they have asked the right questions, done the 
proper validation and verifications, and have the proper 
paperwork to demonstrate that that is the case; Where there was 
a device that was not compliant, that they have done the 
necessary upgrades and properly implemented those.
    We would propose, Mr. Chairman, to phase this concept in. 
As I said, there are somewhere over 300 manufacturers. so the 
concept would be to perhaps do a representative sample of 
perhaps 60 manufacturers initially, and if we found no problems 
with those, we would then consult with others and reassess 
whether we should go do the entire universe of these particular 
manufacturers. and, of course, if problems were found in that 
representative sample, we would be prepared, of course, to go 
to all these manufacturers and do the same sort of audit for 
those.
    With that, Mr. Chairman, briefly, I hope I have given you a 
sense of where we are, and I would be glad to answer any 
questions you have.
    [The prepared statement of William K. Hubbard follows:]
 Prepared Statement of William K. Hubbard, Acting Deputy Commissioner 
  for Policy, Food and Drug Administration, Department of Health and 
                             Human Services
                              introduction
    Good morning, my name is William Hubbard. I am the Acting Deputy 
Commissioner for Policy, Food and Drug Administration (FDA or the 
Agency). I am pleased to be here today to provide information on the 
Year 2000 date issue as it relates to medical devices. FDA has taken a 
number of constructive actions to work with manufacturers and provide 
information to users about medical device Year 2000 compliance.
    FDA promotes and protects public health by helping to ensure that 
medical devices are safe and effective. The Center for Devices and 
Radiological Health (CDRH) is the component of FDA that has 
responsibility for regulating medical devices. CDRH helps carry out the 
Agency's mission by evaluating new products to determine if they can be 
marketed; assuring quality control in manufacture through inspection 
and compliance activities; monitoring adverse events in already 
marketed products; and taking action, when necessary, to prevent injury 
or death. A device manufacturer must comply with all applicable 
requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, 
including, but not limited to, establishment registration and device 
listing, premarket review, use of good manufacturing practices, and 
reporting adverse events.
                       what is a medical device?
    According to the definition in the FD&C Act, a ``device'' is:
        an instrument, apparatus, implement, machine, contrivance, 
        implant, in vitro reagent, or other similar or related article, 
        including any component, part or accessory, which is intended 
        for use in the diagnosis of disease or other conditions, or in 
        the cure, mitigation, treatment, or prevention of disease, in 
        man or other animals, or intended to affect the structure or 
        any function of the body and which does not achieve its primary 
        intended purposes through chemical action and which is not 
        dependent upon being metabolized for the achievement of its 
        primary intended purposes.
    As this definition suggests, many different types of products are 
properly regulated as medical devices. Medical devices include over 
100,000 products in more than 1,700 categories. The products regulated 
by FDA as medical devices range from simple everyday articles, such as 
thermometers, tongue depressors, and heating pads, to the more complex 
devices, such as pacemakers, intrauterine devices, diagnostic imaging 
devices, and kidney dialysis machines.
    Any computer software which meets the legal definition of a medical 
device is within the scope of the law and must comply with applicable 
FDA regulations. Medical devices which use computers or software can 
take several forms including: products containing embedded microchips 
which are part, or components, of the devices; devices employing non-
embedded software which is used with, or to control, the devices or to 
record data from the devices; or individual software programs that use 
or process patient data to reach a diagnosis, aid in therapy, or track 
donors and products.
A. Embedded Computer Software
    Computer software frequently is embedded as a ``component'' of 
devices, i.e., software contained on a microchip to control device 
operation. Examples of such common, important devices are pacemakers, 
infusion pumps and ventilators. The majority of these products will not 
be affected by the Year 2000 problem since almost none of them require 
knowledge of the current date to operate safely and effectively. For 
example, pacemakers do not use the current date in their operation.
B. Non-embedded Computer Software
    Non-embedded software is intended to be operated on a separate 
computer, often a personal computer or work station. Such software 
devices may be used to control or enhance the operation of another 
device or devices and, further, may use the two-digit year format. It 
is possible that non-embedded software devices may rely on date 
information for proper operation and might be affected by the Year 2000 
date change if not designed appropriately.
    An example of non-embedded software is a computer program used to 
plan radiation therapy treatments delivered using radioactive isotopes 
as the radiation source (teletherapy or brachytherapy). These 
treatments possibly could be affected if the computer program that 
calculates the radiation dose parameters uses only a two-digit year 
representation. The calculation of the length of time since the source 
was last calibrated could be in error and thus lead to an incorrect 
treatment prescription.
    Other examples of uses of non-embedded software devices include: 
conversion of pacemaker telemetry data; conversion, transmission, or 
storage of medical images; automated analysis and interpretation of ECG 
data; programming or control of rate response for a cardiac pacemaker; 
perfusion calculations for cardiopulmonary bypass; and calculation of 
bone fracture risk from bone densitometry data. Since there is a chance 
that the two-digit format may affect the performance of these software 
devices, FDA believes that the Year 2000 risk requires that healthcare 
facilities take steps to identify and mitigate such problems through 
proactively working with manufacturers.
                 fda efforts to address year 2000 issue
Year 2000 Database
    In order to give the general public, government agencies, and the 
healthcare and research communities one comprehensive source of 
publicly available information on the Year 2000 compliance status of 
biomedical equipment, the Federal Year 2000 Biomedical Equipment 
Clearinghouse database was established in March 1998 and is available 
to facilities via the World Wide Web. The Biomedical Equipment 
Clearinghouse provides Year 2000 product status information in five 
categories including: products that are Year 2000 compliant; products 
that do not use a date; products that have a date related problem; 
products whose status is provided on the manufacturer's website; and 
identification of manufacturers for whom no information is available 
(nonrespondents to FDA requests).
    The Biomedical Equipment Clearinghouse database is being maintained 
by FDA on its World Wide Web site at the request of the Interagency 
Biomedical Equipment Working Group. This Working Group was organized 
early in 1997 under the Subcommittee on the Year 2000 of the Chief 
Information Officers' Councils. The database can be found on the 
Internet at: http://www.fda.gov/cdrh/yr2000/. Manufacturers also may 
submit a World Wide Web link to their own website, if they so choose, 
where the requested information is provided to the public.
    FDA and the Department of Veterans Affairs (DVA) have worked in 
partnership to develop a single data clearinghouse for biomedical 
equipment Year 2000 status information. DVA, as a purchaser of medical 
devices, collected information from its vendors as to the compliance 
status of the medical devices used in its facilities. This data, along 
with data from the Department of Defense, has been provided to FDA and 
following confirmation by FDA, has been added to the clearinghouse 
database. Both FDA and DVA are working with private sector associates, 
mostly professional associations and organizations such as the American 
Medical Association, the American Hospital Association, the Joint 
Commission on Accreditation of Healthcare Organizations, the Health 
Industry Manufacturers Association (HIMA), the Medical Device 
Manufacturers Association (MDMA), and the National Electrical 
Manufacturers Association (NEMA) that provide advice and assistance as 
requested.
                     recent letters to manufactures
A. March 29, 1999 Letter on Year 2000 Compliant Products
    Biomedical equipment users have expressed the need for specific 
information on all Year 2000 vulnerable products that are compliant and 
have urged the establishment of a single, comprehensive source for this 
information. On March 29, 1999, FDA issued a letter requesting that 
medical device manufacturers submit a complete list of individual 
product models that are Year 2000 compliant to the FDA-operated Federal 
Year 2000 Biomedical Equipment Clearinghouse. Many biomedical equipment 
users have told FDA that a single statement that all of a 
manufacturer's products are Year 2000 compliant does not meet their 
need to have affirmatively identified specific compliant equipment. 
Once information on compliant products is received from medical device 
manufacturers it will be made available, with improved search tools, as 
part of the Biomedical Equipment Clearinghouse.
    This database of Year 2000 compliant products is intended to 
provide information on products that biomedical equipment users might 
consider to be vulnerable to date-related problems because these 
products could utilize software, a computer or microprocessor control. 
Accurate Year 2000 status information on these products is critical to 
these users as they evaluate their product inventory and plan any 
needed remedial actions.
B. March 29, 1999 Letter on Interim Inspectional Policy Regarding Y2K 
        Issues.
    On March 29, 1999, the Director, Division of Emergency and 
Investigational Operations, Office of Regulatory Affairs (ORA), issued 
a memorandum to the FDA field instructing investigators to raise the 
awareness of potential Year 2000 problems to firms during FDA 
inspections. In this letter, ORA expanded the Year 2000 activities to 
include asking questions regarding what the firm has done to assure 
themselves that their computer controlled/date sensitive products, 
manufacturing processes and distribution systems are Year 2000 
compliant, and to include information on this subject in their 
Establishment Inspection Reports when relevant. In addition, if the 
investigators encounter serious problems or concerns, or find the firm 
is not taking appropriate steps to avoid serious Year 2000 problems, 
this information must be reported to appropriate District and Center 
personnel.
C. January 13 and March 3, 1999 Letters on Non-Compliant Products
    On January 13, 1999, FDA issued a letter to device manufacturers 
announcing FDA's intent to expand the product information maintained on 
the FDA-operated Federal Year 2000 Biomedical Equipment Clearinghouse 
and requested the continued cooperation of biomedical equipment 
manufacturers in this effort. The letter requesting this information 
was issued on March 3, 1999. In this letter FDA indicated that in some 
of the manufacturer responses to the earlier requests the information 
on the FDA website was not sufficiently detailed to adequately assist 
facilities in assessing the impact of non-compliant products. FDA 
requested that biomedical equipment manufacturers carefully review the 
Year 2000 status information that they have provided or intended to 
submit, and, where necessary, provide more specific information on non-
compliant products.
                   previous letters to manufacturers
A. June 25, 1997 Notification to Manufacturers
    In light of the review of the impact of the Year 2000 on some 
medical device computer systems and software applications, FDA has been 
actively alerting the medical device industry through a series of 
letters to medical device manufacturers for approximately two years. 
The first alert letter was sent on June--5, 1997, to all CDRH 
registered medical device manufacturers (8,322 domestic and 5,085 
foreign) indicating that manufacturers needed to address this issue and 
review both embedded and non-embedded software products. FDA reminded 
manufacturers that, in addition to potentially affecting the 
functioning of some devices, the two-digit year format also could 
affect computer-controlled design, production, or quality control 
processes. FDA requested that manufacturers review the software used in 
medical devices to determine if there is any risk.
    Device manufacturers who identify products that have a date-related 
problem are required to take appropriate action to remedy the problem. 
An example of appropriate action in some instances would be 
notification to device purchasers so that their devices can be 
appropriately modified before the year 2000.
B. January 21, 1998 Request for Information
    In a letter dated January 21, 1998, Department of Health and Human 
Services (DHHS) Deputy Secretary Kevin Thurm asked approximately 16,000 
medical device and biomedical equipment manufacturers to voluntarily 
provide information on the Year 2000 compliance status of their 
products. Included in the mailing were all FDA registered manufacturers 
without respect to the specific kind of device produced, even though 
FDA estimates that only approximately 2,000 manufacturers make products 
listed in the categories which include computerized products 
potentially sensitive to Year 2000 problems. Approximately 3,000 of the 
manufacturers included in the mailing are not regulated by FDA; for 
example, scientific instrument manufacturers. The letter detailed 
instructions on ways to submit the data requested and explained that to 
be Year 2000 compliant products must function as intended regardless of 
the date. Manufacturers also were given the opportunity to certify that 
their products are not affected, if that is the case, or certify that 
none of their products use computers or date information.
C. Targeted Follow-up with Manufacturers of Computerized Devices
    On June 29, 1998, FDA issued a targeted, follow-up letter to 
specific manufacturers of computerized devices urging them to respond 
to our January 21 request to submit product data. This list was derived 
from the names of those firms which have registered as manufacturers of 
devices in the categories where Year 2000 vulnerability is likely.
    Then on September 2, 1998, FDA issued a follow-up to the June 29, 
1998 letter, directed to the manufacturers of potentially computerized 
devices who had not responded to the previous requests to specific 
manufacturers for information on the Year 2000 status of their devices. 
In the letter, FDA requested that the manufacturers respond to FDA 
within two weeks with the Year 2000 compliance status of their devices, 
or at least indicate that a complete response was being developed.
    On August 14, 1998, Dr. Bruce Burlington, then Director, CDRH, and 
on September 2, 1998, Dr. Friedman, then Acting Commissioner of the 
Food and Drug Administration, issued letters to HIMA requesting that 
HIMA take aggressive and immediate actions to encourage and assist 
medical device equipment manufacturers in providing information to FDA 
about the Year 2000 compliance status of their products.
    In late September 1998, FDA decided that it would be useful to 
provide an indication of whether a particular manufacturer of 
computerized devices potentially susceptible to Year 2000 concerns has 
or has not provided information on Year 2000 compliance. To that end, 
FDA posted on the website those manufacturers of selected product 
categories which are likely to include vulnerable products that had not 
provided a response to FDA's inquiries. FDA will continue to work with 
manufacturers to obtain this data and report to Congress on the status 
of these Year 2000 requests.
                    additional outreach and guidance
    In addition to the website and the letters, CDRH has been 
conducting extensive outreach to the device industry and to other 
consumers on this issue. CDRH's Division of Small Manufacturers 
Assistance provided an article entitled ``Biomedical Equipment 
Manufacturers Urged to Share Year 2000 Information'' to 12 medical 
device trade press contacts and to 65 U.S. and 35 foreign medical 
device trade associations in order to facilitate the dissemination of 
information to their members regarding the website database and to 
encourage the posting of data by manufacturers. The website and 
database were mentioned in the FDA Column of the June 3, 1998, Journal 
of the American Medical Association and in an article in FDA's Medical 
Bulletin that was sent to approximately 700,000 healthcare 
practitioners this past summer.
    In the Spring of 1998, CDRH developed a Guidance Document on FDA's 
expectations of medical device manufacturers concerning the Year 2000 
date problem. The guidance is available on the FDA website. The 
guidance was published in the Federal Register on June 24 for greater 
dissemination. The guidance re-emphasizes the provisions in existing 
regulations that require manufacturers to address any date problems 
which may present a significant risk to public health.
    FDA also developed an article addressed to the users of radiation 
treatment planning systems regarding the need to assess these systems. 
The article was published in the newsletters of relevant professional 
associations. Staff of CDRH have participated in numerous conferences 
and video teleconferences devoted to the Year 2000 problem in 
healthcare in order to communicate with healthcare facilities regarding 
the Biomedical Equipment Clearinghouse and the need to address the Year 
2000 issue with devices.
    Although most devices are regulated by CDRH, FDA's Center for 
Biologics Evaluation and Research (CBER) regulates blood bank software, 
which is of particular concern for potential Year 2000 problems. In 
January 1998, CBER posted guidance for industry entitled ``Year 2000 
Date Change for Computer Systems and Software Applications Used in the 
Manufacture of Blood Products'' on the FDA website. The guidance 
provided specific recommendations to assist industry in its evaluation 
of computer and software systems used in the manufacture of blood 
products and to assist in evaluating the impact of potential Year 2000 
problems.
                 what is the data telling us thus far?
    As indicated above, FDA believes that approximately 2,000 
manufacturers may produce equipment that may be affected by the Year 
2000 problem. As of May 18, 1999, FDA has entered a total of 4,133 
responses from the 16,000 manufacturers originally contacted. The data 
from all of these manufacturers who have responded have been entered 
into the database on the FDA website. These numbers change daily as 
data are entered, corrected or even removed at the request of 
manufacturers. Of the 4,133 manufacturers who have responded, 3,401 
have reported that their products do not use daterelated data or all of 
their products are compliant. Six hundred and sixty-one manufacturers 
[312 manufacturers listed on the FDA website and 349 manufacturers 
listed on the manufacturer's website] have reported one or more 
products with date-related problems. Four hundred and twenty 
manufacturers have provided World Wide Web links (URLs) to data 
provided on their own manufacturer-operated websites. There are a few 
submissions in which the data were incomplete or unclear in some 
manner. FDA is communicating with these manufacturers to obtain 
clarification before entering the information into the database. FDA 
will continue to post additional responses as they are received.
    In reviewing the data received from the manufacturers so far, FDA 
sees no indication of widespread problems which will place patients at 
risk, if and only if the solutions being developed and offered by 
manufacturers are implemented as they have indicated. Of course, FDA 
can not make assurances about manufacturers who have not reported 
product status. FDA believes that the information received to date 
confirms our original expectation that the Year 2000 problems with 
medical devices will not be significant or widespread if facilities 
take appropriate actions to address this issue. There will be specific 
problems which need correction; however, the current assessment is that 
they are much more likely to disrupt patient care rather than be of 
direct danger to patients. Nonetheless, such disruption could be 
serious and the potential for it to happen certainly merits rigorous 
attention to the problem.
    One indication of FDA's belief that Year 2000 problems are not 
significant or widespread has been borne out by DVA in their testimony 
and responses to questions before the House Committee on Veterans' 
Affairs, Subcommittee on Oversight and Investigations. The DVA 
indicated that they had received answers from manufacturers on all of 
the critical care device components and they expected to be ready for 
Year 2000.
Legal Authority
    FDA's Quality System Regulation (QSR) (21 CFR 820) places on 
manufacturers an ongoing responsibility to take corrective and 
preventive actions that may include recall for problems with current 
production. Devices automated with computer software are subject to all 
requirements of Title 21, Code of Federal Regulations (CFR), Part 820, 
unless expressly exempted by regulation. The regulation puts in place a 
system whereby manufacturers must incorporate a set of procedures and 
processes in their design and manufacturing activities to assure that 
products being manufactured are safe, effective finished products. The 
QSR regulation does not require the submission of any reports to FDA, 
however, it does require firms to maintain internal procedures and 
documentation of corrective and preventive actions (21 CFR 820.100).
    The Removals and Corrections Regulation (21 CFR 806) requires 
manufacturers to submit reports to FDA. In order to be reportable, a 
Year 2000 problem must pose a ``risk to health'' as defined in section 
806.2(j). Many of the problems reported in the Biomedical Equipment 
database or on manufacturers' Year 2000 Web pages concern date 
recording or display problems that are readily apparent to the user and 
are unlikely to pose a risk to health. In the Year 2000 context, a 
decision to correct a problem may occur long before the correction 
itself is actually announced to customers. Once the decision for action 
is made, however, and if the action is to correct a risk to health, 
then the firm has 10 working days to notify the Agency through a report 
of correction or removal. A firm that previously notified FDA about a 
removal or correction through a Medical Device Report (under 21 CFR 
803) does not have to submit an additional report under 21 CFR 806.
    FDA will continue to emphasize to manufacturers the importance of 
reporting on the Year 2000 compliance status of their products and take 
additional steps to boost the response rate. Healthcare facilities need 
information from all manufacturers to properly prepare and plan for any 
actions they need to take to assure their devices needing corrections 
or updates receive these well before the Year 2000.
                               conclusion
    Thank you for the opportunity to update you about the issue of the 
Year 2000 and medical devices. Let me assure you that FDA takes this 
issue very seriously and is committed to a scientifically sound 
regulatory environment which will help provide Americans with the best 
medical care. In the public interest, FDA's commitment must be coupled 
with a reciprocal industry commitment: that medical device firms will 
meet high standards in the design, manufacture, and evaluation of their 
products. FDA recognizes that this can only be attained through a 
collaborative effort--between government and industry--grounded in 
mutual respect and responsibility. The protections afforded the 
American consumer, and the benefits provided the medical device 
industry, cannot be underestimated.
    FDA will continue to provide any assistance it can to address 
specific problems that any other agency, such as the DVA, identifies. 
FDA also is working with other agencies, patient groups, medical 
associations and industry to optimize data collection and information 
sharing. FDA will continue urging manufacturers to ensure the continued 
safety and effectiveness of their medical devices by ensuring that 
their devices can perform date recording and computations that will be 
unaffected by the Year 2000 date change.
    Thank you for the opportunity to testify.

    Mr. Bilirakis. Thank you very much, sir.
    Dr. Shope, I know you are not prepared to give an opening 
statement, but do you have anything you would like to add to 
what Mr. Hubbard has said, at least at this point?
    Mr. Shope. No, Mr. Chairman, I think we will just respond 
to questions.
    Mr. Bilirakis. Okay. Mr. Willemssen, please proceed, sir.

                 TESTIMONY OF JOEL C. WILLEMSSEN

    Mr. Willemssen. Thank you, Mr. Chairman, Chairman Upton, 
Ranking Member Brown, members of the subcommittees. Thank you 
for inviting us to testify today. As requested, I will briefly 
summarize our statement.
    As you have noted, biomedical equipment that uses a 
computer or embedded chip to perform date or time calculations 
can be susceptible to a Y2K problem. The significance of that 
problem can range from a nuisance to the more serious, with a 
potential to decrease patient safety.
    FDA has made progress in obtaining Y2K compliance 
information from manufacturers in establishing its biomedical 
equipment clearinghouse. As of May 10, over 4,000 biomedical 
equipment manufacturers have submitted data to that 
clearinghouse. About 60 percent reported having products that 
do not use a date, while about 8 percent reported having date-
related problems. FDA is now in the process of getting more 
detailed information that is product-specific and plans to put 
that on its website.
    Less progress has been made in reviewing biomedical 
equipment test results. Last year, we recommended that HHS take 
steps to review manufacturers' compliance test results for 
critical-care and life-support biomedical equipment, to give 
the public additional assurance that these items would work as 
expected, come January 2000. However, at that time in response 
to our report, HHS had said that submitting compliance 
certifications alone was sufficient.
    What we have found, in contrast to that position, was that 
some hospitals were actually going out and testing their own 
biomedical equipment. They felt it was necessary to prove that 
they had exercised due diligence in the protection of patient 
health and safety. Hospital officials, in some cases, have told 
us that their testing has identified some non-compliant 
equipment that manufacturers had certified as compliant.
    We recently met with HHS and FDA to discuss options for 
reviewing test results, and we are pleased to hear in its 
testimony today that FDA is moving out in this regard. I think 
it will provide you, the Congress, and the American public with 
greater assurance that biomedical equipment items, especially 
critical-care and life-support items, will work as intended 
come the turn of the century.
    Now, while there is much information now available on 
biomedical equipment, it is still not clear how extensively 
healthcare providers are using this available information. 
According to the FDA, it has taken steps to make users aware of 
the clearinghouse. More than 100,000 inquiries have been made. 
However, according to FDA it is not possible to determine the 
source of the inquiries.
    Further, of the Y2K health surveys we reviewed, only the 
AMA survey mentioned the FDA clearinghouse, and for the AMA 
survey only 11 percent of the respondents indicated they were 
aware of the FDA clearinghouse.
    Other information contained in available surveys is also 
not encouraging. For example, less than one-third of hospitals 
responding to the survey of the HHS Inspector General stated 
that the biomedical equipment was compliant, while only 6 
percent of hospitals responding to an American Hospitals 
Association survey said their equipment was compliant. It is, 
therefore, quite apparent that there is a great deal of work 
remaining in a relatively short amount of time. That concludes 
the summary of my statement, and I would be pleased to address 
any questions you may have.
    [The prepared statement of Joel C. Willemssen follows:]
  Prepared Statement of Joel C. Willemssen, Director, Civil Agencies 
 Information Systems, Accounting and Information Management Division, 
                       General Accounting Offive
    Messrs. Chairmen and Members of the Subcommittees: We are pleased 
to be here today to discuss the Year 2000 (Y2K) compliance status of 
biomedical equipment.1 The question of whether medical 
devices such as magnetic resonance imaging (MRI) systems, x-ray 
machines, pacemakers, and cardiac monitoring equipment can be counted 
on to work reliably on and after January 1, 2000, is obviously of 
critical importance to our nation's health care. To the extent that 
biomedical equipment uses computer chips, it is vulnerable to the Y2K 
problem.2 In the medical arena, such vulnerability carries 
with it possible safety risks.
---------------------------------------------------------------------------
    \1\ Biomedical equipment refers both to medical devices regulated 
by the Food and Drug Administration (FDA), and scientific and research 
instruments, which are not subject to FDA regulation.
    \2\ The Y2K problem will affect everyone because it is rooted in 
how dates are recorded and computed. For the past several decades, 
computer systems have typically used two digits to represent the year, 
such as ``98'' for 1998, in order to conserve electronic data storage 
and reduce operating costs. In this format, however, 2000 is 
indistinguishable from 1900 because both are represented as ``00.'' As 
a result, if not modified, systems or applications that use dates or 
perform date- or time-sensitive calculations may generate incorrect 
results beyond 1999.
---------------------------------------------------------------------------
    Responsibility for oversight and regulation of medical devices, 
including the impact of the Y2K problem, lies with FDA--an agency 
within the Department of Health and Human Services (HHS). FDA is 
collecting information from medical device and scientific and research 
instrument manufacturers, and providing this information through an 
Internet World Wide Web site. In addition, the Veterans Health 
Administration (VHA) 3--a key federal health care provider--
has taken a leadership role in determining the Y2K compliance status of 
biomedical equipment by sharing the information obtained from 
manufacturers with FDA.
---------------------------------------------------------------------------
    \3\ A component of the Department of Veterans Affairs (VA).
---------------------------------------------------------------------------
    My testimony today will discuss (1) the status of FDA's Federal Y2K 
Biomedical Equipment Clearinghouse, (2) HHS' and VA's positions on our 
recommendation to obtain and review the test results supporting 
manufacturers' compliance certifications for critical care/life support 
medical devices, and (3) information on the biomedical equipment 
compliance status of health care providers.
                               background
    Biomedical equipment is indispensable; it plays a central role in 
virtually all health care. It is defined as any tool that can record, 
process, analyze, display, and/or transmit medical data--some of which 
may include medical devices, such as pacemakers, that are implanted in 
patients--and laboratory research instruments, such as gas 
chromatographs 4 and microscopes. Such equipment may use a 
computer for calibration or for day-to-day operation. If any type of 
date or time calculation is performed, susceptibility to a Y2K problem 
exists, whether the computer is a personal computer that connects to 
the equipment remotely, or a microprocessor chip embedded within the 
equipment itself. This could range from the more benign--such as 
incorrect formatting of a printout--to the most serious--incorrect 
operation of equipment with the potential to decrease patient safety. 
The degree of risk depends on the role of the equipment in the 
patient's care.
---------------------------------------------------------------------------
    \4\ Such instruments are used to separate the components of a 
solution with heat and measure their relative quantities.
---------------------------------------------------------------------------
    According to officials at VHA, biomedical equipment manufacturers 
reporting products as noncompliant most frequently cite incorrect 
display of date and/or time as the main problem. For example, a 
noncompliant electrocardiograph machine, used to monitor heart signals, 
would print charts with two-digit dates, showing the year 2000 as 
``00.'' According to a VHA official, these cases generally do not lead 
to the devices' failing to operate and do not present a risk to patient 
safety because health care providers, such as physicians and nurses, 
are able to work around such problems.
    However, VHA recognizes that incorrect date-time representation or 
use could pose a risk when the date is used in a calculation, or when 
records generated by the equipment are sorted automatically to present 
a picture of a patient's condition over time to a physician for 
diagnosis and treatment. Specifically, when records are sorted by date 
of recording, the accuracy of such dates can be critical to a 
physician's monitoring of patient progress in, for instance, the case 
of blood sugar readings. If readings were taken, for example, on 
December 25, 27, and 30, 1999, and again on January 1, 2000, the 
ordering might appear with the last entry first if it were abbreviated 
``00'' and read as January 1, 1900. If the physician or other clinician 
did not pay close attention, a diagnosis or treatment decision could be 
made based on a misreading of the data trend.
    VHA also recognizes that an equipment function that depends on a 
calculation involving a date, and that is performed incorrectly as the 
result of a date problem, could present a risk to the patient. Examples 
of such equipment include a product used for planning the delivery of 
radiation treatment using a radioactive isotope as the source. An error 
in the calculation of the radiation source's strength on the day the 
therapy is to be delivered could result in a dose that is either too 
low or too high, which could have an adverse impact on the patient. 
Other examples of equipment presenting risk to patient safety--
identified by FDA--include hemodialysis delivery systems; therapeutic 
apheresis systems; 5 alpha-fetoprotein kits for neural tube 
defects; 6 various types of medical imaging equipment; and 
systems that store, track, and recall images in chronological order.
---------------------------------------------------------------------------
    \5\ Such equipment allows therapeutic apheresis--the exchange or 
purification of blood plasma. Therapeutic apheresis is recognized as a 
successful treatment for more than 40 autoimmune diseases.
    \6\ Devices that use computer calculations of gestational status to 
help assess the risk of neural tube defects in the fetuses of pregnant 
women.
---------------------------------------------------------------------------
     much biomedical equipment status information available in fda 
                             clearinghouse
    Last September we testified that FDA was trying to determine the 
Y2K compliance status of biomedical equipment.7 FDA's goal 
was to provide a comprehensive, centralized source of information on 
the compliance status of biomedical equipment used in the United States 
and make this information publicly available on a web site. However, at 
the time, FDA had a disappointing response rate from manufacturers to 
its letter requesting compliance information. And while FDA made this 
information available to the public, it was not detailed enough to be 
useful. Specifically, FDA's list of compliant manufacturers lacked 
detailed information on the make and model of compliant equipment.
---------------------------------------------------------------------------
    \7\ Year 2000 Computing Crisis: Leadership Needed to Collect and 
Disseminate Critical Biomedical Equipment Information (GAO/T-AIMD-98-
310, September 24, 1998).
---------------------------------------------------------------------------
    To provide more detailed information on the compliance status of 
biomedical equipment, as well as to integrate more detailed compliance 
information already gathered by VHA, we recommended that HHS and VA 
jointly develop a single data clearinghouse to provide such information 
to all users. We said development of the clearinghouse should involve 
representatives from the health care industry, such as the Department 
of Defense's Office of the Assistant Secretary of Defense (Health 
Affairs) and the Health Industry Manufacturers Association. We 
recommended that the clearinghouse contain compliance status 
information by product make and model, and identify manufacturers that 
are no longer in business. Finally, we recommended that FDA and VHA 
determine what actions should be taken regarding biomedical equipment 
manufacturers that had not provided compliance information.
    In response to our recommendation, FDA--in conjunction with VHA--
established the Federal Y2K Biomedical Equipment 
Clearinghouse.8 With the assistance of VHA, the Department 
of Defense, and the Health Industry Manufacturers Association, FDA has 
made progress in obtaining compliance status information from 
manufacturers. For example, according to FDA, 4,116 biomedical 
equipment manufacturers had submitted data to the clearinghouse as of 
May 10, 1999. As shown in figure 1, about 60 percent reported having 
products that do not employ a date, while about 8 percent reported 
having date-related problems such as incorrect display of date/time. 
Also, according to FDA, 232 manufacturers have not yet responded.
---------------------------------------------------------------------------
    \8\ The clearinghouse can be found on the World Wide Web at http://
www.fda.gov/cdrh/yr2000/year2000.html.
---------------------------------------------------------------------------

 Figure 1: Biomedical Equipment Compliance-Status Information Reported 
              to FDA by Manufacturers as of May 10, 1999.
[GRAPHIC] [TIFF OMITTED] T7443.001

    Note: Total number of manufacturers = 4,116.
    Source: FDA.

    In addition, FDA did not have complete information on the number of 
products with date-related problems because some manufacturers did not 
clearly identify their products this way in their original submissions. 
However, according to FDA, on March 3, 1999, it requested information 
on specific product types for products with date-related problems. FDA 
told us it is now receiving updated data.
    Also, in response to our recommendation, FDA has expanded 
information in the clearinghouse; users can now find information on 
manufacturers that have merged with or have been bought out by other 
firms. Further, in collaboration with the National Patient Safety 
Partnership, 9 FDA is in the process of obtaining more 
detailed information from manufacturers on noncompliant products, such 
as descriptions of the impact of the Y2K problem on products left 
uncorrected. FDA also sent a March 29, 1999, letter requesting that 
medical manufacturers submit to the clearinghouse a complete list of 
individual product models that are Y2K compliant.
---------------------------------------------------------------------------
    \9\ The National Patient Safety Partnership is a coalition of 
public and private health care providers, including VA, the American 
Medical Association (AMA), the American Hospital Association (AHA), the 
American Nurses Association, and the Joint Commission on Accreditation 
of Healthcare Organizations.
---------------------------------------------------------------------------
     fda is now considering reviewing manufacturers' certifications
    Last September, we expressed concern that FDA relied on 
manufacturers alone to validate, test, and certify that their medical 
devices were Y2K compliant.10 Further, we said, since FDA 
did not require manufacturers to submit test results certifying 
compliance, the agency lacked assurance that manufacturers have 
adequately addressed the Y2K problem for noncompliant devices. 
Accordingly, we recommended that HHS and VA take prudent steps to 
review manufacturers' compliance test results for devices previously 
determined to be noncompliant but now deemed by manufacturers to be 
compliant, or devices for which concerns about compliance remain. We 
also recommended that HHS and VA determine what legislative, 
regulatory, or other changes were necessary to obtain assurances that 
the manufacturers' devices were compliant, including the need to 
perform independent verification and validation (IV&V) of the 
manufacturers' certifications.
---------------------------------------------------------------------------
    \10\ Year 2000 Computing Crisis: Compliance Status of Many 
Biomedical Equipment Items Still Unknown (GAO/AIMD-98-240, September 
18, 1998).
---------------------------------------------------------------------------
    In response to our report, HHS stated that it did not concur with 
our recommendation to review test results supporting medical device 
equipment manufacturers' compliance certifications. It reasoned that 
submission of appropriate certifications was sufficient, further 
stating that it did not have the resources to undertake such reviews. 
However, we were not aware of HHS' requesting resources from the 
Congress for this purpose.11 In February 1999, FDA's Special 
Assistant to the Director of the Office of Science and Technology, part 
of the Center for Devices and Radiological Health, likewise said that 
FDA saw no need to question manufacturers' certifications. VA stated 
that it had no legislative or regulatory authority to implement the 
recommendation to review manufacturers' test results.
---------------------------------------------------------------------------
    \11\ Year 2000 Computing Crisis: Readiness of Medicare and the 
Health Care Sector (GAO/T-AIMD-99-160, April 27, 1999).
---------------------------------------------------------------------------
    In contrast to FDA's and VHA's positions, several hospitals in the 
private sector said that testing of biomedical equipment is necessary 
to prove that they have exercised due diligence in the protection of 
patient health and safety. Officials at three hospitals told us that 
their biomedical engineers established their own test programs for 
biomedical equipment and, in many cases, contacted manufacturers for 
their test protocols. Several of these engineers informed us that their 
testing identified some noncompliant equipment that the manufacturers 
had previously certified as compliant. According to these engineers, to 
date, the equipment found to be noncompliant all had display problems 
and was not critical care/life support equipment. Equipment found to be 
incorrectly certified as compliant included a cardiac catheterization 
unit, a pulse oxymeter, medical imaging equipment, and ultrasound 
equipment.
    According to FDA, VHA, and the Emergency Care Research 
Institute,12 manufacturers are best qualified to analyze 
embedded systems or software to determine Y2K compliance. They further 
believe that manufacturers are the ones with full access to all design 
and operating parameters contained in the internal software or embedded 
chips in the equipment. VHA believes that such testing can potentially 
cause irreparable damage to expensive health care equipment, causing it 
to lock up or otherwise cease functioning. Further, a number of 
manufacturers have recommended that users not test for these same 
reasons.
---------------------------------------------------------------------------
    \12\ An international, nonprofit health services research agency. 
This organization believes that superficial testing of biomedical 
equipment by users may provide false assurances, as well as create 
legal liability exposure for health care institutions.
---------------------------------------------------------------------------
    We continue to believe that organizations such as FDA can provide 
medical device users with a greater level of confidence that their 
equipment is Y2K compliant through independent reviews of 
manufacturers' compliance test results. The question of whether to 
independently verify and validate biomedical equipment that 
manufacturers have certified as compliant is one that must be addressed 
jointly by medical facilities' clinical staff, biomedical engineers, 
and corporate management. The overriding criterion should be ensuring 
patient health and safety.
    We recently met with HHS' Chief Information Officer and FDA's 
Associate Commissioner for Policy Coordination to discuss options for 
FDA to obtain and review test results supporting manufacturers' Y2K 
compliance certifications. FDA said that it is now thinking about 
reviewing manufacturers' IV&V reports that support compliance 
certification. FDA also informed us last week that it is developing a 
list of critical care/life support biomedical equipment. It plans to 
complete this list by June 1, and use it to identify manufacturers of 
such equipment who have not yet responded to its requests for 
compliance information. In addition, an FDA official stated that the 
list would be used in considering options for reviewing manufacturers' 
test results supporting compliance certifications.
information on biomedical equipment compliance of health care providers 
                               incomplete
    While information is available on the Y2K compliance status of 
biomedical equipment through the FDA clearinghouse and other sources, 
it is not clear at this time how extensively health care providers are 
using this information to determine their Y2K readiness. According to 
FDA, it has taken steps to make users aware of the clearinghouse. For 
example, FDA has published articles in professional trade journals and 
participated in conferences aimed at health care facilities.
    FDA also informed us that the Federal Y2K Biomedical Equipment 
Clearinghouse had received about 101,000 inquiries between May 1998 and 
January 1999. However, according to FDA, it is not possible to 
determine the source of the inquiries.
    To determine whether health care providers were using the FDA 
clearinghouse to assess the Y2K compliance status of their biomedical 
equipment, we reviewed readiness surveys sent to providers by several 
federal agencies and professional health care 
associations.13 Except for the AMA's survey, none referred 
to the FDA clearinghouse. Eleven percent of the respondents to the AMA 
survey indicated they were aware of the FDA clearinghouse.
---------------------------------------------------------------------------
    \13\ These include HHS' Office of the Inspector General, the AHA, 
and AMA.
---------------------------------------------------------------------------
    In addition, the Y2K readiness status of biomedical equipment at 
health care providers is not known because a significant number of 
providers did not respond to the surveys. As shown in table 1, the 
response rates to a survey from the HHS Office of the Inspector General 
to urban hospitals, nursing facilities, home health agencies, and 
physicians were all less than 50 percent. The response rates to surveys 
from the AHA and the AMA on this subject were even less, at 29 and 7.5 
percent, respectively. Lastly, the response rate to a survey from the 
American Health Care Association (AHCA) 14 was very 
disappointing, at less than 3 percent.
---------------------------------------------------------------------------
    \14\ This is a federation of 50 state health organizations that 
represent nearly 12,000 nonprofit and for-profit assisted living, 
nursing facility, long-term care, and sub-acute care providers.

                        Table 1: Survey Results of Y2K Readiness of Biomedical Equipment
----------------------------------------------------------------------------------------------------------------
                                                                                         Percentage   Percentage
                                                                 Number     Number of    Responding   Responding
           Entity Performing Survey/Group Surveyed              Surveyed    Responses    Currently       Not
                                                                                         Compliant    Applicable
----------------------------------------------------------------------------------------------------------------
HHS Office of the Inspector General \1\ (December 1998)
HOSPITALS
  Rural.....................................................          500          281           31            3
  Urban.....................................................          500          208           23            4
NURSING FACILITIES
  Rural.....................................................          500          221           21           31
  Urban.....................................................          500          191           21           27
HOME HEALTH AGENCIES
  Rural.....................................................          500          136           26           41
  Urban.....................................................          500          133           21           39
PHYSICIANS
  Rural.....................................................          500          124           30           36
  Urban.....................................................          500           95           20           52
American Hospital Association (AHA) (February 1999).........        2,000          583            6          n/a
American Medical Association (AMA) (February 1999)..........        7,000          522          \2\          n/a
American Health Care Association (AHCA) \1\ (March 1999)....       12,000          342           24           28
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\1\ The survey instructions directed respondents to mark N/A if a question did not apply.
\2\ According to the survey results, 65 percent of responding physicians rent or lease biomedical equipment that
  will be affected by Y2K; 41 percent of them were confident that their vendors have prepared the equipment for
  Y2K. Data were not provided on the remaining 35 percent of responding physicians.
Source: Organizations listed. We did not independently verify this information.

    The survey results also indicated that much work remains in 
renovating, testing, and implementing compliant biomedical equipment. 
Table 1 shows that less than one third of the hospitals responding to 
HHS' Office of the Inspector General stated that their biomedical 
equipment was currently compliant, and only 6 percent of the hospitals 
responding to the AHA survey stated that their biomedical equipment was 
currently compliant. At the same time, more than one third of the home 
health agencies and physicians responding to HHS' Office of the 
Inspector General stated that the survey question on biomedical 
equipment compliance did not apply to them.
    In summary, while compliance status information is available for 
biomedical equipment through the FDA clearinghouse, FDA has not yet 
reviewed test results supporting manufacturers' certifications. FDA has 
now begun to think about obtaining and reviewing IV&V reports that 
support manufacturer compliance certifications. Such reviews would 
provide the American public with a higher level of confidence that 
medical devices will work as intended. However, because a significant 
number of health care providers are not responding to Y2K surveys sent 
by federal agencies and professional associations, the public lacks 
information on the readiness of providers. Such information would help 
alleviate public concerns about the Y2K readiness of health care 
providers and the biomedical equipment they use in patient care.
    Messrs. Chairmen, this concludes my statement. I would be pleased 
to respond to any questions that you or other members of the 
Subcommittees may have at this time.

    Mr. Bilirakis. Thank you, Mr. Willemssen.
    I have a couple of generic questions, but before I go into 
that, I would like to ask the FDA if FDA is concerned, was 
concerned, will be concerned about the safety of the medical 
device to operate properly after January 1?
    Do you feel, Mr. Hubbard, that the agency presently has 
adequate legal authority to pull a product from the market and 
take steps to ensure that the patients will not be at risk, or 
will it require something from the Congress to be helpful in 
that regard?
    Mr. Hubbard. Well, certainly, we have written regulations 
based on the statutory authority we have been given, Mr. 
Chairman, to do that. If we determine that a medical device has 
not been properly made compliant, and could fail, and could 
cause patient harm, yes, we could order that----
    Mr. Bilirakis. You do have that authority now, you feel?
    Mr. Hubbard. Yes, sir, we believe we do.
    Mr. Bilirakis. You won't need any help from the Congress in 
that regard, any----
    Mr. Hubbard. On that particular issue, I don't believe so.
    Mr. Bilirakis. Are there other issues, on that particular 
issue, but are there other issues involving this where you feel 
that you need more legislative authority in order to be able to 
do your job better?
    Mr. Hubbard. I think funding has really been the issue, to 
some extent, because the program that is doing this, Dr. 
Shope's program, and the other folks, they are working very 
hard, as you know, to get new medical devices on the market 
because we are a gateway to this new technology. It is very 
important and we are putting a huge amount of effort into 
getting all these new products on the market and to take those 
people away to do Y2K has been a stressful situation. But we 
have been seeking additional money through the appropriations 
process, and some has been coming forward.
    Mr. Bilirakis. Thank you. Mr. Hubbard.
    Dr. Shope, based on your experiences at FDA on this issue, 
are you confident that the medical technology industry will be 
ready on January 1?
    Mr. Hubbard. I think we are, Mr. Chairman. I would ask Dr. 
Shope to elaborate on that, if I may.
    Mr. Bilirakis. Doctor?
    Mr. Shope. Yes, sir. I think from my reading of the 
information we have received in our data base and discussions 
with manufacturers, and knowing our regulatory process, that 
manufacturers are taking the necessary steps to evaluate and 
assess their products, to provide information to customers 
about the status of those products, and the steps to remediate 
products, the upgrades, or the fixes that the manufacturer can 
make available for those products.
    So, I am rather sanguine about the situation with regard to 
the manufacturers' actions. I think the question, if there is 
one, is the extent to which hospitals, who own this equipment, 
and use it, are taking advantage of the information and taking 
the necessary steps to ensure that the products they have in 
their inventory have been checked, have been verified as 
having----
    Mr. Bilirakis. All right, that is certainly a significant 
question, I agree with you, but are we taking steps to be sure 
that that is taking place on a timely basis, in the hospitals?
    Mr. Shope. Certainly, FDA has taken as many steps as we can 
to inform the hospitals about this issue, working with the 
American Hospitals Association, the American Medical 
Association, very active participants in our healthcare sector 
working group under Mr. Koskinen's Y2K Conversion Council out 
of the White House. So there is a lot of communication going on 
there.
    FDA took steps such as publishing in the Journal of the 
American Medical Association, mailings of our FDA medical 
bulletin, and other kinds of trade press, and other types of 
announcements, to make people aware of this issue.
    Controlling hospitals is a little bit out of FDA's purview. 
Typically, we are dealing with the manufacturers and the 
manufacturers' responsibilities to provide good products, and 
get those into the hands of the users.
    So, I think that this is an issue that we at FDA have not 
seen as our prime role, as far as actually ensuring that 
hospitals are doing this.
    Mr. Bilirakis. Who has that prime role?
    Mr. Shope. Well, I think that it is the responsibility of 
each hospital to make sure that their patients are treated with 
equipment that is going to work and do the right job.
    Mr. Bilirakis. Let me go to Mr. Willemssen. Mr. Willemssen, 
of course, you and Mr. Hubbard both testified to the fact that 
the GAO has made certain recommendations to them. Taking all 
that into consideration, do you agree with the positive answers 
that we have received from the FDA to my question?
    Mr. Willemssen. As of today, I am more optimistic than I 
would have been even at the hearing that you held a month ago. 
However, there is still a great deal of work remaining. What I 
heard in the oral statement today was very reassuring, that FDA 
intends, for those critical-care and life-support items, to get 
additional information, making sure they do work as intended.
    I will also point out that, if you look at the kind of 
response rate that FDA has gotten compared to where it was less 
than a year ago, that has gone up tremendously, and they should 
be given credit for this. There still are a couple hundred 
manufacturers outstanding who have not yet responded, but this 
is a tremendously better rate than it was. So, bottom line, I 
am more optimistic, but there is a lot left to do, and 
relatively little time to do it.
    Mr. Bilirakis. So, what you are saying is that we are in 
danger of not being ready, as far as GAO is concerned, on 
January 1?
    Mr. Willemssen. I think what is critical right now is that 
FDA follow through on some of the steps that they have 
mentioned here today, and very importantly, to publicize the 
results of those steps, and make it clear to the public, what 
we know and what we don't know. As we move closer to the turn 
of the century and to the extent that we can, increasing the 
percentage of what we do know will go a long way to reducing 
any potential panic that could result.
    Mr. Bilirakis. With the indulgence of the subcommittee, the 
question of whether the hospitals are ready, that Dr. Shope 
mentioned, I mean that is a very significant question, and 
certainly at least the patients of those hospitals ought to 
know whether they are going to be ready, God knows. But, do you 
have any suggestions as to how that can be done, what can be 
done there?
    Mr. Willemssen. I would concur with you, the available data 
are not reassuring on the extent to which hospitals appear, or 
are saying they are checking this. So, I think that FDA can 
step-up its publicity campaign a few more degrees. For example, 
it could make sure this is a major agenda item--and you might 
want to address this with the second panel--at some of the 
major conventions, health-related conventions.
    Also, I think, that when FDA plans to come out on June 1--I 
believe that is the date they are listing the critical-care and 
life-support items they will be checking for Y2K--it should be 
publicizing this list and letting the public know, ``We are 
going to take an extra step for these kinds of items, and give 
you added assurance of what the Y2K issues are, and what we 
have found.''
    So, I think, again, that the FDA has done some good things 
in putting the word out. They can do more, though, especially 
as we get closer to the date.
    Mr. Bilirakis. Well, you know, I can't get over how we have 
gotten into this fix. We have put people on the moon; we have 
done so many great things technologically, and we all knew that 
the year 2000 was coming up. I am certainly not computer 
literate, I am ashamed to say, but most people are, certainly 
the experts and the agencies, departments, and with the various 
companies out there in the industry are. They have all known 
this was coming up, and yet we are running into this problem. 
If we have got to put ourselves into the shoes of that patient 
out there who reads about this, and maybe unduly so, is being 
really shook up--well, all right, Mr. Brown.
    Mr. Brown. Mr. Chairman, thank you. I would first like to 
ask unanimous consent to keep the record open for 3 days, say, 
for questions to be submitted.
    Mr. Bilirakis. By all means and, of course, we always ask 
the witnesses if they are willing to receive additional 
questions, and are willing to respond to them. By all means, 
without objection.
    Mr. Brown. Mr. Willemssen, you have made the argument 
several times that FDA should require manufacturers to submit 
test results certifying compliance because, unless they do so, 
the agency really has no assurance that those manufacturers 
have adequately addressed the Y2K problem. Why should the FDA 
do that?
    Mr. Willemssen. We recommended this, for a subset of 
biomedical equipment items, those considered to be in the 
critical-care and life-support areas. So, we don't recommend 
that for all items, but just a small subset where the impact of 
a Y2K failure would have resulting effects on patient safety. 
We think this additional step is necessary to provide the 
public with added assurance that these items are going to work 
as anticipated.
    As I mentioned in my testimony, we have identified some 
hospitals who told us that in some cases their own testing has 
identified items thought to be compliant that were not 
compliant. Now, in those cases, none of those, to date, that we 
are aware of have had a safety impact. They have primarily been 
display problems. But I think that because of the criticality 
of the issue, we think for that subset of items, that the 
additional step is warranted.
    Mr. Brown. What form would the data take? Would it be in 
great detail, in binders, and hundreds of pages or would it be 
a study or sort of outline of the methodology and then a 
concise report of the results?
    Mr. Willemssen. It would not entail, or should not entail, 
any additional work on the part of the manufacturers because 
they should already have those results available in order for 
them to come to a conclusion that the item, is indeed, 
compliant. I would say, the process would work along the lines 
of FDA asking to look at the information to see if there is 
support behind the determination that the item was compliant.
    Mr. Brown. What kind of resources would it take for FDA to 
do that? Have you conducted any analysis to determine if the 
FDA even has the resources to implement your recommendation, 
even if, in fact, it agreed with it?
    Mr. Willemssen. In talking with FDA on this issue, we 
suggested that they not just look internally, but they also 
look at other available resources, both private and public. You 
may or may not know, one of the leaders in this area has been 
the Department of Veterans Affairs, who actually was on board 
first in putting together quite a bit of information on 
biomedical equipment items. FDA then came on board with VA, but 
VA also has some expertise in this area. So, I think in looking 
at the resource question, FDA needs to go outside of its own 
boundaries and look at what available expertise there is.
    Mr. Brown. Dr. Shope or Mr. Hubbard, do you think that FDA 
has the technical expertise internally and in other parts of 
the government into which it can reach to do that?
    Mr. Hubbard. Well, not in any great numbers, Mr. Brown. We 
have a small staff of physicists and other biomedical engineers 
in Mr. Shope's office. It is a handful of people. They probably 
do have the technical expertise. Beyond that, I don't think so, 
because the kinds of data that you would get from a company, 
you know, probably large stacks of verification data and test 
data results would require someone with some knowledge of the 
product and the way that the software was designed and the way 
it operates. In the case of a fix of a non-compliant product, 
how that was done, and how that was tested and verified to be 
sure.
    There may be the technical talent out in the country that 
could be contracted with to do that, of course, understand that 
the numbers could be perfectly enormous at a 100,000 different 
medical devices and 1,700 different categories. But only around 
2,000 perhaps, have some date issue. We think, perhaps, in 
range of 300 to 600 actually are of the type, so called, 
critical care devices that Mr. Willemssen is talking about that 
might be in that category. So the number that would be most 
concerned is a much more manageable number. We believe that it 
would be possible to contract with professionals in the IT 
area, and perhaps, engineers to go to firms to look at this 
data. It would cost some millions of dollars, however, to do 
that. And I think there is a question as to whether or not the 
taxpayers' funds should be spent to do that sort of thing. That 
is why we are proposing our sampling proposal, which could be 
done much more cheaply, to build additional confidence, and 
then determine if, in fact, we need to do more than that.
    Mr. Brown. Mr. Willemssen, you note in your testimony, FDA 
saw no need to question manufacturers certifications regarding 
Y2K compliance status. Is GAO taking the position that FDA 
should question the reliability or truthfulness of 
manufacturers certificates?
    Mr. Willemssen. What we are saying is for those critical 
care and life support items, added assurance is needed to the 
American public to make sure that they work as intended. Some 
hospitals have told us that their own testing has identified 
some equipment that was thought to be compliant that wasn't. It 
is not to say that organizations are not to be trusted, but 
where the criticality is high, an extra pair of eyes could be 
very useful.
    Mr. Brown. Mr. Chairman, could I ask for 60 additional 
seconds?
    [Mr. Upton nods head to indicate yes.]
    Mr. Brown. Thank you.
    So, Mr. Willemssen, if the FDA does certify that a 
manufacturer has undergone Y2K compliance testing, in taking 
into play, into consideration, the comments of Mr. Hubbard 
about a possible lack of resources, including technical 
expertise in the agency, does the Government run the risk of 
becoming liable if a serious Y2K problem develops with 
equipment that the FDA reviewed?
    Mr. Willemssen. I think there can be no absolute guarantee 
that equipment will work as intended, even with additional 
checks being made. What you have done is closed the gap on the 
risk and made it more manageable for those especially critical 
items.
    Mr. Brown. You have closed the gap on the risk that have 
you, in fact, shifted some of the responsibility then to a 
Government agency from the private sector, who ultimately 
should, in fact, be responsible for compliance and for success.
    Mr. Willemssen. Well, under this recommendation, FDA would 
not be independently testing items themselves. They again, 
would be relying on the work that has been done by the 
manufacturers.
    Mr. Brown. But FDA technical experts would review the 
methodology, look at the results, and ultimately have to make * 
* *, and put a stamp of approval on it. Correct?
    Mr. Willemssen. Under that process, it ultimately come to 
some judgment as to the risk involved, and whether all 
appropriate good manufacturing practices have been followed in 
assuring themselves that this a Y2K compliant item.
    Mr. Brown. So, are they shifting some of the reliability on 
the FDA? This recommendation?
    Mr. Willemssen. I will, in part, defer to the record on 
that because I am not an attorney by training. I would defer to 
Dr. Shope and Mr. Hubbard, but we did not, on the face, see it 
in that way.
    Mr. Brown. Could Dr. Shope answer the question and then I 
will yield back? Dr. Shope.
    Mr. Shope. I just wanted to make a comment on the issue of 
the testing, or not so much testing, but the verification of 
manufacturers activities. What we are talking about here is 
really exactly the same kind of activities that FDA undertakes 
on a routine basis in our inspection of manufacturers quality 
systems. It is the quality system that a manufacturer has in 
place that gives us the assurance that they are developing, 
designing, producing, evaluating medical devices in a way that 
gives us assurance about their safety and effectiveness. And 
what we are talking about here is focusing some additional 
effort, if we were to do it, on those changes related to Y2K. 
We rely on this quality system for the initial development of 
medical devices. We rely on it when we clear them for pre-
market and we rely on them for any other kinds of changes.
    Medical devices frequently are found to have problems; 
those problems get corrected. Particularly with software 
control products, new features are added, those are done under 
the quality system and the design control process. All of that 
is done by the manufacturer, using the quality system that they 
have in place.
    I think that the issue here is that whether something 
additional is needed for dealing with these Y2K upgrades. I 
think, strongly, that our regulatory system that we have, with 
the quality systems that manufacturers use, and that FDA 
exercises oversight to verify that are in place and are being 
used gives us a high level of confidence that these activities 
are being conducted and they do give us this kind of assurance. 
The question is, do we need to do something more and additional 
and special just for the Y2K issues?
    Mr. Brown. Thank you, I thank the chairman for his 
indulgence.
    Mr. Upton. Thank you.
    Mr. Hubbard, I was very interested in seeing that there 
were, I guess, 232 companies that did not respond to the 
inquiry from FDA. What is happening to these companies? What is 
the level of your concern?
    Mr. Hubbard. All right, that is a subset of the firms that 
we believe might make products that are date dependant, as 
opposed to the large universal products that have no computer 
issue involved in them. We are continuing to pursue those 
companies. We have a contractor of calling and trying to 
identify those companies. By and large, we believe that they 
are companies that are, perhaps, foreign companies that have 
gone out of business or we can't find, otherwise, and perhaps, 
aren't marketing a product in this country anymore. Even though 
that is our suspicion, we are trying to confirm that, that is 
in fact true, and that none of those 232 are marketing any 
products. I believe, Tom, that it is actually 199 now, it is 
down to 199, we have found a few more in the last 3 days.
    Mr. Upton. Well, that is good to hear. In your statement, 
your written statement, you didn't talk about the statistical 
sampling that you have now decided to embark on that you talked 
about in your verbal statement. As I recall, you said something 
like, you are going to survey about 60 firms, is that right?
    Mr. Hubbard. Our belief is, we have asked various experts 
at the device program to look at the sorts of devices that the 
GAO has identified, as perhaps, what they call critical care 
devices. But devices that have a potentially high risk to 
patients if they were to fail due to a date dependency. We 
believe there is somewhere over 300 manufacturers of such 
devices. So, the concept would be to develop a representative 
sample of that 300-plus device manufacturers and then go out 
and audit that sample. And 60 sounded like, we are looking 
around 60 as being a good representative sample to feel that we 
have covered the range of these kinds of products.
    Mr. Upton. Is there a reason why you might have waited so 
long, the end of May, to sort of begin to do that?
    Mr. Hubbard. I think, as we have said earlier, Mr. Upton, 
we do have a fairly high confidence level that there is not a 
problem here with these products. Every time that there has 
been an allegation that a device has failed, we have followed 
up on it, stringently, and we have not been able to find the 
sorts of life-threatening concerns that exists. But that is not 
to say that, as Dr. Shope just said, that perhaps we can do 
more. The GAO is saying, take it to one more level and go into 
the firms and look at their data and quiz them more and develop 
yet an additional layer of confidence for the hospitals and the 
public and the Congress that, in fact, things are okay. We have 
a fairly high degree of confidence now that these devices have 
been attended to.
    Mr. Upton. Mr. Willemssen, have GAO's efforts primarily 
been focused on the manufacturing end and the FDA end? Have you 
at all looked at the degree of communication between the 
hospitals and their communication, their networking among 
themselves?
    Mr. Willemssen. We have to some degree, but most of our 
audit effort in this area has been focused primarily at what 
FDA actions have been taken and less so in the other areas.
    Mr. Upton. Do you think that that would be a wise approach, 
to talk to some of the hospitals to see how they are fairing?
    Mr. Willemssen. Yes. One thing, because of our concern on 
what the data was showing about the apparent lack of use by 
some of the healthcare providers of the FDA data base, we were 
pondering whether some independent organizations do spot checks 
of major healthcare providers to ask them, ``Have you checked 
the data base?'', and ``Oh, by the way, did you know that these 
particular items are considered non-compliant? Do you have any 
of these items in your inventory? You should probably go 
check.'' We don't have a high degree of confidence as to 
whether those kind of activities have been done or not. They 
may, in fact, have been done to large degree, but the data 
doesn't show this. And that is the reason for our concern.
    Mr. Upton. Thank you. Mr. Bryant.
    Mr. Bryant. Thank you, Mr. Chairman. I have just a question 
for, I guess, the FDA, Mr. Hubbard. I missed your testimony, I 
had to run to another committee meeting. So, you may have 
talked about this, and this may be a real basic question, a 
simple question, if you will. Regarding the FDA approval 
process for medical devices, has that been a standard, is that 
a standard now for approval of a medical device, that it be Y2K 
compliant?
    Mr. Hubbard. Well, it certainly is now. We have been 
identifying it, as you know, we have review staff, physicians 
and others that review new medical devices for their safety and 
efficacy. And, of course, a different process for changes in 
approved devices that are already on the market. Certainly, our 
reviewers are now making that one of the things that they look 
at. Obviously, the companies have great incentive to make sure 
that that is not a problem, but as an additional check, our 
reviewers are asking that question and making sure that there 
is not a date dependency issue with new devices going on the 
market, now.
    Mr. Bryant. How long has that been a standard? I understand 
that your testimony is that it is a standard of FDA before it 
approves a medical device, that it be Y2K compliant. How long 
has it been the standard?
    Mr. Shope. If I might answer that. We focused on this issue 
early in 1996, and I think we got a general agreement in our 
Office of Device Evaluation that, for those types of devices 
where this date issue could be a critical aspect to their 
functionality, those pre-market review staff were sensitized to 
this issue in late 1996, early 1997. We have to note, however, 
that there are two routes to market. One is a new device, the 
pre-market approval process, which gets a high level of 
scrutiny. The second is substantial equivalence. Back at the 
end of the 1997/98 timeframe, we actually had a few products 
come to market that had been under development through the 
510(k) process, that the manufacturer said, ``I realize this 
product is not Y2K compliant today, but by the time it is an 
issue for this particular product, we will have a software 
upgrade.'' So, based on the issue of substantial equivalence 
determination, those products were allowed to go to the market. 
But, the manufacturer had the understanding that he needed the 
software upgrade in the next couple of years, and to get that 
into the hands of the users. And that those products will be 
misbranded and adulterated as of year 2000, if that hadn't been 
remediated.
    Mr. Bryant. How do we catch and correct those instances 
now?
    Mr. Shope. Those are, again, products----
    Mr. Bryant. The manufacturer?
    Mr. Shope. The manufacturer knows about it already. He has 
communicated to the users of those products, if they are still 
out there, and those early software versions should be listed 
in our website as a non-compliant version that the hospital 
needs to check to make sure that they have gotten the upgrade. 
So I think the information about that is there. Again, a big 
part of the responsibility here is on the healthcare users to 
compare what they have to what has been demonstrated to have 
issues, then to take the remediation steps that are necessary.
    Mr. Bryant. Thank you. I will yield the balance of my time 
to my colleague from Iowa.
    Mr. Ganske. Thank you.
    Mr. Willemssen, I want to be sure that I heard you 
correctly. I think you quoted some study that said only 6 
percent of hospitals say that their equipment is Y2K. Was that 
correct?
    Mr. Willemssen. I believe so, yes, sir.
    Mr. Ganske. Six percent?
    Mr. Willemssen. Yes, the table on page 14 of our statement 
reflects that 6 percent statement.
    Mr. Ganske. Okay. Well, then, coupled with your other 
statement that said that you know of some hospitals that are 
doing their own testing of equipment where they say the 
manufacturers say they are compliant but then when the 
hospitals do their testing, they aren't, can you give me some 
examples of what type of equipment they have checked?
    Mr. Willemssen. Yes. There were equipment such as a cardiac 
catheterization unit, a pulse oximeter, medical imaging 
equipment, and ultrasound equipment. Now, what the hospitals 
that we talked to said, that the issues they found were display 
problems that didn't appear to have immediate health impacts.
    Mr. Ganske. Except that if you have a pulse oximeter and it 
is not reporting correctly, that can be a pretty serious 
problem.
    Mr. Willemssen. Yes.
    Mr. Ganske. Like if you had a pulse oximeter on a patient 
during anesthesia and it is incorrectly reporting. Now, Dr. 
Shope, you are shaking your head no?
    Mr. Shope. I would just say that most of these kinds of 
issues have to do with recording a record of what the device 
has done; and, typically, do not impact the actual 
functionality of the device. The pulse oximeter, I don't know 
the specifics of this one, but my information would be that 
that pulse oximeter would work as intended; it will give the 
display as intended. What might be the problem here is either 
the display on its face or a readout showing the day's date and 
time or a record of what was occurring and the date and times 
associated with that record of what the device did. Typically 
very few medical devices have a date dependency in their 
functionality. Many of the problems that we have that are 
listed as non-compliant problems are problems associated with 
keeping a record of what the device did, or the way in which 
that date is displayed.
    Mr. Ganske. But, some do have time-dependent functions, 
such as ventilators, where you set the rates and things like 
that, or dialysis machines and things like that. Is it possible 
that those could be affected by chips as well?
    Mr. Shope. It is not out of the realm of possibility. 
However, most medical devices are kept as simple as possible, 
and therefore, I can't think of very many of these issues where 
the day of the week or the day of the month, that kind of date 
record is relevant to the operation of the device. What is 
relevant perhaps is time intervals, and there are other ways of 
keeping track of that than having to record date and time 
information.
    So, we think manufacturers, the vast majority of these 
approaches, keep it as simple as possible; use only the timing 
that is necessary; don't depend on date, month, year kind of 
information when that is not necessary. So, it is not out of 
the realm of possibility that a system could be so designed.
    One of the very large issues is many medical devices are 
either controlled by, or provide data to, or through, a PC-type 
system. So if that associated PC can't keep good records of the 
date and time, any recording that it does, files that are 
stored, dates associated with that information, gets corrupted 
because of the Y2K problem. It really doesn't impact the 
functionality of the device. The service that you want from 
that device gets delivered. It is the recordkeeping associated 
with what happened that may not be as you would desired.
    Mr. Bryant. Mr. Chairman, the time is out. I will come 
back. I will try to be back for additional questions.
    Mr. Upton. Thank you. Ms. McCarthy.
    Ms. McCarthy. Thank you, Mr. Chairman. Dr. Shope, I note in 
a article from Healthcare Today last November/December, Joseph 
Jorgen's piece that states, ``Since Y2K non-compliant products 
function appropriately at this time, the Center for Devices and 
Radiological Health will clear and approve Y2K non-compliant 
devices. However, manufacturers will be informed that if these 
devices are not upgraded, they will be considered adulterated 
as of January 1, 2000.''
    You can recall products. Are there any products that you 
intend to recall because of Y2K? If, for example, some 
manufacturers face this dilemma described in this article in 
their projects, or products under investigation, you know, 
don't comply, at what point should healthcare providers go into 
contingency plans? And would you expand upon what those should 
be?
    Mr. Shope. We have no plans right now, or no products 
identified that would merit a recall as far as our authorities 
go, because, by and large, all of the products that have 
problems, those problems have been identified and the 
manufacturer is providing a route to upgrading or correction of 
that problem. It is only if there were a product which 
presented a very serious risk to injury and there was no action 
being taken by the manufacturer, there was no upgrade 
available, then our regulatory authority to do a recall would 
come into play.
    I think the contingency for hospitals, or for healthcare 
facilities, is not so much a contingency, but what they need to 
be doing now. Which is doing their inventory, assessing their 
products, determining which of the inventory might be 
susceptible to a problem, availing themselves of the solution 
that the manufacturer has provided for that problem, and 
remediating their inventory. If there are products for which 
they cannot find the manufacturer because there are a few 
manufacturers that do go out of business--I don't think this is 
a very large issue--but should they not be able to find the 
original manufacturer, and they can't obtain any technical 
information about that product, then the hospital has to make a 
decision based on what that product is and the way it could 
impact patient care as to whether they can somehow evaluate it 
themselves, have a third party evaluate it for them, or take it 
out of service. Probably the best thing is to take it out of 
service and find a replacement for that device.
    Ms. McCarthy. But, you are approving Y2K non-compliant 
devices now, correct, or is this article factually incorrect?
    Mr. Shope. Well, I think at the time that the article was 
written, back in November, we were still anticipating that we 
could get 510(k) submissions which would come in and say, I 
have a problem, I want to get clearance for the software as I 
have designed it now, but it has got to have an upgrade to be 
Y2K compliant 1\1/2\ years from now, or 2 years from now. We 
had no mechanism to deny access to market for that kind of 
product.
    Ms. McCarthy. But you do have the power of recall. So if 
you find, having taken that step that was appropriate, that 
recall is needed, because the next step, per your request, was 
not met, will you take action of recall?
    Mr. Shope. Oh, certainly, if we find any product where 
there is a potential risk to health that would rise to the 
threshold that is contemplated for the recall authority, we 
would certainly vigorously pursue that issue.
    Ms. McCarthy. Well, on a second point that you raised to my 
question on the hospitals taking necessary steps, Health 
Midwest, which is a very huge presence in my congressional 
district in Kansas City, expects to spend about $10 million to 
check the 21,000 biomedical devices that they have. This was in 
a big piece over the weekend in the Kansas City Star. How are 
the smaller hospitals going to pay for these activities, my 
teaching hospitals, Children's Mercy and others?
    Mr. Shope. If they are going to attempt to test all of 
their inventory, they have a rather tremendous undertaking. 
However, I think there is real question about whether hospitals 
need to do this kind of testing. There are a number of groups 
that have weighed in on this issue, FDA has not taken an 
official position, but I think our knowledge of the medical 
device industry and the medical device designs would say that 
the manufacturers is really the only one in a good position for 
a complex medical device to do an adequate evaluation and 
testing of that product. So, my advice to a hospital would be 
to rely on the information from the manufacturers about the 
compliant status of the device and I would question a massive 
undertaking to test medical devices on the part of hospitals.
    Ms. McCarthy. With all due respect, your organization 
having approved non-compliant Y2K products, appropriately at 
the time, and then relying on the companies to come forward and 
assure hospitals, indeed, that all of that has been addressed, 
what does that do for the risk of the hospital if that is 
somehow factually wrong? I can see why hospitals want to do 
their own testing. They have a stake in this, too. They will be 
responsible to the patients that they serve. Do you see the 
sort of argument going round and round.
    Mr. Shope. Right, and it is the same kind of argument that 
would apply, I think, in a much bigger issue, which are the 
products that were approved without knowing they were non-
compliant. Now, we have many of those that are, in fact, non-
compliant, and the manufacturers are developing upgrades. So, 
the situation, I don't see much difference between the 
situation there. The issue is the manufacturers have assessed 
their products; they know which ones have problems; they are 
providing solutions for those. If it comes to our attention 
that there is a product that is out there and it is a type of 
product that could present such a risk to a patient and no 
action is being taken, that is the kind that we would be able 
to exercise our recall authority. I have to say that, there are 
very few products that I can contemplate that would rise to 
that level of risk-to-patients that the manufacturers haven't 
addressed and provided a fix for.
    Ms. McCarthy. I see that I have gone beyond my time, Mr. 
Chairman, and I apologize, but I wanted to pursue this issue, 
and I thank you.
    Mr. Upton. Mr. Burr.
    Mr. Burr. Dr. Shope, let me just say that your answer to 
Dr. Ganske was the most reassuring thing that I have heard in 
this hearing so far, when you answered Dr. Ganske earlier. Let 
me stick with you for just a second. Do I take from your answer 
to Ms. McCarthy that, from a standpoint of a rural versus 
urban, we shouldn't have a concern that rural America is more 
at risk than urban America?
    Mr. Shope. No, I wouldn't conclude that, because I think 
one could anticipate the amount of resources being available to 
the smaller, rural facilities and the kinds of expertise 
available to them to simply do the inventory, to do the 
evaluation, to do the followup, and perhaps, if there are items 
that need to be replaced, to make those replacements. I think 
the facilities have work to do.
    Mr. Burr. We are still very reliant on the facilities to 
make determinations as well?
    Mr. Shope. Yes.
    Mr. Burr. Let me ask you, Mr. Hubbard, 16,000 manufacturers 
originally contacted; we heard, from 4,100, you said that there 
are roughly 200 that you are chasing. That is 4,400. Clarify 
for me, if you will, where the other 12,000 are. Are they 
hospitals, doctors, what?
    Mr. Hubbard. Right, the numbers can get confusing. Our 
initial letter went to 16,000. There are about 13,500 device 
manufacturers; we added in, at the request of the White House, 
2,500 instrument manufacturers, so that the larger world of 
biomedical products would be covered, even though some of those 
are not devices that FDA regulates. Then, I think the important 
number is that about 2,000 are manufacturers of products that 
might have a date-dependency issue. Things like tongue 
depressors, obviously, aren't a problem, so they are in that 
16,000, but they are not a problem. They got a letter, but they 
either didn't write back or we don't care if they don't write 
back.
    Mr. Burr. Do we know all the medical devices that have a 
chip or software problem?
    Mr. Hubbard. Well, as I said, if you take the 2,000, 
roughly, that might have a date-dependency issue, we have heard 
from all but about 200 of those. So, it is those 200 that we 
haven't heard from we are trying to trace down. As I said 
earlier, they seem to be firms that aren't doing business here 
any longer, and they are not a problem, but we don't want to 
just assume that; we are continuing to try to find them.
    Mr. Burr. Based upon what we know today, how many medical 
devices have a potential chip or software problem?
    Mr. Shope. FDA does not, per se, have a list of all medical 
devices by make and model number. What we have are 
manufacturers who have gotten an approval for a particular type 
of device, one of our classification regulation types. We have 
1,700 classifications, different generic types of devices.
    Mr. Burr. Wasn't one of the recommendations of GAO that we 
track this based upon model serial number as far as the 
clearinghouse purposes of listing, so that people would know 
the classification?
    Mr. Shope. Right, we, in fact, have done that. We have 
gone--let me just make the point. We don't have this list of 
make and model because manufacturers design many different 
models, many different makes. So we don't have that list of 
inventory. What we have done, though, is look at the 
manufacturers that make the generic types of products that we 
think are susceptible to being computerized or having computer 
control, or having microprocessor control. It was that activity 
that identified the roughly 2,000 manufacturers that we wanted 
to focus on because they make the types of products that are 
likely to be susceptible, even though we don't know for a fact 
that each one of those has computerized their particular 
versions. There can be computerized and non-computerized 
versions of the same equipment. Our data base doesn't get to 
that level of specificity.
    So, to address this issue of specific information about 
products that could be vulnerable, we have asked the 
manufacturers, that same universe of roughly 2,000 
manufacturers, to give to us a list by make and model number of 
the devices that they have verified do not have a Y2K problem. 
And we are in process now of collecting that information.
    Mr. Burr. That do not?
    Mr. Shope. Do not have a problem. We already had 
information on the products that have problems.
    Mr. Burr. And there are how many that have a problem?
    Mr. Shope. We don't have that exact number. I can tell you 
that in our data base we have heard from roughly 310 
manufacturers that have described 800 or so products that have 
specific problems.
    Mr. Burr. So the number is, from the respondents so far, 
800-plus?
    Mr. Shope. Plus, and the plus is because we have 350 
manufacturers that haven't given us the list of problem 
products. They have posted it on their website, and we haven't 
enumerated those.
    Mr. Burr. And what was the deadline that the FDA gave these 
manufacturers for reporting this information?
    Mr. Shope. This is a voluntary effort, and we didn't give 
them a deadline. We asked them, as soon as you have finished 
assessing all of your products, because one of the issues here 
is that manufacturers with extensive inventory had to have 
assessed all their current and previously manufactured products 
that might be in use in order to submit this information, and a 
conclusive list of any product that could have a problem, and I 
think the rate of submissions of that have slowed down 
considerably around the first of the year.
    In March, we asked some of the manufacturers who hadn't 
given us sufficient detail to provide additional detail on the 
nature of the problems. So a hospital going to our data base 
would see, not just the product as non-compliant, but why it is 
non-compliant and how that would affect the functionality of 
the product.
    Mr. Burr. Does the FDA have any contact with hospitals 
relative to this list of 800-plus pieces of equipment that 
might or might not have a problem?
    Mr. Shope. I am not sure I understand your question.
    Mr. Burr. Well, I take it for granted that Mr. Hubbard's 
answer earlier that, in the 16,000 people contacted, that did 
not include hospitals or doctor's offices----
    Mr. Shope. No, that's just manufacturers' devices.
    Mr. Burr. My question is, now that we have identified 800-
plus possible devices that might have a date-sensitive or 
software-sensitive problem, has there been any correspondence 
from the FDA to hospitals saying, ``Here is what we have found 
so far.''? Or are we relying on hospitals to go into the 
website to look up this information?
    Mr. Shope. Right, we are making the website our mechanism 
of disseminating this information. I will add that the Health 
Care Financing Administration and several mailings to all of 
their practitioners and healthcare facilities have emphasized 
the need, not just to address their financial systems and their 
payment issues, but also their hospital equipment inventories, 
and have given the hospitals the reference of how to find the 
FDA data base and the kind of information that is there. So, 
there has been a lot of notification to hospitals about this 
issue.
    Mr. Burr. Does HHS look at HCFA as their conduit to 
hospitals and rural health clinics and community health centers 
and doctors' offices? Is that our line of communication?
    Mr. Hubbard. Well, certainly not solely; I think, in fact, 
that they have that conduit; that has been very helpful. But, 
as we said earlier, we have also tried a number of direct means 
through the press, mailings directly to physicians and others, 
articles in various professional journals that we know these 
people read and other things.
    Mr. Burr. Is there a primary part of HHS that is 
responsible for hospitals and community health centers and 
rural health clinics and doctors' offices?
    Mr. Hubbard. Certainly HCFA is in the sense of payments, 
and has regular contact with them and knows who they are and 
how to reach them. We do not; we do not regulate the practice 
of medicine or these facilities.
    Mr. Burr. Are we the first one to ask that question?
    Mr. Hubbard. I am sure that you are not.
    Mr. Burr. I see that my clock has run out, and I hope that 
we will be the last ones to ask the question of whose 
responsibility it is.
    And I will yield back.
    Mr. Upton. The gentlemen's time has expired. Dr. Ganske.
    Mr. Ganske. Thank you, Mr. Chairman.
    Dr. Shope, can you provide us with that list of 800-plus 
products?
    Mr. Shope. Yes, sir, that is on our website. It can be 
downloaded by any citizen that wants it, and we can provide it.
    Mr. Ganske. Okay. Please send that directly to my office.
    Now, we were having a discussion before where I think you 
were basically saying that a lot of this is equipment with the 
timer function related to readout data. Congressman Vern 
Ehlers, who I respect a lot on his knowledge on these issues, 
has pointed out that, for instance, with household appliances--
i.e., let's say thermostats that run off of computer chips that 
have timer functions, they don't necessarily have a year on 
your readout, but the chips that are in there may be older 
chips or chips that are not Y2K compliant. And he has 
speculated that there could be problems with the functioning of 
the rest of the chip if it is not Y2K compliant, even though 
you may not get the readout. Do you have any perspective on 
that?
    Mr. Shope. I think in our discussions with our design 
engineers about this issue, our conclusion is that we would be 
very surprised if a medical device designer inserted into a 
medical device, particularly a medical device that had any 
critical life-supporting, life-sustaining kind of 
functionality, that kind of a timing chip or device that was 
unnecessary to the design. So, I think this is an issue that 
has been speculated a lot about, but I have really no hard 
evidence that, in fact, is an issue.
    Mr. Ganske. Except for the fact that the hospitals that 
have done some of their own testing have shown that some of 
those devices that were supposed to be Y2K compliant are not.
    Mr. Shope. That's right, and to the ones that I am aware 
of, it has not been the kind of problem that you have just 
described. It was usually an oversight between a manufacturer 
and a parts supplier about a functionality for some accessory 
device used with the device, and missing the fact that there 
was a minor date issue there that needed to be addressed and 
didn't get addressed in the initial assessment.
    Mr. Ganske. Dr. Shope, I see that you are with the Center 
for Devices and Radiological Health, so I want to go to ask you 
a question specifically I think that is from Mr. Willemssen's 
testimony on page 4, where he talks about radiation treatment 
delivery devices using a radio isotope as a source and that an 
error in the calculation in the radiation source strength on 
the day therapy is to be delivered could result in a dose that 
is either too high or too low. Are you familiar with this 
particular device and potential problem?
    Mr. Shope. Yes, sir.
    Mr. Ganske. Could you describe that in a little bit more 
detail?
    Mr. Shope. Okay. Radiation treatment planning systems are 
basically software programs, or computer programs, and often 
they come with a workstation interface that the medical 
physicists in the hospital or the radiation therapists in the 
hospital use. These are programs that use imaging data that is 
acquired, either from something like a computer tomography x-
ray machine or a MRI scanner, where you delineate the patient's 
anatomy. You then take that information, import it into the 
computer program that plans the radiation treatment, and the 
radiation therapist, in consulting with the medical physicist, 
develops the plan for the direction of the radiation beams and 
the intensity of the beams and the number of them and frequency 
with which they will be used to treat a tumor volume and to 
spare radiation damage to the surrounding tissues. So, these 
are very complex calculational programs.
    This kind of therapy is typically delivered, for the most 
part, currently, by a device called a linear accelerator. That 
is a big machine; you turn on the switch, and it emits 
radiation or electrons, and you turn it off and it stops.
    There are some older versions of radiation therapy, 
however, that don't use an electronic means for the source of 
the radiation; they use radioactive isotopes. This is referred 
to as teletherapy when it is a cobalt-60 unit, which is a 
source of the radiation. You open the shutter, and let the beam 
out for the radiation.
    Another type of treatment is called brachytherapy, which is 
when the isotopic source is either inserted into the patient or 
applied directly to the patient. In either of those types of 
planning, if you are planning brachytherapy or teletherapy, one 
of the calculations that has to be made about the therapy is 
what is the strength of that radioactive source on the day you 
use it, compared to the day in which it was calibrated 
initially, which may be 6 months ago. And so there is a date 
calculation involved. Some of the earlier versions of software 
that incorporated brachytherapy or teletherapy features for 
planning that kind of therapy did, in fact, use two digits to 
represent the year. So this calculation of source strength on 
the day of use could be an error, if that wasn't corrected.
    There were products on the market that did that 
incorrectly. The manufacturers have identified those, and have 
either said, this is the upgrade, the software fix needed to 
address that issue, or this product is so old, there are so 
many new features in our current version of product, that we 
aren't going to upgrade the old product; we suggest you buy a 
new replacement. In fact, the Department of Veterans' Affairs, 
I think, had seven of those types of systems that they had to 
replace, at no small expense. But they chose to do the 
replacement.
    Mr. Ganske. Do you know where all of those machines are?
    Mr. Shope. No, sir. These are software programs that are 
purchased by hospitals.
    Mr. Ganske. Right. So you do not know, then, whether the 
hospitals that have those software programs have received data 
warning them of that?
    Mr. Shope. No, sir, we don't have specific knowledge of 
that.
    Mr. Ganske. So, it is possible, then, that on January 1, 
2000 a patient could get an inappropriate calculation?
    Mr. Shope. If the hospital has paid no attention to this 
issue and ignored all of the information that has been 
presented, I have to----
    Mr. Ganske. And what would be the consequence of a patient 
receiving an overdose?
    Mr. Shope. It could be either an overdose or an underdose; 
one would be----
    Mr. Ganske. Underdose, they don't get treated enough.
    Mr. Shope. Complications to the therapy used.
    Mr. Ganske. Could a patient die if they get an overdose?
    Mr. Shope. It depends on the level of the overdose, sir.
    Mr. Ganske. Possible?
    Mr. Shope. It is certainly possible.
    Mr. Ganske. Thank you.
    Mr. Upton. Thank you. We will go to a second round for 
those that have additional questions, and I do have one.
    You know, when I think about my own purchase habits, 
whether it is a gas grill, or certainly an automobile, even an 
alarm clock, you get a little warranty card and they ask for 
your name and address, and if something is wrong, I suspect 
that they come back to you. The fact is that I have had 
problems with even seatbelts and that type of thing; I hear 
back from the manufacturer, and when I take that car back in to 
the facility, it is on record there, so if I happen to forget 
that was a cause, then they remind me and they take care of it.
    Is there any such, when you talk about the 800 devices that 
are, in fact, could be a problem with the date, is there any, 
other than checking the website--and I appreciate that, and we 
are going to get that information out to my providers in our 
State for sure--but is there any way that the hospital would 
hear or that the provider would hear directly from the 
manufacturer that their product is on that list of 800 
products, directly from the manufacturer versus them taking the 
initiative?
    Mr. Shope. Yes. There has been a tremendous amount of 
communication from manufacturers to their purchasers, 
particularly for products that the manufacturer has identified 
as being non-compliant. We can't say 100 percent that every 
manufacturer of every one of those 800 products has mailed a 
letter to each one of their purchasers, if they know them. But, 
I think manufacturers have a very large interest in 
communicating with those purchasers. If it is known that a 
purchaser has a product that needs replacement, it certainly 
makes a lot of good business sense that the company would want 
to be there and be involved in that purchaser's mind about 
replacement activity. So, I think the original manufacturer has 
lots of incentive to communicate to their purchasers problems 
about products they may have in the past purchased. This is a 
very common activity.
    Mr. Upton. So, to your knowledge, what would you say, 90 
percent, a 100 percent of the providers have been contacted if 
they are on the list of 800?
    Mr. Shope. I couldn't put a number on it, sir. But, I think 
it is not uncommon. You might ask the representative from the 
manufacturers about this. But, I think the vast majority of 
manufacturers do communicate with their customers about these 
issues.
    Mr. Upton. But, probably not 100 percent?
    Mr. Shope. No, sir.
    Mr. Upton. Okay. Mr. Brown.
    Mr. Brown. Dr. Shope or Mr. Hubbard--Dr. Shope, you 
mentioned, in response to a question I believe from Mr. Burr--I 
am not sure--that you had some information on which specific 
companies have Y2K problems. Talk through that again. I mean, 
the overall feeling that I am getting from this hearing is 
neither of you, Dr. Shope or Mr. Hubbard, seems real concerned 
that there is any significant problem here yet. When I hear 
some of your answers to which companies, how many companies 
making how many products, have problems, I am a little 
concerned. So, run through. Does the FDA have a list of medical 
equipment, one, that presently has a Y2K problem; second, 
presently has a Y2K problem that might actually be life-
threatening? Tell me what you know about that.
    Mr. Shope. We have two kinds of information about products 
with problems. We have the information that the manufacturers 
have voluntarily provided to us, and that is posted on our 
website. That is currently on the order of 900 specific 
products.
    Mr. Brown. That is some 300 companies, you said?
    Mr. Shope. Yes. The second kind of information is 
information from roughly 350 companies that are posted on their 
own websites. I can't say that I have looked at every one of 
those companies, but I have reviewed a large number of that 350 
to see what kind of information is there, what kind of products 
are being described, what the nature of the problem is. I have 
also looked at our own website, probably when the number was 
more like 600, instead of 800, and gone through that list and 
looked and tried to gather some impressions of the kind of 
products that were there, the nature of the problems, and 
whether any of those presented a very significant risk.
    There are a few products there that one would be concerned 
about if the hospital didn't take action. The vast majority of 
them are date display or recording in a way that, I think, 
would be rather insignificant in terms of patient-immediate 
impact. It could lead to some potential confusion and hospital 
records later on and after the fact. Is that----
    Mr. Brown. That is the start. Can you tell me, can you tell 
these subcommittee, No. 1, how many companies there are that 
have not reported to you--you have looked at their website 
perhaps--but how many there are that haven't reported to you 
and how many products those companies make and how many of 
those products might be life-threatening?
    Mr. Shope. We can do some arithmetic. We certainly know, of 
our original estimate of roughly 2,000 companies, there are 
less that 200 that we haven't heard from, and we don't expect 
that they are manufacturers of any significant volume in that 
sample. We have not gone and done an individual company-by-
company comparison to see what kind of product those non-
responding companies make. However, that is something that is 
on our plate to take a look at as we continue our effort to 
analyze this information.
    We don't have a list of the products manufactured by every 
company by make and model. We just don't have that information.
    Mr. Brown. Don't you need that? Some of them might be life-
threatening perhaps.
    Mr. Shope. We can identify by manufacturer if they make a 
life-threatening-type product. We are currently developing that 
list of manufacturers which would be the focus of our extensive 
follow-up effort that we are talking about here.
    Mr. Brown. Mr. Willemssen, what should they be doing?
    Mr. Willemssen. Well, I want to express one caveat to some 
of the numbers that have been discussed. That has to do with, 
as of May 10, we show that for about 420 manufacturers, FDA 
relies on their web sites to provide information on non-
compliant products. Usually those manufacturers are larger 
companies. So in terms of the number of 800 or 900 devices that 
are non-compliant, the actual number is significantly higher 
than that.
    For example, I went on the web site this morning and pulled 
up one company, and just within the digital imaging sub-systems 
area of that one company, it listed 11 products with a Y2K 
issue. So I want to caution you on the numbers that have been 
discussed, that the numbers are probably, quite a bit higher, 
because we haven't been talking about all of these web sites 
that give you an avenue into another whole wide range of 
products.
    Mr. Brown. Isn't this a pretty serious problem? There are 
400 companies on the website; you have spent some time looking 
at one and found 11 products. I mean, obviously, you don't 
necessarily multiply 400 by 11, but you have a significant 
number, some of them probably, life-threatening. Don't we need 
to know a lot more than what we know?
    Mr. Willemssen. That is why we agree with what FDA is doing 
now. You have got to have a list of critical care and life 
support items and, based on that list, take the additional 
actions that we have talked about earlier. We think that is a 
step in the right direction.
    Mr. Brown. How do you define critical care? Does FDA define 
it? Do you define it? What do you mean?
    Mr. Willemssen. I would rely on Dr. Shope's medical 
expertise to come up with that definition, but during the 
course of work it is clearly something that has come up. Our 
overriding criterion is patient safety and where that patient 
safety can be degraded because of a Y2K issue in a biomedical 
equipment device. We feel that needs to be addressed.
    Mr. Brown. Okay. Thank you, Mr. Chairman.
    Mr. Upton. Mr. Bilirakis?
    Mr. Bilirakis. Well, and I really planned to go into this 
with the next panel, too, but we have asked a lot of questions, 
and of course, a lot of statistics have been thrown out and 
that sort of thing. How difficult would it be for the Congress, 
for this committee, to receive the hard data supporting some of 
the statements that you have made and some of the responses 
that you have given us, Dr. Shope? I mean, you know, the 
particular companies that you have contacted and communicated 
with; the critical medical devices associated with those 
companies, things of that nature. I mean, is that something 
that is available that you could just push a button and, in 
effect, give us a copy of all of that?
    Mr. Shope. Certainly, the data that is on our website is 
available in that fashion. We are continuing to work on our 
list of these, what we call, high-risk devices, and we expect 
to complete that list very shortly. We will use that list, 
then, to identify the manufacturers of those types of products. 
So, any of the information that we have with regard to what we 
know about manufacturers is certainly available. It would be 
difficult to produce lists of the products that are on the 
manufacturers' websites. We haven't downloaded that 
information.
    We have to go back and look at the intended purpose of this 
website, initially, which was the outgrowth of a joint Federal 
agency activity to determine which products would have negative 
impacts from the year 2000 and how to get information out to 
the Federal purchasers and to the public purchasers of that 
equipment. The website was seen to be a convenient method for 
doing that. We relied on manufacturers to voluntarily provide 
this information because we didn't have a regulatory authority 
or regulation on the books that would require that kind of 
information to be provided to us.
    Mr. Bilirakis. You know, Doctor, with all due respect, I 
really don't feel any better about everything. You know, you 
and Mr. Hubbard flat out said that you feel that we will be 
ready, insofar as the medical devices are concerned, insofar as 
the FDA jurisdiction area is concerned. But you can't be very 
much help, apparently, as far as hospitals are concerned, the 
use of those devices, so to speak, down at that level. And 
again, how in the hell did we get ourselves into this kind of a 
situation, knowing darn well that the year 2000 was coming, et 
cetera, et cetera?
    You have enough to know, and I don't want to add anything 
additional to your workload, when you can better be using your 
time getting ready, rather than giving us any of this hard 
data. And I don't know, Mr. Chairman, whether getting that hard 
data would be of any consequence as far as help is concerned to 
this subcommittee. Maybe we can talk about that rather than 
request it now; we can always request it if we feel that it 
would be.
    But, Mr. Willemssen, you have been kind of chomping at the 
bit when Mr. Burr was asking you a question, and Dr. Ganske. Is 
there anything more that you want to add? I just want to kind 
of give you the rest of my time.
    Mr. Willemssen. The issue that I was concerned about was 
when some of the numbers were being discussed, and I wanted to 
make sure there was some context for those numbers, and that 
the numbers that weren't talked about were all of those items 
on large companies' web sites, which increases the number 
exponentially. So, I just wanted to make sure that item was out 
on the table.
    Mr. Bilirakis. Yes, sir, Doctor.
    Mr. Shope. I just make the comment, the fact that those 
items are on the manufacturer's website normally means the 
manufacturer has assessed that product; he has looked at the 
vulnerability of that product, and he has provided the solution 
for that product, or a description of what kind of solution he 
is going to provide for that product. So, I think one needs to 
know that piece--I think the concern that may still be there 
is, how well has the manufacturer done that? That is the kind 
of thing that we depend on our quality system for and our 
potential follow-up activities to address and get some 
additional assurance.
    Mr. Bilirakis. Thanks, Mr. Chairman. I still don't really 
feel very good about it.
    Mr. Upton. Well, make sure you get the end-of-the-year 
checkup.
    I would just like to note, for those in the audience that 
those that don't have the testimony, that the website is 
www.fda.gov.
    Mr. Bryant, do you have additional questions?
    Mr. Bryant. Just a couple of quick questions. I hope that 
they have quick answers.
    I know all of you have been working very diligently trying 
to assess this situation and remediate it, but I am still 
unclear--there appear to be some 200 to 400 people out there 
who have manufactured medical devices that have not responded 
to this survey. Am I understanding your testimony, that the FDA 
is going to be more aggressive in contacting these people, 
affirmatively contacting them, to determine if they are 
bankrupt, if they have merged, if they have disappeared, but 
trying to get together this information?
    Mr. Hubbard. That is right, Mr. Bryant. We have been doing 
that. Our contractors are trying to find them, call them, 
whatever way we can contact them, to find out if, in fact, they 
still exist, if they are still manufacturing medical devices, 
if those medical devices are being sold in the United States or 
exist anywhere in the United States. You know, our suspicion 
is, as I said, that they are perhaps not marketing products any 
longer; they are foreign companies that planned to market here, 
never did, or companies that have gone out of business, or such 
things as that. We think the vast majority of manufacturers we 
have been able to find and asked the questions and gotten the 
answers. But, we are not giving up on those 200, either; we are 
continuing to look for them.
    Mr. Bryant. Are you trying to get help from the hospitals 
and the doctors and the people who----
    Mr. Shope. We haven't pursued that kind of assistance to 
locate these manufacturers. It usually works the other way 
around. We hear from the hospitals, ``Can you tell me how to 
find this manufacturers,'' as opposed to, ``I found one for 
you; here he is.'' I think a comment needs to be made about the 
source of our list of manufacturers. That comes from our 
registration and listing data base, and that data base 
oftentimes can have in it people who are no longer in business 
at the time that we use that address list, people who had an 
intention when they registered with us that they were going to 
go into business, but that never came to fruition, people who 
maybe submitted a pre-market submission, but, for one reason or 
another, had a clearance for a product but never took that 
product to market. So there are a lot of business kinds of 
problems that arise that prevent someone who actually 
registered and listed with us from continuing in business.
    I suspect the large number of the ones that we are trying 
to track down now are that type of company that really never 
brought a product to market. The other issue is that they may 
have a product that they brought to market, but it my not be a 
computerized device. It got flagged because they make an 
accessory or supply used with the computerized device. So, when 
we ask them about computerized device status, they have no real 
incentive to respond to us.
    In fact, just a couple of days ago, I got a list of 20 
companies that our contractor had tried and failed on three 
different occasions to try to contact. We will now take that 
list and see if there are any products that we can associate 
with any of those companies that would raise concern. If not, 
we will have to say this is a list of 20 that we are writing 
off as non-contactable and products of non-concern.
    Mr. Hubbard. So, if it is any consolation, Mr. Bryant, it 
is unlikely that these manufacturers, if they exist at all, are 
making any large number of products where there is a very large 
problem. But, again, even if there is a small problem, we would 
like to track them down.
    Mr. Brown. Okay. Mr. Willemssen, do you have any comments.
    Mr. Willemssen. One thing that I would add related to that 
is to the extent that, if FDA cannot get that information, then 
they need to consider publicizing that list of non-respondents 
on its web site, so that hospitals are aware of who those 
manufacturers are, and if they have equipment from those 
manufacturers in their inventory, they will want to think twice 
about whether to use it or not.
    Mr. Brown. Very good. Thank you.
    Mr. Upton. Dr. Ganske? Okay. Mr. Burr.
    Mr. Burr. Thank you, Mr. Chairman.
    Let me ask you, Mr. Hubbard, somebody earlier asked about 
the possible 510(k)'s that were in process now.
    Mr. Hubbard. Right.
    Mr. Burr. What process do you go through to assure of 
compliance?
    Mr. Hubbard. I will have to ask Dr. Shope to answer that.
    Mr. Burr. Okay. Dr. Shope.
    Mr. Shope. The process for 510(k), and basically for 
software products, they are very similar between a 510(k) and a 
pre-market approval application. That is, the manufacturer, if 
they are making a computerized device, will provide to us, 
based on what we call our level of concern or the level of risk 
that device could present to a patient, varying levels of 
information and documentation about the software development 
process used in developing that device. What we would see are 
artifacts of that software development design process, such 
things as the overall description of the design process, the 
types of verification and validation activities the 
manufacturer undertook, and perhaps some sample test records 
and test data for the very-high-risk devices. That comes in as 
part of the application and is reviewed by the pre-market 
reviewer or sometimes by some of our software specialists. It 
is not a line-by-line review of the code.
    Mr. Burr. In your estimation, is it possible for a device 
that is non-compliant to be approved today?
    Mr. Shope. It is probably possible if a manufacturer makes 
a good case to us that, ``I have been working on this product 
for 2 years.''
    Mr. Burr. The manufacturer makes the case that it is 
compliant, and in fact, the product is not compliant in some 
fashion?
    Mr. Shope. Certainly, that is possible. Our review process 
is not foolproof.
    Mr. Burr. You mentioned earlier, Mr. Hubbard, resources.
    Mr. Hubbard. Yes, sir.
    Mr. Burr. I won't dispute it with you. I will only ask, did 
the FDA make a line-item request in the 1999 budget for 
specifically the compliance resources needed for this?
    Mr. Hubbard. Well, what we have done, Mr. Burr, is I 
believe Congress appropriated a sum of funds for Y2K across the 
administration as being the funds that have been managed by the 
Office of Management Budget at the White House, and agencies 
have gone to that, to the OMB, for specific Y2K-related 
activities. We have done so for our internal systems correction 
and had some money funded. We have done some of our emergency 
response process, so to have our field prepared if problems 
occur later in the year, and there has been funding for that. 
We are preparing now to survey drug and device manufacturers to 
ask more questions about the compliance.
    Mr. Burr. So, you do have sufficient resources?
    Mr. Hubbard. Well, certainly funding is coming. The 
activity we describe today has not been funded, and we will 
have to go back to the OMB and ask to release some of those 
funds for that activity.
    Mr. Burr. But, you have never made a line-item request from 
Congress for money for compliance?
    Mr. Hubbard. Not to my knowledge, but, again, because there 
was this money appropriated by Congress for all of the agencies 
across----
    Mr. Burr. How about in the 2000 budget, even though that 
doesn't kick in until extremely late in the year; there wasn't 
a specific line item in the request?
    Mr. Hubbard. Again, I think the reliance has been on these 
funds already appropriated, Mr. Burr.
    Mr. Burr. May I ask you--let us assume for a minute that 
you ID an non-compliant device. What happens?
    Mr. Hubbard. Depending on the risk, obviously, if we found 
one today, we would be advising the manufacturer that they need 
to do to make it compliant. We have the authority, if we 
believe that device poses a risk to health and could fail some 
way, we have authority to have it seized or the manufacturing 
might be stopped, or to have it recalled if it is out in the 
marketplace.
    Mr. Burr. How do you go through that market recall?
    Mr. Shope. The market recall process is in section 518 of 
the act.
    Mr. Burr. No, I am asking specifically, what process kicks 
in where you ask or request the recall? The actual products to 
go back to the manufacturer to be pulled off of the market, not 
to be used, what process does the FDA go through?
    Mr. Shope. We would be working with the manufacturer to 
identify purchasers of those products.
    Mr. Burr. Manufacturer would supply you with the list of 
people that purchased?
    Mr. Shope. Yes, sir. I am not an expert on these 
compliance-type operations. So, I am getting into unknown 
territory from my personal knowledge to describe this 
compliance activity.
    Mr. Burr. I hope you understand, what I am trying to 
determine is, to what degree do we search for the relevant 
information when we identify we have a potential health risk in 
the marketplace versus what are we doing now with our ability 
to identify equipment that may or may not have a Y2K compliant 
problem? It seems like the two processes are significantly 
different. Would you agree?
    Mr. Shope. I am not sure I can compare the processes.
    Mr. Burr. Well, let me put it this way: Have we in any of 
the Y2K-compliant activities at FDA sought from the 
manufacturer every location that purchased a specific device 
and contacted to say, ``You purchased this. We understand it is 
non-compliant to Y2K. We would advise you to go through this 
process.''?
    Mr. Shope. No, sir. We haven't done that because I think it 
is a little premature for that decision. What would be 
happening now would be manufacturers----
    Mr. Burr. How close to January 1 do we get before it is no 
longer premature?
    Mr. Shope. I think it has to be pretty close if the 
manufacturer is working on a fix and is going to make that 
available.
    Mr. Burr. Define ``pretty'' for me, because I need to know 
at what time do we cry ``wolf'' and start notification, and how 
long does it take you to notify?
    Mr. Shope. I can give you a personal view here. If it is 
after October 1 and we come across a device that could present 
a significant risk to patient health, and the manufacturer 
hasn't taken the appropriate action to make a solution 
available, I think we would get very engaged with that 
manufacturer about his intentions.
    Mr. Burr. Now, let me ask you, because there is still a 
discrepancy today about whose responsibility it is about 
oversight, can I safely assume there are some non-compliant 
devices in hospitals and non-compliant devices in doctors' 
offices?
    Mr. Shope. Yes, sir.
    Mr. Burr. Private homes?
    Mr. Shope. Possibility.
    Mr. Burr. Okay. There is still a disagreement over whose 
primary responsibility it is for hospitals, doctors' offices, 
and I don't even think we have discussed private homes. Who 
will take the lead if we get to October 1, you identify a piece 
of equipment or several pieces of equipment, the alarm goes 
off, who takes the primary lead on hospitals? You, HCFA, who?
    Mr. Shope. I think the realistic scenario would be, if 
there is a product that has a problem that is not being 
appropriately addressed and it rises to the level, we could do 
a mandatory recall-type activity. Typically, before we get to 
that level, the manufacturer has exercised the voluntary recall 
and has notified purchasers and had that product removed--
either a product withdrawal or some kind of voluntary recall, 
offering a solution or an alternative to that solution.
    Mr. Burr. Mr. Chairman, could I ask for unanimous consent 
for 2 additional minutes?
    Let me skip over to the in-home use. Has FDA determined the 
amount of time it would take, once you have requested of a 
manufacturer to contact every person who had a specific non-
compliant devices if it were in people's homes, how long would 
it take a manufacturer to go through the process of 
notification and for the FDA to receive assurances that 
everybody had been contacted and that these devices had been 
taken care of? Is that something that you feel could be done in 
90 days?
    Mr. Shope. It is a little bit beyond my expertise, but I 
suspect that a critical-type device like that manufacturers 
could do a reasonable job of identifying and providing 
information in a 90-day timeframe.
    Mr. Burr. So, the likelihood is that they would have to 
contact a distributor of medical devices or something, who then 
sold that or has it out on rent or loan or something to an 
individual, and that whole chain is going to work, and they are 
going to contact that individual and have all of that 
information back in a 90-day timeframe? Do you feel like that 
is possible?
    Mr. Shope. I am a little beyond my expertise here in terms 
of how fast these compliant recall-type activities work. I am 
sure we can provide some information on that.
    [The following was received for the record:]

    FDA routinely oversees recalls of all products regulated by the 
Agency under its voluntary recall authority, and, less frequently, has 
required recalls of medical devices under the authority of the Federal 
Food, Drug and Cosmetic (FD&C) Act. The Agency's recall authority 
provides FDA with a highly effective and expeditious means of 
protecting the public from potentially harmful products. The length of 
time the entire recall process takes can vary widely based on the 
device and the extent to which it has been distributed.
    Although the ultimate goal of any recall is to repair a dangerous 
product or remove it from distribution, the primary public health goal 
of the recall authority--halting the use of a product that poses a 
health risk--can be accomplished during the initial stages involving 
notification and publication of information concerning the device. 
Under the mandatory recall requirements, the individual or firm to whom 
FDA issues the order must immediately issue notifications and 
instructions to cease use. This is accomplished through directed 
notification to the manufacturers, distributors, purchasers, etc., and 
also through press releases. These actions ensure that health care 
workers can make informed decisions about patient care.
    FDA's mandatory recall authority is reserved for medical devices 
that pose a high degree of risk to the public health. Section 518(e) of 
the FD&C Act requires that the Agency first order an appropriate 
individual to issue notification of the risk of the device to user 
facilities and health professionals, along with instructions to cease 
use of the device. The appropriate individual is the individual most 
well-situated to locate the device and contact those responsible for 
its use. This person frequently will be the manufacturer, although FDA 
may use its authority under 518(e) to impose orders on distributors, 
importers, or other individuals the Agency determines are best able to 
respond to the requirements of the order. Most mandated notifications 
can be completed within 48 hours.
    The procedures under FDA's voluntary recall regulation are more 
flexible. Under its procedures for voluntary recall, the Agency can 
work with manufacturers to initiate a variety of actions, including 
notifications and recommendations concerning discontinuation or 
modification of use of the product. Voluntary recall procedures are 
available for all levels of product risk.
    The length of time it will take to remedy the device or remove it 
from distribution will depend on the number of devices in distribution 
and other factors; FDA cannot predict this time period in the absence 
of a particular set of facts. FDA'S mandatory recall regulations, 
however, provide authority for the Agency to respond with immediacy to 
serious threats. Although the mandatory recall regulations require that 
FDA provide an opportunity for a hearing before amending a notification 
order to include recall, the preamble to the regulation makes clear 
that FDA may issue its notification order, hold its hearing, and amend 
the order to require recall all in a single day when the public health 
requires immediate action. 61 FR 59004, 59007 (November 20, 1996). Only 
an extreme risk would dictate such an urgent response. FDA's recall 
authority was designed to empower the Agency to respond with Urgency to 
significant health threats. FDA anticipates this authority will enable 
the Agency to control health risks it identifies by October 1, 1999, 
(or an earlier date) within 90 days.

    Mr. Bilirakis. If the gentleman would yield?
    Mr. Burr. Yes, back to you.
    Mr. Bilirakis. So this gets back to your ``pretty close,'' 
``pretty close'' point, Doctor. The discussion here is 90 days, 
and I guess I am not sure where the 90 days came from; maybe I 
wasn't paying attention. I was ordering something to eat.
    Mr. Burr. There is a lead time in any case, particularly if 
we are going to go to the private homes.
    Mr. Bilirakis. And that sort of thing--I don't know, I hope 
we are not really making a mountain out of a molehill here. I 
think it is just significant that we not leave anything 
unlooked at. But keeping in mind the timeline, you know, there 
is a period of time here for recall and getting into the 
private homes and getting into the hospitals, et cetera, et 
cetera. When you say, ``pretty close,'' what are we talking 
about there? You are certainly not talking December, are you? 
Are you talking December or are you talking November or are you 
talking October? October is 30 days; September is really 30 
days.
    Mr. Shope. I think we would be wanting to have some good 
understanding of the situation by October 1 in order to be 
realistic about taking care of a significant problem. I would 
like to add that I have a very hard time thinking about a 
device used in the home that is date-dependant in a way that it 
would present a significant risk to the patient. There are 
blood glucose monitors that are used in home use, and some of 
those do trending of readings, and there is a potential for 
problems there with some models of that type of device. But, I 
am hard-pressed to think of other products used in the home 
where a date functionality is critical to the use of the 
device. But, that is not to say there may not be something.
    Mr. Burr. Doctor, have we ruled out every implantable 
device possibly having a Y2K-compliant problem?
    Mr. Shope. We know of no implantable devices that have Y2K-
date dependencies.
    Mr. Burr. I appreciate the answer, but I asked it in a 
different way. Are we assured that there are no implantable 
devices that might have a Y2K problem?
    Mr. Shope. I am not sure that I can answer it in any other 
way than the fact that we are not aware of any product like 
that. We have been in touch with the manufacturers of such 
things as pacemakers, implantable infusion pumps, implanted 
defibrillators. It just doesn't make sense to design those with 
an unneeded date dependency. And none of those products work in 
a way that requires them to have knowledge of the date. Those 
things use timing circuits, but when they use timing circuits, 
they are using a register counting oscillations of a 
oscillator. It is the external device that maybe interrogates 
that device that adds the date-time type of information to the 
record that it brings out from that device.
    Mr. Burr. Well, I thank all of you. This has been 
enlightening. Just as a personal observation, I think we still 
have quite a bit of work to do. I don't think that I would find 
disagreement from any of our panelists. I would also urge my 
colleagues that we, as a committee, try to work with the FDA 
and with all the agencies that have some oversight. I would 
encourage the FDA to encourage HHS to draw a little clearer 
lines of responsibility as it relates to hospitals and rural 
health centers and doctors' offices. I think it is important 
that at least that question have an answer versus to pass it 
off on the manufacturers. It may be their responsibility. If it 
is, then let us make sure that we clearly communicate it. If it 
is not, let us make sure that we know which arm of the Federal 
Government is going to be responsible for notification.
    I yield back.
    Mr. Hubbard. We will follow up on that, Mr. Burr.
    Mr. Bilirakis. I would hope, Mr. Chairman, if I may, I 
would hope that we get our heads together and schedule another 
hearing, maybe like in September, something of that nature, as 
we get closer to these timelines.
    Mr. Upton. I think that would be a very good idea.
    If no other members have questions----
    Mr. Brown. I would just add, thank you, Mr. Chairman. If we 
do another hearing in September, as Chairman Bilirakis 
suggests, and we do find ourselves continuing to give more 
responsibility and expect more responsibility to and expect 
more from the FDA, that we look at their funding also. That is 
something that, at least, we should consider because Mr. 
Hubbard's comments on the technical expertise, in response to 
my question, sound like partly a paucity of resources, in 
addition to a lack of technical expertise. I think we should at 
least consider that in an emergency situation, if it comes to 
that.
    Mr. Upton. Thank you. Panel, you are excused. Thank you 
very much for your testimony, and you may be getting some 
questions further down the road from us as well.
    Our next panel includes Mr. Kent Smith, who is the global 
project manager of Baxter Health Care Corporation. He is the 
spokesperson for the Health Industry Manufacturers Association, 
HIMA. Mrs. Noel Brown Williams, senior vice president at 
Columbia HCA Health Care Corporation, spokesperson for the 
Federation of American Health Systems. And Mr. John C. Nunn, 
vice president for patient care services from Henry Ford 
Hospital, representing the American Hospital Association.
    We are delighted that you are here this morning, and we 
appreciate you listening, certainly, to the first panel. And as 
you heard me say to the first panel, we have a long tradition 
in the Oversight and Investigations Subcommittee of taking 
testimony under oath. Do you have any objection to that?
    [No response.]
    Seeing none, also, under House rules, you are allowed to 
have counsel, if you prefer that. Do you have a need for a 
counsel?
    [No response.]
    Then if you would stand and raise your right hand?
    [Witnesses sworn.]
    You are now sworn in, and as we did with the first panel, 
your entire statement will be made part of the record. If you 
would like add or summarize, but try and observe the 5-minute 
rule, that would be terrific. We will start with you.

  TESTIMONY OF KENT T. SMITH, GLOBAL PROJECT MANAGER, BAXTER 
   HEALTHCARE CORPORATION, ON BEHALF OF THE HEALTH INDUSTRY 
  MANUFACTURERS ASSOCIATION; NOEL BROWN WILLIAMS, SENIOR VICE 
 PRESIDENT, COLUMBIA HCA HEALTH CARE CORPORATION, ON BEHALF OF 
 THE FEDERATION OF AMERICAN HEALTH SYSTEMS; ACCOMPANIED BY DON 
  WORKMAN, COLUMBIA HCA HEALTH CARE CORPORATION; AND JOHN C. 
  NUNN, VICE PRESIDENT FOR PATIENT CARE SERVICES, HENRY FORD 
    HOSPITAL, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION

    Mr. Smith. Thank you, Mr. Chairman. As mentioned, I am the 
chairman of Baxter Healthcare Corporation.
    Mr. Bilirakis. Will you pull the mike closer?
    Mr. Upton. Yes. Pull the mike up a little bit closer.
    Mr. Smith. That is the first time I have ever heard 
somebody tell me I couldn't speak loud enough, by the way.
    I am the chairman of Baxter Healthcare Corporation's 
committee on the year 2000. And just for your information, 
Baxter is a global medical products and services company that 
provides critical therapies for patients' life-threatening 
conditions. I am very pleased to testify today on behalf of 
HIMA and the medical device industry's Y2K readiness.
    The device industry shares the concern of healthcare 
providers and patients regarding the year 2000 date problem. 
Over the past year, HIMA has stepped up the challenge and 
worked effectively with the FDA, the Veterans' Administration, 
and the National Safety Patients' Partnership, as well as 
others, to identify critical issues, communicate Y2K 
compliance, and ensure patient access to safe and effective 
devices on January 1, 2000.
    To date, HIMA members are at different levels in their Y2K-
compliance process. Most are now focused on the Y2K business 
contingency planning process. And I want to emphasize the point 
that all HIMA members have a year 2000 process in place today. 
On device compliance, HIMA has worked closely with the FDA and 
the Veteran's Administration to ensure the FDA's year 2000 
clearinghouse is an effective central data base for Y2K device 
compliance information.
    HIMA has also ensured a 100 percent response rate from its 
800 member companies who manufacture 90 percent of the devices 
sold in the country in the US. They communicated with 6,000 
non-member companies, urging them to respond to the FDA to 
ensure their devices were Y2K compliant, which we have heard 
from. They have made phone calls to non-HIMA member companies 
who did not respond to the FDA or the VA request for this 
information. And they have sponsored advertisements with the 
FDA and the VA in industry trade magazines, urging companies to 
respond to the FDA request on the Y2K status information. So, 
in summary, I believe the device industry has risen to the 
challenge of coordinating and effectively communicating the 
medical device industry's progress toward Y2K compliance, 
though we still have some work to do.
    As a window into the activities of a large company with a 
diverse product line, let me quickly highlight elements of 
Baxter's comprehensive Y2K program which have been in place 
since early 1997. Our product compliance checking is complete, 
and it identified fewer than 20 products with Y2K issues. 
Modifications and replacements for these products will be 
complete by mid-1999. Information regarding our Y2K-compliance 
status and implementation solution has been available since 
December 1, 1998. We have sent out over 30,000 compliance 
letters to customers worldwide, describing product issues and 
the process for implementing product fixes.
    To evaluate our suppliers, we have required each supplier 
to communicate its Y2K compliance. We have over a 95 percent 
response rate to questionnaires sent to 7,000 critical 
suppliers. We are conducting face-to-face as well as telephone 
audits with these targeted suppliers.
    With respect to our manufacturing plants, 80 percent of our 
manufacturing and facility systems have been fixed. 
Implementation will continue through the mid-part of this year 
for that piece. And finally, we have a very extensive business 
contingency planning process in place for all of our businesses 
and regions around the world, focused on customer 
communication, human resource planning, and inventory 
management.
    With respect to contingency planning that I just mentioned, 
I participated in a HIMA-wide teleconference to educate the 
other HIMA members on Y2K contingency planning. And while these 
are a normal course of business, in this particular case, we 
happen to know when the year 2000 transition will occur, and so 
it is easier to plan from a contingency planning perspective.
    HIMA has now turned its attention to the serious issue of 
potential or provider stockpiling, if you will, or provider 
hoarding. As a member of the healthcare sector of the 
President's Council on the Year 2000 Conversion, HIMA is 
working with the American Hospital Association, the Health 
Industries Distributors Association, the FDA, HCFA, and others 
on a White House-sponsored roundtable on hospital supplies to 
be held in early June.
    In closing, we are encouraged by the progress of our 
industry in achieving Y2K readiness. However, we cannot achieve 
success alone. The government must play an integral role in 
helping the diverse and segmented healthcare sector coalesce in 
responding to Y2K. You can help us by supporting any consensus 
that is developed in the forthcoming White House roundtable. In 
so doing, you will help every patient in America. Working 
together, we can assure patients that the healthcare sectors 
will continue to provide value and safety into, during, and 
beyond January 1, 2000.
    And obviously, I would be glad to take any questions you 
may have.
    [The prepared statement of Kent T. Smith follows:]]
  Prepared Statement of Kent T. Smith, Chairman, Year 2000 Committee, 
    Baxter Healthcare Corporation On Behalf of the Health Industry 
                       Manufacturers Association
    My name is Kent Smith. I am Chairman of Baxter Healthcare 
Corporation's Committee on Year 2000. Baxter is a global medical 
products and services company that provides critical therapies for 
patients' life-threatening conditions. The company's products and 
services in blood therapies, biopharmaceuticals and blood collection, 
separation and storage devices, cardiovascular medicine, medication 
delivery and renal therapy are used by health care providers and their 
patients in 112 countries.
    I am pleased to testify today on behalf of the Health Industry 
Manufacturers Association (HIMA) on the status of the medical device 
industry's Year 2000 readiness. HIMA is a Washington, D.C.-based trade 
association that represents more than 800 manufacturers of medical 
devices, diagnostic products, and medical information systems. HIMA's 
members manufacture nearly 90 percent of the $62 billion in health care 
technology products purchased annually in the United States and more 
than 50 percent of the $147 billion purchased annually around the 
world. As such, HIMA is the largest medical technology trade 
association in the world.
    The medical device industry recognizes and shares the concerns of 
health care providers, patients, and the general public regarding the 
possible effects of the Year 2000 computer date problem. The American 
medical technology industry has built a reputation for leadership and 
excellence that is recognized worldwide. It goes without saying that 
the health and safety of patients constitute the paramount concerns of 
our industry.
    Over the past year, I believe that the device industry has stepped 
up to the challenge and has worked closely and effectively with key 
constituencies including the FDA, the Department of Veterans' Affairs, 
the National Patient Safety Partnership and others to identify critical 
issues, communicate the industry's compliance, and ensure patient 
access to safe and effective medical devices on January 1, 2000 and 
thereafter. I can speak directly for Baxter Healthcare Corporation when 
I say that we are devoting significant resources to assure the Year 
2000 compliance of our devices and to communicate our compliance status 
to interested parties. I am personally aware of numerous other 
companies that are acting similarly. I am confident that the medical 
technology industry will do whatever is necessary to maintain the 
health and safety of our patients.
    In my testimony today, I will outline for the Subcommittee the 
numerous activities, both past and present, that HIMA has undertaken to 
ensure that both HIMA member and non-member companies fulfill their 
responsibility to provide compliance information to appropriate 
government entities as well as their customers. I will also share with 
you the comprehensive Year 2000 compliance program that Baxter 
Healthcare has developed.
    I would be remiss, however, if I did not express to you the 
legitimate liability fears of the medical technology industry--fears 
that are shared by other industries. Congress recognized these in 
enacting the Year 2000 Information and Readiness Act that has helped 
tremendously to encourage all industries to disseminate Year 2000 
compliance data without fear of liability. The House has now taken the 
second step of passing liability legislation that will help create an 
environment that will encourage remediation and discourage frivolous 
lawsuits. It is our hope that the House, the Senate, and the 
Administration will be able to reach a compromise to ensure that 
liability legislation is passed as soon as possible.
A Diverse Industry Poses Unique Challenges
    The medical device industry is extremely concerned about the 
potential hazards associated with the Year 2000 problems and has put 
substantial effort into ensuring that medical devices function properly 
and safely during and after the century change. We have committed to 
Congress to work with the federal government and other concerned 
parties to ensure that information about Year 2000 medical device 
compliance is publicly available. While we remain confident that there 
will be few disruptions to patient health care as a result of non-
compliant medical equipment, it might be useful to understand the true 
diversity of the medical technology industry.
    More than 50 scientific and engineering disciplines, including such 
diverse fields as solid state physics and holography, are involved in 
the development of our products. Over 50 different medical specialties, 
such as orthopedic surgery, cardiology and ophthalmology, utilize the 
industry's products in applications throughout the human body. There 
are more than 3,000 distinct, major product lines, and approximately 
84,000 individual products. For these reasons, the challenge posed by 
the Year 2000 bug does not represent a single problem that will yield 
to a single solution. For the majority of cases, solutions developed by 
one firm likely will not apply to, or be feasible for, others. Rather, 
each company faces a unique set of circumstances involving its own 
technologies.
    Further, while the number of electrical medical devices containing 
software has been rising, it is important to understand that many of 
the highest risk devices vital to keeping patients alive are not date 
sensitive. For instance, many have cited the potential Year 2000 risks 
associated particularly with pacemakers and implantable defibrillators. 
Pacemakers and implantable defibrillators are required to operate at 
all times regardless of the day or date. We know of no pacemakers or 
defibrillators that are date dependent.
HIMA's Year 2000 Activities
    As a matter of course, HIMA has strongly encouraged its members to 
work to ensure that their devices are Year 2000 compliant and to 
communicate Year 2000 compliance status to their customers. We have 
developed and executed a comprehensive program to advise HIMA member 
and non-member companies regarding their responsibility to provide 
compliance information to the government and have worked closely with 
the FDA and others to disseminate necessary information.
    HIMA has also:

 Established a member committee to advise on and oversee the 
        Association's efforts to successfully address Year 2000 issues.
 Created a Year 2000 section on HIMA's Web site to communicate 
        with the public and our members on Year 2000 issues.
 Consistently reached out to all segments of the industry 
        including the National Electrical Manufacturers Association 
        (NEMA), and the Medical Device Manufacturers Association (MDMA) 
        to coordinate our efforts and to help ensure that critical Year 
        2000 messages reach virtually all device manufacturers.
    Early in the Year 2000 debate, an important coalition--the National 
Patient Safety Partnership--comprising the Department of Veterans' 
Affairs, the American Hospital Association, the American Nurses 
Association, and others concerned about the impact of the Year 2000 
problem on patient health, proposed the development of a central 
clearinghouse on the compliance status of medical technology. Other 
private organizations, such as Rx2000 Solutions Institute, also called 
for centralized databases.
    HIMA has worked diligently and closely with the Food and Drug 
Administration (FDA) and the Department of Veterans' Affairs to help 
the FDA's Year 2000 Biomedical Equipment Clearinghouse become a central 
collection point for Year 2000 device compliance information. The 
initial focus of the FDA clearinghouse effort was to gather information 
on non-compliant devices. In support of that critically important goal, 
HIMA:

 Ensured a 100-percent response rate from HIMA's 800 member 
        companies who together manufacture 90 percent of the medical 
        technology products sold in the U.S. market.
 Communicated with more than 6,000 primarily small non-HIMA 
        member companies in the industry urging them to respond to the 
        FDA request for Year 2000 status information and to ensure that 
        their devices are Year 2000 compliant.
 Sponsored advertisements with the FDA, the Department of 
        Veterans' Affairs, and other industry associations in key 
        industry trade magazines urging device companies to respond to 
        FDA's request for Year 2000 status information.
    It is important to note that in the current device industry 
environment of mergers and acquisitions, it is not always obvious how 
one company may be affiliated with another, or which corporate entity 
should be the responsible reporting entity for a particular product. It 
is accurate to describe our industry as something of a corporate maze. 
For example, HIMA's membership of more than 800 companies actually 
consists of 300 companies and parent companies and their more than 500 
separate subsidiaries and divisions. For these reasons, HIMA also:

 Asked each member company to designate an individual who is 
        responsible for coordinating Year 2000 activities.
 Worked with the FDA and the VA in an effort to ensure that 
        their communications were going toY2K coordinators, especially 
        in instances where they were receiving no response.
 Made calls to non-HIMA member companies who had failed to 
        respond to the VA and FDA requests for Year 2000 information to 
        urge them to post their compliance information on the FDA 
        Biomedical Equipment Web site.
    Of the more than 13,000 FDA-registered device companies, the FDA 
identified 1,935 whose products are likely to have a date-dependent 
function. We understand that FDA's non-response rate is now just over 
200 companies. We can probably assume that many of these companies are 
no longer in business.
    More recently, in an effort to provide ``one stop shopping'' for 
health care providers on Year 2000 compliance information, the FDA has 
expanded their Web site to include information on Year 2000 compliant 
devices. HIMA worked closely with the FDA to help develop a workable 
template in order to facilitate a better industry response. We also 
strongly encouraged our members to respond to this new FDA request for 
information. HIMA's President urged all HIMA members, in a memorandum, 
to provide the requested information. HIMA also used its Web site to 
promote compliance with the request.
Baxter Healthcare Corporation Year 2000 Actions
    As a window into the activities of a large medical technology 
corporation with a diverse product line, I would like to highlight the 
Year 2000 progress and awareness initiatives Baxter Healthcare 
Corporation has undertaken. Given our goal of providing quality care 
for patients, Baxter has since early 1997 been actively addressing Year 
2000 issues relating to our customers, employees, suppliers, 
manufacturing and facility systems, products, services and internal 
systems. We have made tremendous progress and we anticipate that we 
will meet our goal of being Year 2000 compliant by September 30, 1999. 
To date, we have spent approximately 85 percent of our $135 million 
Year 2000 budget to address our role in the health care supply chain. 
Baxter's Year 2000 initiatives are comprehensive and include a variety 
of activities.
    Products--Baxter delivers critical therapies for life-threatening 
conditions. It is important work. Important to patients whose lives 
depend on our products and services. Important to health care 
professionals who count on us to help them treat their patients. 
Consequently, providing timely information regarding the status of Year 
2000-affected products and services is one of the Year 2000 team's top 
priorities. Baxter's product and software engineers have identified 
fewer than 100 electronic medical products that could have been 
affected by Year 2000 issues. Information regarding the Year 2000 
compliance status and implementation solutions for Baxter's electronic 
date-dependent products was available December 1, 1998. Our compliance 
checking has been completed and identified fewer than 20 products with 
Year 2000 issues. Product modifications and replacements are expected 
to be complete by mid-1999.
    Customers--The Year 2000 challenge isn't just about rewriting 
computer code, it's about being responsive to customers. We are 
actively working with customers to address various Year 2000 issues, 
including medical device compliance, viability of the supply chain, and 
Electronic Data Interchange (EDI). Beginning in June 1998, Year 2000 
certification documentation (letters, compliance certificates, and 
Baxter's compliance definition) began to be distributed to customers we 
identified as having date-dependent products.
    Also in June 1998, Baxter launched its Year 2000 Web site, which 
includes a complete list of Baxter's electronic medical products, 
detailed information regarding Year 2000-affected products, a customer 
inquiry form, compliance definition, product supply requirement 
information and other information on Baxter's Year 2000 Program. To 
date, we have responded to over 4,500 Year 2000 customer inquiries and 
have mailed over 25,000 compliance letters to customers worldwide. 
40,000 Baxter brochures in 10 languages were distributed to customers, 
suppliers, and employees to help increase global Year 2000 awareness.
    In early 1999, all customers who communicated with Baxter through 
EDI were notified about Baxter's implementation of the newest EDI 
standards that are Year 2000 compliant. While a change to a newer 
version may not have been required in all cases, it is the preferred 
way to communicate with Baxter.
    Suppliers--Suppliers in the broadest sense include all those 
parties that provide material, products, or services to Baxter. One of 
the biggest risks facing our global company is the potential failure of 
key strategic business partners, suppliers, and third parties on which 
we depend to address Year 2000 issues. To evaluate our suppliers, we 
have a coordinated effort through Baxter's Purchasing Council to 
address our raw materials/finished goods and maintenance, repair and 
operations (MRO) suppliers. Each Baxter facility is also requiring 
their local suppliers to communicate their progress toward Year 2000 
compliance. These suppliers may include utilities, telecommunications, 
third-party logistics providers, distributors, service providers, 
property managers and any other critical business supplier. We have 
received an over 90 percent response rate from questionnaires sent to 
our identified 7,000 critical suppliers asking for their Year 2000 
readiness information. We are also conducting face-to-face and 
telephone audits with targeted suppliers. Our goal is to complete these 
audits by mid-1999.
    Manufacturing--Baxter manufacturing worldwide adheres to high 
standards of quality. Our manufacturing plants are consistently 
recognized for their dedication to total quality and manufacturing 
excellence. As a health care manufacturer, Baxter has over 70 
manufacturing facilities, distribution centers and replenishment 
centers around the world. To date, 80 percent of Year 2000 
manufacturing and facility systems have been fixed and implementation 
will continue through mid-1999 according to plan.
    Internal Systems--As a global company, Baxter has literally 
thousands of internal interconnections and interactions amongst and 
between computer operating systems. In an effort to make it easier for 
our customers to do business with us, enhance our employees' ability to 
respond to customers, as well as improve our overall economic 
efficiency, we are implementing a global integration project. This 
project will implement software upgrades that are certified as Year 
2000 compliant as well as integrate our operational processes. To date, 
Baxter has achieved all major milestones relating to systems 
initiatives with approximately 75 percent of systems implementations 
complete as of March 1999.
    Contingency Planning--As part of its contingency planning and 
awareness efforts, Baxter is:

 meeting with customers to discuss their requirements and 
        obtain key information as input into our contingency plans;
 contacting customs officials to identify potential Year 2000 
        issues;
 monitoring the Year 2000 progress of its key distributors and 
        suppliers;
 assessing the viability of the entire supply chain and 
        developing appropriate contingency plans at each of its 
        manufacturing facilities worldwide;
 upgrading, replacing or modifying all major computer-based 
        business and finance systems where necessary to enhance 
        interactions with customers; and
 developing strategies for communicating with customers during 
        the Year 2000 transition.
    We are confident our comprehensive Year 2000 plan and 
implementation strategy will help us continue our mission of providing 
critical therapies for life-threatening conditions.
HIMA Contingency Planning Activities
    With respect to company operations' contingency planning, HIMA has 
helped to educate its membership on the importance of Year 2000 
contingency planning and the various components involved. For example, 
I participated in an association-wide teleconference to educate my 
colleagues on the many aspects of the contingency planning process in 
order to avoid critical interruptions of the supply chain and to 
enhance communications with customers. Year 2000 contingency planning 
is focused on developing alternate operating procedures that support 
business continuity. It should be noted that contingency plans are part 
of a company's normal course of business. Prudent companies must 
protect their operations during storms, strikes and other potential 
disruptions. In the case of Year 2000, these plans could range from 
taking customer orders by hand instead of by computer to establishing a 
Year 2000 command center for critical communications during the Year 
2000 transition.
    The President's Council on Year 2000 Conversion is working to 
evaluate the readiness of critical industries. To support the Council's 
initiative, HIMA circulated to its members a survey based on a template 
prepared by the President's Council. While we have not completed our 
analysis of the survey, our initial work indicates that the companies 
that supply the bulk of the country's medical devices are well on the 
way to complete Year 2000 readiness before the end of the year. The 
results collected thus far have given us a handle on general industry 
trends. For instance, we believe the companies that sell the vast 
majority of medical devices sold in the U.S. are communicating with 
their suppliers and their customers using multiple means such as face-
to-face meetings, 800 numbers, Web sites, e-mail, etc. In addition, the 
preliminary results indicate that these same companies expect to be 
Year 2000 compliant with respect to both their products and their 
operations.
Preemptive Buildup of Supplies
    On another equally important front, HIMA has recently turned its 
attention to the more serious issue of the potential for preemptive 
inventory build-up or stockpiling. As January 1, 2000 nears, serious 
concerns have been expressed throughout the supply chain that some 
providers may, as part of their contingency planning, preemptively 
hoard supplies. As a member of the Health Care Sector of the 
President's Council on Year 2000 Conversion, HIMA is working closely 
with the American Hospital Association, the Health Industry 
Distributors Association and others on a White House-sponsored 
Roundtable on Hospital Supplies to be held in early June.
    We expect the Roundtable to be a major source of valuable 
information and policy development that will relieve the pressure 
related to concerns over potential hoarding of hospital supplies. For 
instance, a possible outcome could be an industry/health care provider 
consensus that would, in effect, limit the amount of inventory 
providers would purchase to previous historical levels plus some 
minimal additional amount.
Proposals for Independent Verification of Industry Test Protocols
    A number of parties, including the General Accounting Office, have 
called for third-party verification of medical technology Year 2000 
test protocols. Others have advocated user or third-parting testing of 
devices. Some have argued that FDA should properly take on such 
responsibilities. Still others have called on industry to make public 
its test protocols as well as detailed testing results. We would like 
to highlight a number of concerns with such approaches:

 It is unlikely that enough independent third-party test 
        organizations exist to analyze and process the highly complex 
        test protocols associated with thousands of devices in the 
        available time.
 It would take tremendous resources and staffing for any 
        organization, including the FDA, to begin to verify 
        independently the numerous testing protocols involved for each 
        model of each device, some of which for complex devices can 
        approach 100 pages.
 Making public test protocols assumes that the provider 
        technicians responsible for such testing would be able to 
        properly and safely use and understand the protocols.
    We believe that at this late date, such activity would be a 
misdirection of resources. We understand that this view is shared by 
ECRI, a leading independent, non-profit research agency for health care 
technology and the Department of Veterans' Affairs, which expressed 
this opinion in several of our meetings with them. We have attached a 
slide prepared by the chief biomedical engineer of the Department of 
Veterans' Affairs describing the reasons for not entering into a major 
program to retest medical devices.
    Medical device manufacturers are strictly required by the FDA to 
verify and validate all product changes affecting patient safety. These 
activities are undertaken as part of each company's Design Control 
program under the FDA Quality Assurance regulation. These rules require 
written procedures for design change validation and verification, and 
independent internal audits of quality assurance activities. There are 
severe sanctions for failure to validate changes, and FDA has 
significant inspection authority to assure compliance. It is difficult 
to conceive that either users or third parties can more effectively 
verify device Year 2000 readiness than the manufacturers who originally 
designed the devices.
Conclusion
    In closing, HIMA will continue to work on a variety of fronts to 
ensure that the medical technologies on which millions of patients 
depend continue to function safely and effectively as we move into the 
next millenium. We want the patients who we serve as an industry to 
have confidence in us, and we will continue to do whatever we must to 
deserve their trust. We are committed to working cooperatively with 
anyone who shares this goal. We are open to suggestions and look 
forward to working with members of the Subcommittees.

    Mr. Upton. Thank you very much.
    Mrs. Williams.

                TESTIMONY OF NOEL BROWN WILLIAMS

    Ms. Williams. Good afternoon, Mr. Chairman and members of 
the subcommittee.
    Mr. Upton. Could you just put the mike just a little bit 
closer?
    Ms. Williams. A little bit closer. How is that?
    I am pleased to appear before you today on behalf of 
Columbia HCA Health Care Corporation, who is a member of the 
Federation of American Health Systems. The federation 
represents nearly 1,700 hospitals. I am here today to discuss 
Columbia HCA's activities and experience concerning year 2000 
and the medical devices.
    Columbia HCA is one of the leading healthcare service 
companies in the United States. We currently operate 236 
hospitals throughout the country and employ approximately 
225,000 workers, each of whom is committed to the care and 
improvement of human life. Columbia HCA estimates that we will 
spend approximately $86 million on Y2K, which does not include 
capital costs related to replacing non-compliant equipment.
    Columbia HCA began planning for the year 2000 in 1996. We 
established a year 2000 executive committee and have formed a 
multi-disciplinary Y2K support team. This team is monitoring 
over 1.4 million medical equipment information systems and 
physical plant assets. Our Y2K efforts have included activities 
such as contingency planning, coordination with our fiscal 
intermediaries, and medical equipment planning.
    Medical equipment planning has been, and continues to be, 
one of the key areas in our Y2K planning effort. The first 
thing we did was an inventory of our medical equipment assets. 
With few exceptions, this included anything that had a battery 
or power cord. The current medical equipment inventory includes 
over 450,000 pieces of equipment.
    In an attempt to prioritize our medical equipment and 
device planning efforts, we developed a classification system. 
This classification system enables us to focus our efforts on 
medical equipment that is essential to providing patient care. 
The classification has five impact ratings. However, our focus 
is mission-critical equipment, which includes life-support 
equipment such as ventilators and anesthesia machines.
    Next, we identified almost 900 prevalent vendors in the 
Columbia HCA medical equipment network. We then surveyed each 
of these vendors for compliance information. Ninety-five 
percent of those vendors have responded to our request.
    Next, vendor responses were evaluated by our survey teams, 
subject matter experts, and then risk management experts before 
being published in our internal data base. We now have 
compliance information on over 28,000 items in this data base, 
including 11,000 in the medical equipment category. Our 
facilities can now match their equipment inventory back to this 
data base to determine if it is compliant or non-compliant.
    The final step is facility decisions and remediation. Once 
our facility has completed an equipment match to an item to our 
internal data base and have identified that the equipment is 
non-compliant, they can plan accordingly--to use the equipment 
as is, where the Y2K impact does not affect how the equipment 
is used in a patient care setting, plan a workaround, consider 
an upgrade, replace the equipment, or retire the equipment. The 
facility evaluation is based on the equipment classification 
and how this equipment is being used in the facility.
    Our research and evaluation of medical equipment varied 
based upon the equipment's classification. For example, 
stricter acceptance criteria from vendors was required for 
mission-critical devices. Of approximately 450,000 medical 
equipment assets, over 190,000 are mission-critical or impact 
level one. We have identified approximately 8 percent of these 
as limited or non-compliant and will require remediation. In 
addition, we have identified over 800 pieces of mission-
critical or impact level one medical devices which we have 
placed in a status of unknown, because the manufacturer has 
indicated that they are not evaluating the compliance status of 
the devices or for which we have not received acceptable vendor 
information. And I might add, that represents 18 companies.
    There are several issues we feel might be of particular 
significance to the subcommittees, which we have discussed in 
our written testimony. They are proof of compliance, the FDA 
clearinghouse, hospital medical device testing, and supply 
chain issues. We believe that the healthcare providers, the 
equipment manufacturers, and the FDA all have responsibilities 
in this process. The provider must identify their medical 
equipment, obtain the compliance information from the 
manufacturer, and then determine if the Y2K impact requires 
remediation. The manufacturer should be responsible for 
accurately determining the Y2K status of its equipment, 
communicate that status, including specific details about what 
makes the device compliant or non-compliant to the healthcare 
community.
    The FDA can support these initiatives by requiring the 
manufacturers to determine the compliance status of all of the 
equipment, what the impact is, the availability of upgrades, 
replacements, or workarounds, and ensuring that there is an 
easily accessible mechanism for all healthcare providers to get 
the information, including updates. Of special interest is the 
need for manufacturers to provide compliance information for 
all of their devices, as some have chose not to test obsolete 
or retired devices.
    Columbia HCA has taken the initiative to manage the year 
2000 issue in order to protect the safety of our patients and 
to continue providing quality health services. This effort 
requires the support and cooperation of public and private 
sectors. We appreciate the opportunity to testify today and I 
would be happy to answer any questions you have. Thank you.
    [The prepared statement of Noel Brown Williams follows:]
 Prepared Statement of Noel Brown Williams, Sr. Vice President & Chief 
        Information Officer, Columbia/HCA Healthcare Corporation
                              introduction
    Good morning Mr. Chairman and Members of the Subcommittees. I am 
Noel Williams, Senior Vice President and Chief Information Officer of 
Columbia/HCA Healthcare Corporation. I am pleased to appear before you 
today on behalf of my company who is a member of the Federation of 
American Health Systems. The Federation of American Health Systems 
represents nearly 1,700 privately owned and managed community-based 
hospitals and health systems that offer traditional acute care, 
ambulatory care, rehabilitative care; and allied companies involved in 
health care systems.
    For purposes of today's hearing, I will specifically discuss 
Columbia/HCA's activities and experience concerning Y2K and medical 
devices. I will also refer to Columbia/HCA Healthcare Corporation and 
it's affiliates as simply Columbia/HCA. Columbia/HCA is one of the 
leading health care service companies in the United States. We 
currently operate 236 hospitals throughout the country and employ 
approximately 225,185 workers, each of whom is committed to the care 
and improvement of human life.
    Let me begin by thanking you for the dedication and interest you 
have shown for the Year 2000 issue. Columbia/HCA recognizes and shares 
your concern and I appreciate the opportunity to explain how we, as 
representatives of the medical industry, are preparing for Y2K.
    Columbia/HCA estimates that we will spend approximately $86 million 
on Y2K, which does not include capital costs related to replacing non-
compliant equipment.
                   columbia/hca's y2k planning effort
    Columbia/HCA began planning for the Year 2000 in 1996. We 
established a Y2K Executive Committee that includes our CEO and other 
senior managers, and we periodically update our Board of Directors on 
our progress. In addition, we have formed a multi-disciplinary Y2K 
support team made up of physicians and other health care professionals, 
information systems (IS), engineering, risk, financial, audit and other 
experts to provide guidance, oversight and support for our facilities. 
This team is currently monitoring over $1.4 million assets in our 
medical equipment, IS infrastructure and facility and physical plant 
tracks.
    We have also worked closely with other groups and organizations on 
the Y2K issue. These include the American Hospital Association and the 
Odin Group. The Odin Group is a collection of healthcare-related 
companies that include equipment manufacturers, hospitals, 
pharmaceuticals, health equipment manufacturers and others involved in 
the healthcare process.
    Our Y2K efforts have included activities such as contingency 
planning, coordination with our fiscal intermediaries, medical 
equipment and device planning. I would like to talk briefly about our 
activities in the medical equipment and medical device area.
                       medical equipment planning
    Medical equipment planning has been and continues to be one of the 
key areas in our Y2K planning effort. Our process for the evaluation 
and remediation of medical devices includes the following:

1. Inventory. This involved an inventory of all of our medical 
        equipment assets. With few exceptions, this included anything 
        that had a battery, electrical power or power cord. The current 
        medical equipment inventory includes over 450,000 pieces of 
        equipment. Our next step in this process was to classify the 
        equipment.
2. Classification. In an attempt to prioritize our medical equipment 
        and device planning efforts, we developed a classification 
        system. This classification system enables us to focus our 
        efforts on medical equipment that are essential to provide 
        patient care. The classification system includes mission 
        critical equipment, which includes life-support equipment such 
        as ventilators and anesthesia machines, and impact ratings one 
        through four. The next step in our process was vendor research.
3. Vendor Research. We identified approximately 880 prevalent vendors 
        in the Columbia/HCA medical equipment network. We then surveyed 
        each of these vendors for compliance information. I am pleased 
        to say that 95% of these vendors have responded to our request 
        for compliance information.
4. Evaluation. After the research component was completed, we analyzed 
        the survey results using a 3-step process. Vendor responses 
        were evaluated by our survey teams, subject matter experts and 
        then risk management experts, before being published in our 
        internal database. We now have compliance information on over 
        28,000 items in this database, including 11,000 in the medical 
        equipment track. Our facilities can now match their equipment 
        back to this database to determine if it is compliant or non-
        compliant.
5. Facility Decisions/Remediate. Once our facilities complete an 
        equipment match to an item in our internal database and have 
        identified the equipment that is non-compliant, or has a 
        limited compliance status, they can plan accordingly. Their 
        options include:
1) use the equipment ``as is'' where the Y2K impact does not affect how 
            the equipment is used in a patient care setting,
2) plan a ``workaround'',
3) consider an upgrade,
4) replace the equipment or,
5) retire the equipment. The facility evaluation is based on the 
            equipment classification and how this equipment is being 
            used in the facility.
    Our research and evaluation of medical equipment varied based on 
the equipment's classification. For example, stricter acceptance 
criteria from vendors were required for mission critical and impact 
level one devices.
    Of approximately 450,000 medical equipment assets, over 190,000 are 
``mission critical'' or ``impact level one.'' Approximately 92% of 
these mission critical or impact level one devices are compliant, while 
approximately 8% of these have been identified by us as limited or non-
compliant and will require remediation.
    In addition, we have identified 51 models, representing over 800 
pieces of mission critical or impact level one medical devices, which 
we have placed in a status of ``unknown'' because the manufacturer has 
indicated they are not evaluating the compliance status of the devices 
or for which we have not received acceptable vendor information.
    There are several issues we feel might be of particular 
significance to the Subcommittees. I'd like to take a moment to discuss 
these with you.
                          proof of compliance
    The General Accounting Office (GAO) has indicated that medical 
device manufacturers should provide to the FDA and VHA documentation of 
the tests they have conducted on their devices, so they can determine 
whether or not the equipment was compliant. As I have previously 
stated, we required different levels of information from our 
manufacturers, based on the impact level of the equipment.
    For mission critical and impact level one medical devices, we asked 
the manufacturers for version specific compliance information, as well 
as documentation to prove that they had performed testing. We also 
required them to provide testing documentation, or testing scripts and 
protocols indicating appropriate due diligence was exercised. There are 
some obvious advantages in having the FDA manage and standardize such a 
process, but unfortunately it is probably too late to initiate this 
effort.
                           fda clearinghouse
    Although we understand that the FDA has established a clearinghouse 
of medical devices, our approach has been to gather information 
directly from the manufacturers. While the clearinghouse provides a 
source of information for hospitals, there are areas for enhancement of 
the site, which would make it more user friendly. These include 
consistency in the presentation of compliance data, a mechanism for 
tracking manufacturer's compliance updates or changes and standardized 
requirements for compliance information acceptance criteria.
                    hospital medical device testing
    To summarize our process at Columbia/HCA, we begin with a detailed 
inventory of our medical devices, including model, version and in some 
cases serial number.
    Next, we match compliance information from the manufacturer with 
the specific device in our inventory. We rely on the manufacturer to be 
the authoritative source for compliance information, and have adopted a 
testing policy based on the ECRI recommendations that testing should 
not be performed by any one other than the manufacturer, except in 
cases where insufficient information is available from the 
manufacturer.
                            responsibilities
    We believe that the healthcare providers, the equipment 
manufacturer and the FDA all have responsibilities in this process. The 
provider must identify all their medical equipment, obtain the 
compliance information from the manufacturer, and then determine if the 
Y2K impact requires remediation. The manufacturer should be responsible 
for accurately determining the Y2K status of its equipment and 
communicate that status, including specific details about what makes 
the device compliant or non-compliant to the healthcare community. The 
FDA can support these initiatives by requiring the manufacturers to 
determine the compliance status of all of their equipment, what the 
impact is, the availability of upgrades, replacements or workarounds, 
and ensuring that there is an easily accessible mechanism for all 
healthcare providers to get the information, including updates.
    Of special interest is the need for manufacturers to provide 
compliance information for all of their devices, as some have chosen 
not to test obsolete or retired devices.
                          supply chain issues
    There are several supply chain issues related to medical equipment. 
These are:

1) availability of upgrades and service personnel to fix the non 
        compliant equipment, and
2) availability of disposable supply items and reagents that are 
        required for operating the medical devices.
    Hoarding of hospital supplies has recently become a concern in the 
industry. We are working closely with our peers, the American Hospital 
Association, our suppliers and distributors to evaluate the supply 
chain and put safeguards in place to ensure uninterrupted supply 
availability. In our opinion, hoarding or stockpiling of additional 
supplies could create shortages well ahead of the Year 2000 transition. 
We encourage all parties to work collaboratively on this critical 
issue.
                               conclusion
    Columbia/HCA is taking the initiative to manage the Year 2000 issue 
in order to protect the safety of our patients and to continue 
providing quality health services.
    There are serious challenges ahead of us, but we are confident that 
the healthcare industry will meet these challenges. This effort 
requires the support and cooperation of both public and private 
sectors. We appreciate the opportunity to testify today and welcome any 
questions you may have at this time. Thank you.

    Mr. Upton. Thank you.
    Mr. Nunn.

                    TESTIMONY OF JOHN C. NUNN

    Mr. Nunn. Good afternoon. I am John Nunn, vice president 
for Patient Care Services at Henry Ford Hospital, part of the 
Henry Ford Health System in Detroit. I also co-chair the 
Systems Y2K Contingency Planning Committee. I am here on behalf 
of the American Hospital Association's 5,000 hospitals, health 
system networks, and other providers of care.
    Most of the Nation's hospitals expect to be Y2K compliant 
by January 1, 2000, based on the results of the nationally 
representative AHA survey. Of the remainder, almost all expect 
to be sufficiently prepared that critical operations will not 
be affected. Approximately 2,000 hospitals responded to the AHA 
survey which was conducted in February: 5.7 percent of the 
hospitals said that their medical devices were compliant, 90.4 
percent expected their devices to be compliant by the year end 
or expected no problems in their operations, and only .5 
percent expected compliance with possible adverse effects.
    Henry Ford Health System is in the middle category. Our 
devices are not 100 percent compliant, but like the great 
majority of hospitals, we expect no problems as a result. Put 
another way, all of our devices may not be compliant, but our 
hospitals themselves will be.
    At Henry Ford we have about 25,000 medical equipment 
devices; we have completed the Y2K assessment in all but 7,800. 
Those are held up largely because the communication process 
between us and the manufacturers is ongoing. Some cases, 
especially in older devices, simpler devices, or where 
manufacturers are out of business or merged and no longer 
servicing their devices, we are having difficulty getting 
devices declared or certified compliant.
    Of the items we have assessed, only about 3 percent, or 
about 500 devices, required action. Of those, 60 percent 
required a software upgrade; 20 percent will be subject to what 
we call a workaround, which means that staff can work around 
the problem without modification of the device; 18 percent of 
the equipment will need to be replaced. Remediation is required 
if the two-digit date in the medical device's computer chip is 
used in a calculation, archiving or sent to another computer. 
The decision to upgrade or replace the device depends on 
availability and cost. If the data is not critical used in one 
of these calculations, the workaround solution may be used.
    For example, we are replacing or upgrading some of our EKG 
machines because they report to a central reporting computer. 
We will upgrade that equipment. Our standalone EKG equipment, 
on the other hand, may show the wrong date and be technically 
not compliant, but we will work around by striking that date, 
writing in the correct date on the report, and signing the 
correct date.
    Most devices that we still need information on are not 
critical care or the life support area. We have machines in our 
labs that mix--shake blood samples, for example; it monitors 
other equipment that do not have a safety hazard associated 
with them. While we are convinced that many of these devices 
which are electric will not be affected, until we hear from the 
manufacturer, we are hesitant to declare them compliant. As 
January 1 approaches, we will make those decisions and are 
prepared to move ahead without manufacturer information.
    We do rely heavily on the manufacturer testing and 
information, and the information we have been receiving appears 
to be reliable. As the new year approaches, if we cannot get 
the information we need, we will have four options: Try to do 
limited testing ourselves; hire a third-party tester; wait 
until the date change and then recalibrate the device to make 
sure it works, using our normal QC processes, or ultimately 
retire or replace specific devices.
    No matter how hard we prepare, surprises happen. 
Fortunately, hospitals are experienced in and ready for 
surprises. Whether it is Oklahoma, Kansas, Colorado, Georgia, 
forces of nature, failures of man, hospitals expect the 
unexpected. Last summer a construction company dug through our 
hospital's main power line. Ultimately, we lost two-thirds of 
the power to our hospital, and we were able to manage that 
situation without harm to our patients.
    I note that my time is up and am just entering my 
conclusion. Of course, Y2K could be different, but then, again, 
we plan for the unexpected. Y2K is not unexpected. It is 
something that we know will happen; it is at a known time in a 
controlled environment. We have identified the contingencies we 
need to prepare for and are preparing for them. I believe the 
hospitals and the health systems will succeed because of the 
people inside of them. Emergency department personnel to the 
CEO do this type of work and are prepared to make the decisions 
that will be required.
    I would be glad to answer any questions.
    [The prepared statement of John C. Nunn follows:]
  Prepared Statement of John C. Nunn, Vice President for Patient Care 
   Services, Henry Ford Hospital on Behalf of the American Hospital 
                              Association
    Mr. Chairman, I am John C. Nunn, vice president for patient care 
services at Henry Ford Hospital, part of the Henry Ford Health System 
in Detroit. I am here on behalf of the American Hospital Association's 
(AHA) nearly 5,000 hospitals, health systems, networks, and other 
providers of care.
    The AHA and its members are committed to continuing the smooth 
delivery of high-quality health care, at the turn of the century and 
beyond, uninterrupted by the calendar change that will occur at 
midnight December 31. We appreciate this opportunity to update you on 
our efforts, to outline the role that the AHA has taken in aiding the 
health care field, and to focus on what hospitals are experiencing as 
they work to assure themselves, their patients, and their communities 
that the medical devices and equipment they rely on will operate 
safely.
                       progress on y2k compliance
    The majority of the nation's hospitals expect to be completely 
``Y2K compliant'' by January 1, 2000, based on the results of a 
nationally representative survey we conducted. Of the balance, almost 
all expect to be sufficiently prepared that critical operations will 
not be affected. The survey occurred in February 1999, and medical 
device readiness was one of the focuses. Respondents represented not-
for-profit and investor-owned hospitals in urban and rural areas. 
Following are highlights from the medical devices portion of the 
survey:

 5.7% of hospitals said their devices were compliant when they 
        responded in February.
 Another 90.4% of hospitals expected their devices to be Y2K 
        compliant by year end or expected no problems in their 
        operations.
 0.5% expected non-compliance with possible adverse effects.
    In the survey, hospitals were asked whether their medical devices 
would be compliant, or noncompliant with no adverse effects. This is 
important, because some medical devices could technically be labeled 
non-compliant, even though they will not fail to operate as a result of 
the date change.
    For example, an EKG machine may provide accurate heart rate 
information, while the strip recording the test information notes the 
date of the test incorrectly. In such cases, medical personnel would 
simply write the correct date onto the readout. In no way would this 
machine be a danger, but it technically would be labeled non-compliant 
because it did not recognize the date change.
                      how hospitals are preparing
    In general, hospitals have been taking the following steps to 
ensure the safety and reliability of their medical devices at the turn 
of the century:

 Taking inventory of all equipment and devices--identifying 
        which may be potentially affected by Y2K.
 Determining which are actually affected and how their 
        functioning will be altered--this is done through contact with 
        the manufacturers to get the results of their assessments and 
        testing.
 Taking follow-up action if those devices or equipment are 
        affected by Y2K--depending on the device or equipment, this may 
        mean repairing, taking out of service, or training staff on how 
        to use the equipment going into the new year.
 Developing contingency plans--even with all the advance 
        preparations. Hospitals still need to anticipate the 
        unforeseen.
                          contingency planning
    America's hospitals and health systems are in the business of 
dealing with the unexpected. They are used to mobilizing quickly in the 
face of floods, hurricanes and potentially disastrous events that are 
an unfortunate fact of life. There is no reason to believe that they 
will not also be ready for the Year 2000, whether or not every medical 
device in the hospital is Y2K-compliant.
    Patient safety is the highest priority for hospitals and health 
systems. Our ultimate contingency plan is to take care of patients at 
the bedside--as we do 24 hours a day, seven days a week, 365 days a 
year. Should a medical device turn out to be non-compliant, it is very 
likely that the ramifications will be limited, because it is a 
hospital's people who take care of patients, not a hospital's medical 
devices.
    Hospitals are examining a range of options, such as having extra 
staff available for the date change and for the few days after, and not 
scheduling elective surgeries, thus ensuring that only people who 
absolutely need to be in the hospital are there.
    This is not being done out of a sense of panic, but to provide the 
broadest latitude for dealing with the unexpected. Some devices and 
equipment can only be operated in real-time--that is, after the clock 
turns from Dec. 31 to Jan. 1--and hospital personnel will literally 
watch this equipment's clock change to ensure that it works properly 
before allowing it to be used for patient care. The ultimate 
contingency plan is to provide care the old-fashioned way in the 
unlikely case of a modern medical device impeding care.
    Some outside factors could also have an indirect effect on how our 
people deliver care. Specifically, it is incumbent upon hospitals to 
prepare now to respond to the potential loss or disruption of any 
essential hospital processes or services, and our survey indicates that 
our members are doing just that. They are directing their efforts both 
internally across hospitals' facilities, and externally within 
communities. This includes working with such entities as utility 
companies, emergency medical services, and other health care providers.
    According to the AHA's survey, 66 percent of hospitals have 
initiated contact with utilities in their area; 44 percent have 
initiated contact with other hospitals; 38 percent have initiated 
contact with fire and police authorities; 36 percent have initiated 
contact with ambulance services; and 35 percent have initiated contact 
with their local governments.
                        relying on manufacturers
    Hospitals have historically relied on manufacturers' 
representations of the fitness and safety of their products. There is a 
sound reason for this: Manufacturers are in the best position to 
analyze and test their products, and they have a regulatory obligation 
to do so. Absent some bona fide basis for believing that a 
manufacturer's compliance statement is inaccurate, hospitals need to 
rely on the longstanding presumption that manufacturers are acting in 
good faith and issuing information backed up by proper analysis and 
research.
    The FDA's Y2K guidance to manufacturers emphasizes the 
responsibility of manufacturers for their products' Y2K compliance and 
safety. FDA has stressed that the technical know-how for determining 
the compliance status of devices rests with the manufacturers.
    A complex question that hospitals face is whether to undertake 
independent testing of their medical devices and equipment. This is a 
decision that ultimately must be made using the judgement of the 
leaders of each individual hospital or health system.
    ECRI, an international nonprofit health services agency that is 
recognized as the ``Consumer Reports'' for biomedical devices, recently 
published its position recommending how health care organizations 
should address the Y2K medical device testing issue. At AHA's request, 
this position statement was reviewed and discussed by a number of 
health care systems and biomedical manufacturers. Considerations for 
evaluating the thoroughness of a manufacturer's compliance disclosure 
statement also were discussed. The AHA has made the ECRI paper 
available on the AHA Web site and issued a companion advisory.
    The ECRI statement cautions that a program of testing is not a 
panacea for health care providers. Rather, ECRI recommends that health 
care facilities address the Y2K medical device problem in the following 
way:

 Obtain manufacturer information regarding Y2K compliance 
        status of any susceptible medical devices in their inventories 
        either directly from the manufacturer or through the Food and 
        Drug Administration (FDA) or a commercial data base.
 If a facility has received complete compliance information for 
        a device, testing of that device by the health care institution 
        is not necessary.
 If clear and complete information on a device's Y2K compliance 
        status cannot be obtained, the facility should perform Y2K 
        testing or take other appropriate action.
    The ECRI position identifies reasons why health care institutions 
should proceed cautiously when considering a testing program, including 
the lack of expertise and information at most institutions to perform 
an adequate level of testing. ECRI argues, in fact, that the testing a 
provider can accomplish is superficial and may provide false assurances 
about compliance and introduce a wholly different set of problems.
    Although a few hospitals have identified discrepancies between what 
some manufacturers have reported and their own tests of medical 
equipment. ECRI believes that the total number of these occurrences is 
extremely small and none are mission critical.
    The ECRI position separately addresses situations in which testing 
is warranted: devices that are interfaced as a system, those with 
replacement parts, and those user-modified.
                          the role of the fda
    The AHA, as part of the National Patient Safety Partnership, has 
been collaborating with the FDA to ensure that its Federal Year 2000 
Biomedical Equipment Clearinghouse is receiving accurate and useful 
information from manufacturers. This information, easily available on 
the agency's Web site at www.fda.gov, has been improved significantly.
    As the General Accounting Office recently testified before these 
subcommittees, ``In collaboration with the National Patient Safety 
Partnership, FDA is in the process of obtaining more detailed 
information from manufacturers on noncompliant products, such as make 
and model and descriptions of the impact of the Y2K problem on products 
left uncorrected. For example, FDA sent a March 29, 1999, letter 
requesting that medical device manufacturers submit to the 
clearinghouse a complete list of individual product models that are Y2K 
compliant.''
    It is critical that the FDA continue to closely monitor the 
reporting of manufacturers about their medical devices and equipment. 
FDA has the expertise, the resources, and the authority to ensure that 
products are safe and reliable.
    At the same time, we believe that the FDA should play a ``rumor 
control'' role, monitoring such arenas as the Internet and the media to 
make sure that information that circulates about the effects of Y2K on 
medical devices and equipment is accurate, and correcting it when it is 
wrong.
                             y2k liability
    Hospitals cannot meet the Y2K challenge alone. We depend not only 
on medical device manufacturers, but also on vendors and suppliers, 
software companies, even the companies that maintain the elevators we 
use to transport patients, to name a few. Hospitals have made hundreds 
of thousands of contacts through letters and phone calls to learn 
whether manufacturers' and vendors' products are Y2K compliant and, if 
not, what modifications may be necessary to bring them into compliance.
    In most cases, hospitals depend on manufacturers and vendors for 
information and support; hospitals cannot make the changes themselves. 
Unless hospitals are provided the necessary information, they will not 
be able to take appropriate action, including the development of 
responsible contingency plans. Vendors and manufacturers must take the 
initiative for several reasons. From a legal perspective, license 
agreements, warranties and other protections will be at risk if the 
hospital takes action on its own. From a practical perspective, only 
the vendors and manufacturers have the know-how needed to make 
technical evaluations and recommendations.
    In spite of all that is being done, some problems may still arise. 
The AHA and its member hospitals understand and appreciate the desire 
to avoid litigation. Dollars diverted from the delivery of health care 
are dollars lost to the mission of hospitals. In considering any 
proposal for Y2K liability reform, hospitals and health systems have 
one overriding concern: that their ability to deliver high quality care 
will not be hurt in any way.
    We want to ensure that hospitals remain on a level playing field 
when defending personal injury cases. Hospitals must retain all of 
their current rights to take legal action against a vendor or 
manufacturer whose product is involved in a claim. While we believe 
that the legislative proposals do not intend to create a disadvantage 
for hospitals, it is essential that, if a hospital is sued by a patient 
for a Y2K related event, explicit language be included in any proposal 
to ensure that the hospital has the same recourse against a vendor or 
manufacturer as it has today. H.R. 775, recently passed by the House 
does this. We are working to assure that the Senate includes a similar 
provision in their Y2K legislation.
               the role of the aha and other associations
    Mr. Chairman, all of the activities I've described above are part 
of an overall effort by the AHA and its state associations to help 
hospitals and health systems in their Y2K preparation. This effort 
includes:

 Working with state hospital associations to sponsor Security 
        Third Millennium (SIIIM), an Internet tool helping health care 
        providers get information to minimize malfunction or failure of 
        biomedical devices and equipment on January 1, 2000;
 Developing a members-only Y2K section of AHA's Web site with 
        up-to-date news and resources to help manage the Y2K computer 
        challenge;
 Using a toll-free 800 number to provide Y2K information to 
        members on educational opportunities, peer and consultant 
        referrals and speaker recommendations;
 Creating the ``Y2K: Mission Critical'' executive briefing, a 
        notebook for hospitals that outlines the Y2K problem and offers 
        information on how to deal with it;
 Using AHA's publications to provide members with information, 
        including ``The Clock's Ticking'' column, devoted entirely to 
        Y2K, in AHA's weekly newspaper;
 Developing the members-only ``Y2K Communications Action Kit,'' 
        a resource with tools to help communicate a hospital's Y2K 
        progress with the public; and
 Distributing a contingency planning workbook with templates to 
        help hospitals create internal and external back up plans.
    The AHA, along with state, regional and metropolitan hospital and 
health system associations, is also working hard to make sure that 
America's hospitals and health systems are informed about, educated on, 
and assisted with Year 2000 contingency planning. We recently 
distributed to every AHA member a briefing on hospital contingency 
planning. This briefing emphasizes the interdependent nature of health 
care, and stresses the need for hospitals to plan in advance, with 
their key partners, how they will handle potential Y2K-induced losses 
or disruptions. This executive briefing was followed up by ``how-to'' 
materials for hospital contingency planning, including a business 
continuity planning guide.
    In addition, the AHA will be working with the Federal Emergency 
Management Administration to coordinate emergency preparedness efforts 
at a national level with contingency planning taking place at 
individual hospitals in local communities. We recently brought together 
representatives of major health systems and health care manufacturing 
and supply companies to discuss how we can provide guidance to the 
health care field on issues related to Y2K preparedness and concerns 
about health care equipment and pharmaceutical and medical supply 
stockpiling. We are also participating in the President's Y2K Council's 
roundtables on the issue of stockpiling.
                          the role of congress
    As I have described, health care providers and the associations 
that represent them are devoting significant time, resources and energy 
to preventing potential Year 2000 problems from affecting patient 
safety. It is essential that we all look for ways to help prepare 
America's health care system for the turn of the century, and Congress 
can play an important role. Your attention to this issue, through 
hearings such as this, reflects your understanding of the gravity of 
the situation.
    One major step toward Y2K compliance occurred when Congress passed 
its ``Good Samaritan'' legislation. By shielding from liability the 
sharing of information among businesses that provide it in good faith, 
this law encourages all parties--providers, suppliers, manufacturers, 
and more--to work together.
    We ask you to help America's health care system avoid Year 2000 
problems by taking several other steps:

 Congress should provide the FDA with any additional authority 
        or resources it needs to ensure the necessary information is 
        disclosed by medical device manufacturers, and to serve a 
        ``rumor control'' function regarding devices.
 Recently, John Koskinen, chairman of the President's Council 
        on Year 2000 Conversion, mentioned the possibility of creating 
        a contingency fund from which states (in the case of Medicaid, 
        for example) or hospitals could draw monies needed to continue 
        operating in case of a Y2K disruption. We support that 
        principle, and would be glad to be a part of any discussions 
        concerning how such a fund should be set up.
 MedPAC has included in its hospital prospective payment system 
        update recommendation for fiscal year 2000 an additional 0.5 
        percent to cover hospitals' costs of becoming Y2K compliant. We 
        ask Congress to increase the congressionally mandated hospital 
        update factor by 0.5 percent to reflect this MedPAC 
        recommendation.
                               conclusion
    America's hospitals and health systems, their state associations, 
and the AHA are partners in the effort to prepare for the Year 2000. We 
believe that most manufacturers are being forthcoming and complete in 
their assessments of the medical devices they provide to hospitals. We 
look forward to continuing our work with you, the FDA, and medical 
device manufacturers in ensuring a smooth--and healthy--transition into 
the new millennium.

    Mr. Upton. Thank you very much.
    I will recognize first the vice chair to the subcommittee, 
Mr. Burr, for 5 minutes.
    Mr. Burr. Thank you, Mr. Chairman.
    Mr. Smith, let me commend HIMA for I think going above and 
beyond what associations are set up, but with Y2K we have got 
somewhat of a circumstance we have never been faced with 
before. I think it is wise for the association to engage to the 
degree that they have, and I am hopeful that will be in a form 
of a partnership as well, but the Federal Government will do 
equally their share.
    Let me just ask you, going back to this point where we 
begin to panic, if in fact we have a product in the marketplace 
that is non-compliant, can the manufacturers handle some type 
of recall in 90 days?
    Mr. Smith. As I listened to that earlier discourse, I was 
struck with the fact that perhaps one manufacturer could handle 
a recall in 90 days. I am not so sure that many, many multiple 
manufacturers could handle the recourse in that case.
    Mr. Burr. And the fact is that we don't know whether we 
will have any problems, or whether we will have 10 problems, or 
whether we will have 100 problems. Is that a pretty safe 
assumption right now?
    Mr. Smith. It is a safe assumption that we don't know that. 
I think it is a safe assumption as well that we are all working 
to mitigate those problems such that we have many fewer than 
most.
    Mr. Burr. And I think----
    Mr. Smith. I would like to add one more thing--I am sorry.
    Mr. Burr. Yes, sir.
    Mr. Smith. And that is that I think we have lost, to some 
degree, the ideology that, as the year 2000 gets closer, there 
is much more focus and effort put on trying to solve issues 
associated with the year 2000. It is very common-sensible to me 
that a year ago, having not been as focused on the problem, we 
see things in a certain way. A year later, 6 months later, the 
dynamic nature of this, we are making tremendous strides, I 
think, maybe exponential strides, to continue to address 
things. I think that is true throughout the healthcare arena, 
by the way.
    Mr. Burr. I think one of the responsibilities of this 
committee is to instill the same sense of urgency----
    Mr. Smith. I agree.
    Mr. Burr. [continuing] in all areas of the Federal 
Government.
    Let me ask you, Ms. Williams, who do you think as far as 
Federal agencies has the oversight over this issue as it 
relates to hospitals? Who would you expect to contact you 
relative to Y2K-compliance issues from the Federal Government?
    Ms. Williams. Probably the FDA. Possibly the HCFA, but 
primarily FDA.
    Mr. Burr. Mr. Nunn?
    Mr. Nunn. I think that the best source of communication 
will come from the manufacturer. The most effective source, if 
we do get communicative from the government, I think it is the 
FDA.
    Mr. Burr. Do you see the FDA by design or just because 
nobody else wants to deal with it as the oversight agency?
    Mr. Nunn. Yes.
    Mr. Burr. It wasn't a yes or no, but I will take it by 
design.
    I ask those specifically for Dr. Shope, because he is here, 
interested enough to stay, and I think it is important that 
they understand how hospitals look at FDA's role relative to 
the Y2K, when they go back and try to answer some of these 
questions.
    Ms. Williams, for a hospital that has not done what 
Columbia has done, gone through, looked at the number of items, 
looked at contacting manufacturers, and asked for proof of 
compliance to determine how many potential problems you may 
have in your facilities, let us assume that today they got that 
sense of urgency; can they go through the process that Columbia 
has between now and January 1, 2000?
    Ms. Williams. I would say it would depend on the size of 
the hospital. I mean, if they had a very focused effort. But 
again, it is going to depend on the size of the hospital, the 
number of----
    Mr. Burr. You said for Columbia you started working in 
1996, or at least you began to identify the problems in 1996. 
Is it realistic that there is a hospital that has the 
capabilities in a 7-month period now to actually go through and 
evaluate all their devices?
    Ms. Williams. I would say it would be difficult, but if 
they applied proper resources and, you know, very focused 
efforts.
    Mr. Burr. The smaller the hospital, the fewer the 
resources; the larger the hospital, the more the resources, but 
larger hospitals also have more equipment.
    Ms. Williams. It would be difficult.
    Mr. Burr. Okay. Let me ask you about the FDA clearinghouse 
real quick, because you made some statements, ``although we 
understand the FDA has established a clearinghouse of medical 
devices.'' That statement leads me to believe that you haven't 
even looked at the website.
    Ms. Williams. We have looked at it. We do not rely on it as 
our primary resource. We rely on the manufacturers.
    Mr. Burr. Have you used it in any way as a resource?
    Ms. Williams. Not as a primary resource. We have looked at 
it.
    Mr. Burr. Have you used it as a secondary resource other 
than to just look at it? I would like you to be as honest as 
you can, because I think there is a tremendous reliance at the 
FDA on the clearinghouse as a search, and if it is not 
something that hospitals--I say that in a broad way--are 
utilizing today, I think it is important that we point it out 
to the FDA, so that they can plan accordingly.
    Ms. Williams. As I said, we rely primarily on the 
manufacturers, and our primary use of the FDA website is for 
addresses of the manufacturers, and so forth.
    Mr. Burr. Mr. Nunn, would you like to comment?
    Mr. Nunn. We have used the FDA website. Talking to our 
clinical engineers, they do use it as an information source. 
They also like that you can click into the manufacturer data 
bases when you are in and researching particular information.
    Mr. Burr. If you identified something through the 
clearinghouse, is the likelihood that you would stop there if 
it expressed some concern, or would you then contact 
manufacturer?
    Mr. Nunn. No, we are working directly with the 
manufacturers. We consider them to be our prime source of 
information.
    Mr. Burr. So it is not a one-stop shop?
    Mr. Nunn. That is correct.
    Mr. Burr. I see that my time has run out. Let me just thank 
all three of our panelists today. I can ensure you that it is 
our intent to serve as a facilitator in making sure that sense 
of urgency, but also that the resources are available for that 
partnership between the private sector and the Federal 
Government. So that everybody can have the assurance, not just 
the size of Columbia, or your facility, Mr. Nunn, but also 
right down the rural health clinics that many of us have 
throughout our districts.
    With that, Mr. Chairman, I yield back.
    Mr. Upton. Thanks. The Chair recognizes Mr. Klink.
    Mr. Klink. Thank you, Mr. Chairman.
    Let me ask each of you, the GAO has argued that the FDA 
should not necessarily rely on medical device manufacturers' 
certification of Y2K compliance. Instead, the GAO has advocated 
the FDA itself certify such testing has been completed and then 
review the results themselves. So my question is, do you think 
that the manufacturers' certificate certifying Y2K compliance 
is enough or is it trustworthy, or do you think the FDA needs 
to go behind such certification and review the data itself? Let 
me start with you, Mr. Smith.
    Mr. Smith. From my perspective, I believe we have been 
doing this all along from an industry perspective for many 
years prior to Y2K. And therefore, I think the information that 
is there is sufficient and should be sufficient. I think the 
GAO request to go beyond that on behalf of Y2K, quite frankly, 
is another intervening step. I understand their concern, but at 
the same time I think there is a process in place that has been 
in place for a long time that has met both the industry's needs 
and, more importantly, met the needs of patients during that 
time as well.
    Mr. Klink. Thank you. Ms. Williams.
    Ms. Williams. We agree with that.
    Mr. Klink. Mr. Nunn.
    Mr. Nunn. Yes, I agree with that.
    Mr. Klink. You concur?
    Is there a role that all--let me go back and ask each of 
you and maybe start with you, Mr. Nunn. Do you see a role for 
the FDA in reviewing any of these compliance certificates? What 
role would you think the FDA should have?
    Mr. Nunn. I agree with Dr. Shope that the FDA's role is in 
the assurance that their process is appropriate rather than 
individually looking at equipment. And if there is some 
specific equipment, in terms of high-risk equipment, that it is 
felt that an additional level of diligence is required, I would 
be supportive of that.
    Mr. Klink. Ms. Williams, you concur? Mr. Smith?
    Mr. Smith. I would agree with Dr. Shope's comments that the 
issue is probably the critical items in that--again, while I 
don't think it is necessarily based on the process that goes 
on, the 60 categories that he referenced being critical, et 
cetera, if the FDA feels that is where they should go from a 
HIMA perspective, and certainly from a Baxter perspective, we 
would be very supportive of that.
    Mr. Klink. Ms. Williams, what particular types of equipment 
do you think, at the present time, we should be most concerned 
about regarding Y2K compliance?
    Ms. Williams. I have my colleague, Don Workman, here with 
me who is very technically oriented in this regard. Might I 
defer that question to him?
    Mr. Klink. Mr. Chairman, is that fine?
    Mr. Upton. Sure.
    Mr. Klink. Pull a chair up, sir. Welcome to the committee.
    Mr. Workman. Kind of like Thanksgiving.
    Mr. Klink. If you are the turkey, right?
    Invited to a party.
    Mr. Workman. If I understood the question or heard it 
correctly, what types of devices should we be concerned about?
    Mr. Klink. Yes, what devices should we be most concerned 
about concerning Y2K compliance?
    Mr. Workman. We have a classification system that has 
categorized approximately 700 medical device categories. We are 
focused on the mission-critical in level one. These are devices 
that would have some sort of impact on patient safety or 
patient care--either deliver care to a patient; they are 
electrically charged in some way, shape, or fashion, or a 
failure of these devices would impact patient safety or 
business continuity.
    Mr. Klink. Does anyone else, Mr. Smith or Mr. Nunn, have 
anything to add to that?
    Mr. Nunn. No.
    Mr. Smith. No.
    Mr. Klink. You concur?
    The GAO mentions in their testimony some hospitals have had 
their own in-house compliance engineers test biomedical 
equipment that they believe is the most susceptible to the Y2K 
bug. These hospitals reportedly told GAO that this was proper 
due diligence regarding Y2K testing. This seems to imply that 
hospitals not doing this type of in-house testing are somehow 
being negligent with regard to the public's health and safety. 
Do you believe that every user of a biomedical device should be 
doing their own testing? In other words, is there a certain 
group of providers such as hospitals that should be doing their 
own in-house testing?
    I will start with you, Mr. Smith.
    Mr. Smith. I think, as I mentioned earlier Congressman, I 
don't think they do. I think the process is in place, and has 
been in place for quite a while for medical device 
manufacturers, per the FDA, to meet those standards. We follow 
good manufacturing practices; we have for a long time, and I 
think this has become an issue simply because we are dealing 
with the year 2000. Left to our own device, this would be going 
on as it has many years prior to this.
    Mr. Klink. Ms. Williams.
    Ms. Williams. We agree with that.
    Mr. Klink. You don't have your own in-house biomedical 
engineers at Columbia?
    Ms. Williams. We do, but we are not----
    Mr. Klink, Can you pull the microphone over a little bit?
    Ms. Williams. We do have biomedical engineers, but we are 
not testing every piece of equipment ourselves. We are relying 
on the information that we got from the manufacturers.
    We visited a number of manufacturers in order to understand 
the information that they are providing to us that we asked for 
their testing protocols when we did this compliance survey. So, 
we are, with the exception of those 800 pieces of equipment 
that we don't have answers on, we continue to try to get 
answers on that equipment, and if we don't, then we will make a 
determination what level of testing we need to do there. But, 
otherwise, we are relying on the manufacturer.
    Mr. Klink. Can you tell me how you determine what it is you 
test and how that is decided?
    Ms. Williams. We have relied upon the manufacturers and an 
understanding of their testing protocols. The 800 pieces of 
equipment that we have not received information on we continue 
to try to go back to the manufacturer and receive information. 
If we don't, probably in the third quarter we will determine 
what level of testing we need to do on that equipment based 
upon the impact of the equipment on patient care.
    Mr. Klink. Let us forget about Y2K for 1 second. I assume 
that you didn't just hire these biotechnical engineers because 
the year 2000 is coming up; they work for you?
    Ms. Williams. Right.
    Mr. Klink. At other times, how would you determine what you 
would have them test?
    Ms. Williams. I need to defer that to----
    Mr. Klink. That is fine. Do they test everything that comes 
in or there is certain protocol as to what equipment they test?
    Mr. Workman. No, sir. When the manufacturers come in and do 
software upgrades or bring in new pieces of equipment, we 
depend on the manufacturer to certify that that equipment is 
ready for patient safety or patient care.
    Mr. Klink. Then, how do you determine what it is your 
people are going to test?
    Mr. Workman. We are following the ECRI guidelines. ECRI is 
a sort of the Consumer Reports for medical device testing. They 
came out with a position that said that, in the absence of 
adequate manufacturers' compliance information, a limited 
testing strategy should be put in place. Our program is focused 
on mission-critical and level one and we are going to follow a 
three-step process. Originally, we would hope that the original 
equipment manufacturer would test for us. If we are unable to 
do that, we are going to bring in an authorized service 
provider for that manufacturer, and if we can't get to that 
level, then we signed a contract with General Electric for 
their biomedical folks to come in and help test devices for us.
    Mr. Klink. What does this say about the hospitals that are 
not doing this testing? Do they count on hospitals the size of 
Columbia to do this kind of testing? And is this information 
shared with other hospitals? And if other hospitals are doing 
tests, is that made available to you?
    Mr. Workman. I am not aware of a source for that type of 
information.
    Mr. Klink. Well, let me go back to the first part of my 
question. Does this make any statement about other hospitals 
that don't have the biotechnical engineers or biomedical 
engineers on staff, and aren't able to do the kind of testing 
that you do? I don't want to put you in a bad place; it just 
raises a question to me.
    Mr. Workman. I can express a personal opinion. I think some 
of those hospitals are going to have some problems meeting the 
deadline, given the 7 months that are left.
    Mr. Klink. Thank you very much.
    Mr. Chairman, I see the red light is on also.
    Mr. Upton. Thank you.
    Mr. Smith, first of all, I want to commend the work of 
HIMA, and with your testimony, congratulations certainly are 
deserved as you look at 100 percent compliance with your 
association and your ability to reach out. I think that is 
really terrific, and I want to thank you for that.
    Mr. Smith. Thank you.
    Mr. Upton. You know, as I think about my own congressional 
district, it is really a lot--it is a microcosm, I think, of 
the real Nation in terms of a blend between urban and rural. We 
have got small hospitals and larger ones like Bronson and 
Borges, which I certainly know, Mr. Nunn, you are familiar 
with. There has been a lot of association work, a lot of 
communication between the hospitals, whether they are 
affiliated or not, in terms of how to comply with a number of 
different things.
    Do you feel that the State associations have done a pretty 
good job, and what relationship has Henry Ford had with some of 
the hospitals that it has on the other side of the State from 
me?
    Mr. Nunn. We have been in communication with the State 
associations. There has been work on the issue and education 
around the issue, those kinds of things. We have met with 
hospital groups. In fact, we are meeting next week with a group 
of hospitals in the metropolitan Detroit area on this issue. 
Ultimately, though, I believe when it comes down to your 
devices and what your plans are for your devices, it becomes 
much more focused on the issues as they have been discussed 
here today, which is communication between the manufacturers, 
potentially FDA, and yourself, and what your plans are for your 
devices.
    I think there has been, though, from what I can see, and in 
my discussions with our people who are involved in this, 
extensive communications with people outside of our hospital 
and other hospitals, whether it is trade groups, associations, 
at conventions. This has been on the agendas at conventions to 
be talking about it. So I think that communication has been 
there, but it won't drive the answer, which I think is between 
us and manufacturers.
    Mr. Upton. Do you think that the hospitals have had some 
feeling that they have had to reinvent the wheel, or do you 
think because of the association and the cooperation with other 
hospitals, whether they be in the region or system that they 
might be affiliated with, that it has been a pretty good 
relationship?
    Mr. Nunn. I think it has been a good relationship. It 
certainly was not our intention to reinvent the wheel, but to 
use the information that was out there and bring it into our 
organization and have it work for us. I think the information 
is there for people to do that.
    Mr. Upton. Ms. Williams.
    Ms. Williams. We have worked actively with the federation 
members as well as the American Hospital Association and 
another group called ODEN, which is a research and advisory 
group dedicated to healthcare technology issues. Members of 
that group are equipment manufacturers, pharmaceutical 
companies, payers, and other providers, and we have worked 
within that group across the industry on the medical device 
issues as well as contingency planning. So we have been active 
in a lot of groups in terms of information-sharing and 
coordinated planning.
    Mr. Upton. You know, one of the questions that I have asked 
a number of my folks back home as they prepare for Y2K, they 
always seem to say we think we are going to be okay as long the 
power stays on or, you know, a variety of other units have made 
their successful effort. There has been talk about hoarding of 
supplies. You see that in the news media as well. Have the 
hospitals made any real effort, do you think, to hoard supplies 
in fear that the supply train may have some problem beginning 
January 1?
    Mr. Nunn. Our pharmacy is working with the other pharmacy 
departments at other hospitals around the Detroit area, in 
conjunction with the manufacturers in the supply chain, to 
ensure that there is not a disruption in the supply chain for 
pharmaceuticals, because pharmaceuticals, in particular, the 
supply chain is long. If there is hoarding, there could be a 
problem. So we are working with the appropriate people to 
prevent that from happening. So I think there is recognition of 
the supply chain issues, and work is going on in those.
    I think that one of the areas that support can be given is 
in helping manage the rumors and not having a panic situation 
going into the fourth quarter. If the public is convinced that 
the sky is falling, it will be very difficult, and there will 
be hoarding going on, and I think accurate information being 
distributed so that we are not a society in panic would be very 
helpful in this regard.
    Mr. Upton. Thank you. My light is on and I will recognize 
the chairman of Health and Environment, Mr. Bilirakis.
    Mr. Bilirakis. Thank you, Mr. Chairman.
    I did want to put into record that Dr. Shope is here to 
hear your testimony, and I think that is always very helpful. 
We appreciate your staying, Doctor.
    Well, let us see, Baxter, your company is a global 
company----
    Mr. Smith. Yes.
    Mr. Bilirakis. [continuing] and you have shared with us 
some apparently good work that your company is doing regarding 
addressing this issue. But you do business, as I understand it, 
in over 100 countries?
    Mr. Smith. We do.
    Mr. Bilirakis. Yes, all right, and I don't want you to give 
me any details, but would you say that you are basically being 
prepared or are prepared insofar as the global is concerned?
    Mr. Smith. We have taken the same process in the other 
countries we have taken in the United States, which is from a 
business contingency plan perspective. We have gone out and 
contacted our customers and contacted all the elements, if you 
will, associated with making sure that we can provide 
consistent supply of products in that country. That could be 
something as broad as talking with the customs folks to making 
sure that the import/export activities don't go down as a 
result of a Y2K problem, or something as small as looking at a 
particular product that we only sell in that particular 
country.
    Mr. Bilirakis. Well, how about a medical device that is 
manufactured in one of these other countries. I suppose maybe 
we could have asked FDA that, but in terms of, you know, their 
cooperation, compliance, and things of that nature, what can we 
anticipate there?
    Mr. Smith. From a Baxter----
    Mr. Bilirakis. And I really don't know off the top of my 
head what device I could be referring to, but I would assume 
there are some out there that have been approved that are being 
used by Americans but manufactured elsewhere.
    Mr. Smith. I probably would defer that question to Dr. 
Shope, because I think he is probably better suited to answer 
it. From a Baxter perspective, those plants outside the United 
States where we do make medical devices fall into the same 
provisions as plants that we manage within the United States. 
So we run them just the same way.
    Mr. Bilirakis. You run them?
    Mr. Smith. Meaning we follow the same manufacturing 
practices.
    Mr. Bilirakis. If they are your plants, but if they are not 
your plants?
    Ms. Williams, I know that, and I am not just referring to 
Columbia, but a lot of hospitals around the country, certainly 
many in my area, are having problems these days. What BPA 97 
did to them--I know Herb Katz would want me to make that 
comment. And you know, in other words, they are having some 
problems. So, I know that this is an additional load, because 
obviously there is going to be some finances involved here.
    With all that Columbia apparently has done, I think you 
have said that it has been done in cooperation with the 
American Hospital Association and with other groups. Is that 
right?
    Ms. Williams. Right. That is right.
    Mr. Bilirakis. Well, Mr. Nunn, you said that while all of 
your devices--I don't know that I am quoting you correctly--may 
not be compliant in your hospitals, but all of your hospitals 
will be, or words to that effect.
    Mr. Nunn. Yes.
    Mr. Bilirakis. What do you mean by that?
    Mr. Nunn. If we have a device that we cannot get certified 
or determine that it is compliant, we will be prepared to 
either retire it from service or have a workaround. We know 
that some of our EKG machines will not be technically 
compliant, and we will have a workaround in place, so that that 
does not impact the patient or our storage of information, 
which is really the----
    Mr. Bilirakis. So, you are basically saying that you feel 
that your hospitals will be completely up to par by the year 
2000, by January 1, 2000. So all of the medical devices may not 
be, but your hospitals will be----
    Mr. Nunn. Yes.
    Mr. Bilirakis. [continuing] will be alert, et cetera?
    Mr. Nunn. Yes.
    Mr. Bilirakis. That is what you are saying. Now, you know, 
I think I have kind of expressed it here; sure, we are 
concerned about the FDA role and things of that nature, but we 
also express, I think, maybe even more concern with devices at 
the hospital level, and rural healthcare, and, of course, in 
the homes, and that sort of thing.
    What is the percentage of hospitals that belong to the 
American Hospital Association? I mean, they don't all belong to 
the AHA?
    Mr. Nunn. No. There are 5,000 hospitals in the American 
Hospital Association.
    Mr. Bilirakis. But there is a lot more than 5,000 hospitals 
out there.
    Mr. Nunn. Yes.
    Mr. Bilirakis. So you are working with your hospitals?
    Mr. Nunn. That is correct.
    Mr. Bilirakis. How about all the others that are not 
members of the AHA? In terms of being ready?
    Mr. Nunn. I can't comment on their----
    Mr. Bilirakis. This is not a pitch now for the American 
Hospital Association, although I would suggest probably a good 
idea that they all be members.
    Well, all right, my time is up, but you know we are really 
concerned about this and I am not sure--I mean, frankly, I am a 
little more optimistic in listening to you all. I am not saying 
that FDA has lowered that optimism somewhat, but I guess I see 
a gap there, particularly when it involves the hospitals, home 
health, and whatnot, which FDA apparently does not have overall 
jurisdiction responsibility for, and we not just really sure 
who is going to cover that gap. That is really what concerns 
me, I guess, more than anything else.
    Well, we may have further questions. I was really going to 
ask these good people for some hard data on some of the things 
they have been telling us, but at this point, again, I don't 
want to add just make-work to their heavy responsibilities in 
this regard. If we request that, we will do so at another time 
and give you an opportunity to respond.
    Thank you very much. Thank you, Mr. Chairman.
    Mr. Upton. Thank you, Mr. Chairman.
    And I, again, appreciate the testimony from the witnesses, 
all the witnesses on both panels this morning. And we do have 
four votes in a row on the House floor, so we are going to be 
scurrying over there, but this hearing is now adjourned. Thank 
you.
    [Whereupon, at 12:49 p.m., the subcommittees were 
adjourned.]
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