Year 2000 Computing Challenge: Concerns About Compliance Information on
Biomedical Equipment (Testimony, 06/10/1999, GAO/T-AIMD-99-209).

Can medical devices--from magnetic resonance imaging systems to x-ray
machines to pacemakers--be depended on to work reliably on and after
January 1, 2000? To the extent that biomedical equipment uses computer
chips, it is vulnerable to the Year 2000 problem. The Food and Drug
Administration (FDA) is collecting information from manufacturers of
medical devices and scientific and research instruments and is posting
this information on the Internet. In addition, the Veterans Health
Administration has taken the lead in determining the Year 2000
compliance status of biomedical equipment and is sharing this
information with FDA. This testimony discusses (1) the status of FDA's
Federal Y2K Biomedical Equipment Clearinghouse, (2) the compliance
status information on manufacturers' web sites referred to in FDA's
clearinghouse, (3) FDA's efforts to address GAO's recommendation to
obtain and review the test results supporting manufacturer's compliance
certifications for critical care and life support medical devices, and
(4) the biomedical equipment compliance status of health care providers.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-AIMD-99-209
     TITLE:  Year 2000 Computing Challenge: Concerns About Compliance
	     Information on Biomedical Equipment
      DATE:  06/10/1999
   SUBJECT:  Clearinghouses (information)
	     Systems conversions
	     Computer software verification and validation
	     Medical information systems
	     Embedded computer systems
	     Computer software
	     Medical equipment
	     Strategic information systems planning
	     Y2K
IDENTIFIER:  Y2K
	     FDA/VHA Federal Year 2000 Biomedical Equipment
	     Clearinghouse

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Ai99209t.book GAO

United States General Accounting Office

Testimony

Before the Special Committee on the Year 2000 Technology Problem,
U.S. Senate

For Release on Delivery Expected at 9:30 a.m. Thursday, June 10,
1999

YEAR 2000 COMPUTING CHALLENGE

Concerns About Compliance Information on Biomedical Equipment

Statement of Joel C. Willemssen Director, Civil Agencies
Information Systems Accounting and Information Management Division

GAO/T-AIMD-99-209

Page 1 GAO/T-AIMD-99-209

Mr. Chairman and Members of the Committee: 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.

Responsibility for oversight and regulation of medical devices,
including the impact of the Y2K problem, lies with FDAan 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
providerhas taken a leadership role in determining the Y2K
compliance status of biomedical equipment by sharing with FDA
information it obtained from manufacturers.

My testimony today will discuss (1) the status of FDA's Federal
Y2K Biomedical Equipment Clearinghouse, (2) compliance status
information on manufacturers' web sites referred to in FDA's
clearinghouse, (3) FDA's efforts to address our recommendation to
obtain and review the test results supporting manufacturers'
compliance certifications for critical care/life support medical
devices, and (4) information on the biomedical equipment
compliance status of health care providers.

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 As is widely known by now, 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.

3 A component of the Department of Veterans Affairs (VA).

Page 2 GAO/T-AIMD-99-209

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 datasome of which may include
medical devices, such as pacemakers, that are implanted in
patientsand 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 benignsuch as incorrect formatting of a printoutto the most
seriousincorrect 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.

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.

4 Such instruments are used to separate the components of a
solution with heat and measure their relative quantities.

Page 3 GAO/T-AIMD-99-209

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 safetyidentified by FDAinclude
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.

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 to 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 specific information
on the make and model of compliant equipment.

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 that 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

5 Such equipment allows therapeutic apheresisthe exchange or
purification of blood plasma. Therapeutic apheresis is recognized
as a successful treatment for more than 40 autoimmune diseases.

6 These devices use computer calculations of gestational status to
help assess the risk of neural tube defects in the fetuses of
pregnant women.

7 Year 2000 Computing Crisis: Leadership Needed to Collect and
Disseminate Critical Biomedical Equipment Information (GAO/T-AIMD-
98-310, September 24, 1998).

Page 4 GAO/T-AIMD-99-209

clearinghouse identify 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, FDAin 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, 4,142 biomedical equipment
manufacturers had submitted data to the clearinghouse as of June
1, 1999.

Based on the data submitted, FDA places a manufacturer into one of
four categories:

 Products that do not employ a datemanufacturer that reported Y2K
status to be All Products Do Not Use a Date.  Products that are
all compliantmanufacturer that reported products

as Y2K compliant.  Products with date-related problemsmanufacturer
that reported its

Y2K status to be Products With Date Related Problem.  Product
status is on the manufacturer's web pagemanufacturer that

reported its Y2K status to be Product Status Specified on a (Web)
Page.

As shown in figure 1, as of June 1, 1999, about 61 percent of the
manufacturers reported having products that do not employ a date,
while about 8 percent (311 manufacturers) reported having date-
related problems such as incorrect display of date/time. According
to FDA, the 311 manufacturers reported 897 products with date-
related problems.

8 The clearinghouse can be found on the World Wide Web at
http://www.fda.gov/cdrh/yr2000/ year2000.html.

Page 5 GAO/T-AIMD-99-209

Figure 1: Biomedical Equipment Compliance- Status Information
Reported to FDA by Manufacturers as of June 1, 1999

Note: Total number of manufacturers = 4,142. Source: FDA.

FDA accepts references to manufacturers' web sites for compliance
information rather than requiring individual submissions to the
clearinghouse; 427 manufacturers provided FDA with links to their
web sites as of June 1. However, FDA stated that it did not know
the total number of biomedical equipment products reported by
these manufacturers, or how many of them were noncompliant. Also,
according to FDA, 192 manufacturers have not yet responded.

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.

2 ,51 2 892

311 427

0 500

1 ,000 1 ,500

2 ,000 2 ,500

3 ,000 Number o f m an ufactu rers

Products do not employ a date

All products are compliant Products with date

related problems Product compliance stat

us reported in manufacturer's

web site

Page 6 GAO/T-AIMD-99-209

However, according to FDA, on March 3, 1999, it requested
information on specific product types for those products with
date-related problems. FDA told us it is now receiving updated
data.

FDA has also expanded, in response to our recommendation, data 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 complete
lists of individual product models that are Y2K compliant.

Quality of Compliance Information on Manufacturers' Web Sites
Varies Significantly

Because FDA could not provide detailed information on the
compliance status of products listed on manufacturers' web sites,
at the request of the Committee we reviewed these web sites.
Specifically, we obtained from FDA's clearinghouse a listing of
the manufacturers referring users to their web sites, downloaded
information from these sites, and reviewed this information to
identify the total number of biomedical equipment products
reported, and categorized their compliance status. 10 We also
reviewed the information reported on the manufacturers' web sites
to determine its quality in terms of clarity and completeness.

As of June 1, 1999, FDA's clearinghouse listed 427 manufacturers
referring users to their web sites. Of this total,

 328 manufacturers reported compliance status information for at
least 35,446 individual biomedical equipment products; 11

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.

10 We summarized the results of our review in four compliance
categoriesproducts that do not employ a date, products that are
compliant, products that are noncompliant, and products whose
compliance status is currently unknown. This last category
includes those manufacturers who reported that they have not
completed an assessment of their products, have discontinued a
product, or have a product that is now obsolete.

11 This includes medical devices, scientific and research
instruments, and other supporting products, such as printers and
software.

Page 7 GAO/T-AIMD-99-209

 33 manufacturers reported information under a parent company
included in the list of 328 manufacturers;  3 manufacturers' web
site links in FDA's clearinghouse did not work; 12

 42 manufacturers' web sites contained insufficient information on
the number of products and their compliance status;  18
manufacturers' web sites did not clearly distinguish biomedical

equipment from nonbiomedical products; and  3 of the listed
manufacturers are actually distributors of products, such

as scientific equipment, video camera recorder, printers,
chemicals, and furniture.

Because of the limitations cited above for many of the
manufacturers' web sites, our ability to determine the total
number of biomedical equipment products reported and their
compliance status was impaired. Accordingly, the actual number of
products reported by these manufacturers could be significantly
higher than the 35,446 products that we counted.

As shown in figure 2, our analysis of the 35,446 products
indicates that over half of these reportedly do not employ a date,
while just under one-third of the products are considered
compliant. About 4,445, or 12.5 percent, are considered
noncompliant by the manufacturer.

12 According to FDA, the contractor assisting it with the
clearinghouse verified two of these web site links as operable.

Page 8 GAO/T-AIMD-99-209

Figure 2: Biomedical Equipment Compliance- Status Information
Reported on Manufacturers' Web Sites as of June 1, 1999

Note: Total number of products = 35, 446. Source: GAO analysis of
manufacturers' web sites.

The 4,445 reported noncompliant products on their web sites is
almost five times the number of individual noncompliant products
(897) that manufacturers reported to FDA's clearinghouse. The
compliance status of the remaining 1,324 products was unknown for
reasons such as the manufacturer's ongoing assessment of the
product.

Examples of noncompliant products reported by manufacturers on
their web sites included a bedside monitor, film digitizer,
ultrasound systems, radiology information systems, and laboratory
information systems. For these noncompliant products, in many
cases the manufacturer provides users with solutions to correct
the problem, such as software upgrades and manual calculations.

18,466 11,211

4,445 1,324 0 2,000

4,000 6,000

8,000 10,000

12,000 14,000

16,000 18,000

20,000 Number of

products

Product does not employ a date

Product is compliant Product is noncompliant

Product compliance status is currently unknown

Page 9 GAO/T-AIMD-99-209

The quality of the information on the manufacturers' web sites
varied significantly, ranging from general assurances of
compliance to detailed information on specific product make and
model. For example:

 A manufacturer reported that its products had no Y2K issues, but
it did not identify the products.  A manufacturer reported that it
was still assessing its products, and did

not provide any detailed information on its web site.  A
manufacturer did not list any of its products but did report that
the

only Y2K problem it was having was with the software it used to
run its business.  A manufacturer listed about 65,000 products,
but did not sort them by

type so that the biomedical products could be easily identified.
A manufacturer reported that for its 279 products, 79 were
compliant,

50 were noncompliant, the status of 43 was currently unknown, and
107 were not affected by the Y2K problem. It also provided
solutions for its reported noncompliant products.  A manufacturer
reported compliance information for 70 products, by

make and model. Of these, 53 were compliant, 14 were noncompliant,
2 products were currently under assessment, and Y2K did not apply
to 1 product. It also provided solutions for various noncompliant
products, including information on the availability of solutions
and whether to replace the noncompliant product.

In addition, at least nine manufacturers noted that some of their
products were obsolete. Of these, four manufacturers indicated
that they had not or would not assess such products for
compliance, three stated that they would not support obsolete
products, and two did not list their obsolete products. Obsolete
products reported by these manufacturers include defibrillators,
chemistry analyzers, and blood gas analyzers.

It is critical that users have specific information on product
make and model to determine the compliance status of their medical
devices. Accordingly, FDA should request that manufacturers who
have not already provided this information to the clearinghouse
include this on their web sites. FDA should also consider having
its clearinghouse contractor verify that manufacturers are
providing information on product make and model.

Page 10 GAO/T-AIMD-99-209

FDA Is Planning to Review 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. 13 Further, we said, since FDA
did not require manufacturers to submit test results certifying
compliance, the agency lacked assurance that manufacturers had
adequately addressed the Y2K problem for noncompliant devices.
Accordingly, we recommended that HHS and VA take prudent steps to
jointly review manufacturers' test results for critical care/life
support biomedical equipment. We were especially concerned that
HHS and VA review test results for equipment previously determined
to be noncompliant but now deemed by manufacturers to be
compliant, or equipment 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.

In its response to our draft report, HHS did not agree 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. 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. Similarly,
VA stated that it had no legislative or regulatory authority to
implement the recommendation to review manufacturers' test
results.

In contrast to this position, several hospitals in the private
sector consider testing of biomedical equipment 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 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

13 Year 2000 Computing Crisis: Compliance Status of Many
Biomedical Equipment Items Still Unknown (GAO/AIMD-98-240,
September 18, 1998).

Page 11 GAO/T-AIMD-99-209

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,
14

manufacturers are best qualified to analyze embedded systems or
software to determine Y2K compliance. Further, they 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.

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.

FDA has subsequently changed its position. On May 25, 1999, FDA's
Acting Deputy Commissioner for Policy testified that FDA now plans
to review manufacturers' test results supporting their compliance
certifications for a sample of critical devices. Specifically,
FDA's proposal consists of two phases. The first phase is to

 develop a list of critical care/life support medical devices,
referred to as computer-controlled potentially high risk devices
(PHRD) 15 by June 1;  develop a list of the manufacturers of these
devices;  from this list of manufacturers, select a sample of
manufacturers for

review; and  hire a contractor to develop a program to assess
manufacturers'

activities to identify and correct Y2K problems with PHRDs.

14 The Emergency Care Research Institute is 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.

15 According to FDA, these devices, whose failure could result in
patient injury or failure of an intended treatment, are used in
the direct treatment or therapy of a patient and in the monitoring
of vital patient parameters, the information for which is
immediately necessary for effective treatment or necessary to
support or sustain life during treatment or patient care.

Page 12 GAO/T-AIMD-99-209

According to FDA, the second phase of the evaluation would be
undertaken only if the results of the first phase indicated that
there is a need for further review of manufacturer Y2K activities
to provide confidence that manufacturers are properly addressing
this issue. In this second phase, the contractor would review a
portion of the remaining manufacturers of PHRDs not yet reviewed.
The extent to which this review would be comprehensive and include
all manufacturers of PHRDs would depend on the types of problems
noted in the first phase. According to FDA, any manufacturer whose
quality assurance system appeared deficient based on the
contractor's review would be subject to additional review by FDA
to determine what actions would be required to eliminate any risks
posed by noncompliant devices.

We recently met with FDA's Acting Deputy Commissioner for Policy
and the Special Assistant to the Director of the Office of Science
and Technology to discuss the agency's timetable for carrying out
these tasks. The Special Assistant informed us on May 27, 1999,
that FDA had developed a draft list of computer-controlled
potentially high risk devices. This draft list currently contains
about 70 devices, including a powered emergency ventilator,
infusion pump, glucose test system, fetal cardiac monitor,
implanted spinal cord stimulator for bladder evacuation, and
radiation therapy simulation system. As of June 7, FDA officials
could not tell us when this list would be finalized, even though
the initial target date of June 1 had already been missed.

Further, although FDA has established a target date for completing
a review of the first sample of manufacturers by the end of
August, as of June 8, it had not demonstrated that it had
established milestones for completing interim steps in the
proposal. In addition, while FDA told us that the contractor's
statement of work would clearly spell out the steps in FDA's
proposal, FDA has not yet developed a statement of work. It is
critical that FDA expeditiously develop such a statement of work
and establish milestones for implementing its proposal to ensure
that the necessary work can be completed no later than August.

Page 13 GAO/T-AIMD-99-209

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 185,000 inquiries from April 1998
through May 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. 16 Except for the AMA's survey, none referred to the
FDA clearinghouse. Eleven percent of the respondents to the
AMAsurvey indicated that they were aware of the FDA clearinghouse.

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) 17 was very disappointing, at less than 3
percent.

16 These include HHS' Office of the Inspector General, the AHA,
and the AMA.

17 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.

Page 14 GAO/T-AIMD-99-209

Table 1: Survey Results of Y2K Readiness of Biomedical Equipment

a The survey instructions directed respondents to mark n/ a if a
question did not apply. b This organization represents
approximately 45, 000 physicians in more than 230 medical groups
across 40 states.

c 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. d
The survey did not ask respondents to mark n/ a if a question did
not apply. Source: Organizations listed. We did not independently
verify this information.

Entity performing survey/ group surveyed Number

surveyed Number of responses

Percentage responding

currently compliant

Percentage responding not

applicable HHS Office of the Inspector General a (December 1998)

Hospitals

Rural Urban 500

500 281 208 31

23 3 4

Nursing Facilities

Rural Urban 500

500 221 191 21

21 31 27

Home Health Agencies

Rural Urban 500

500 136 133 26

21 41 39

Physicians

Rural Urban 500

500 124 95 30

20 36 52

American Hospital Association (AHA) (February 1999) 2,000 583 6 d

American Medical Association (AMA) (February 1999) 7,000 522 c d

American Health Care Association (AHCA) a

(March 1999) 12, 000 342 24 28

American Medical Group Association (AMGA) b (March 1999) 230 99 42
d

Page 15 GAO/T-AIMD-99-209

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, a large amount
of information can be found on the manufacturers' web sites
referred to in the clearinghouse. However, the quality of the
compliance information on the manufacturers' web sites varies
significantly, ranging from general assurances of compliance to
detailed information on specific product make and model.

To identify and correct Y2K problems with potentially high-risk
devices, FDA now plans to hire a contractor to assess
manufacturers' activities. Such reviews would provide the American
public with a higher level of confidence that medical devices will
work as intended. FDA needs to establish and meet milestones for
this effort to ensure that it is finished in time.

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.

Mr. Chairman, this concludes my statement. I would be pleased to
respond to any questions that you or other members of the
Committee may have at this time.

Let t er

Page 16 GAO/T-AIMD-99-209

Contact and Acknowledgments

For information about this testimony, please contact Joel
Willemssen at (202) 512-6253. Individuals making key contributions
to this testimony included Gwen Adelekun, Nabajyoti Barkakati, Tim
Case, Michael Fruitman, Seth Goodman, Robert Kershaw, Tonia
Johnson, Linda Lambert, Helen Lew, Barbara Oliver, Michael Resser,
Glenn Spiegel, Aaron Ulm, Sonal Vashi, and Greg Yenner.

(511730) Let t er

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