Year 2000 Computing Challenge: Much Biomedical Equipment Status
Information Available, Yet Concerns Remain (Testimony, 05/25/99,
GAO/T-AIMD-99-197).

Pursuant to a congressional request, GAO discussed the year 2000
compliance status of biomedical equipment, focusing on: (1) the status
of the Food and Drug Administration's (FDA) Federal Year 2000 Biomedical
Equipment Clearinghouse; (2) the Department of Health and Human
Services' (HHS) and the Department of Veterans Affairs' (VA) positions
on GAO's 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.

GAO noted that: (1) responsibility for oversight and regulation of
medical devices, including the impact of the year 2000 problem, lies
with FDA; (2) FDA is collecting information from medical device and
scientific and research instrument manufacturers, and providing this
information through an Internet World Wide Web site; (3) in addition,
the Veterans Health Administration (VHA) has taken a leadership role in
determining the year 2000 compliance status of biomedical equipment by
sharing the information obtained from manufacturers with FDA; (4) FDA,
in conjunction with VHA, established the Federal Year 2000 Biomedical
Equipment Clearinghouse; (5) 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; (6) also, 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; (7) further, 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 descriptions of the impact of the year
2000 problem on products left uncorrected; (8) in response to GAO's
report, HHS stated that it did not concur with GAO's recommendation to
review test results supporting medical device equipment manufacturers'
compliance certifications; (9) it reasoned that submission of
appropriate certifications was sufficient, further stating that it did
not have the resources to undertake such reviews; (10) however, GAO was
not aware of HHS' requesting resources from Congress for this purpose;
(11) VA stated that it had no legislative or regulatory authority to
implement the recommendation to review manufacturers' test results; (12)
according to FDA, VHA, and the Emergency Care Research Institute,
manufacturers are best qualified to analyze embedded systems or software
to determine year 2000 compliance; (13) 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; and (14) while information is available on the year 2000
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 year 2000
readiness.

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

 REPORTNUM:  T-AIMD-99-197
     TITLE:  Year 2000 Computing Challenge: Much Biomedical Equipment
	     Status Information Available, Yet Concerns Remain
      DATE:  05/25/99
   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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1-LG-BW logo.eps GAO United States General Accounting Office

Testimony Before the Subcommittee on Oversight and Investigations
and the Subcommittee on Health and Environment,

Committee on Commerce, House of Representatives For Release on
Delivery Expected at 10 a. m. Tuesday, May 25, 1999

YEAR 2000 COMPUTING CHALLENGE

Much Biomedical Equipment Status Information Available, Yet
Concerns Remain

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

GAO/T-AIMD-99-197

  GAO/T-AIMD-99-197

Page 1 GAO/T-AIMD-99-197

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. 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.

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, 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.

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

Page 2 GAO/T-AIMD-99-197

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.

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

relative quantities.

Page 3 GAO/T-AIMD-99-197

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.

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. 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, 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 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-99-197

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.

Page 5 GAO/T-AIMD-99-197

Figure 1: Biomedical Equipment Compliance- Status Information
Reported to FDA by Manufacturers as of May 10, 1999

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

Products that do not employ a date

All products are compliant Products with date

related problems Product compliance status reported

in manufacturer's web site

Page 6 GAO/T-AIMD-99-197

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. 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.

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

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 Year 2000
Computing Crisis: Compliance Status of Many Biomedical Equipment
Items Still Unknown (GAO/AIMD-98-240, September 18, 1998). 11 Year
2000 Computing Crisis: Readiness of Medicare and the Health Care
Sector (GAO/T-AIMD-99-160, April 27, 1999).

Page 7 GAO/T-AIMD-99-197

regulatory authority to implement the recommendation to review
manufacturers' test results.

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.

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. 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.

Page 8 GAO/T-AIMD-99-197

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 that 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 from May 1998
through 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. 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, 13 These
include HHS' Office of the Inspector General, the AHA, and the
AMA.

Page 9 GAO/T-AIMD-99-197

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.

Table 1: Survey Results of Y2K Readiness of Biomedical Equipment

14 This is a federation of 50 state health organizations that
represent nearly 12, 000 nonprofit and forprofit assisted living,
nursing facility, long- term care, and sub- acute care providers.

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 n/
a

American Medical Association (AMA) (February 1999)

7,000 522 b n/ a

American Health Care Association (AHCA) a (March 1999)

12, 000 342 24 28 (Table notes on next page)

Page 10 GAO/T-AIMD-99-197

a The survey instructions directed respondents to mark n/ a if a
question did not apply. b 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.

(511756) Lett er

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