oversight

Year 2000 Computing Challenge: Much Biomedical Equipment Status Information Available, Yet Concerns Remain

Published by the Government Accountability Office on 1999-05-25.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                          United States General Accounting Office

GAO                       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.
                          YEAR 2000 COMPUTING
Tuesday,
May 25, 1999              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
             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.

             2The 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 1                                                                          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 chromatographs4 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 2                                                                         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         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
Equipment Status        comprehensive, centralized source of information on the compliance status
Information Available   of biomedical equipment used in the United States and make this
                        information publicly available on a web site. However, at the time, FDA
in FDA Clearinghouse    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.

                        6These 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 3                                                                           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 4                                                                      GAO/T-AIMD-99-197
Figure 1: Biomedical Equipment Compliance-Status Information Reported to FDA by
Manufacturers as of May 10, 1999




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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




Page 5                                                                             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              Last September, we expressed concern that FDA relied on manufacturers
                        alone to validate, test, and certify that their medical devices were Y2K
Considering Reviewing   compliant.10 Further, we said, since FDA did not require manufacturers to
Manufacturers’          submit test results certifying compliance, the agency lacked assurance that
                        manufacturers have adequately addressed the Y2K problem for
Certifications          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.

                        10Year
                             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 6                                                                        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 7                                                                          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         While information is available on the Y2K compliance status of biomedical
                       equipment through the FDA clearinghouse and other sources, it is not clear
Biomedical Equipment   at this time how extensively health care providers are using this
Compliance of Health   information to determine their Y2K readiness. According to FDA, it has
                       taken steps to make users aware of the clearinghouse. For example, FDA
Care Providers         has published articles in professional trade journals and participated in
Incomplete             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 8                                                                           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

                                                                       Percentage
Entity performing                                                      responding       Percentage
survey/group                    Number            Number of               currently responding not
surveyed                       surveyed           responses              compliant       applicable
HHS Office of the
Inspector Generala
(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                   2,000                  583                      6                     n/a
Association (AHA)
(February 1999)
                                                                                    b
American Medical                    7,000                  522                                            n/a
Association (AMA)
(February 1999)
American Health                   12,000                   342                    24                      28
Care Association
(AHCA)a
(March 1999)
                                                                           (Table notes on next page)




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.




Page 9                                                                             GAO/T-AIMD-99-197
                   aThe   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)   Leter   Page 10                                                                           GAO/T-AIMD-99-197
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