oversight

Year 2000 Computing Challenge: Concerns About Compliance Information on Biomedical Equipment

Published by the Government Accountability Office on 1999-06-10.

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

                          United States General Accounting Office

GAO                       Testimony
                          Before the Special Committee on the Year 2000 Technology

                          Problem, U.S. Senate




For Release on Delivery

Expected at               YEAR 2000 COMPUTING
                          CHALLENGE
9:30 a.m.

Thursday,

June 10, 1999




                          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
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 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
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 1                                                                          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 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.

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




             Page 2                                                                         GAO/T-AIMD-99-209
                       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 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.


Biomedical Equipment   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
Status Information     comprehensive, centralized source of information on the compliance status
Available in FDA       of biomedical equipment used in the United States and to make this
Clearinghouse          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 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 3                                                                           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, 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, 4,142 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 date—manufacturer that reported Y2K
  status to be “All Products Do Not Use a Date.”
• Products that are all compliant—manufacturer that reported products
  as Y2K compliant.
• Products with date-related problems—manufacturer that reported its
  Y2K status to be “Products With Date Related Problem.”
• Product status is on the manufacturer’s web page—manufacturer 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 4                                                                         GAO/T-AIMD-99-209
Figure 1: Biomedical Equipment Compliance-Status Information Reported to FDA by
Manufacturers as of June 1, 1999




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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.


Page 5                                                                                                                    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   Because FDA could not provide detailed information on the compliance
                        status of products listed on manufacturers’ web sites, at the request of the
Information on          Committee we reviewed these web sites. Specifically, we obtained from
Manufacturers’ Web      FDA’s clearinghouse a listing of the manufacturers referring users to their
Sites Varies            web sites, downloaded information from these sites, and reviewed this
                        information to identify the total number of biomedical equipment products
Significantly           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 categories—products 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 6                                                                          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 7                                                                           GAO/T-AIMD-99-209
Figure 2: Biomedical Equipment Compliance-Status Information Reported on
Manufacturers’ Web Sites as of June 1, 1999




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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.


Page 8                                                                                                              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 9                                                      GAO/T-AIMD-99-209
FDA Is Planning to      Last September, we expressed concern that FDA relied on manufacturers
                        alone to validate, test, and certify that their medical devices were Y2K
Review Manufacturers’   compliant. 13 Further, we said, since FDA did not require manufacturers to
Certifications          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 10                                                                     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 11                                                                            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 12                                                       GAO/T-AIMD-99-209
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
Care Providers         taken steps to make users aware of the clearinghouse. For example, FDA
                       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 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 AMA survey 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 13                                                                             GAO/T-AIMD-99-209
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
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

aThe    survey instructions directed respondents to mark n/a if a question did not apply.
bThisorganization 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.
dThe    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.




Page 14                                                                            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.




Leter   Page 15                                                        GAO/T-AIMD-99-209
Contact and        For information about this testimony, please contact Joel Willemssen at
                   (202) 512-6253. Individuals making key contributions to this testimony
Acknowledgments    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)   Leter   Page 16                                                  GAO/T-AIMD-99-209
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