Year 2000 Computing Challenge:

Much Biomedical Equipment Status Information Available, Yet Concerns Remain

T-AIMD-99-197: Published: May 25, 1999. Publicly Released: May 25, 1999.

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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.

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