Year 2000 Computing Challenge

Concerns About Compliance Information on Biomedical Equipment Gao ID: T-AIMD-99-209 June 10, 1999

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

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 with FDA information it obtained from manufacturers; (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; (8) because of limitations cited by GAO for many of the manufacturers' web sites, its ability to determine the total number of biomedical equipment products reported and their compliance status was impaired; (9) in response to GAO's report, the Department of Health and Human Services stated that it did not agree with GAO's recommendation to review test results supporting medical device equipment manufacturers' compliance certifications; (10) it reasoned that submission of appropriate certifications was sufficient, further stating that it did not have the resources to undertake such reviews; (11) similarly, the Department of Veterans Affairs stated that it had no legislative or regulatory authority to implement the recommendation to review manufacturers' test results; (12) FDA has subsequently changed its position; (13) 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; 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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