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

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Report Type Reports and Testimonies
Report Date June 10, 1999
Report No. T-AIMD-99-209
Subject
Summary:

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.

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