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Year 2000 Computing Challenge: Compliance Status Information on Biomedical Equipment

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Report Type Reports and Testimonies
Report Date Oct. 21, 1999
Report No. T-AIMD-00-26
Subject
Summary:

Can medical devices, such as magnetic resonance imaging systems, x-ray machines, and pacemakers, be counted 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 computer problem. The Food and Drug Administration (FDA) is responsible for overseeing and regulating medical devices. Since the fall of 1998, FDA has been providing information collected from manufacturers of medical devices and scientific and research instruments through its Federal Y2K Biomedical Equipment Clearinghouse. This testimony discusses (1) the status of FDA's clearinghouse; (2) compliance status information on manufacturers' web sites referred to in FDA's clearinghouse; (3) FDA's efforts to review the Year 2000 activities of manufacturers of computer-controlled, potentially high-risk devices; (4) the compliance status of health care providers' biomedical equipment; and (5) compliance testing of equipment.

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