Year 2000 Computing Challenge:

Compliance Status Information on Biomedical Equipment

T-AIMD-00-26: Published: Oct 21, 1999. Publicly Released: Oct 21, 1999.

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Joel C. Willemssen
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Office of Public Affairs
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Pursuant to a congressional request, GAO discussed the year 2000 status of biomedical equipment, focusing on: (1) the status of the Food and Drug Administration's (FDA) Federal Year 2000 Biomedical Equipment 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) information on the compliance status of health care providers' biomedical equipment; and (5) information on compliance testing of equipment.

GAO noted that: (1) compliance status information on biomedical equipment can be found in FDA's clearinghouse or on manufacturers' web sites; (2) the quality of the compliance information on the web sites, however, varies significantly, ranging from general assurances of compliance to detailed information on specific product make and model; (3) given the criticality of having medical devices function as intended on and after January 1, it is important that FDA encourage manufacturers to provide detailed information on the product make and model, compliance status, and availability of solutions for noncompliant equipment; (4) to its credit, FDA has assessed the year 2000 compliance activities of 80 potentially high-risk devices manufacturing sites; (5) although most appeared to have been assessed as having low degrees of concern, one site had a concern in two areas assessed at high; (6) FDA is reviewing this site to make sure that there are no unresolved issues affecting patient safety; (7) because a significant number of health care providers are not responding to year 2000 surveys sent by federal agencies and professional associations, the public lacks information on the readiness of providers; (8) such information would help alleviate public concerns about the year 2000 readiness of health care providers and the biomedical equipment they use in patient care; and (9) although there are varying views on whether end users should test their biomedical equipment for year 2000 compliance, the overriding criterion should be ensuring patient health and safety.

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