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General Accounting Office, Year 2000 Computing Crisis: Leadership Needed to Collect and Disseminate Critical Biomedical Equipment Information (T-AIMD-98-310) (Sept. 24, 1998) (full-text).


Pursuant to a congressional request, the GAO discussed the year 2000 compliance status of biomedical equipment, focusing on: (1) the progress that the Veterans Health Administration (VHA) and the Food and Drug Administration (FDA) have made in determining the compliance status of biomedical equipment; and (2) further actions they need to take to minimize associated year 2000 risks.

The GAO noted that: (1) the VHA had made progress in implementing its year 2000 strategy for biomedical equipment, but it still does not know how pervasive the problem is; (2) this is because it has not received compliance and cost information from many of the manufacturers on its list of suppliers, as well as from nearly 100 additional manufacturers no longer in business; (3) like the VHA, FDA has sent letters to biomedical equipment manufacturers, requesting information on products affected by the year 2000 problem; (4) the response rate to the FDA has been disappointing; (5) failure to obtain timely compliance information from the manufacturers increases the risk to health care providers and biomedical equipment users that such equipment may not operate properly after the turn of the century; and (6) it is critical that such information be obtained and publicized; while many reported non-compliant equipment items do not present a risk to patient safety, some could present such risks.