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Although year 2000 (Y2K) readiness status information on biomedical equipment is available through the Food & Drug Administration’s (FDA) clearinghouse, it has not been able to review the claims of manufacturers who say their products are compliant.
Because the FDA has not been able to review test results supporting manufacturers’ certifications, there is still a concern that biomedical equipment with date-dependent chips may not work as intended.
In testimony before a House subcommittee, Joel C. Willemssen, director of civil agencies’ information systems, accounting, and information management division of the General Accounting Office (GAO), told committee members that the FDA and Veterans Health Administration (VHA) have made progress in obtaining compliance information from more than 4,000 biomedical equipment manufacturers.
But there is still some concern, because the FDA has relied only on manufacturers to validate compliance; the agency did not require the same equipment makers to submit their test results. But the FDA and VHA have balked at such requirements, citing that neither agency has the resources to verify manufacturers’ test results.
"We continue to believe that [an] organization such as the FDA can provide medical device users with a greater level of confidence that their equipment is Y2K-compliant through independent reviews of manufacturers’ compliance test results," Willemssen said. "The question of whether to independently verify and validate biomedical equipment that manufacturers have certified as compliant is one that must be addressed jointly by medical facilities’ clinical staff, biomedical engineers, and corporate management. The overriding criterion should be ensuring patient health and safety."
Information from users incomplete
Despite the growing availability of Y2K-compliance information through FDA’s clearinghouse, it’s not clear how extensively health care providers are using the information, Willemssen said.
The GAO reviewed readiness surveys sent to providers by several federal agencies and found that only a small percentage were aware of the FDA clearinghouse. Only 26% of home health providers responded to the Y2K readiness survey and only 4.7% said their organizations’ were compliant. Forty-one percent of nursing homes responded. Of those only 4.2% reported being compliant.
"Because a significant number of health care providers are not responding to Y2K surveys sent by federal agencies and professional associations, the public lacks information on the readiness of providers," Willemssen said. "Such information would help alleviate public concerns about the Y2K readiness of health care providers and the biomedical equipment they use in patient care."