FDA ‘fails to keep track of transplant patients’

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The US Food and Drug Administration (FDA) lacks an adequate means of locating tissue transplant recipients if donor tissue is discovered to be infected, according to the General Accounting Office (GAO), the investigative arm of Congress. And tighter regulations that the agency is proposing fail to address the problem adequately.

A report on human tissue banks issued by the GAO in December concludes that the FDA is seriously hindered in protecting public health because it has no register of the 400-or-so US tissue centres which process several hundred types of human tissues. Fewer than half of these centres are accredited by industry associations.

The FDA “can neither notify all tissue facilities as potential public health threats arise nor plan inspections from a complete registration of tissue facilities”, says the report. In one typical case, researchers were unable to track the recipient of a tissue graft infected with hepatitis C.

The FDA has proposed a broad strengthening of its oversight of tissue transplantation, to be implemented slowly over coming years. It plans to require all tissue centres to register with the agency, and to report “adverse events”. But the GAO report says that, in failing also to require centres to report “errors and accidents,” the agency “is missing an opportunity to target facilities that may need additional oversight”.

For instance, the FDA recently discovered while inspecting one company that it had distributed corneas before receiving test results showing that one cornea had tested positive for HIV. Under the agency's proposed plan, such an event would not have to be reported.

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Wadman, M. FDA ‘fails to keep track of transplant patients’. Nature 391, 315 (1998) doi:10.1038/34733

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