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Infected Human Tissue Under FDA InvestigationThe
Food
and Drug Administration (FDA) is investigating human tissue used for transplants
that may not have been properly screened for certain infectious diseases. The
FDA reports that their donor eligibility requirements may not have been met on
the infected tissue used for certain transplants between 2004 and September 2005. The FDA, along with the Centers for Disease Control and Prevention (CDC), say there is low risk of infection from the infected tissue, but recommend any patient who received a transplant of the suspect tissue be screened for HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Certain requirements are maintained by the FDA concerning transplant donor eligibility to limit the risk of infection. These are: reviewing the donor's medical history, physically assessing the donor, and testing for communicable diseases. No adverse reactions related to transplants of the infected tissue have been received by the FDA, although some transplant recipients of the infected tissue may be at a higher infection risk. The actual infection risk is still unknown. Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, procured the infected human tissue and sent it on to tissue processors. Receiving the infected tissue are the following processors:
All unused tissue has been voluntarily recalled by the processors and they have notified the transplant physicians, according to a statement by the FDA. Also contacted were physicians who transplanted tissue directly from BTS. |
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