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 Infected Tissue Transplants
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The Food and Drug Administration (FDA) is investigating certain infected tissue used in human transplants because it may not have been properly screened for infectious diseases. FDA reports that its donor eligibility requirements may not have been met. The infected tissue was used for certain transplants between early 2004 and September 2005.
The Centers for Disease Control and Prevention (CDC) and the FDA maintain that there is a low risk of infection from the infected, but they are recommending that patients who received transplants of the infected tissue be screened for HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis.
The FDA reports no adverse reactions related to transplants of the infected tissue have been received, but some transplant recipients of the infected tissue could face a higher infection risk. Actual risk of infection is unknown.
The FDA has certain requirements concerning transplant donor eligibility that seek to limit the risk of infection. They are: reviewing the donor's medical history, a physical assessment of the donor, and testing for communicable diseases.
Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, New Jersey, a tissue procurement company, forwarded the infected human tissue to tissue processors. The companies receiving the infected tissue include these processors:
All unused tissue has been voluntarily recalled. Transplant physicians have been contacted, the FDA said. Doctors who transplanted tissue directly from BTS have also been notified, according to a statement from the FDA. |
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