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FDA Investing Infected Tissue Used in Human Transplants
Infected tissue used in human transplant is under investigation by the Food and Drug Administration (FDA) because it may not have been properly screened for infectious diseases. FDA 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 say a low risk of infection from the infected tissue exists, but they recommend patients who received transplants of the infected tissue have a screening for HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis.
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.
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.
A tissue procurement company, Biomedical Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, sent the infected human tissue to tissue processors. Those receiving the infected tissue include the following processors:
These processors have voluntarily recalled all unused tissue. They also have notified the transplant physicians, the FDA said. Physicians who transplanted tissue directly from BTS have also been notified, according to a statement from the FDA.
See also:
www.tissuetransplant.info
www.infectedtissue.com
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