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Infected Tissue Under FDA InvestigationThe
Food
and Drug Administration (FDA) has announced an investigation of certain human
tissue that may not have been properly screened for certain infectious diseases.
The donors of the infected tissue may not have met FDA donor eligibility requirements
and may have been transplanted in patients from early 2004 to September 2005. Although
they say the risk from the infected tissue is low, the FDA and the Centers
for Disease Control and Prevention (CDC) recommend that anyone receiving a
transplant of the questionable tissue be screened for certain communicable diseases,
including HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis
C virus, and syphilis. The infected human tissue was recovered by Biomedical
Tissue Services, Ltd. (BTS) of Ft. Lee, NJ, and forwarded to tissue processors
for transplant. Tissue processors receiving infected tissue include: The FDA reports these tissue
processor firms have voluntarily recalled all unused tissue and notified the implanting
physicians of the problem. Physicians who used the transplant tissue directly
from BTS also have been contacted. The FDA has certain requirements concerning
donor eligibility to ensure donors of transplanted tissue are free of infections
that may be transmitted to recipients. These include a review of the donor's medical
history and other factors, a physical assessment of the donor, and testing for
relevant communicable diseases. No adverse reactions related to a transplant
of the infected tissue have been reported to FDA. However, some recipients of
the infected tissue may have an increased risk of infections. The actual infectious
risk is unknown.
See also:
www.tissuetransplant.info
www.infectedtissue.com
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