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FDA
Public Health Notification: Recovered Tissues
The Food and Drug
Administration (FDA) has issued a public
health notification to inform the health care community that human
tissues – including human bone and tendon – recovered by Donor
Referral Services (DRS) may not have met FDA requirements for donor
eligibility. This notification is the result of an ongoing FDA
investigation of DRS which was located in Raleigh, NC (formerly located
in Las Vegas, NV). On August 18, 2006, FDA issued an Order
to Cease Manufacturing and to Retain Human Cells, Tissues and Cellular
and Tissue Based Products (HCT/Ps) to Philip Guyett, Owner, Donor
Referral Services.
No adverse reactions related to these tissues have been reported to the
FDA at this time. In addition, these tissues subsequently
underwent processing methods at other sites that are designed to reduce
the risk of disease transmission.
The
following firms distributed tissue initially recovered by DRS and have
conducted recalls:
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Alamo Tissue Services of San Antonio, TX
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Lost Mountain Tissue Bank of Kennesaw, GA
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TissueNet of Orlando, FL
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US Tissue and Cell
(USTC) of Cincinnati, OH
(Allosource of Centennial, CO, is performing all recall and physician notification activities for
USTC)
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All
unused tissue has been recalled and the tissue processors are working
with the FDA to ensure that physicians whose patients may have received
the products are properly notified. Physicians who receive
notification should inform their patients and provide patients with
access to appropriate infectious disease testing for the following
communicable diseases: HIV-1 and HIV-2, hepatitis B, hepatitis C, and
syphilis.
The AAOS is interacting with the FDA and the Centers for Disease Control
and Prevention (CDC) and will provide members with more information as
it becomes available.
The FDA encourages surgeons to report adverse reactions possibly related
to a tissue transplant through the FDA’s MedWatch
reporting program.
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