Tissues Harvested by DRS May Transmit Infectious Diseases

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Medscape Alerts
Tissues Harvested by DRS May Transmit Infectious Diseases

http://www.medscape.com/viewarticle/544264?src=mp

Yael Waknine

September 6, 2006 — The US Food and Drug Administration (FDA) and the US
Centers for Disease Control and Prevention (CDC) have informed healthcare
professionals regarding the potential for infectious disease transmission in
recipients of tissues initially recovered by Donor Referral Services (DRS).

Donors for these products may not have been screened according to FDA
eligibility regulations, according to an alert sent recently from MedWatch,
the FDA's safety information and adverse event reporting program.

Although subsequent processing may have decreased the risk for disease
transmission, the FDA and CDC strongly advise that tissue recipients be
informed of the risks for transmission of HIV-1 and HIV-2, hepatitis B virus
(HBV), hepatitis C virus (HCV), and syphilis, and they should be offered
appropriate testing. Specific recommendations for certain patient
populations are available on the CDC Web site at
http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html.

Implicated tissues include human bone and soft tissues such as tendons that
were recovered at the company's Raleigh, North Carolina, site from 2005 to
2006, and from the Las Vegas, Nevada, location during 2004 to 2005. These
products represent a very small percentage of the overall US tissue supply
and no related adverse events have been reported thus far.

In light of the continuing investigation into this matter, the FDA has
issued DRS an order to cease manufacturing and to retain all human cells,
tissues, and cellular/tissue-based products. In addition, voluntary recalls
of all unused products obtained from DRS have been announced by Alamo Tissue
Services of San Antonio, Texas; Lost Mountain Tissue Bank of Kennesaw,
Georgia; TissueNet of Orlando, Florida; and US Tissue and Cell of
Cincinnati, Ohio.

Healthcare providers with concerns or questions regarding the source of
their patients' tissue implants are advised to contact the facilities in
which the procedures were performed.Additional questions may be directed to
FDA's Center for Biologics Evaluation and Research at 1-800-835-4709 or by
email to [email protected]">[email protected].

Adverse events potentially associated with a tissue transplant should be
reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at
1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600
Fishers Lane, Rockville, MD 20852-9787.
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Yael Waknine is a freelance writer for Medscape.

Medscape Medical News 2006