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U.S. Department of Health and Human Services

Safety

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Human Tissues recovered by Donor Referral Services (DRS)

Audience: Surgeons, dentists, hospital surgical service managers and risk managers

[Posted 08/31/2006] FDA notified healthcare professionals that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, healthcare providers who were supplied with these tissues are being notified of the potentially increased risk for infectious disease transmission.

FDA and the Centers for Disease Control and Prevention (CDC) are strongly recommending that healthcare providers inform their patients who received tissues initially recovered by DRS that they may have received tissue from donors for whom adequate donor eligibility determinations were not performed, and offer patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. Further recommendations for testing are posted on the CDC website at: http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

[August 30, 2006 - Public Health Notification - FDA]