Increased Risk of Infectious Disease Transmission from Human Tissue Recovered by Donor Referral Services

FDA is notifying healthcare professionals that certain human tissues used in patients may have an increased risk for transmitting infectious diseases. These tissues, including human bone and soft tissue such as tendons, came from a tissue recovery company called Donor Referral Services (DRS). The problem is that DRS' tissues may not have met FDA requirements for donor eligibility, which involve donor screening and donor testing. These tissues did undergo processing after recovery to reduce the risk of disease transmission, and at this time no adverse reactions have been reported. Even so, FDA and CDC are strongly recommending that healthcare providers tell patients who received these tissues that they may have been from donors who didn't meet requirements for eligibility. Practitioners should also offer patients appropriate infectious disease testing, including HIV-1 and 2, hepatitis B virus, hepatitis C virus, and syphilis. FDA Patient Safety News: November 2006 For more information, please see our website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=57#3

Google Video | March 16, 2007

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