FDA Health Notification Regarding Human Tissue for Transplantation

On August 30, 2006, the Food and Drug Administration (FDA) issued a Public Health Notification to inform the health-care community that human tissues recovered by a tissue recovery organization called Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. On August 18, 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. However, FDA's ongoing investigation of Philip Guyett (DRS owner) and DRS has uncovered additional information regarding manufacturing and blood sampling practices at DRS that has heightened concern for all recipients of tissue recovered by DRS.

The following firms received and distributed tissue initially recovered by DRS and have conducted recalls:

• Alamo Tissue Services of San Antonio, TX
• Lost Mountain Tissue Bank of Kennesaw, GA
• TissueNet of Orlando, FL
• US Tissue and Cell (USTC) of OH (Allosource of Centennial, CO, is performing all recall and physician notification activities for USTC)

No adverse reactions have been reported to FDA. However, because the actual infectious risk is unknown, FDA and CDC strongly recommend that health-care providers inform patients who received these tissues that they may have received tissues from donors whose eligibility assessments may not have been adequately performed. Further, FDA and CDC recommend that health-care providers offer to provide patients access to appropriate infectious disease testing. Health-care facilities that received tissues from DRS should notify clinicians who implanted the tissues so that patient notifications can be initiated.

Health department officials who would like to determine if tissues recovered by DRS were distributed to facilities in their jurisdictions should contact the tissue banks listed above. Health-care providers who have concerns or questions about the source of tissue implants should contact the facilities where the procedures were performed.

Patients and health-care providers should report any adverse reaction which may be related to a tissue transplant to the appropriate processing and/or distributing firms. Reactions should also be reported to state or local health departments and to FDA's MedWatch system.