Date: August 30, 2006
The Food and Drug Administration (FDA) is issuing this notification to inform the health care community that human tissues recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. This notification is a result of an ongoing FDA investigation of DRS which was located in Raleigh, NC, and at a former location in Las Vegas, NV. While no adverse reactions associated with these tissues have yet been reported, and subsequent processing should reduce the potential risks of infectious disease transmission, health care 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 health care 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.
FDA's ongoing investigation of Philip Guyett (DRS owner) and DRS has recently uncovered additional information regarding manufacturing and blood sampling practices at DRS that has heightened our concern for all recipients of tissue recovered by DRS. At this time, it is known that the implicated tissues from DRS were shipped for further processing and include human bone and soft tissue such as tendons. These products represent a very small percentage of the overall US tissue supply. It has been determined that DRS recovered tissue at the Raleigh, NC, site from 2005-2006, and from the Las Vegas, NV, location from 2004-2005.
Donor eligibility is determined through donor screening and donor testing. Donor screening involves reviewing all relevant medical records, physically assessing the donor and questioning the donor's next of kin to identify risk factors for or clinical evidence of certain communicable diseases. Donor blood samples (obtained either pre- or post-mortem) are also tested for HIV-1 and 2, hepatitis B virus, hepatitis C virus and syphilis. A donor is deemed eligible to donate tissues only if the results of donor screening and testing indicate no risk factors for or infection with these diseases.
No adverse reactions related to these tissues have been reported to FDA at this time. In addition, these tissues subsequently underwent processing steps 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:
- Alamo Tissue Services of San Antonio, TX
- Lost Mountain Tissue Bank of Kennesaw, GA
- TissueNet of Orlando, FL
- US Tissue and Cell (USTC) of Cincinnati, OH (Allosource of Centennial, CO is performing all recall and physician notification activities for USTC)
These firms have already voluntarily recalled all unused tissue remaining in inventory. With regard to patient safety, where FDA had previously identified specific cases of concern, the firms cooperated fully in efforts to inform patients and offer testing in those cases. The firms noted above continue to work cooperatively with FDA to notify the health care facilities that received these tissues so that the health care providers of all patients who received the products can in turn inform their patients and offer testing.
Additionally, 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. More information on the Order is available at: http://www.fda.gov/cber/compl/drs081806.htm.
FDA and CDC strongly recommend that health care providers inform their patients who received tissues initially recovered by DRS that they may have received tissues from donors whose eligibility 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. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), 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. Health care providers who still have concerns or questions about the source of their patients' tissue implants should contact the health care facilities where the procedures were performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.
Patients and health care providers should report any adverse reaction which may possibly be related to a tissue transplant to the appropriate processing and/or distributing firms. FDA requires tissue establishments to investigate any adverse reaction involving a communicable disease for which there is a reasonable possibility that the transplanted HCT/P, distributed by them, caused the reaction, and to report fatalities and/or serious injuries to FDA. Information on reporting of such reactions may be found on the web at: http://www.fda.gov/cber/tissue/hctadverse.htm.
We also encourage health care providers to report all adverse reactions related to HCT/Ps directly to FDA. You can report any adverse reaction to MedWatch, FDA's voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch. Consumers can also report any adverse reaction directly to MedWatch.
Getting More Information
Additional questions may be directed to FDA's Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at email@example.com.
*This public health notification by the Center for Biologics Evaluation and Research is intended to quickly share safety information with health care providers when the information available and our understanding of an issue are still evolving. We will revise this notice as new information merits and so encourage you to check this site for updates.