Notice to Readers: Public Health Notification Regarding Concern Over Recovered Human Tissues --- United States, 2006

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 company called Donor Referral Services (DRS) (Raleigh, North Carolina) and subsequently used in transplant procedures, might not have met FDA requirements for donor eligibility. Tissue products used for transplantation typically include bone, demineralized bone matrix, skin, and soft tissue (e.g., tendons) (1).

On August 18, FDA issued to DRS an Order to Cease Manufacturing and to Retain Human Cells, Tissues and Cellular and Tissue-Based Products.^† Since then, an ongoing FDA investigation has obtained additional information regarding manufacturing and blood-screening practices at DRS that has heightened concern for all recipients of tissue recovered by DRS. The four tissue banks that received and distributed tissue initially recovered by DRS have conducted recalls: Alamo Tissue Services (San Antonio, Texas); Lost Mountain Tissue Bank (Kennesaw, Georgia); TissueNet of Orlando, Florida; and U.S. Tissue and Cell (USTC) (Cincinnati, Ohio; Allosource [Centennial, Colorado] acquired USTC in March 2006 and is performing all recall and physician notification activities for USTC). These four firms have voluntarily recalled all unused tissues remaining in inventory and continue to work with FDA to notify health-care facilities that received these tissues so that health-care providers can inform their patients who received transplants and offer testing.

No adverse reactions related to these tissue transplants have been reported to FDA. After recovery by DRS, the tissues underwent processing steps at other sites that are designed to reduce the risk for disease transmission. However, because the actual risk for infection is unknown, FDA and CDC strongly recommend that health-care providers inform their patients who received tissues recovered by DRS that assessment of eligibility of the tissue donors might not have been performed adequately. In addition, FDA and CDC recommend that health-care providers offer patients access to appropriate testing for infectious diseases. The relevant communicable diseases for which a tissue donor is required to be tested are human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus, hepatitis C virus, and syphilis. Health-care facilities that received tissues from DRS should notify clinicians who implanted the tissues so that patient notifications can be initiated. Further information regarding tissue transplants and specific testing recommendations is available at http://www.cdc.gov/ncidod/dhqp/tissuetransplantsfaq.html.

State and local health department officials who seek to determine whether tissues recovered by DRS were distributed to facilities in their jurisdictions should contact the four tissue banks identified. Health-care providers who have concerns or questions about the source of their patients' tissue transplants should contact the health-care facilities where the procedures were performed. Tissue recipients who are concerned that they might have received tissue recovered by DRS should contact the health-care providers who performed their implants.

FDA's Current Good Tissue Practice Rules,^§ effective May 25, 2005, require manufacturers to prevent introduction, transmission, or spread of infectious diseases through human cells, tissue, and cellular and tissue-based products. On August 30, 2006, FDA announced formation of a Human Tissue Task Force^¶ to assess the effectiveness of the implementation of these new tissue regulations, to review recently reported findings that certain recovery establishments were not following federal requirements for tissue recovery, and to develop an action plan for proposed changes to existing policies. Health-care providers should report any adverse reaction that might be related to a tissue transplant to the appropriate processing or distributing firms; patients with suspected adverse reactions should contact their health-care providers or the health-care facilities where the procedures were performed. These reactions also should be reported to FDA's MedWatch system (by telephone, 800-FDA-1088; fax, 800-FDA-0178; mail, MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online, http://www.fda.gov/medwatch). Adverse reactions also can be reported to CDC by telephone, 800-893-0485, or to state or local health departments.

Reference

1. CDC. Investigation into recalled human tissue for transplantation---United States, 2005--2006. MMWR 2006;55:564--6.

* Available at http://www.fda.gov/cber/safety/drs083006.htm.

^† Available at http://www.fda.gov/cber/compl/drs081806.htm.

^§ Available at http://www.fda.gov/bbs/topics/news/2004/new01137.html.

^¶ Available at http://www.fda.gov/bbs/topics/news/2006/new01440.html.

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Date last reviewed: 9/7/2006