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U.S. Department of Health and Human Services

Safety

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Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS)

Audience: Surgeons, surgical supervisory personnel and hospital risk managers

[Posted 03/02/2006] FDA notified healthcare professionals of an update to the October 26, 2005 information paper on human tissues recoved by BioMedical Tissue Services (BTS). The tissue, including human bone, skin, and tendons, was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. As part of its ongoing investigation, FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While FDA believes the risks from these tissues are low because the tissues were routinely processed using methods to help to reduce the risk of infectious disease, the actual infectious risk is unknown.

[March 02, 2006 – Public Health Notification – FDA]
[February 03, 2006 – Order to Cease Manufacturing – FDA]
[October 26, 2005 – Information Paper – FDA]