Tissue Recall

The safety of all tissue used for transplantation has been called into question by recent recalls by the Food and Drug Administration.

Since human tissue is used as an important resource in certain medical treatments, a tissue recall will affect many areas. Health professionals use donated tissue for a number of medical purposes such as healing burn victims and reconstructive surgery. Bone donations are implanted to replace cancerous bone, for knee and hip replacements and for spinal surgery.

Once families agree to donate tissue from loved ones, they want it to be used for important medical needs. A tissue recall will have a chilling effect on those families, according to an attorney familiar with the issue.

A tissue recall is usually because of suspicion that the tissue has not been properly screened by physical examination, comprehensive medical history and social risk review of the donor. The U.S. Public Health Service has established criteria which should be used to lower the risk of a tissue recall. This criteria identifies donors with high-risk behavior and excludes them from the transplant list.

The American Association of Tissue Banks (AATB) and the FDA require all donated tissue be analyzed for infectious diseases including HIV, hepatitis B and C, and syphilis. According to these groups, this will lower the risk of tissue recalls.

Also, tissue data is evaluated by a team of infectious disease and tissue bank specialists to limit the possibility of a tissue recall. Tissue is never released from the tissue bank until the medical director has ruled on its safety. These safeguards are credited in the lowering of the number of tissue recalls.

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