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Bone Recall

Despite rigorous regulation by the Food and Drug Administration, the recall of bone tissue slated for transplant is a real possibility. This is illustrated by a recent recall of bone and tissue following an FDA warning.

This voluntary recall of bone and tissue followed a warning by the FDA that the suspected material had not undergone the proper screening methods.

Types of Screening

The methods include physical examination, comprehensive medical history and social risk review. To lower the risk of a bone recall the information collected on potential donors is compared against criteria established by the U.S. Public Health Service that identifies and excludes individuals with high-risk behaviors.

In addition, all bone and other tissue is quarantined until microbiological and blood tests are completed to limit the possibility of a recall. These tests are required by the American Association of Tissue Banks (AATB) and the FDA, and include analysis of infectious diseases including HIV, hepatitis B and C, and syphilis.

To further limit any hint of a bone recall, all of the information is evaluated by a team of medical specialists in the fields of infectious disease and tissue banking. No bone tissue is released until the tissue bank's medical director determines it to be safe following a review of the screening and testing information.

Safety of Bone Tissue

To ensure safety and eliminate a possible bone recall, the tissue is soaked in a variety of solutions to prevent the transmission of bacteria and viruses. It is processed and packaged using sterile techniques in clean room conditions to maintain biological integrity. Sometimes, low dose radiation is used to aid in sterilization. United States Pharmacopeia (USP) guidelines are used in the final processing of the tissues and they are tested for microbiological contamination to ensure compliance with regulatory requirements.

Although some theoretical risk for disease transmission may be present, the use of tissue that has undergone rigorous donor screening, serological testing and formal processing significantly reduces the risk of a bone recall. However, experts strongly recommend that anyone receiving a recall notice from the FDA seek legal advice to protect their rights.

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