Bone Recall

The recall of bone tissue slated for transplant is a real possibility in spite of rigorous regulation by the Food and Drug Administration. A recent recall of bone and tissue following an FDA warning illustrates this point.

Material suspected of not undergoing proper screening methods triggered this voluntary recall of bone and tissue following a warning by the FDA.

Screening Methods

The methods thought to have been sidestepped include physical examination, comprehensive medical history and social risk review. All information collected on potential donors is compared against criteria set by the U.S. Public Health Service identifying and excluding individuals with high-risk behaviors as a way to lower the risk of a bone recall.

Also, all bone and other tissue is placed in quarantine until certain tests are finished to limit the possibility of a recall. These tests, required by the American Association of Tissue Banks (AATB) and the FDA, include an analysis of infectious diseases such as HIV, hepatitis B and C, and syphilis.

The information is then evaluated by a team of medical specialists to further limit any hint of a bone recall. The tissue bank's medical director must determine the bone tissue is safe before it is released.

Bone Tissue Safety

As a way to make sure of safety and to eliminate any possible bone recall, the tissue is soaked in a variety of solutions to prevent the transmission of bacteria and viruses. The bone tissue is processed and packaged using sterile techniques in clean room conditions to maintain biological integrity. Often, a 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.

Some risk for disease transmission may be present, according to lawyers familiar with the issue , but the use of tissue that has undergone donor screening, serological testing and formal processing reduces the risk of a bone recall.