Wednesday, February 22, 2006

Bone Recall

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."

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