Safety and FDA regulations for musculoskeletal allografts: perspective of an orthopaedic surgeon.

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Abstract

[Indexed for MEDLINE] 20. Instr Course Lect. 1988;37:13-24. Bone banks and allografts in community practice. Czitrom AA, Gross AE, Langer F, Sim FH. The increasing volume of orthopaedic reconstructive procedures requiring replacement of bone stock justifies the initiation of programs of bone banking in community hospitals. Provided that strict criteria are followed to assure rigorous screening of donor bone and the reliable preservation of bone graft material, community banking is safe and cost-effective. Banked allograft bone can be used successfully in a wide variety of orthopaedic procedures performed in community hospitals. In general, the best uses are filling bone cavities, buttressing, and augmenting the quantity of autograft bone. In revision reconstructive surgery of the hip, bank bone is used to replace bone stock in protrusio, acetabular dysplasia, and proximal femoral deficiency. The best and most common indication for the use of bank bone in tumor surgery is after curettage or excision of benign lesions. Allografts may be used to reconstruct bony defects after excision of malignant tumors and in the surgical treatment of metastatic disease. These instances require larger bone bank facilities than those commonly available in a community hospital setting. Medicolegal considerations related to bone banking and the use of allografts in community practice include the regulatory requirements outlined in the UAGA, questions concerning negligence liability, and theories of strict product liability. Overall, good medical practice and obtaining informed consents will minimize legal risks related to bone banking and transplantation in a community setting.