Safety and FDA regulations for musculoskeletal allografts: perspective of an orthopaedic surgeon.
The Musculoskeletal Transplant Foundation Symposium held in September 2003, in Edinburgh, Scotland provided the opportunity for an orthopaedic surgeon experienced in tissue banking and musculoskeletal allograft transplantation to summarize to orthopaedic colleagues the past and current efforts made by the Food and Drug Administration to ensure the safety of allograft tissues, aspects of tissue banking, concerns of allograft safety and future Food and Drug Administration proposals. The review allows an orthopaedic surgeon an understanding of allograft safety issues and provides information for better informed consent to be obtained by the orthopaedic surgeon from the recipient patient.
Joyce
Michael J
MJ
Department of Orthopaedic Surgery, Cleveland Clinic Foundation, 9500 Euclid Avenue/A41, Cleveland, OH 44195, USA. joycem@ccf.org
D016025:Bone Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D009985:Orthopedics / Q000331:legislation & jurisprudence* / Q000592:standards*; D011785:Quality Assurance, Health Care; D012449:Safety; D016378:Tissue Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration