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

Abstract

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.