Allograft tissue safety
By Jeanie Kennedy
While the Academy has been involved in the clinical uses and safety aspects of allograft transplantation for several decades, the public became keenly aware of lapses in some patient safety measures after the October 2001 death of a 23-year old Minnesota patient who had reconstructive knee surgery. In response to the heightened awareness of safety issues, the AAOS Board of Directors (BOD) assembled a project team to assess the tissue banking industry and provide recommendations to the Committee on Patient Safety.
The Tissue Banking Project Team (TBPT), chaired by Gary E. Friedlaender, MD, submitted their report to the BOD at the December 2002 meeting and made the following recommendations:
The BOD approved implementation of all the recommendations of the TBPT including the formation of a national Biological Safety Coalition (BSC) to move forward on allograft safety issues. The AAOS is contacting other surgical specialty societies, the National Institutes of Health, the CDC, the FDA, the American Society for Testing and Materials (ASTM) and the AATB to assemble a coalition to address several areas of concern.
Goals of the BSC include ensuring a safe tissue and tissue-based product supply and advocating for significant federal funding for basic, clinical, and translational research tissue that will retain the biological and biomechanical properties to provide efficacy.
Additionally, the BSC will advocate for the development and validation of nucleic acid testing for cadaveric serum, provide consensus on acceptable bioburden levels, provide guidance on the use of the term "sterile," arrive at consensus on the destruction of tissue due to pathogen concentration and advocate for uniform package inserts. In the meantime, member surgeons should seek tissues from processors following best-known practices, such as those from an AATB-accredited bank, from a tissue processor with a FDA-validated processing method, or from a processor that has passed inspection by the FDA. Approximately 800,000 grafts were implanted last year in the United States. Allografts continue to be an important therapeutic alternative with relatively few cases of disease transmission.
Fellows interested in providing assistance to the coalition should contact me at AAOS headquarters in Rosemont.