Recently, a fair amount of media attention, particularly through radio and Internet sources, has focused on allograft tissue. These reports concentrated on the source of human allograft tissue and its eventual use with respect to the informed consent of the donor’s families. Although most of the material presented was factual, the overall messages were that allograft tissue may be unsafe due to its source and that many tissues are used inappropriately.
During the past several years, the high demand for allograft tissue has led tissue processors to seek allograft tissue outside of the United States. But doing so is problematic. For example, the reliability of European procurement agencies has been questioned, particularly with regard to the health and medical history of donors, the adequacy of the serologic testing performed, and the actual quality of the tissue.
In addition, because supplying tissue from overseas for the American market may be driven by a profit motive, rather than a humanitarian motive, misrepresentation and forgery of donor records may occur. Indeed, some such cases were discovered and appropriate legal action taken.
It is also true that in several instances, donor families consented to the use of their loved one’s tissues but were not informed that those tissues might be used for research, cosmetic, or reconstructive purposes by for-profit companies. In most of these instances, the misrepresentation was part of an attempt by those companies to increase monetary gain. In light of these issues, a reminder about the parameters that orthopaedic surgeons and surgery facilities should consider when acquiring allograft tissue seems appropriate.
Issues to consider
Any allograft tissue brought into a hospital for use during orthopaedic surgery should meet the following requirements:
- The exact geographic and eligibility details of any tissue procured outside of the United States should be easily obtainable. If this information is not available or reliable, the tissue should not be used. Tissues procured in Eastern Europe with a questionable history have been transferred to Western European facilities and distributed as “Western” tissue. As a result, orthopaedic surgeons and hospitals should be extremely cautious in dealing with Western European distributors.
- The orthopaedic surgeon should be acutely aware of the criteria that the tissue processor or tissue bank uses in selecting and preparing tissue.
- The orthopaedic surgeon and purchasing institution should know what kind of consent was given by the donor or donor’s family. Donors and/or their families should consent to the particular use of the tissue, particularly in cases where the tissue is being used for research, cosmetic purposes, or possible eventual for-profit involvement.
- The orthopaedic surgeon must discuss the allograft material to be used, as well as the risks and benefits of using allografts, in detail with the recipient (informed consent).
Institutions and orthopaedic surgeons should only use tissues provided by a tissue processing facility or bone bank that is both registered with the U.S. Food and Drug Administration and inspected by the American Association of Tissue Banks (AATB). These organizations have spent many years developing criteria and requirements for the use, processing, and distribution of human tissue. Efforts are currently under way to improve information regarding all of these factors. In addition, systems are being developed to improve tissue tracking from the donor to the recipient.
Any questions or concerns about the source and qualifications of allograft tissue and or allograft suppliers can be directed to the AATB via its website, www.AATB.org
Ross M. Wilkins, MD, (medical director of The Denver Clinic for Extremities at Risk) and Steven Gitelis, MD, (professor and vice chairman, department of orthopedic surgery, Rush Medical College, and president, Rush University Medical Staff) are members of the AAOS Biological Implants Committee.
Disclosure information: Dr. Wilkins—Senior Medical Director, AlloSource; Chairman-elect, Physicians Council, American Association of Tissue Banks; Wright Medical Technology, Inc. Dr. Gitelis—Medical Director, Gift of Hope Organ and Tissue Bank; Wright Medical Technology, Inc.
- Careful selection of allograft tissue suppliers and appropriate informed consent are necessary in any tissue transplantation service.
- Orthopaedic surgeons should be able to trace the exact source (geographic and eligibility details) of any allograft tissue procured from outside the United States.
- Any tissue processing facility or bone bank used by orthopaedic surgeons and hospitals should be registered with the FDA and inspected by the AATB.