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Document Title: McAllister-AJSM-2007.shtml
Article Title: Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization (Basic Science Update)
Authors: David R. McAllister, MD, Michael J. Joyce, MD, Barton J. Mann, PhD, and C. Thomas Vangsness Jr, MD
Publication: American Journal of Sports Medicine, Baltimore, Maryland
Date: December 2007
Volume: (AJSM preview article)
Keywords: allografting, tissue regulation, tissue procurement, tissue processing, tissue sterilization, tissue-bank fraud.
(Reference-denoting numbers appear in the same font and point size as the document text. As with all Knee Library documents, this article is provided in full-text form, complete with all figures and tables.)
Comments: This superb article, from authors who have spoken on this topic before, provides a comprehensive and penetratingly insightful overview of the infectious-disease-transmission concerns associated with allografts. It also provides insight into how various government organizations and tissue banks are addressing these concerns. The article delves into topics such as the different methods of graft sterilization, and discusses a series of well-publicized cases of fraud and negligence by disreputable tissue banks. It also highlights the advantages of correctly harvested and correctly processed allografts, as provided by reputable tissue banks. Sue Barber-Westin, a seasoned knee researcher, notes that there are five key areas any allograft knee-ligament-graft recipient should ask about: (1) Is the tissue bank accredited by the American Association of Tissue Banks and has it undergone recent inspection by the FDA? (2) Given that older donors translate into a greater risk of poor biomechanical graft quality, is the donor of age 45 or under? (3) What sterilization methods was the allograft subjected to (e.g. chemical, low-dose irradiation)? (4) Has the tissue bank had any problems, for example anything resulting in a recall of previous grafts? (5) What type of body tissue is the graft from, and what fixation method will be used? Will the fixation method reliably ensure that the graft is anchored along its length inside the tunnel, so as to avoid the "bungee-cord effect"?
Abstract
Allografts are commonly used during sports medicine surgical procedures in the United States, and their frequency of use is increasing. Based on surgeon reports, it is estimated that more than 60 000 allografts were used in knee surgeries by members of the American Orthopaedic Society for Sports Medicine in 2005. In the United States, there are governmental agencies and other regulatory bodies involved in the oversight of tissue banks. In 2005, the Food and Drug Administration finalized its require-ments for current good tissue practice and has mandated new rules regarding the “manufacture” of allogenic tissue. In response to well-publicized infections associated with the implantation of allograft tissue, some tissue banks have developed methods to sterilize allograft tissue. Although many surgeons have significant concerns about the safety of allografts, the majority believe that sterilized allografts are safe but that the sterilization process negatively affects tissue biology and biomechanics. However, most know very little about the principles of sterilization and the proprietary processes currently used in tissue banking. This article will review the current status of allograft tissue regulation, procurement, processing, and sterilization in the United States.
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