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First published on November 1, 2007, doi:10.1177/0363546507308936
This version was published on December 1, 2007
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The American Journal of Sports Medicine 35:2148-2158 (2007)
© 2007 American Orthopaedic Society for Sports Medicine


Basic Science Update

Allograft Update

The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization

David R. McAllister, MD{dagger},*, Michael J. Joyce, MD{ddagger}, Barton J. Mann, PhD§ and C. Thomas Vangsness, MD, Jr||

From the {dagger} Department of Orthopaedic Surgery, Center for Health Sciences, David Geffen School of Medicine, University of California, Los Angeles, California, {ddagger} Cleveland Clinic Foundation, Cleveland, Ohio, § American Orthopaedic Society for Sports Medicine, Rosemont, Illinois, and || Keck School of Medicine, University of Southern California, Los Angeles, California

* Address correspondence to David R. McAllister, MD, Department of Orthopaedic Surgery, Center for Health Sciences, David Geffen School of Medicine at UCLA, Box 956902, Los Angeles, CA 90095–6902.

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 requirements 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.

Key Words: allograft • tissue regulation • tissue procurement • tissue processing • tissue sterilization




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L. L. Greaves, A. T. Hecker, and C. H. Brown Jr
The Effect of Donor Age and Low-Dose Gamma Irradiation on the Initial Biomechanical Properties of Human Tibialis Tendon Allografts
Am. J. Sports Med., July 1, 2008; 36(7): 1358 - 1366.
[Abstract] [Full Text] [PDF]




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