Human Allograft Bone Processing and Safety

Ross M. Wilkins, MD; Steven Gitelis, MD; Robert A. Hart, MD; and Allen E. Gross, MD, FRCSC, Prof

During the past 50 years, the use of human bone allograft has been increasing, with the most dramatic increases occurring during the past decade. An estimated 1 million allografts will be used in the United States in 2013. Because allografts are biologic materials that come from various sources, orthopaedic surgeons need to understand not only the origin and safety profile of the materials, but also the material and structural properties of bone allografts in making a decision about their use in reconstructive surgery.

Disease transmission, either viral or bacterial, is extremely rare with bone allografts. The last incidence of a fatality due to disease transmission from bone allograft occurred in 2001 and was due to a major deviance from standard industry practice. The incidence of viral transmission, such as hepatitis or HIV, is calculated to be less than 1 in 1.6 million, with no cases reported in several years. This safety profile compares very favorably to other biologic materials.

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