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At Issue: Does orthopedic allograft tissue need more regulation?

Orthopedics Today asked surgeons: Based on your needs and experience and your patients’ concerns, how sufficient is the current testing/processing of orthopedic allograft tissue? How would closer regulation of this industry affect the situation, and graft safety in particular?

Issue: April 2006

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Douglas W. Jackson, MD

It is my impression and experience that the risks and safety concerns in using allografts are minimal. As a result of the standards that have be established and followed by most legitimate tissue banks, the risks to patients is extremely small. More government regulation will result in increased costs and add another level of bureaucracy to enforce and oversee allograft utilization. Most of the problems that have and will occur are very infrequent and usually involve individual human mistakes. These are the result of inadequately following current screening standards for donors and tissue processing guidelines. In addition, on rare occasion there can be contamination at the time of harvesting or handling the tissue. A certain level of risk will still be present even in a heavily regulated industry. I am comfortable using the tissue banks we use and do not feel any more governmental regulation is necessary.

Douglas W. Jackson, MD, can be reached at Memorial Ortho. Surgical Group, 2760 Atlantic Ave, Long Beach, CA 90806-2755; 562-424-6666; fax: 562-989-0027; e-mail: JACKSONDW@aol.com.

Scott D. Boden, MD

The current testing procedures as outlined by the American Association of Tissue Banks (AATB) are quite adequate and appropriate. The recent incident resulted from a supplier of donor tissue not following the protocol. This is not a failure of regulation or the protocol, but rather the failure of individual ethics, which is always the weak link in any chain. The key is to ensure that all tissue suppliers follow these national standards. Currently that is not the case.

Scott D. Boden, MD, Professor of Orthopaedic Surgery and Director of The Emory Orthopaedics & Spine Center, can be reached at 59 Executive Park South, Ste. 3000, Atlanta, GA 30329; 404-778-7143; fax: 404-778-7117; e-mail: scott_boden@emoryhealthcare.org.

Gary E. Friedlaender, MD

Musculoskeletal allografts are an extremely important opportunity for many patients with a wide variety of disorders. The current guidelines of the AATB coupled with their voluntary program of onsite inspection, accreditation and guidance documents promulgated by the Food and Drug Administration provide a high degree of patient safety. Until or unless the federal government provides sufficient funding for closer scrutiny of tissue banks and for more research focused on enhanced safety and efficacy, our most responsible actions at this time are to obtain tissue grafts from AATB-accredited banks, to clearly and knowledgeably discuss the significant opportunities and small risks associated with use of these valuable reconstructive materials and to continue to encourage the altruistic donation of these scarce resources.

For more information:
Gary E. Friedlaender, MD, Wayne O Southwick Professor and Chair, Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, can be reached at P.O. Box 208071, New Haven, CT 06520.