Recalls on Donor Bone Tissue

You've probably heard about the recent recalls on baby food, pet food, and peanut butter. But have you ever heard of a recall on allograft (donated) bone? The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) report almost 60,000 allograft tissue samples were recalled over the last 15 years. All of those were musculoskeletal tissue specimens.

In this study, researchers from the Neuroscience Institute, Center for Spine Health at the Cleveland Clinic in Ohio investigated and reported the type and reasons for these recalls. Types and incidence of disease transmission in spine surgeries were also examined. They set out to answer the question: is the use of allograft bone safe in spine surgery? They also provide guidelines for surgeons to follow to improve the safety of bone grafts from donor sources.

What they found was that allograft tissues have been recalled from more than 60 tissue banks. The recalls were on a variety of tissues (e.g., heart valves, corneas, veins) but mostly musculoskeletal. The reasons for recall included improper recovery from the donor, poor donor selection, and positive blood tests for diseases or bacterial infections that could be passed to the recipient.

Only one case of viral disease transmission (HIV) from allograft bone in a spine fusion patient has ever been reported. Antibody testing has been available since 1985, so the risk of HIV transmission has been eliminated.

Sometimes it is impossible to trace the infection to its source -- whether that's from the allograft or something else. And if it's from the allograft, how did that happen? It could have been a problem during the donor screening process, during actual recovery of the donor tissue, or an error in serologic (blood) testing of the donor tissue. Other areas of consideration include methods and safety in transporting, delivering, and implanting the donor tissue.

But there's more to the story than the known cases. No one knows for sure if infections that develop later (postoperatively) are from the graft, something in the operating room, or other health factors. Patients with diabetes, heart disease, or other health problems seem prone to infections. Blood transfusions can be a potential source of contamination.

Since 1993, there have been government regulations in place to safeguard donor tissue. Safety rules, on-site inspections of tissue banks, and reporting of adverse effects of allograft tissue are now in place. All donor tissue must be tested for hepatitis and HIV. In addition, hospitals and surgery centers are required to follow a standard method for handling all donor tissues.

Surgeons are also responsible for following all safety measures as these relate to allograft tissue. For example, they must know where the tissue came from (e.g., morgue, operating room, funeral home) and make sure the recovery facility is practicing all recommended steps in assuring safety of the donor tissue. This includes proper donor screening and valid methods of tissue sterilization. Both of these steps are important in reducing the risk of donor tissue contamination.

They are advised to deal only with tissue banks that have been inspected by the Food and Drug Administration and/or are accredited by the American Association of Tissue Banks (not all are). And they must be prepared to report their concerns or any adverse events that occur.

Given the fact that there is only one known case of infection transmission among patients who received allograft (donor) bone during spinal surgery, the use of these tissues seems safe. The fact that not all tissue banks are regulated and inspected raises the concern for improper or even illegal means of obtaining, processing, and distributing donor tissue.

The authors advise surgeons to remain alert and responsible for assuring the safety of all tissue used in spinal surgeries. It must not be assumed that all the necessary steps in processing and sterilization have been carried out. Dealing with an accredited tissue bank directed by a physician is the best way to make sure tissues used are safe for patients.

Thomas E. Mroz, MD, et al. The Use of Allograft Bone in Spine Surgery: Is It Safe? In The Spine Journal. April 2009. Vol. 9. No. 4. Pp. 303-308.

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