Patient Information Resources


Orthopedic Services
Glendale Adventist Medical Center
1509 Wilson Terrace
Glendale, CA 91206
Ph: (818) 409-8000






Ankle
Elbow
Foot
Fractures
General
Hand
Hip
Knee
Pain Management
Shoulder
Wrist

View Web RX

« Back

Have you ever heard of bone graft being recalled? I thought that was just for food items. But my neighbor is a surgeon and she says it can happen. I can't tell if she's pulling my leg or not.

Yes, you've heard about the recent recalls on baby food, pet food, and peanut butter. But there has been a less widely publicized recall on allograft (donated) bone as well. 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. 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. In fact, 96.5 per cent of all allograft tissue recalled comes from musculoskeletal tissues. 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. 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. That's probably why your neighbor is aware of this problem. For example, the surgeon 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.

References:

« Back





*Disclaimer:*The information contained herein is compiled from a variety of sources. It may not be complete or timely. It does not cover all diseases, physical conditions, ailments or treatments. The information should NOT be used in place of visit with your healthcare provider, nor should you disregard the advice of your health care provider because of any information you read in this topic.


All content provided by eORTHOPOD® is a registered trademark of Mosaic Medical Group, L.L.C.. Content is the sole property of Mosaic Medical Group, LLC and used herein by permission.