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Concerns About Safety of Tissue Grafts From Donors
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Posted on: 10/14/2008
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Surgeons beware: it's up to you to use musculoskeletal allografts safely. Tissue used as grafts during orthopedic surgery from a donor source are called allografts. Almost all allograft tissues recalled for any reason have been musculoskeletal (e.g., tendons, bone, meniscus). The authors of this article investigate and report what's going on. They provide surgeons with a safety checklist for the use of musculoskeletal allografts.
Tissue grafts are now under the regulation of the U.S. Food and Drug Administration. Before 1993, government regulation of this practice was lacking. Disease transmission through contaminated allografts became enough of a safety issue that something had to be done.
Besides bringing tissue transplants under the regulatory guidance of the FDA, there is also the Current Good Tissue Practice rule to improve and ensure tissue safety in the United States. The Joint Commission on the Accreditation of Hospital Organizations (JCAHO) and the American Association of Tissue Banks (AATB) have also published tissue safety guidelines. Improving public health and maintaining patient safety are the key areas of focus.
But with the one million musculoskeletal tissue grafts provided each year, problems can occur. The Centers for Disease Control and Prevention (CDC) has reported cases of bacterial and viral infections in donor grafts. The risk is small but there is some concern that the number of actual cases reported is less than what really occurs. Serious problems (including death) can occur with infections of allografts.
Using a search method of all databases, the authors of this report compiled a list of all recall reports for bone and soft tissue. Product type, manufacturer, and reason for recall were all categorized. Data from 1994 through the first half of 2007 was analyzed.
The results showed a trend for inadequate or improper donor selection. Processing errors accounted for some tissue recalls. Positive lab tests helped screen out contaminated specimens. Tissues are often processed carefully but they are not sterilized. Many of the tissue banks don't have what is needed to conduct tissue sterilization.
The authors also made note of the fact that in 2005, less than 20 per cent of the 1,970 registered tissue banks had actually been inspected by the FDA. Other studies have shown an increased rate of infection the longer the time between the donor's death and the time of tissue recovery from the deceased.
It also appears that the standard practice of using a surface swab to culture donor tissue is not enough. Recovery teams are advised to use techniques that require tissue samples to be extracted and destroyed in the testing process. Safety and accuracy are improved at the risk of losing some tissue.
Confirmed reports of HIV, West Nile Virus, Clostridium infections, and Hepatitis C virus (HCV) in donor tissue have resulted in new FDA guidelines. For example, as of August 2007, nucleic acid testing is required for all new tissue donors. This test will identify musculoskeletal tissues from donor tissue infected with HIV/HCV. The same test will be used to screen donor blood for HIV/HCV and West Nile virus.
What this study points out is that not all donor tissue is safe. Some tissue samples will be processed and make it to the shelf for use but they are still contaminated. Regulatory measures must be taken to ensure that all samples are properly screened, processed, sterilized, stored, and distributed. Sterilization procedures must be investigated and new sterilization techniques developed.
Overall, the regulation of tissue-banking companies is very poor. The FDA doesn't fund regulation of the industry. Groups like the Joint Commission on the Accreditation of Hospital Organizations (JCAHO) and the American Association of Tissue Banks (AATB) provide guidelines but no regulation.
Therefore, until things improve, surgeons must be on the look out for potential problems. Besides conducting a checklist screening exam, careful surgical technique to avoid contaminating sterile donor tissue in the operating room is important. Here are some additional tips for surgeons:
Know where your tissue samples come from (and their processing practices)
Take the time to inspect all allograft samples (do not leave this task to anyone else)
Know and follow the hospital or clinic guidelines for keeping a sterile environment
Take measures to prevent contamination of the donor tissue
Seek tissue banks that are knowledgeable of the guidelines and that have a physician as the medical director
The authors advise that all patients should be warned of the risks associated with allografts during surgery. Although the risks are low, the effects can be devastating. Everyone from the government regulatory agency to the Joint Commission, AATB, tissue banks, hospitals, clinics, and surgeons must cooperate to ensure as good of a result as possible for the patient. Promoting safety at every level is extremely important.
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References:
Thomas E. Mroz, MD, et al. Musculoskeletal Allograft Risks and Recalls in the United States. In Journal of the American Academy of Orthopaedic Surgeons. October 2008. Vol. 16. No. 10. Pp. 559-565.
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*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. |
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