Health News
Improving Safety When Using Bone and Soft Tissue Allograft
October 1st, 2008
Education and communication are keys to ensuring patient safety and piece of mind
Each year in the United States more than 1.3 million donated bone and bone-related allografts are successfully implanted in orthopedic patients. Musculoskeletal allografts are frequently used in orthopedic surgery to replace bones, tendons, or other soft tissues damaged by trauma, tumors or sports related injuries.
Reports of tissue recalls in recent years have raised public concerns over the safety of donated tissue, or allograft. Refinements in donor screening and heightened involvement by the FDA have improved the overall safety record of the industry, but there is room for continued and necessary improvements, according to a review article published in the October issue of the Journal of the American Academy of Orthopedic Surgeons.
Recent statistics show only about 10 percent of all types of tissue banks in the United States have been accredited by the American Association of Tissue Banks (AATB), the national standard-setting organization which oversees the safety of the tissue process. However, it is estimated that over 90 percent of the musculoskeletal tissue is supplied by AATB accredited tissue banks. The accreditation process is voluntary. AATB-accredited tissue banks are subjected to much more stringent standards than their non-accredited counterparts. Both the FDA Current Good Tissue Practice regulations and AATB Standards focus on:
- Maintaining records that trace tissues through each step of the donation process
- Standardized procedures for handling tissue
- Guidelines for reporting problems
"The important thing to understand is that the large number of recalls indicates, in part, that the safety guidelines that are in place are working," said the article's lead author, Thomas Mroz, MD, Staff Spine Surgeon at The Cleveland Clinic Center for Spine Health. "The likelihood of disease transmission is very low. By using allograft bone, we can avoid some of the complications associated with using the patient's own bone. These include infection, additional incisions, and most importantly, persistent pain from the site of the graft".
Dr. Mroz and co-author Michael Joyce, MD, Staff Surgeon at The Cleveland Clinic Department of Orthopedic Surgery and Medical Director of the Clinic's Musculoskeletal Tissue Storage Facility, recommend patients take the following steps when preparing to undergo an allograft procedure.
Ask your orthopedic surgeon:
- whether the tissue bank being used is an AATB-accredited tissue bank and if the tissue bank facility has been inspected by the FDA
- to explain the potential risks of infection that may occur with allograft tissue
- to provide you with educational literature available from the tissue bank being used
- if there is a quality assurance process at the hospital to help ensure the inspection and safety of the allograft tissue.
"In order to truly have informed consent from the patient, the surgeon needs to be informed about where the graft is coming from, whether the tissue is documented to be culture negative for bacteria or is truly sterilized by additional methods, and the safety record of the tissue bank they are using," said Dr. Joyce.
The tissue donation process begins with a history and physical evaluation of the donor, looking for exclusionary conditions, such as:
- active infection
- history of certain viral illnesses, including hepatitis and Human Immunodeficiency Virus (HIV)
- rheumatoid arthritis, lupus, or syphilis
- significant malignancies and bone diseases
The donor is also blood tested for certain diseases, including:
- HIV
- syphilis
- Hepatitis B and C
Tissues are processed to help eliminate bacteria and other disease organisms.
"The envisioned future use of a universal donor numbering system shared by organ and musculoskeletal donors and an online database would allow tissue banks, hospitals and physicians to track all allograft from the donor stage to the recipient, and to better locate recalled tissue." Dr. Joyce added, "It would also allow timely recognition of allograft tissue that has been recalled and should not be used in patients."
SOURCE: American Academy of Orthopedic Surgeons
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