According to McGowan Institute for Regenerative Medicine faculty member, Freddie H. Fu, M.D., the David Silver Professor of Orthopedic Surgery and Chairman of the Department of Orthopedic Surgery at the University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center, while the use of musculoskeletal allografts has increased, and in turn the safety of these tissues has improved, surgeons should still be aware of the dangers related to their use.
"In most cases, the orthopedic sports medicine surgeon has a choice between allograft and autograft tissues and often this isn't life or death surgery ... so why choose allograft?" Dr. Fu asked at the Orthopedics Today Hawaii 2008 meeting.
He noted that the reasons for using allograft tissues are the lack of donor-site morbidity, a decrease in OR time, and their usefulness in more complex cases for those surgeons who use multiple bundles.
"However, there are no absolute indications or contraindications for orthopedics, especially sports medicine," said Fu. “Disadvantages of allograft use include: disease transmission; cost, a slow incorporation; availability, because so many surgeons are using it now; secondary sterilization, which can damage the graft; and there may be an immune response," he said.
Fu noted that U.S. Food and Drug Administration oversight has increased since 1990 and the American Association of Tissue Banks (AATB) has standards and accreditation processes for its members.
"The AATB requires better testing than the FDA," Fu said. However, he noted that the AATB does not have the power to close a violating facility, which the FDA does.
As for harvesting, using a sterile technique does not mean that all the contaminants have been removed.
"Occult infections can exist," he said.
Compounding this is that not all tissue banks have the same donor screening, tissue harvesting, or secondary sterilization methods, he said.
"Allograft safety has improved greatly over the last 15 years; however we need more," he said.
Dr. Fu presented his talk, “Allograft safety 2008,” at Orthopedics Today Hawaii 2008, January 13-16, 2008, Lahaina, Maui, Hawaii.
Illustration: McGowan Institute for Regenerative Medicine.
Medical Device Forum (01/2008)