AUG. 14–WASHINGTON– A Georgia tissue bank linked to a death and serious infections has been ordered by the U.S. Food and Drug Administration (FDA) to stop selling cadaver tissue, charging that CryoLife Inc. cannot guarantee the grafts are free of fungus or bacteria.
The unusually harsh action by the FDA comes after months of failed inspections and negotiations with the Kennesaw, GA.-company.
CryoLife was ordered by the agency to recall all the soft tissue such as cartilage and tendons that it has processed since Oct. 3, a month before a 23-year-old Minnesota man died from a bacterial infection linked to CryoLife cartilage that he received during reconstructive knee surgery.
The company cannot resume distribution of tissue until it begins meeting federal standards to ensure the products are not contaminated, according to the FDA. Among the FDA’s top complaints is CryoLife sent out tissue from a cadaver even after it had confirmed the presence of harmful germs in tissue samples from the same donor.
Calls placed by CleanRooms magazine were not returned, but a receptionist there noted a company press release that indicated CryoLife will exercise its right to appeal the order and had requested a hearing with the FDA.
“Initiating this appeal and request will place the destruction order in abeyance pending resolution of the hearing request,” the statement says. “The company has place all vascular, non-valved cardiac and orthopedic tissue that has been distributed but not implanted.”
The order, however, does not recall cadaver heart valves that CryoLife also sells. FDA inspectors are studying whether the donated heart valves, which typically undergo more strenuous processing than soft tissue, also may pose a risk.
”This order not only protects patients from the unacceptable level of risk associated with tissue processed by CryoLife, it sends a clear signal that FDA stands ready to take whatever action is necessary to ensure the safety of human tissue,” says FDA acting commissioner Lester Crawford.
Patients who have received CryoLife-sold grafts should not panic, according to the FDA. Any infection associated with tissue should occur within days or at most weeks of the transplant. But the agency urged doctors to be aware of signs of infection that might be linked to a contaminated graft.
The death of Brian Lykins of Willmar, MN., touched off a major investigation by the Centers for Disease Control and Prevention that concluded infections from cadaver tissue used in orthopedic implants are more widespread than previously thought.
The CDC so far has uncovered 54 cases of infections associated with soft tissue grafts during orthopedic surgery, 25 of them involving tissue from CryoLife. The CDC has said the infections show an urgent need to update federal regulations and industry standards for preventing contamination.
Meanwhile, Lykins’ family last month sued CryoLife. Health investigators found a bacterium called Clostridium sordellii in his body and in the cadaver from which the cartilage was lifted. The suit charged CryoLife left the cadaver unrefrigerated for 19 hours and failed to test it for the pathogen. Several other lawsuits connected to graft infections also have been filed.
CryoLife has declined comment on pending litigation.