The government has ordered a Georgia tissue bank whose products are linked to a death and serious infections to stop distributing its implant tissue, charging that CryoLife Inc. can't guarantee the grafts are free of fungus or bacteria.
The unusually harsh action by the Food and Drug Administration comes after months of failed inspections and negotiations with the Kennesaw, Ga., company, which the FDA said has refused to adopt and follow procedures to prevent contamination of donated tissue.
"FDA is taking this action because it has been determined that Cryolife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants," an FDA statement said.
The FDA ordered CryoLife 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 received during reconstructive knee surgery.
Nor can the company resume distribution until it meets federal standards to ensure the products aren't tainted, said Mary Malarkey, the FDA compliance officer in charge of the case.
Among the FDA's top charges: that CryoLife sent out tissue from a cadaver even after it had confirmed the presence of harmful germs in tissue samples from the same donor.
The order does not recall cadaver heart valves that CryoLife also provides. But 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," said FDA acting commissioner Lester Crawford.
CryoLife said it would appeal FDA's order but quarantined all its donated soft tissue while requesting a hearing to argue its case. CryoLife also asked to FDA to allow immediate shipment of tissue needed for potentially lifesaving surgery, such as blood vessels for heart bypass operations.
But company officials declined to estimate how much tissue would have to be recalled, or how much the crackdown would cost the company. CryoLife charges hospitals for the costs of processing and transporting donated tissue.
"We are confident about the quality and safety of CryoLife processed tissue," said company chief executive Steven G. Anderson.
Malarkey said FDA would expedite the appeal request, which would be CryoLife's last recourse, short of going to court, to stave off the tissue sales shutdown.
Patients who have received CryoLife-sold grafts should not panic, Malarkey said. Any infection associated with tissue should occur within days or weeks of the transplant. But she urged doctors to be aware of signs of infection that might be linked to a contaminated graft.
The death of Brian Lykins of Willmar, Minn., 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 infections associated with soft tissue grafts, 26 of them involving tissue from CryoLife.
"We applaud the FDA action and would hope that this is the final wake-up call to CryoLife to clean up its house," Lykins' family said in a statement issued by attorney Don Keenan of Atlanta. "Brian's life should not be in vain, and it appears that it was his death and the serious injuries of many other persons that finally brought a halt to a dangerous company."
Health investigators found a bacterium called Clostridium sordellii in Lykins' body and in the cadaver from which the cartilage was donated. Lykins' family sued CryoLife last month, charging the company left the cadaver unrefrigerated for 19 hours and failed to test it for the germ.
The CDC said the infections, while fairly rare compared to the hundreds of thousands of grafts performed, show an urgent need to update federal regulations and industry standards for preventing tissue contamination.