SEPT. 6–ROCKVILLE, MD–The nation’s largest supplier of living human tissue for implantation will be allowed to supply specimens in emergencies while a recall of potentially tainted tissue continues, federal regulators said Friday.
The U.S. Food and Drug Administration (FDA) extended the permission to Cryolife Inc. for 45 days, saying the risk of some patients not receiving the tissue in emergencies outweighs the danger of potential contamination, agency spokeswoman Lenore Gelb says.
CryoLife can supply veins, arteries and non-valved cardiac conduits and patches, amounting to about 80 percent of the company’s tissue business, said Ashley Lee, its chief financial officer.
On Aug. 13, the FDA ordered CryoLife to stop distributing cadaver tissue, saying the Kennesaw, GA-based company failed to follow contamination control protocols to keep fungus and bacteria from infesting soft tissue.
The FDA ordered CryoLife to recall all soft tissue processed since Oct. 3, a month before a Minnesota man died from tainted tissue he received in a knee operation.
The death of Brian Lykins touched off an 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 agreement requires CryoLife to obtain prescriptions from surgeons who want to use company tissue, and it says patients must be advised of a risk of infection from the tissue, which is under recall.
CryoLife also must determine if the tissue had been tested after it was procured. If not, the tissue must contain additional warning labels.
The FDA is requiring CryoLife to establish new culture testing protocols and to file a corrective action plan within 30 days. The nation’s largest supplier of living human tissue for implantation, CryoLife is appealing the order. It also is under investigation by the FDA and Securities and Exchange Commission.
On Wednesday, CryoLife laid off 105 employees because of the FDA order and restated its second-quarter results to show a $5.5 million loss instead of the $2.8 million profit it had recorded previously. CryoLife said it has supplied more than 41,000 heart valves and 48,000 grafts since its 1984 founding.