The largest processor of human cadaver tissue in the US has been ordered to recall cartilage, ligaments, tendons and other soft-tissue products processed since 3 October 2001, and to withhold any tissue from the market or destroy any in stock that was processed after that date.
According to the US Food and Drug Administration, CryoLife Inc (Kennesaw, GA) is guilty of ‘numerous, significant’ violations of FDA regulations and that, despite warnings, ‘failed to take adequate corrective measures to address possible infectious disease contamination of tissue in inventory and distribution’. FDA officials also allege that CryoLife ‘improperly distributed tissue from a donor after the firm confirmed the presence of harmful microorganisms in tissue samples from the same donor’.
CryoLife was investigated last year after two men developed infections after reconstructive surgery using tissue supplied by the company. It was discovered that both men had received tissue from the same donor. One of the men died as a result of the infection (with Clostridium sordellii, a spore- and toxin-forming organism).
There was no evidence that the donor had C. sordellii infection at the time of death, but it was revealed that the donor’s body had not been refrigerated until 19 hours after death, which may have allowed bacteria from the intestines to spread.
Since the initial case reports, federal officials have identified 54 cases of infections in otherwise healthy patients receiving tissue implants. These findings, which may be underestimates of the problem, are bound to rock the confidence of anyone considering reconstructive or other surgery using donor tissue (Lancet, 2002; 360: 623).