FDA Warns Costa Mesa Red Cross Facility of Safety Violations in Handling Donated Human Tissue
FDA on Tuesday made public a warning letter sent to the American Red Cross' Costa Mesa branch about violations of safety requirements for handling donated human tissue, the Orange County Register reports. In the letter, which was dated March 11, FDA cited the Costa Mesa facility for failing to properly test disinfectants used to clean human tissue and failing to ensure that the human tissues were "safely packed and shipped," the Register reports (Heisel, Orange County Register, 3/31). The letter also said that employees in "critical management and production positions" had not been properly trained, the Los Angeles Times reports (Anton, Los Angeles Times, 4/1). The facility provides about 20% of the nation's skin for hospital burn units and about 20% of the nation's heart valves for transplants (AP/San Jose Mercury News, 4/1). Tissue banks are required to take steps to prevent contamination of human tissues used for transplants, because donated products can carry infection-causing microbes. A routine inspection of the Costa Mesa facility in November 2003 uncovered "significant violations of the requirements for human tissue intended for transplantation," Alonza Cruse, FDA district director in Irvine, wrote in the letter. He said that that subsequent responses by the facility to correct the deficiencies in the tissue-collecting system were "inadequate" (Orange County Register, 3/31). The letter gave Red Cross officials 15 days to take "specific steps" to ensure that the tissue bank is following safety procedures, the Times reports (Los Angeles Times, 4/1). In response, the Red Cross voluntarily suspended distribution of all heart valves and skin from the Costa Mesa facility, Ryland Dodge, a spokesperson for the Red Cross, said. Dodge added that people should still donate human tissue and that the Red Cross is looking for a partner to temporarily distribute those tissues (Orange County Register, 3/31). "Obviously we want to make the proper corrections as soon as we can, and that is what we will do," Dodge said (Los Angeles Times, 4/1). The letter is available online.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.