TISSUE BANKS: Company’s Practices Raise Concerns

      The Florida-based tissue bank Regeneration Technologies plans to combine bone and tissue products from multiple donors, despite fears that the process spreads disease, the Orange County Register reports. Products from these donations are sold to doctors and hospitals, typically as specialty pins, screws, dowels and tissue grafts. The practice of combining body parts from separate donors was banned by the American Association of Tissue Banks in the 1980s after more than 40 deaths in Japan were associated with tissue "processed in batches" (Katches, 7/9). Because Regeneration Technologies is not a member of the association, it is exempt from this rule, which, if violated, results in loss of tissue banks' accreditation. The company's BioCleanse technology is essentially a "high-tech dishwasher" that simultaneously sterilizes bone from up to 100 donors (Associated Press, 7/10). The cleansing process has the ability to kill or inactivate "all classes of conventional pathogens, viruses, including HIV, microbes, bacteria and fungi in the tissue, while retaining the useful properties," according to the company's validation studies. But, the company added, "we can never completely eliminate the risk of errors, defects or failures."

Industry Makes No Bones About It
     Bruce Stroever, who runs the Muscoskeletal Transplant Foundation, the largest not-for-profit tissue bank in the United States, questioned the need for such an efficient but risky process, noting that "most tissue implant procedures are not lifesaving and do not have to be done immediately. A patient can wait for the proper graft ... there is no need to rush the process or expose a patient to any risks." Billy Anderson, president of LifeNet, a Virginia organ recovery agency, said, "If I had a process today where I could [combine body parts], I wouldn't." Anderson recalled an incident in the early 1990s in which AIDS-infected body parts distributed by LifeNet killed three recipients. Although the infected tissue was not pooled, the incident has led several industry leaders to avoid "unnecessary risks" in the distribution process. Ernest Carabillo, a former FDA official and now a consultant for Regeneration Technologies, said that critics at the American Association of Tissue Banks are just "jealous" of Regeneration's BioCleanse technology, noting, "Quite candidly, I think this is all about the fact they're left behind." Carabillo also said the company is not required to file scientific findings with the FDA. Although the pooling of human tissue "hasn't been much of an issue up to this point" with the FDA, according to FDA spokeswoman Lenore Gelb, the agency is "considering addressing pooling more specifically in future regulations." After news reports that tissue banks were profiting from donated tissue alarmed donor families, ethicists and lawmakers, HHS Secretary Donna Shalala ordered a "sweeping probe" of the human tissue industry. Initial findings of the investigation are due next month (Orange County Register, 7/9).