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(MCT) In 2001, doctors implanted cartilage from a cadaver to repair the knee of college student Brian Lykins. It killed him instead. The cartilage had been rejected by two different tissue banks. But it was accepted by Georgia-based CyroLife Inc., the nation's largest tissue bank. The cartilage, never properly disinfected, caused a fatal infection. Three years after Lykins' death, the U.S. Food and Drug Administration published new rules that were supposed to clean up the largely unregulated tissue and bone bank industry. But the problems have not disappeared. If anything, they've become worse. Last week, a 48-year-old Alton, Mo., man sued Barnes-Jewish Hospital and Washington University over bits of bone it had implanted in his neck. Glenn Wetzler claims the bone came from an unsuitable donor. His attorney said the donor may have had AIDS. The hospital and university declined comment on the suit. Most tissue banks operate with high standards, particularly banks accredited by the American Association of Tissue Banks. But others, including Biomedical Tissue Services Ltd., the New Jersey company that provided bone for Wetzler's surgery, aren't accredited. Such banks often underbid competitors. Some hospitals, operating with razor-thin margins, can use tissue from unaccredited tissue banks. The FDA has no rules forbidding the use of tissue from the elderly or ill. British journalist Alistair Cooke, who died at the age of 95 from lung cancer that had spread to his bones, became an unwilling donor after his death. Biomedical Tissue Services apparently took bone and tissue from his body without obtaining permission from him in advance or from his family after his death. There is no tracking system in place to ensure tissue comes only from suitable donors and has been handled safely. Funeral homes, where most tissue procurement takes place, aren't required to report the donor's cause of death or other information to any central registry. That opens the door to tissue from unsuitable donors or tissue that is obtained fraudulently. Nor are tissue-related infections required to be reported. In many cases, they aren't even diagnosed. Had Lykins, the college student, not died at the height of the 2001 anthrax scare, it's unlikely doctors would have spent the time to prove the source of his infection. A few large outbreaks, including fungus infections linked to donated heart valves, have been documented but most go unrecognized and unreported. It's going to take more than lawsuits to fix problems with tissue banks. It's going to take increased FDA regulations and rigorous inspections of tissue banks. That hasn't happened so far because Congress hasn't demanded it from the FDA. The agency has asked for more resources - 10 new employees and $2.5 million in additional funding. Congress hasn't provided it. Each year, well over 1
million tissue transplant operations occur around the
country. For the sake of those patients, and the donors who
make their operations possible, it's time to close loopholes
in tissue-bank safety regulations. Have a comment? Please e-mail us. ŠThe Voice 2006 Revised 01/13/2008 03:10:43 PM — http://www.uamont.edu/Organizations/TheVoice/4_5/commmct2.htm |