Scandal grows over suspect body parts

If you are scheduled for reconstructive orthopaedic surgery, or need a new heart valve, you might want to check where the tissue you are given has come from. For the second time this year, a firm supplying body parts for surgery has been shut down by the US Food and Drug Administration, and more safety scandals are expected to emerge from this booming industry. The latest scare surrounds Donor Referral Services, based in Raleigh, North Carolina, which harvested body parts, including bone, tendons and heart valves, from corpses in funeral homes. FDA inspectors found numerous safety breaches, including a failure to follow procedures intended to prevent bacterial contamination, and errors in the medical histories of the donors. The FDA is still investigating, and will not comment on how many patients received tainted tissues.

This incident follows a scandal surrounding Biomedical Tissue Services of Fort Lee, New Jersey, which closed in February after similar safety breaches. Company staff were called “bodysnatchers” in media reports, after harvesting tissues from donors without proper consent, and four men now face criminal charges. Retrieving, processing and distributing body parts is a massive industry, with annual revenues in the US exceeding $1 billion. Yet the safety regulations breached by the two firms did not come into effect until May last year. “We’re now peeling the onion and finding where it’s rotten,” says Areta Kupchyk, a lawyer who helped write the regulations while at the FDA.

The European Union has also started regulating the tissue industry. Since April this year, organisations handling human tissues for use in surgery must be licensed and are subject to inspection. So far, no major problems have emerged with European operators. The US scandals may have a global reach nonetheless. Australian patients were among those given tissues harvested by Biomedical Tissue Services. Also, Don Keenan, a lawyer in Atlanta, Georgia, is representing patients in Germany and Austria who claim they were infected by other tissues exported from the US.

New Scientist
September 12, 2006

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