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. In this case, four men 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. Keenan's firm has already won damages for American victims of tainted tissues, including the family of Brian Lykins, who died in 2001 from a massive infection of Clostridium bacteria. His knee was rebuilt using cartilage from a corpse left unrefrigerated for at least 19 hours.
The FDA's inspectors face a huge task, as hundreds of organisations in the US handle human tissues for use in surgery.
One way forward would be to require them all to be accredited by the American Association of Tissue Banks, which would open them up to additional inspections. Registration takes months, and neither Biomedical Tissue Services nor Donor Referral Services went through this process, which is still voluntary. Similarly, CryoLife of Atlanta, which processed the tissue that killed Lykins, was not accredited at the time.
Legislation to force accreditation was introduced into both houses of Congress in April, but observers are not optimistic that it will pass into law. "These are very strong lobbies," says Michele Goodwin, director of the Health Law Institute at DePaul University in Chicago.
Author: Peter Aldhous
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