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 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. 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. 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.
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.
MEDICA.de; Source: New Scientist