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Tissue bankers study rules in wake of body scandals

By ASSOCIATED PRESS
Published September 24, 2006

SAN DIEGO - The nation's tissue bankers are considering new rules aimed at preserving public trust in their industry, following two recent scandals that made some of them appear more like body snatchers than people who help improve the lives of millions of Americans.

The leading professional association will vote next month on tighter controls over those who supply cadaver flesh and bone. Though it sounds ghoulish, body parts are used in more than a million medical procedures each year in the United States.

The government also has formed a task force to look for regulatory gaps.

It has been almost a year since Biomedical Tissue Services, a now-defunct New Jersey company, was accused of plundering corpses for body parts, including that of former Masterpiece Theatre host Alistair Cooke. Company owner Michael Mastromarino and three others have pleaded not guilty to charges. About 10,000 people received tissue supplied by the company.

In August, the federal Food and Drug Administration shut down Donor Referral Services of Raleigh, N.C., citing "serious deficiencies" in tissue processing, donor screening and recordkeeping. Company owner Philip Guyett has denied any wrongdoing. The FDA will not say how many people received tissue in that case because the investigation is continuing.

People who received tissue supplied by the companies have been urged to seek testing for HIV and other diseases. No infections have been confirmed, but experts say that proving such a link is almost impossible unless other tissue from the donor is still available to test.

After the Mastromarino case, the American Association of Tissue Banks appointed a task force that inspected companies that did business with him. It also adopted a new rule allowing inspection of any business partners of association members, even if the partners themselves do not belong.

Tissue bankers and outside experts have made other suggestions for both the industry and FDA to improve safety:

- Requiring licensing and training. The FDA only requires tissue establishments to register each year.

- More money and staff for FDA inspections.

- Requiring tissue banks to be certified by the association. The group has stricter and more specific tissue safety standards than the FDA.

- Limiting profits on donated tissue. Federal law says body parts can't be bought and sold but allows companies to earn "reasonable fees" for obtaining and supplying them.

- Regulating or banning tissue recovery at funeral homes.

- Reducing risk from "fresh" or "fresh frozen" tissue. Bone can be irradiated to kill germs, but some fresh tissue cannot without destroying its usefulness. That makes the screening of donors and sterile removal techniques critically important.

- Requiring state-of-the-art sterilization.

- Using a bar-code system to track tissues. There is no uniform, automated system to trace tissue from recovery to processor to supplier to doctor to patient.

[Last modified September 24, 2006, 01:34:54]