Editorial: Ghastly risk for patients

Monday, June 5, 2006 | 7:19 a.m.

A million patients a year in the United States have surgeries that require tissue transplants from donated dead bodies, the Associated Press reports, but the procedure puts thousands of them at risk because of shoddy practices by some tissue suppliers and weak regulation by the federal government.

AP spent three months investigating how tissue from a donated body gets to the operating room. The news service reported that most tissue transplants "involve reputable companies and do a lot of good." Reporters Marilynn Marchione and Seth Borenstein found, however, that "When things go wrong, the consequences are horrific."

A 23-year-old Minnesota man, for example, had elective surgery on his knee. Four days after the operation, he died of a "raging infection" because the cadaver cartilage he received had been contaminated. The AP found that the cartilage had come from a corpse that had been left unrefrigerated for 19 hours.

Poor oversight on the part of the Food and Drug Administration constitutes much of the problem, AP found. Loosely written regulations and a lack of staff to conduct inspections invite abuses on the part of many individuals and businesses involved in procuring tissue.

AP found that accredited members of the American Association of Tissue Banks follow high standards, but that the booming tissue-supply business - generating revenue of a billion dollars a year - has attracted many unscrupulous people. As unassuming doctors and hospitals sometimes buy tissue based on price, not on the reputation of the supplier, the chances of it being contaminated are becoming unacceptably high.

According to AP's investigation, the FDA falls short in many areas. It doesn't require the most accurate tissue-testing procedures available. It sets no age or health limits for donors. It hasn't established a tracking system for tissue, making it difficult to learn the donor's identity when problems arise after an operation. Hospitals and doctors do not have to report transplanted tissue infections to health agencies, leaving the nation blind as to the scope of the problem.

Every member of Congress should read AP's report. If the government does not have the resources to vastly increase its oversight of this industry, more funding should be provided.

And then the FDA should be held to its job, that of protecting patients in this country from this type of risk.