FDA Issues Regulations Governing Tissue Banks After Years of Delay

On Thursday, the Food and Drug Administration issued new safety standards (PDF) for tissue banks that process donated skin, ligaments and bones for transplant. The regulations, which will take effect in May, aim to prevent infection and disease in an industry that has gone unregulated during a period of explosive growth. So far this year, doctors have performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for the industry. In January, FDA required all tissue banks to register with the agency and allow regular inspections. In May, FDA said tissue donors, like blood donors, must be screened for diseases including HIV, hepatitis B and C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need for regulations, with investigators reporting widespread problems: operators running multiple tests on recovered tissue in hope a second test would find the material healthy when the first did not; mishandling cadavers after removing bone and skin; and tissue banks pooling donors' material despite the medical risk of one person's tissue contaminating another's.

"This rule is a major step toward ensuring that tissue contaminated with life-threatening diseases is not transplanted into unsuspecting patients," Sen. Susan Collins (R-Maine), the panel's chairperson, said in a statement.

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