FDA to regulate sale of body tissue for transplants

December 12, 1993|By New York Times News Service

WASHINGTON -- The Food and Drug Administration announced yesterday that beginning next week it would regulate the sale of bone, skin and other tissues used for transplants to help protect recipients from infection with the virus that causes AIDS.

Two years ago, officials found that a Virginia donor who died in a 1985 shooting had been infected with HIV, even though two tests on his blood before the removal of his organs and tissues did not detect the human immunodeficiency virus. Three people who had received transplants from the donor later died of AIDS.

Medical experts noted that testing procedures for detecting the AIDS virus were much better now than in 1985 but that some HIV infections can still elude detection if they are too recent to have caused the immune system to produce detectable amounts of antibodies.

The sale of cadavers from which tissues and bone are harvested has never been regulated. The tissue bank industry now takes in $100 million a year supplying tissue for about 400,000 grafts. This compares with about 16,000 transplants of whole organs, a business that has been regulated for decades.

Tissues subject to regulation include bone, skin, corneas, cartilage, tendons and similar non-blood-vessel-bearing tissues.

Most of the tissue used is bone, chiefly to replace pieces of bone destroyed in accidents until a patient's own bone can grow back.

The FDA commissioner, Dr. David Kessler, said that the rules to take effect on Tuesday will be supplemented by more detailed rules next year.

Both actions are interim, he said, pending passage of laws now under consideration in Congress.

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