FDA seeks to tighten donations of sperm, transplant tissues

Yesterday, the Food and Drug Administration announced rules that could cut risky donations: Tissue banks must test and screen potential donors for signs of infectious diseases that render them ineligible.

The FDA had first proposed those rules and a list of others to strengthen tissue safety in 1997. The death of Lykins sped up the long-delayed proposals.

Federal investigations of the death prompted the FDA to suspend some operations at the nation's largest tissue supplier and identified more than 60 other patients sickened from tainted tissue transplants. With 1 million tissue transplants a year, problems are rare, Dr. Jesse Goodman, FDA's chief of biological products, said yesterday. Still, ''we can do a better job," he said.

The new rules require tissue banks to test donors and donated tissue for the AIDS virus, hepatitis B and C, syphilis, and Creutzfeldt-Jakob disease, the human form of mad cow disease. There's no specific test for Creutzfeldt-Jakob, so banks instead must perform other checks such as examining the brain of a cadaver donor.

Additional testing is required for some tissue donations, such as ensuring that the donors of sperm and eggs do not have the sexually transmitted diseases chlamydia and gonorrhea. The rules also allow the agency to order checks for new diseases, such as West Nile virus or SARS, as it deems necessary.

Tissue banks also must check donors' medical records for such problems as recent bacterial or fungal infections. In addition, tissue banks must ask a living donor or the relatives of a dead one about risk factors for infections, similar to the screening that blood banks now perform.

Part of the rules drew objection from some gay rights activists, who objected to refusing donations from gay men. ''HIV affects every part of our nation's population, and the FDA needs to realize that fact and stop treating gay men as the only people who contract HIV," said Kevin Cathcart, executive director of Lambda Legal.