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FDA Tightens Rules on Tissue Donation

Bones, veins, ligaments, even skin will now come under federal scrutiny

THURSDAY, May 20, 2004 (HealthDayNews) -- The U.S. government has finalized new rules on who can safely donate human cells, tissues and cellular and tissue-based products.

Among the new rules is one barring men who admit to having had sex with another man within the past five years from donating sperm anonymously.

The rules, the second of a three-part framework to update donor regulations, come amid an explosion in the transplantation industry, and in the wake of several injuries and even deaths.

Perhaps the most notable case was that of Brian Lykins, 23, who died in 2002 after routine knee surgery in Minnesota. The cartilage he received was infected with bacteria; the cadaver from which the transplant came had been left unrefrigerated for 19 hours.

At least 66 other people have had similar, if not lethal, infections after tissue transplants, according to the U.S. Centers for Disease Control and Prevention.

About 1 million tissue transplants are conducted every year, up from 350,000 in 1990, Dr. Jesse Goodman, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, said at a news conference Thursday.

"The rules will help enhance the safety of transplanted tissues and help keep them safe in the face of future threats. We believe that this represents a significant public health advance," Goodman said. "While the FDA has had limited rules in place in determining donor eligibility since 1993 and precautions in manufacturing since 1997, the industry has grown tremendously and changed since then, and new risks have been recognized."

Transplant industry officials said the new rules won't change actual practice.

"This basically codifies what we've been doing already," said Bob Rigney, chief executive of the American Association of Tissue Banks, which represents 83 accredited banks providing about 90 percent of tissue for transplantation in the United States.

"We go through a several-step process which includes not only testing for communicable diseases for which we have tests available, (but also) medical and social history to try to identify high-risk behavior or other criteria which may render the donor ineligible. For example, certain criteria that we look for might be indicative of CJD [Creutzfeldt Jakob Disease, the human version of mad cow]."

The new rules expand the types of tissues that will be tested or screened as well as the specific diseases that will be looked for. In addition to blood and organs, which have already been regulated, bones, veins, eye parts, ligaments, sperm, skin and more will now come under the government's scrutiny.

Potential donors will be screened or tested for infection with HIV, hepatitis B and C, syphilis and CJD. Sperm donors will have to be screened for sexually transmitted diseases such as chlamydia and gonorrhea.

Goodman acknowledged there were not yet tests for such diseases as CJD. "We can't have people do things that aren't available," he conceded.

Instead, donor candidates will be screened for neurological problems and asked about their travel history. Countries such as Great Britain have experienced dozens of CJD cases.

Should a CJD test become available in the future, "this will allow us the flexibility of asking that test to be performed and added without having to go through years of additional rule-making," Goodman said.

Activists have been pushing for the more stringent donor rules.

The new rules will become effective May 25, 2005, to coincide with another set of rules addressing handling, processing and storing of tissues.

More information

The U.S. Food and Drug Administration has more on the new rules. Check with the American Association of Tissue Banks for more on tissue donation.

SOURCES: May 20, 2004, press conference with Jesse Goodman, M.D., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rickville, Md.; Bob Rigney, chief executive, American Association of Tissue Banks, McLean, Va.; FDA rules
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