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U.S. Strengthens Rules Governing Tissue, Organ Transplants

Move designed to prevent contamination with infections

FRIDAY, Nov. 19, 2004 (HealthDayNews) -- U.S. officials announced Thursday the last of three rules intended to enhance the safety of human cells and tissues that are slated for transplantation.

This final rule covers "good tissue practice," which refers to the methods, facilities and controls used to manufacture the products.

"We believe these rules represent a significant public health advance," Dr. Jesse Goodman, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, said at a news conference. "We need new and better ways to test tissue and better methods to reduce contamination. Taken together, we believe these methods will help make products as safe as possible while allowing flexibility for new methods and approaches."

What Goodman referred to as the agency's new "comprehensive risk-based approach" will be fully implemented in May 2005. The rules will apply to cellular and tissue-based products recovered for transplantation on or after May 25, 2005.

Although Goodman made only passing reference to the case, the new rules seemed at least partly designed to prevent tragedies like 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.

According to the U.S. Centers for Disease Control and Prevention, at least 66 other people have had similar, though not always fatal, infections after tissue transplants.

About 1 million tissue transplants are conducted every year, up from 350,000 in 1990, Goodman said. "These transplanted tissue products span a broad range, from muscular tissue, to corneas to restore vision," he added.

There are far fewer tissue donors than blood donors but, while a blood donation may go to three or four people, a tissue donation could conceivably go to as many as 100 people. Earlier this year, organs from the corpse of a donor in the United States transmitted rabies to four people, all of whom died.

Limited rules governing eligibility and manufacturing have been in place since the early 1990s but, according to Goodman, since then "the [transplantation] industry has changed and grown tremendously and new needs and risks have been identified."

The new rule requires manufacturers to recover, process, store, label, package and distribute human cells, tissues and cellular and tissue-based products in such a way that prevents the introduction, transmission, or spread of communicable diseases. The regulations apply to a broad range of products, including human heart valves, the lining of the brain (dura mater) and cellular therapies, in addition to musculoskeletal tissue and corneas.

"We are trying to get the right balance of comprehensive regulations and an approach that can evolve as we see benefits and gains to quality in this industry," Goodman said. "We don't want to be fixed in time."

The previous two rules in the series covered registration and listing (published in 2001) and donor eligibility (published earlier this year).

Among other things, the new rules allow the FDA to continue to perform inspections and will require that tissues have unique identifying codes. Certain tissues that previously hadn't been inspected, such as hematopoietic stem cells, will now come under the FDA's purview.

More information

The FDA has more on tissue safety.

SOURCES: Nov. 18, 2004, news conference with Jesse Goodman, M.D., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
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