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FDA Steps Up Oversight of Body Parts Companies
Inspections said to show no risk to transplant patients from tissue taken from cadavers
By Steven Reinberg
HealthDay Reporter
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TUESDAY, June 12 (HealthDay News) -- U.S. health officials said Tuesday that they're stepping up inspections of companies that use cadavers to harvest body parts for tissue transplants.
The increased vigilance comes after scandal shook the transplant industry last year when it was discovered that funeral homes were harvesting body parts and selling them without consent, including body parts from Alistair Cooke, the 90-year-old former host of PBS' Masterpiece Theater.
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If not screened properly, transplanted tissues can cause serious infections, including HIV, hepatitis -- even death. Harvested tissues are used in some 1 million medical procedures in the United States each year, many of them for knee and back surgeries. Up to 100 recipients may receive tissue from a single donor, the FDA said.
In response to the scandal, the U.S. Food and Drug Administration formed the Human Tissue Task Force, which issued its first report Tuesday.
"Today's report finds no significant industry-wide problem in the recovery of human tissues," Dr. Celia Witten, director of FDA's Office of Cellular, Tissue and Gene Therapies, said during an afternoon teleconference. "This provides our belief that the risk of disease transmission is very low for patients who receive these products."
Still, the task force is calling for still more inspections. "There is reason to be ever vigilant because the tissue industry is growing," Witten said.
There are more than 2,000 cell and tissue establishments registered with FDA, the agency said.
Originally, the task force recommended targeted inspections -- or a "blitz" -- of U.S. companies that recover human tissues, including tendons, ligaments, bone and other musculoskeletal tissues, said David Elder, director of the FDA's Office of Enforcement, Office of Regulatory Affairs.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 6/12/2007
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SOURCES: June 12, 2007, teleconference with Celia Witten, M.D., Ph.D., director, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration; David Elder, director, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration; Associated Press; June 12, 2007, prepared statement, Sen. Charles Schumer, D-N.Y.
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