TUESDAY, June 12, 2007 (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.
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.
To date the FDA has inspected 153 major human tissue recovery firms and plans on inspecting an additional 300 companies, Elder said. "What our investigators found was encouraging for tissue safety," he said during the teleconference. "Although we identified some deviations from regulations, we generally saw no unsafe or deceptive practices that could put tissue recipients at risk for disease."
The biggest company involved in illegally harvesting body parts was Biomedical Tissue Services of New Jersey. The company faces trial, along with a former New York state funeral home director, on charges they stole bodies and dissected them unlawfully, the Associated Press reported.
In addition, seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by the company have been recalled. About 10,000 people are believed to have received tissues from the company, according to the AP.
The FDA task force is also recommending:
- Increased education and outreach. The FDA should sponsor a workshop on tissue processing and microbiology for industry, surgeons and academics, to develop and share best practices for reducing the risk of disease transmission.
- Research regulations and guidance. In September 2006, the FDA issued a "guidance document" that emphasized responsibilities for ensuring tissue safety between establishments and their contractors. The FDA will issue guidance on "current good tissue practices" to encourage tissue manufacturers to seek the best methods to further reduce the risk of infection transmission.
The FDA's Center for Biologics Evaluation and Research has strengthened its collaboration with the U.S. Centers for Disease Control and Prevention, to oversee tissue-safety surveillance and adverse reaction investigations, according to the report.
New York Sen. Charles Schumer, who has a bill pending to regulate the tissue industry, called the new report a good first step but more needs to be done.
"Recent tissue scandals highlight a new problem that is not only profoundly troubling, but also threatens the health of the very individuals who believe they are receiving life-saving treatments," Schumer, a Democrat, said in a prepared statement. "More inspections are certainly needed but we hope that the FDA will also consider an accreditation system for tissue banks, strict information standards and tougher penalties for violators. All four are needed to plug gaping holes in the tissue transplant industry."
More information
For more on tissue for transplants, visit the U.S. Food and Drug Administration.
