3:58 p.m.
Federal regulators say they have dramatically boosted inspections of companies that harvest cadaver body parts for transplant, acknowledging weaknesses in government oversight of the multibillion-dollar human-tissue industry that last year was rocked by scandal.
Releasing a task force report today, the Food and Drug Administration said the inspections turned up no serious problems but the agency called for still more inspections.
The targeted companies remove bones, tendons, cartilage, heart valves and other non-organ parts from corpses. The tissues are used in roughly 1 million medical procedures in the United States each year, many of them for routine knee and back surgeries.
In a recent interview, the FDA’s Dr. Jesse Goodman said the “blitz” of inspections came after he read stories last year on how little government oversight there was of the industry. Improperly obtained and poorly processed tissue can transmit dangerous infections, including HIV and hepatitis, to the patients who get the transplanted parts.
Dr. Goodman, director of the FDA’s Center for Biologics Evaluation and Research, said the agency has inspected all 153 companies that remove tissue from cadavers, with future inspections to include some of the more than 2,000 companies that prepare the tissue for use by doctors.
In recent years, the FDA has never inspected more than a few hundred of these businesses annually.
The tissue industry and FDA’s lax oversight of it were highlighted by recent scandals, the biggest involving Biomedical Tissue Services of New Jersey. The company’s operator faces trial with a former New York funeral-home director on charges that they stole bodies and unlawfully dissected them. Among the corpses that had body parts removed was that of Alistair Cooke, the 90-year-old former host of PBS’ “Masterpiece Theater,” who died of cancer.
Seven funeral home directors have pleaded guilty, and tens of thousands of body parts removed by Biomedical Tissue Services have been recalled. About 10,000 people are believed to have received tissues from the company.
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