WASHINGTON – 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.
The U.S. Food and Drug Administration said the inspections turned up no serious problems. But an internal task force report urges agency officials to set up a method for tracking body parts from cadaver to transplant patient — a system that currently doesn't go that far.
The targeted companies remove bones, tendons, cartilage, heart valves and other non-organ parts from corpses. These tissues are used in roughly 1 million medical procedures in the United States each year, many of them for routine knee and back surgeries.
If improperly screened and processed, these tissues can cause serious infections, including HIV or hepatitis, or even death in transplant recipients. Fears about the lax regulation of the industry arose after scandals involving two companies and the recall of thousands of tissues, many of which were already transplanted.
A three-month investigation by The Associated Press last year detailed many gaps in oversight by the FDA.
The task force recommends steps to address some of those problems, but operators of accredited tissue banks and others familiar with the industry say the report doesn't go far enough to clean up the problem.
The FDA says it is reviewing the recommendations, which include:
— A tracking system that ends with the recipient of the transplanted tissue. Currently, the tracking requirement ends with the doctor or hospital that does the transplant. As a result, it has been difficult to warn patients who may have received improperly processed cadaver parts.
The agency says it must review the legality of enforcing such a requirement...
"They have the legal authority, they just need the backbone to do it," said former FDA attorney Areta Kupchyk, an expert in the tissue industry. She was among several critics of the task force report, which was written by FDA employees.
— Requiring companies that use tissue parts to audit their suppliers regularly. In an interview the FDA's Dr. Jesse Goodman said his agency has reiterated to doctors and tissue banks that they are responsible for making sure that their suppliers comply with the law and are safe.
— Hiring a microbiologist to resolve scientific questions about tissue safety — such as what sterilization or treatment processes are best.
Experts in the field criticized the task force for not urging more, such as:
— Tightening standards for who can run a tissue bank, or require licensing or background checks. Under current regulations, even convicted felons could start such a business and would only have to register their intent with the FDA.
— Requiring inspections at the time a tissue handler first starts in the business.
— Limiting or banning retrieval of tissue at funeral homes. Many in the industry have urged such limits because unsterile retrieval can increase the chances of germs being passed to recipients.
In the meantime, 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. He said future inspections would 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 on an annual basis.
Goodman, in an interview with The Associated Press, said only minor problems were turned up from the agency's inspections and overall, "the finding there was generally reassuring."
Dr. Celia Witten, who oversees FDA's cellular tissue and gene therapies office, said: "Today's report finds no significant industrywide problem in the recovery of human tissues"
However, some in the industry disagree. And weaknesses came to light through recent scandals, the biggest involving Biomedical Tissue Services of New Jersey. The company's operator faces trial along with a former New York funeral home director on charges that they stole bodies and unlawfully dissected them unlawfully. Among the corpses that had body parts removed was Alistair Cooke, the 90-year-old former host of PBS' "Masterpiece Theater," who died of cancer.
Seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by BTS were recalled. About 10,000 people are believed to have received tissues from the company.
One victim of the BTS scandal, Alicia Dawes who received a bone implant from that company, said she wanted a ban on tissue recovery at funeral homes and some kind of background check on companies that harvest cadaver tissue.
"There is just too much money in body parts for profit," said Dawes, of Medford, Ore. "You're going to find the same thing happening over and over."
Dawes has not become ill from the bone that was implanted in her neck, but she has been told to be tested for the AIDS virus and hepatitis, like thousands of other patients who received BTS body parts.
"If this is the end of it, they've missed some opportunities" to improve tissue safety, Robert Rigney, head of the American Association of Tissue Banks, said of the task force report.
He said the task force consulted once by phone with the association, which requires members to follow tougher standards than the FDA's. All of the scandals and problems with tissue so far have involved companies not accredited through the tissue bank group association, but the FDA has not required accreditation or similar standards, he noted.
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