Officials from the U.S. Food and Drug Administration 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 FDA claims the inspections turned up no serious problems. But an internal task force report urges the agency to establish a method for tracking body parts from cadaver to transplant patient as well as other 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 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.
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 is concerned over the legality of enforcing such a requirement, however legal critics argue the agency has the legal authority, but lacks “the backbone to do it.”
— 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 non-sterile retrieval can increase the risk of germs being passed to recipients.
In the meantime, the FDA’s Center for Biologics Evaluation and Research has inspected all 153 companies that remove tissue from cadavers. 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.
Weaknesses in the industry 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. See our blog Cadaver Parts Become Growth Industry?
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.
A little unsettling when one considers this is the agency which can’t protect us from contaminated spinach or peanut butter…