FDA scrutinise companies selling human tissue

Jun 13 2007

Following an inspection blitz by the Food and Drug Administration (FDA) on companies which handle a variety of human material from deceased donors, no serious problems have apparently been unearthed.

The blitz was prompted by two high-profile body parts scandals in 2006 when two companies that sold human tissue, bone and other body parts were forced to close.

The FDA discovered one was using tissue from a North Carolina funeral home and another had used stolen bodies but had also shipped nearly 20,000 potentially contaminated body parts.

Biomedical Tissue Services of New Jersey is now facing court action trial along 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 the famous broadcaster 90-year-old Alistair Cooke, who died of cancer.

Seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by BTS have been recalled.

As many as 10,000 people are believed to have received tissues from the company.

Such companies harvest a variety of human tissue, bone, ligaments, skin and tendons from deceased donors that can be transplanted into patients.

The FDA inspected 153 companies and say they found no suggestion that patients might be at risk of transplants from contaminated or diseased cadavers.

The FDA were searching for widespread problems in tissue recovery after the cases last year revealed the two companies were not following procedures intended to prevent infectious disease transmission.

Dr. Celia Witten, director of the FDA's Office of Cellular, Tissue and Gene Therapy, says the FDA wanted to see if these cases were symptomatic and found they were not.

Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, says the results show that the FDA's new tissue regulations help keep human tissue safe.

Tissue collection companies are usually inspected by the FDA every four years but the agency is now recommending more frequent inspections (every 2 years) of some high-risk tissue establishments.

Dr. Goodman points out that 1.5 million musculoskeletal tissue transplants are performed annually in the United States but reports of disease transmission are rare.

However tissue collection companies are not part of the organ donation program, which is administered separately and is generally non-profit.

The FDA has more than 2,000 active cell and tissue establishments registered on it's books and aims to conduct a total of 484 inspections this year, including the 153 just completed.

Experts say improperly obtained and poorly processed tissue can transmit dangerous infections, including HIV and hepatitis, to the patients who receive the transplanted parts.