The inspection 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.
Seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by Biomedical Tissue Services 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.
The FDA wanted to see if these cases were symptomatic and found they were not.
Tissue collection companies are usually inspected by the FDA every four years but the agency is now recommending more frequent inspections of every two years at some high-risk tissue establishments.
http://www.news-medical.net/?id=26223
