Hospitals Used Stolen Tissue in 17 Implants

Seventeen former Duke University Health System patients received implants of human tissue that was stolen from funeral homes, DUHS administrators recently said.

The stolen bone and skinwhich allegedly were taken from sites in New York, Pennsylvania and Florida, among other places, were implanted in Duke patients in 2004 and 2005.

The U.S. Food and Drug Administration issued a national advisory Oct. 26 that the tissue might not have been properly screened.

Investigators think hospitals across the country received the tissue over the past five years.

Among its many uses, skin tissue is often used in reconstructive surgeries, and bone tissue is used in orthopedic surgeries.

Dr. Michael Cuffe, vice president for medical affairs for DUHS, said nobody has reported any infections related to the stolen tissue.

Four patients were exposed at Duke Hospital, 12 at Durham Regional Hospital and one at Duke Health Raleigh. All affected patients were notified in October 2004 and tested for infection or disease. Duke also offered counseling for the patients.

National and local specialists said there was minimal infection risk from the tissue, since it was processed and sterilized before being implanted in patients.

Cuffe noted, however, that risk could not be ruled out because donors are usually screened for a variety of illnesses and behaviorsincluding certain neurological disorders and infectionsbefore donations are accepted, but because the records of the stolen tissue were allegedly falsified, no such screening took place.

DUHS bought some of the tissue from Regeneration Technologies, Inc., a Florida-based company that specializes in tissue processing. The company is one of several tissue sources for Duke hospitals.

Regeneration Technologies purchased its supply in part from the New Jersey-based Biomedical Tissue Services, which investigators think took bone and tissue from corpses without permission from families of the deceased.

Biomedical Tissue Services allegedly altered paperwork that documented where the tissue came from and sold the samples to five tissue processing companiesincluding Regeneration Technologiesthat sell the tissue to hospitals.

Cuffe said Regeneration Technologies was not a major vendor for Duke.

He also said Duke officials noticed a voluntary recall of the tissue before the FDA issued the Oct. 26 warning and had already worked to clear their supply of the potentially tainted samples.

This case also highlights the vigilance you have to have of your vendors, Cuffe said. Having diligence over medical safety is not just wrong patient, wrong pill.

One of the individuals from whom tissue was stolen was Alistair Cooke, the former host of Masterpiece Theatre and a renowned broadcaster.

His bones were allegedly stolen and sold for about $7,000.

Cooke died when he was 95 from cancer that spread to his bones. His bones would be considered too old and cancerous by general implant standards and would not have been able to be donated. But The Times of London reported that the paperwork describing Cookes bones was changed to say they came from an 85-year-old man.

Other hospitals in the Triangle area have also reported recently they were affected by the incident. The News & Observer reported Jan. 6 that 30 of Wake Meds patients received the stolen tissue.