Report: Tissue Banks Lack Checkups

Tuesday, January 9th 2001, 12:00 am

By: News On 6

SANTA ANA, Calif. (AP) â€” Tissue banks are not routinely inspected and donor families rarely hear about the profits being made from donated body parts, according to two reports released by the U.S. Department of Health and Human Services.

The reports released Friday detail how donations of cadaver tissue have helped to fuel an industry with no accountability or federal oversight.

``It is not surprising that donor families could feel misled,'' one of the reports stated.

The department began an investigation after an Orange County Register report last year revealed that a single dead body can yield more than $220,000 in products for tissue banks and companies and that the families were never told. The newspaper also found that burn victims often are forced to compete with cosmetic surgeons for skin.

Scientific advances have helped to create a $500 million industry in the sale of human body parts. In 1999, the health department found, about 750,000 pieces of tissue, other than organs, were implanted into patients from about 20,000 donors nationwide. Nonprofit tissue banks act as middlemen for corporations developing products crafted from donated bone, heart valves, veins and tendons.

The National Organ Transplant Act prohibits anyone from profiting from human body parts, although it allows ``reasonable'' fees for recovery, processing and distribution.

Families generally are not told that donations to a nonprofit tissue bank may ultimately go to for-profit companies that process skin, bone and other tissue. They also are not told that body parts may be used in cosmetic surgery or may be exported.

The FDA, which is responsible for inspecting tissue banks and ensuring that its tissues are free of disease, failed to inspect 36 of 154 banks it identified, according to the report. More than half of those that had been inspected had been checked only once since 1993.

The department also found that tissue banks and companies accepted tissue without proof of inspection and failed to repeatedly test bodies for hepatitis B and C.

The department recommended that tissue banks make their finances public but it has no enforcement authority. It also recommended setting guidelines for tissue banks, such as giving families a copy of their consent forms; describing potential uses of donated tissue and disclosing all relationships with other companies.

The American Association of Tissue Banks, the industry's trade group, said that it welcomed the report and that reforms are in progress.

The Food and Drug Administration said it intends to begin registering all tissue banks this spring.

``As a result of the public attention that has been drawn to this area, important steps are already under way toward making improvements,'' wrote Health Secretary Donna Shalala.

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Department of Health and Human Services: http://www.hhs.gov