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Two government reports released in January reveal that tissue banks are not routinely inspected, and donor families often do not hear about profits made from a family member’s donated body parts.
The reports, released by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), state that cadaver tissue donations have promoted an industry with no accountability as well as federal oversight. As a result, one report concludes, donor families could feel misled. (See editor’s note, at end of this article, on how to obtain copies of the reports.)
Nonprofit tissue banks serve as middlemen between corporations that craft products from donated bone, heart valves, veins, tendons, and other tissues. The National Organ Transplant Act, however, prohibits persons or organizations from profiting from human body parts. The act does allow reasonable fees for recovery, processing, and distribution.
HHS began its investigation last year following a report in the Orange County Register in Santa Ana, CA, that explained how a single body can result in more than $220,000 in products for tissue banks and other companies.
The report stated that families were never told of the resulting profits from the deceased family member. Families are not told, for example, that tissue banks may ultimately go to a company that processes skin, bone, and other tissue. Families also may not be told that body parts might be used in cosmetic surgery or be exported to another country.
Three organ and tissue organizations completed a unified list of elements to include on informed consent forms in November 2000. The list is included in the OIG report. HHS officials say that in 1999, about 750,000 pieces of tissue (other than organs) were im-planted into patients from about 20,000 donors nationwide. Other findings in the reports include the following:
• The Food and Drug Administration (FDA), the federal agency responsible for inspecting tissue banks and ensuring that tissues are free of disease, failed to inspect 36 of 154 banks it identified.
• More than half of those 154 banks that were inspected had been checked only once since 1993.
• Tissue banks and companies accepted tissue without proof of inspection and failed to repeatedly test bodies for hepatitis B and C.
Improvements and reforms are in progress, say officials with the American Association of Tissue Banks, the industry trade association. The FDA announced it will require tissue banks to register and list products with them this spring.
HHS recommended in the reports that tissue banks voluntarily divulge finances to the public and set guidelines for tissue banks, such as giving families copies of their consent forms. Tissue banks should also describe potential uses of donated tissue and disclose all relationships with other companies, the agency recommends.
(Editor’s note: Copies of the reports from the OIG can be obtained from the Internet. Informed Consent in Tissue Donation: Expectations and Realities and Oversight of Tissue Banking can be downloaded. Web: www.hhs.gov/oig/new.html.)