HHS Calls for Closer Controls on Donated Tissues
BY LAUREN UZDIENSKI, DECEMBER 30, 2009
The Wall Street Journal reported last week on the rising demand for donated organs and tissues and the potential increase in the risk of disease transmission to patients. While donors are screened and harvested tissues are tested and sterilized, making the tissue supply generally safe, there are still calls for additional regulation. The government has dubbed this action "biovigilance," and while it's designed to further reduce risk, biovigilance may also raise healthcare costs and delay organs and tissues to the patients who need them.
In 2006, HHS commissioned a report on the state of biovigilance in the U.S. This report was published in October and noted that tissue oversight was largely decentralized and consists of a "patchwork of activities." Among some of the concerns HHS raised specifically related to donated human cell and tissue products are: limited ability to link reported infections to the donated tissue; lack of required adverse reaction reporting from the healthcare facility or provider; and that information about adverse reactions in other recipients of tissue from the same donor may not be available. This suggests that HHS believes infections and adverse reactions are underreported in tissue recipients.
To address these issues, HHS recommended the creation of a national program to monitor organ and tissue safety; integrating public and private sector tissue donation systems (presumably including procurement, distribution and adverse event reporting); and efforts to enhance surveillance mechanisms (presumably including testing.)
National controls on donated tissue do already exist. The American Association of Tissue Banks offers an accreditation program for U.S. tissue banks, reviewing the bank's retrieval, processing, storage and distribution processes to ensure the safety of the supply and the professionalism of the procurement and distribution system. Potential donors undergo a selection process designed to weed out high-risk donors, and harvested tissues undergo rigorous serological testing and sterilization processes. More intensive testing would be costly; the Journal describes one recent case where hepatitis C was spread to eight of 40 recipients of tissue from one donor, including tendon-bone grafts. They note that the donor tested negative for hep C in routine tests, but that a more sensitive nucleic-acid test may have caught the infection. It is estimated that if nucleic-acid testing were used routinely, "the cost of eliminating one hepatitis C-infected donor would be $2.3 million."
