Surgeons Object to New CDC Organ-Screening Guidelines

New draft guidelines for reducing the risk of HIV and hepatitis B and C virus (HBV, HCV) transmission through solid organ transplants are too restrictive, according to the head of the American Society of Transplant Surgeons. The CDC proposal issued Wednesday is open to public comment for 60 days, and ASTS plans to weigh in during the process, said Mitchell Henry, its president.

"We support guidelines which help to decrease disease transmission, but we want them to be evidence-based and balanced by the risks of dying without an organ transplant," Henry said.

Using the more sensitive and expensive nucleic acid test -- for HIV, HCV, and under certain circumstances HBV -- would not always be feasible, such as when an organ is flown to a remote location where no labs are available, Henry added.

ASTS believes the expansion of donors considered risky includes too many population groups that might otherwise be good candidates, Henry said. Potential donors who have had sex with two or more partners in the last year "could cover three-quarters of college kids in America," he noted.

While the guidelines are not enforceable, they often become mandatory standards of care, Henry said. ASTS plans to submit criticism that its concerns have not been taken into account, as well as suggestions about how to modify the guidelines.

The draft rules are meant to give potential organ recipients and their physicians as much information as possible about transmission risks so they can make informed decisions, said Dr. Matthew J. Kuehnert, director of CDC's Office of Blood, Organ, and Other Tissue Safety.

"The guidelines may actually expand available organs by providing more confidence in the risk assessment of the donor, which will in turn improve the chances a patient and doctor will accept the organ," said Kuehnert.

For more information about the proposal, visit: www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=CDC-2011-0011.

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