Media Statement

New proposed guidelines for organ transplantation

Draft guidelines on organ transplants call for more thorough donor screening and more advanced organ testing to help protect patients from infections transmitted through transplants. The draft from the Centers for Disease Control and Protection concerns infections such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).  It recommends adding HBV and HCV to the list of organisms to be screened.

From 2007 to 2010, CDC participated in more than 200 investigations of suspected unexpected transmission including HIV, HBV, and HCV through transplants.  Of those that were confirmed, some led to the death of the transplant recipient. To update standards for safe transplants, CDC led a multidisciplinary group of transplant and infection prevention experts through a systematic review of the best available evidence. The result includes recommendations based on this review.

The full draft guidelines can be found at www.regulations.gov, and CDC encourages review and response during the 60–day comment period. The document is entitled Draft 2011 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation. CDC was the lead scientific agency in writing the report; the PHS is responsible for guidelines that address the transmission of communicable diseases through transplantation to regulatory requirements.

“Our first priority must be patient safety. These recommendations will save lives and reduce unintended disease in organ recipients,” said Matthew J. Kuehnert, M.D., director of CDC′s Office of Blood, Organ, and Other Tissue Safety Office. “The guideline will help patients and their doctors have information they need to fully weigh risks and benefits of transplanting a particular organ.”

Major changes from the 1994 PHS Guideline include:

• Recommending HBV and HCV screening, in addition to HIV. Previous recommendations include only HIV.
• Recommending updated, more sensitive laboratory tests for organs. The ultimate goal is to ensure organ recipients are informed of risk to the extent possible and protected from unintentional infection transmission.
• A revised set of donor risk factors that can give clinicians a more thorough picture about possible risks associated with donors′ organs.
• Focusing only on solid organs and vessel conduits, and not other tissues. The Food and Drug Administration has implemented more comprehensive regulations for tissue and semen donors, leaving the focus of the 2011 Draft PHS Guideline on organ safety.

“We recognize that organ demand is much greater than availability, and that organ transplantation is often a lifesaving procedure,” said Kuehnert. “This guideline will assist the transplant community in ensuring that each patient is protected against unexpected diseases from the organ they so desperately need.”

The federal register posting can be found at http://www.ofr.gov/OFRUpload/OFRData/2011-24189_PI.pdf.

Editor′s Note: Clarification to sentence in press release. From 2007 to 2010, CDC participated in more than 200 investigations of suspected unexpected disease transmission including HIV, HBV, and HCV through transplants.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES