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

The CDC took part in over 200 investigations of suspected unforeseen transmissions of HIV, HBV, and HCV made through transplants. The investigations ran from 2007 to 2010; and of those cases confirmed, some resulted in a deadly outcome for the transplant recipient.

The CDC invited a multidisciplinary group of transplant and infection prevention experts and conducted a systematic review of the best available evidence to update standards for safe transplants. This review is based on the recommendations they agreed on, with the full draft guidelines being available at http://www.regulations.gov. The CDC encourages review and response during the 60-day comment period.

The title of the document is ‘Draft 2011 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation’. The CDC is the leading scientific agency in writing the report, with the PHS being responsible for guidelines that address the transmission of communicable diseases through transplantation to regulatory requirements.

Matthew J. Kuehnert, M.D., director of CDC’s Office of Blood, Organ, and Other Tissue Safety Office commented:

“Our first priority must be patient safety. These recommendations will save lives and reduce unintended disease in organ recipients. The guideline will help patients and their doctors have information they need to fully weigh risks and benefits of transplanting a particular organ.”

The new draft includes the following key changes to the 1994 PHS Guideline:

  • The recommendation to include screening for HBV and HCV in addition to HIV. Previous recommendations include only HIV.
  • Recommending up-to-date and more precise laboratory tests for organs. The ultimate aim is to make sure that organ recipients are made aware of risk to the extent possible and protected from unintentional infection transmission.
  • A revised set of donor risk factors that enable clinicians to obtain a more thorough picture about possible risks linked to 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.

Kuehnert said in a concluding statement:

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

Written by Petra Rattue