Today, the U.S. Department of Health and Human Services (HHS) released a new guideline Exit disclaimer icon to improve patient safety by reducing unexpected disease transmission through organ transplantation. This guideline updates the 1994 U.S. Public Health Service (PHS) guideline for preventing transmission of human immunodeficiency virus (HIV) through organ transplantation and adds guidance for reducing unexpected transmission of hepatitis B virus (HBV) and hepatitis C virus (HCV) through organ transplants.
The 2013 PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus and Hepatitis C Virus Transmission through Organ Transplantation, published in Public Health Reports Exit disclaimer icon, recommends the use of more sensitive tests so that patients can be informed of risks to the greatest extent possible and protected from unintentional infections caused by transplanted organs.
“Transmission of infections through organ transplants is a critical concern for patients, their families and healthcare personnel involved in transplant procedures,” said HHS Assistant Secretary for Health Howard K. Koh, MD, MPH. “Putting these new recommendations into practice will allow doctors and patients to make better, more informed decisions when accepting organs for transplantation.”
To update standards for safe transplants, CDC led an HHS workgroup comprised of experts on evidence-based guidelines and a multidisciplinary group that included transplant and infection prevention experts to conduct a systematic review of the best available evidence on reducing HIV, HBV and HCV infection transmitted through organ transplantation. The 2013 PHS guideline includes recommendations based on this review.
The major changes from the previous PHS guideline are:
Recommendation that donors be screened for both HBV and HCV, in addition to HIV. Although organ donors are routinely screened for HBV and HCV, there were no specific PHS recommendations for this screening included in the 1994 guideline.
Recommendation for new, more sensitive laboratory testing. Since the 1994 PHS guideline was published, more sensitive tests for HIV, HBV and HCV have become available. The 2013 guideline recommends the use of more sensitive tests for living and deceased organ donors.
Inclusion of a revised set of risk factors for HIV, HBV or HCV infection.
Updated information about risk factors for these diseases can give clinicians a clearer picture about possible risks associated with donated organs to improve recipient informed consent, and in certain circumstances, to trigger more sensitive laboratory testing of the donor and recipients.
Focus on organs and vessel conduits recovered for transplantation, and not on tissues, eyes or cellular products. The Food and Drug Administration (FDA) has implemented more comprehensive regulations for tissue and semen donors since the 1994 PHS guideline was published.
Recommendation for a robust informed consent discussion between the transplant candidate (or medical decision maker) and the clinician. With the availability of more sensitive tests, doctors and patients can have a more thorough discussion about potential risks and benefits associated with accepting and rejecting individual organs.
“The decision to accept the risk and the benefit of an organ transplant should be made by a fully informed patient, and the new guideline will help patients and their doctors have the information they need to weigh risks and benefits of transplanting a particular organ,” said Matthew J. Kuehnert, MD, director of CDC’s Office of Blood, Organ, and Other Tissue Safety.
Several federal agencies oversee or regulate aspects of the procurement and transplantation of organs. The Health Resources and Services Administration (HRSA) provides oversight of solid organ transplantation, including donor screening policies, recipient evaluation and informed consent, through the Organ Procurement and Transplantation Network (OPTN), established by Congress under the National Organ Transplant Act of 1984. This act requires the OPTN to be administrated by a private, non-profit entity through a contract overseen by HRSA. The United Network for Organ Sharing Exit disclaimer icon is the entity that operates the OPTN. The Centers for Medicare and Medicaid Services (CMS) establishes performance standards and conducts surveys of transplant centers and organ procurement organizations (OPOs) to determine certification or recertification. Currently, there are 58 OPOs and 247 organ transplant centers in the United States. Public Health Reports Exit disclaimer icon is the official journal of the U.S. Public Health Service and the Office of the Surgeon General. It is published by the Association of Schools of Public Health Exit disclaimer icon.