Changing the US Public Health Service Guideline for Reducing Viral Transmission Through Organ Transplantation

In response to several inadvertent transmissions of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation, the US Public Health Services issued guidelines to prevent the transmission of HIV through transplantation of human tissue and organs in 1994. Despite significant changes in the epidemiology of HIV in the USA and advances in screening assays for detecting latent infection, the guidelines remained generally unchanged for nearly 20 years. Although the 1994 guidelines identified risk factors in donors that placed them at increased risk of HIV transmission, compliance with the recommendations was highly variable at US transplant centers. After the cotransmission of HIV and HCV from one donor to four transplant recipients, the OPTN policies were amended to incorporate the definitions of donors at increased risk for HIV and required transplant centers to obtain specific informed consent and follow-up when such donor organs were utilized. With renewed attention, it became obvious that the guidelines needed to be revised and expanded to include HBV and HCV. A revised US PHS Guideline was developed over a several year period, and final recommendations were published in 2013. Despite the revisions, definitions of donors at increased risk of disease transmission require further review and revision. This article will attempt to review the revision process of the US PHS Guideline and make suggestions for next steps in further refining the guideline.