The U.S. Department of Health and Human Services (HHS) has released a new guideline 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, 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.
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.
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