The CDC’s draft guidance concerns infections such as human immunodeficiency virus, hepatitis B virus and hepatitis C virus. Major proposed revisions of the 1994 Public Health Service Guideline include the following:
• Recommending HBV and HCV screening. 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, not other tissues. The FDA has implemented more comprehensive regulations for tissue and semen donors, leaving the focus of the 2011 Draft PHS Guideline on organ safety.
The full draft guidelines can be found here. www.regulations.gov The CDC is accepting all responses during the 60-day comment period.
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