The U.S. Food and Drug Administration (FDA) recently published final guidance titled, “Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of HIV Transmission by Blood and Blood Products.” This groundbreaking change moves to individual donor assessments for blood donor screening, replacing the previous practice of time-based deferrals, including those for sexually active gay and bisexual men, and women who have sex with them.
Community blood centers across the country are actively working to implement the final guidance, with many already completing this work. Implementation of the guidance is a rigorous process that must be conducted with due diligence to uphold the safety of the blood supply. Individuals are encouraged to contact their local blood center to learn the timeline in their area.
It is important to note that the deferral for individuals using PrEP and PEP medications remains in place. This deferral is not specific to any gender or sexual orientation and is based on the fact that these medications may prevent the detection of HIV by current screening tests used for blood donations. This precautionary measure ensures the safety and accuracy of blood donations.
All U.S. blood centers are regulated by the Food and Drug Administration (FDA) and must adhere to their donor eligibility policies. When FDA changes to donor eligibility occur, blood centers must undertake extensive changes before welcoming impacted donors. This includes updating the Donor History Questionnaire (DHQ) that determines an individual’s eligibility to donate; updating their Blood Establishment Computer Software (BECS) and validating the changes to ensure all information is entered to allow all blood products to be properly tracked and labeled; and updating center operations, including Standard Operating Procedures (SOPs). Blood center staff must be trained on these changes, and informational and educational materials must be updated to reflect the changes.
The blood community is committed to upholding the safety and availability of the nation’s blood supply, with America’s Blood Centers, the American Red Cross, and the Association for the Advancement of Blood & Biotherapies (AABB) jointly expressing support for the FDA guidance. For additional information and resources about the change, click here.