FDA Proposed Change to Assessment of Blood Donor Eligibility

photo of blood cellsThe U.S. Food and Drug Administration (FDA) recently proposed “a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.”  The draft recommendations are based on FDA’s review of “data from other countries with similar HIV epidemiology that have instituted this approach as well as ongoing surveillance of the U.S. blood supply.”  Proposed guidance changes include revising the donor history questionnaire to ask prospective donors about new or multiple sexual partners in the past three months, and the deferral of prospective donors who have had anal sex with new or multiple sexual partners in the past three months.  There is no proposed change to donor deferral time periods for other HIV risk factors (eg, non-prescription injection drug use), individuals who have tested positive for HIV or taken medication to treat HIV will continue to be deferred permanently, and blood establishments will still be required to test all blood donations for transfusion-transmitted infections (eg, HIV, hepatitis B, hepatitis C).  The FDA will receive comments on the proposed guidance until March 31, 2023 (see 88 Fed. Reg. 5894, 1/30/2023).  For more information on current questionnaires, see the Association for the Advancement of Blood & Biotherapies Blood Donor History Questionnaires page.