We are preparing to implement changes to donor eligibility later this month. Blood providers across the United States received final guidance on changes to donor eligibility from the U.S. Food and Drug Administration in May 2023. Since that time, ImpactLife has been preparing to implement Individual Donor Assessment by revising our donor history questionnaire and data systems, and by providing training for our employees on these changes.
Moving to Individual Donor Assessment will create more equitable donor eligibility standards for prospective blood donors by using gender-inclusive, individual sexual behavior-based questions in pre-donation screening. Please see below for more information on this change, and check this page for additional resources once we have implemented the new donor eligibility criteria in late September.
AABB: FAQs on Individual Donor Assessment
May 11, 2023 - The U.S. Food and Drug Administration has finalized its recommendations on changes to donor eligibility that will have U.S. blood providers move to an Individual Donor Assessment to determine eligibility for blood donation. Blood establishments in the U.S. may now implement these recommendations by revising donor history questionnaires, data systems, staff training, and procedures. While there is no set timeline for implementation, ImpactLife expects to adopt the new donor eligibility guidelines before the end of 2023.
ImpactLife News Release: US Food and Drug Administration Issues Final Guidance On Changes To Donor Eligibility (May 11, 2023)
FDA News Release: FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations (May 11, 2023)
Joint Statement by AABB, America’s Blood Centers, and American Red Cross: Blood Community Applauds Important Step Forward for Blood Donor Eligibility (May 17, 2023)
The Food and Drug Administration has released draft guidance to change the blood donation deferral of males who have sex with another male. ImpactLife, along with America’s Blood Centers, the Association for the Advancement of Blood and Biotherapies, and blood centers across the country are united in support of evidence-based change to an individual sexual-behavior-based screening process for all donors intended to expand blood availability while maintaining blood safety.
Once blood centers have been issued the FDA draft guidance, a finalized version will be available after a period of review. At that time, blood centers will have 6–12 months to implement the changes involving modification to donor management software, donor screening and questionnaire protocols that will allow for new donor eligibility. ImpactLife will update communications as information becomes available.
FDA News Release on New Draft Guidance (Jan. 27, 2023)
America's Blood Centers news release (Jan. 27, 2023)
ImpactLife news release (March 14, 2023)
Government of Canada United Kingdom Department of Health and Social Care Examining FDA’s policies on blood donations from gay and bisexual men