AABB Applauds FDA’s Recommendations to Implement Individual Risk Assessment for Blood Donors

Proposed guidance will expand the donor pool and increase the inclusivity of blood donation while maintaining the highest level of safety for the blood supply.

BETHESDA, Md. – AABB (Association for the Advancement of Blood & Biotherapies) applauds the Food and Drug Administration (FDA) for its recent draft guidance recommending blood donor eligibility be based on an individual’s behavior and risks, regardless of the donor’s gender or sexual orientation. Under the new recommendations, time-based blood donation deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.

In a newly published position statement, AABB commended FDA for its recommendations. AABB said it appreciated that FDA based the new recommendations on currently available scientific evidence, including results from the ADVANCE (Assessing Donor Variability and New Concepts in Eligibility) study.

“AABB strongly supports the FDA’s recommendations, which represent a landmark advancement for the blood community and our country,” said Debra BenAvram, AABB CEO. “We believe that the implementation of individual risk assessment protocols to determine donor eligibility will increase the accuracy of risk assessment for all blood donors and will help to better identify individuals who should be deferred from donating blood, while increasing the potential of eligible donors and decreasing unnecessary deferrals. In short, this guidance will expand the nation’s blood supply and make our blood donor pool more diverse, while maintaining optimal levels of patient and donor safety.”

FDA is accepting public comments on the draft recommendations through March 31. Throughout the next few months, AABB’s Donor History Task Force will continue to provide resources for the nation’s blood collection facilities, including an updated Donor History Questionnaire once the recommendations are finalized. AABB looks forward to working with its member institutions to begin welcoming new and returning donors later this year.

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About AABB: AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit organization representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association works collaboratively to advance the field through the development and delivery of standards, accreditation and education programs. AABB is dedicated to its mission of improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide. For more information, visit www.aabb.org.