On May 11, 2023, the U.S. Food and Drug Administration (FDA) released newly approved guidance regarding blood donor eligibility, specifically addressing outdated terminology singling out gay men. Taking into consideration the results from the FDA’s ADVANCE study, the updated guidance recommends the removal of donor eligibility questions that consider the gender of a donor and their sexual partners, focusing instead on individual risk-based donor eligibility questions related to sexual activity.
We commend the FDA on its commitment to following the best available science to inform and revise their recommendations to be more inclusive, expanding those eligible to donate blood while maintaining the appropriate safeguards to protect patients. The FDA sets requirements for blood banks throughout the U.S. and follows a data-driven approach to inform blood establishments that collect blood or blood components of revised recommendations for evaluating donor eligibility to protect the recipients of blood products.
At San Diego Blood Bank, our top priority is the safety of our volunteer blood donors and the patients in need of lifesaving blood products. Our mission is “connecting diverse communities to save and improve lives through blood and biotherapies,” and we treat all potential donors with fairness, equality, and respect. The elimination of time-based deferrals based on gender or sexual orientation and the recommendation to assess donor eligibility using screening based on individual risk factors is a welcome change.
We are excited to implement the new FDA guidance. The Association for the Advancement of Blood & Biotherapies (AABB) has developed a uniform questionnaire for all the blood centers that honors the new guidance which was formally recognized by the FDA as of May 11, 2023. We've begun the implementation process, which includes revising procedures, updating our systems, and training staff.
Our commitment is to be able to welcome donors at San Diego Blood Bank donor centers and mobile drives with the updated questionnaire within 120 days.
Stay connected with us through our website and social media platforms to receive timely updates on San Diego Blood Bank's progress in implementing the latest FDA guidance.
Thank you for saving lives with us.
For blood donor questions and concerns, please contact Donor Services at firstname.lastname@example.org or call (619) 400-8251.
For any Press or Media Inquiries, please contact Claudine Van Gonka, Director of Community Relations and Media at email@example.com.