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FDA Implements Individual Assessment of All Blood Donors

Orlando, Florida
May 11, 2023

OneBlood supports the U.S. Food and Drug Administration’s (FDA) decision to implement a gender-inclusive, individual assessment of all donors to reduce the risk of HIV in the blood supply. The change has been decades in the making and means restrictions that make it challenging for gay and bisexual men to donate blood will be eliminated.

The current FDA policy known as Men Who Have Sex with Men (MSM) requires gay and bisexual men to wait three months following their last sexual contact with another man to donate blood. The new FDA policy will eliminate the time-based restriction of three months and instead screen all potential donors equally, using a series of questions that will assess their individual risk of HIV, regardless of gender or sexual orientation.

“The FDA’s shift in policy is the start of a new era of blood donor eligibility,” said Susan Forbes, senior vice president of corporate communications and public relations. “Individual assessment of all donors will maintain the safety of the blood supply, make blood donation more inclusive, ensure all donors are treated equally and enable more people the opportunity to donate blood.”
-Susan Forbes
Senior VP of Corporate Communications & Public Relations

The FDA’s new donor eligibility policy is in line with blood donation policies currently in place in the United Kingdom and Canada.

Safety of the blood supply is OneBlood’s top priority.  All blood donations undergo more than a dozen tests to ensure donations are safe for patients, including HIV, Hepatitis B and C, West Nile and other infectious diseases. Testing takes place at OneBlood’s state-of-the-art testing facility, Creative Testing Solutions (CTS). Click HERE for our story about the CTS Laboratory.

Timeline to Implement New Policy

OneBlood has been anticipating the FDA’s announcement and has already begun to make the required changes to their regulated software platform to implement the new Donor History Questionnaire (DHQ) and will soon begin the required training for frontline team members.

“OneBlood looks forward to implementing the FDA’s new guidance and is moving as quickly as possible to make the necessary changes. We anticipate being ready to begin accepting donors under the new policy in the coming months. In the meantime, the current three-month restriction for men who have sex with men will remain in effect,” said Forbes.

OneBlood Helped Lead the Way

Three of the nation’s largest blood centers, OneBlood, Vitalant and the American Red Cross enrolled nearly 1,600 gay and bisexual men into the groundbreaking ADVANCE Study.  The data gathered from the two-year study was provided to the FDA and contributed to the FDA’s decision to eliminate the time-based restriction and move to an individual assessment of HIV for all donors.

OneBlood partnered with the LGBTQ+ Centers in Orlando and South Florida to enroll participants into the study.

“OneBlood is proud to have helped lead the way towards a new era in donor eligibility. We are grateful to the LGBTQ+ community for their partnership and are grateful to the study participants for their willingness to be enrolled.  They should take great pride in knowing they were part of a groundbreaking study that contributed towards making blood donation more inclusive while maintaining the safety of the blood supply,” said Forbes.

Next Steps

  • People who were previously deferred under the FDA’s MSM policy prior to July 2017, (when the FDA’s lifetime ban of MSM was in effect) will need to be re-entered as a potential blood donor, as long as they meet all other requirements to be a blood donor.
  • The re-entry process will take place online at oneblood.org once the new FDA policy is implemented. Specifics about donor re-entry will be communicated after OneBlood implements the new FDA policy.
  • In the meantime, anyone who was previously deferred from donating under the MSM policy prior to July 2017 should refrain from attempting to donate until OneBlood is able to complete the donor re-entry process.

History of FDA’s MSM Policy

  • The FDA’s MSM policy was first put in place in the 1980’s during the height of the AIDS epidemic. Back then, men who had sex with men were banned from donating blood. The lifetime ban remained in place for more than two decades.
  • In 2015 the FDA updated the policy and moved to a one-year deferral period.  This meant any man who had sex with another man would have to wait one year following their last sexual contact with another man before they could donate blood.
  • In 2020 the FDA implemented the three-month deferral period, requiring men who have sex with men to wait three months following their last sexual contact with another man before they can donate blood.
  • In 2023, the FDA eliminated the MSM policy and implemented gender-inclusive, individual assessment of all donors for HIV risk. 

OneBlood is a not-for-profit 501(c)(3) community asset responsible for providing safe, available and affordable blood to more than 300 hospital partners and their patients throughout Florida, North Carolina, South Carolina, Georgia and Alabama.  OneBlood operates more than 90 donor centers and deploys nearly 250 Big Red Bus bloodmobiles throughout the southeastern United States for blood drives. Generally healthy people age 16 or older who weigh at least 110 pounds can donate blood. To learn more about OneBlood visit www.oneblood.org.

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