The U.S. Food and Drug Administration (FDA) has formally announced its decision to implement gender-inclusive, individual assessment of all blood donors to reduce the risk of HIV in the blood supply.
An 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.
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 our state-of-the-art testing facility, Creative Testing Solutions.
Implementing an individual assessment of all blood donors means restrictions that make it challenging for gay and bisexual men to donate blood will be eliminated.
Current FDA Policy
The change in donor eligibility is centered on the FDA’s policy known as Men Who Have Sex with Men (MSM). The policy has been in place since the mid-1980’s and has evolved over the years. Currently, the MSM policy requires gay and bisexual men to wait three months following their last sexual contact with another man to donate blood.
New FDA Policy
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 new donor eligibility policy is in line with blood donation policies currently in place in the United Kingdom and Canada.
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
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.
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.