Recently, the US Food and Drug Administration (FDA) finalized its recommendations on gender neutral blood screening and assessing blood donor eligibility. This comes after CAP advocacy added comments to the FDA suggesting that there be an expansion of the number of people eligible to donate blood while protecting the safety of the nation’s blood supply. Lifting the gender barriers in the blood donor screening measure, while still maintaining the highest safety protocols, is critical to making the blood donation process more inclusive, objective and approachable. Broadening the pool of eligible donors is also essential to alleviating the severe nationwide blood shortage crisis.
Previously, the FDA issued time-based deferrals for gay and bisexual men, as well as women who have sex with gay and bisexual men, to donate blood within a given timeframe. At the start of the pandemic in April 2020, the deferral periods were shortened from 12 months to three months to address the shortage of the nation’s blood supply. However, there is still a severe shortage of blood in the United States, particularly with O-negative and O-positive red blood cells.
Now the new guidance recommends that blood donor eligibility be assessed with individual risk-based questions to continue reducing risk of transfusion-transmitted HIV. This would also allow monogamous gay and bisexual men to donate blood without previous restrictions. These recommendations also eliminate screening questions specific to men who have sex with men and women who have sex with men who have sex with men.
In comments submitted to the FDA, the CAP supported the use of individual risk-based questions instead of gender-based criteria to evaluate donors for risk of HIV and encouraged the FDA to continue monitoring blood donor and donation safety.
Under this finalized guidance, all prospective donors would be subject to the same individual, risk-based questions to determine eligibility regardless of their gender or sexual orientation. Prospective donors who have had new or multiple sexual partners and anal sex in the past three months would still be subject to deferral to reduce the likelihood of HIV transmission.