Memorial Blood Centers (MBC) applauds the U.S. Food and Drug Administration’s (FDA) final guidance establishing a blood donor screening process based on Individual Donor Assessment, not sexual or gender identity.
For decades, we have strongly advocated for scientifically-based changes to the FDA policies about men who have sex with men (MSM), and we fully support the shift to individual donor assessment to determine eligibility.
MBC will complete implementation of these new changes and will be begin accepting newly eligible donors on Monday, September 25, 2023.
All presenting donors will be asked if they’ve had new and/or multiple sexual partners in the past three months. If they answer yes to either question, they will then be asked if they’ve had anal sex in the past three months.
If they answer yes to the anal sex question, they will be required to wait three months from when they most recently had anal sex to donate. If they have not and meet all other eligibility criteria, they will be able to donate.
FDA determined, based on its review of currently available scientific data, that this change will not compromise the safety or adequacy of the United States blood supply. Similar changes in the United Kingdom and Canada have not resulted in higher HIV detection rates.
The new approach to donor screening will continue to defer those with a higher chance of acquiring a new HIV infection. Other criteria already in place identify additional risk factors for acquiring HIV, and these will continue to be applied. Evidence from the ADVANCE Study, the Transfusion – Transmissible Infections Monitoring System, and other data assessed by the FDA support making this change.
Currently the risk of HIV being introduced to the blood system is extremely low. All available evidence confirms that an individual donor assessment approach to screening will continue to ensure a high rate of safety and quality for the blood supply.
Statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex. This does not account for individuals’ safe sex practices, such as condom use, but is based on an evidence-based approach to overall risk.
Condom use, while an excellent sexual health practice, isn’t an evidence-based method of screening donors because condoms are not always effective and can break or slip.
The individual donor assessment screening criteria focus on anal sex in the context of new or multiple partners, rather than vaginal or oral sex. This is because, statistically, anal sex has a significantly higher chance of HIV transmission per sex act than vaginal or oral sex. Multiple sexual partners can increase the chance of HIV transmission. This does not account for individuals’ safe sex practices, such as condom use, but is based on an evidence-based approach to overall risk.
Pre-exposure prophylaxis (PrEP) is a highly effective medication regimen used for HIV prevention. In people taking PrEP or post-exposure prophylaxis (PEP), low levels of HIV may be missed by current testing methods. The blood community relies on accurate HIV testing as part of its multilayered approach to safety. This is an issue impacting blood operators worldwide, and more research is needed to further evaluate how PrEP and PEP affect HIV testing.
At this time, individuals who take oral PrEP or PEP are deferred from donation for three months from their most recent use. Individuals who have received PrEP by injection are deferred from blood donation for two years from their most recent injection due to how long the drug remains in the person’s system.
NOTE: We do not recommend stopping the use of PrEP or PEP as prescribed by your healthcare provider in order to be eligible to donate blood.
It’s amazing that HIV care has reached a point where people’s viral loads can be undetectable.
“Undetectable equals untransmissible” only applies to sexual transmission of HIV. Unfortunately, this does not apply to the risk for transfusion-transmission. Even blood donated by those who have an undetectable viral load could potentially put a patient at risk for HIV following a blood transfusion.
The risk of transmission is much higher with a unit of blood due to the large volume of a blood transfusion and the much higher total amount of virus present.
The new Donor History Questionnaire is gender-neutral and poses questions to all donors regardless of gender or sexual orientation. Transgender individuals are welcome to donate blood.
The new guidelines focus on assessing each blood donor individually. Out of an abundance of caution, some people may be asked to defer their donation based on criteria that indicate there could be an increased risk for a newly acquired infection that would not be detected by currently available testing methods.
Yes, every donation is tested for an array of infections that could potentially be transmitted by blood transfusion, but no test is perfect. One reason we have such a safe blood supply is the layering of a donor screening questionnaire with donation testing.
Tests used on blood donations have a limitation called the “window period.” This is the time between when a donor has acquired a new infection to the time a lab test can reliably detect the infection. If a donor has recently acquired an HIV infection, current testing methods may not pick it up. Very low amounts of virus may escape detection in the small volume tested. The Donor History Questionnaire is critical in helping identify people who may have had a recent new exposure to an infection, such as HIV.
No. The blood community’s goal is to be as inclusive as possible while maintaining the highest level of safety for the blood supply. Donor eligibility undergoes frequent revisions resulting in changes based on current scientific evidence.
We recognize these changes are a monumental step forward, but we know there is still work to be done. We encourage continued evaluation of the FDA’s donor eligibility guidelines to make blood donation as inclusive and safe as possible.
For additional information regarding these eligibility changes, visit aabb.org/ida.