DAVENPORT, IOWA (May 11, 2023) — The US Food and Drug Administration has finalized its recommendations on changes to donor eligibility that will have US blood providers move to an individual risk-assessment to determine eligibility for blood donation. Blood establishments in the US may now implement these recommendations by revising donor history questionnaires, data systems, staff training, and procedures. While there is no set timeline for implementation, ImpactLife expects to adopt the new donor eligibility guidelines before the end of 2023.
The change will create more equitable donor-eligibility standards for prospective blood donors by using gender-inclusive, individual sexual behavior-based questions in pre-donation screening. Under the proposed guidance:
- The current blanket deferrals for men who have sex with men and for women who have sex with men who have sex with men will be eliminated.
- The current donor history questionnaire will be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who have had a new sexual partner, or more than one sexual partner in the past three months, will then be asked about a history of anal sex in the past three months.
- If prospective donors have had a new sexual partner or more than one sexual partner and had anal sex in the past three months, they will be deferred from donation.
- Under the new guidance, a prospective donor who has not had new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
- Medications taken to prevent or reduce likelihood of HIV infection (PrEP or PEP) will result in deferral for three months (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
“These changes allow for us to assess donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender while maintaining the safety and availability of the blood supply,” said Dr Daniela Hermelin, Chief Medical Officer of ImpactLife. “This is a substantial move forward for our blood industry.”
Timeline for implementation
Blood establishments in the US will now take approximately six to twelve months to implement the new rules. This involves modifying systems for donor screening, the pre-donation donor history questionnaire, and donor-management software. These processes include a validation phase to ensure systems are working properly as well as training for blood-center employees. ImpactLife expects to implement final guidance from FDA before the end of 2023 and will update communications regarding the timeline for implementation as information becomes available. For additional information and updates on the timeline for implementation at ImpactLife, see bloodcenter.org/update.
About ImpactLife
ImpactLife is a not-for-profit community organization providing blood services to more than 120 hospitals and emergency services providers in Illinois, Iowa, Missouri, and Wisconsin, as well as resource sharing partners across the country. (For a map of the ImpactLife service region, see bloodcenter.org/hospitals.) ImpactLife operates 22 Donor Centers and holds approximately 5000 mobile blood-drives annually to provide blood components needed for patient transfusions at hospitals throughout our region.
For more information, see www.bloodcenter.org and find us @impactlifeblood on Facebook, Instagram, LinkedIn, TikTok, Twitter, Snapchat, and YouTube.
ADDITIONAL RESOURCES
View the FDA news release here: (May 11, 2023) FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations
In reviewing initial news coverage of the FDA’s draft announcement, ImpactLife has noted use of the following terms and descriptions can lead to inaccurate or unclear communication.
Monogamy/non-monogamy
For example: “Gay and bisexual who are non-monogamous would be deferred from donation.” These terms are unclear because the definition of monogamy varies by the individual. It would be clearer to use specific language from the FDA:
- The current donor history questionnaire will be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who have had a new sexual partner, or more than one sexual partner in the past three months, will then be asked about a history of anal sex in the past three months.
- If prospective donors have had a new sexual partner or more than one sexual partner and had anal sex in the past three months, they will be deferred from donation.
Abstinence/Sex/Sexual Contact
Similar to the example above, news reports have inaccurately stated that gay and bisexual men who abstain from sex or sexual contact for at least three months would be eligible to donate under the draft guidance from FDA. We believe these terms are unclear because a reader’s definition of sex or sexual contact may vary. The draft guidance from FDA refers specifically to anal sex and will apply to all prospective donors, regardless of gender.
Terms related to sexual orientation versus sexual behavior
It is not always accurate to describe these changes as applying specifically to gay and bisexual men. We note that one may identify as gay or bisexual without engaging in sexual behavior described in the draft guidance. Likewise, an individual may engage in the sexual behavior described and not identify as gay or bi-sexual. Please note the guidance from FDA refers to sexual behavior rather than sexual orientation.
Impact on blood supply
We don’t know if this change will lead to an increase in eligible donors presenting to give blood with ImpactLife. Certainly, there are individuals not currently eligible to give blood who will become eligible to donate under the new guidance. However, there will be others who are currently eligible to donate who may be deferred when the new guidance is implemented. It is too soon to say what the effect of this change will be on our region’s blood supply.
