Published by Kirby Winn on Tuesday, March 14, 2023 in News Releases
Leaders at ImpactLife are preparing for potential changes to eligibility requirements for blood donation after the U.S. Food and Drug Administration (FDA) issued draft guidance on donor eligibility in late January. The FDA draft guidance proposes a shift that will create more equitable donor eligibility standards for prospective blood donors by using gender-inclusive, individual sexual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 would be eliminated.
- The current donor history questionnaire would 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, would 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 would be deferred from donation.
- Under this proposal, 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 90 days (oral medication) or two years (injection) as they may delay detection by licensed screening tests for blood donations, potentially resulting in false negative results.
FDA is now seeing public comment on the proposal. To review the draft guidance and to share feedback with FDA, see: www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-evaluating-donor-eligibility-using-individual-risk-based-questions-reduce-risk-human.
Timeline for implementation
As part of the FDA’s established process, the draft guidance issued on January 27 will be open for public comment for 60 days. The agency will then review and consider all comments before issuing final guidance.
After that time, blood collection establishments will take approximately 6 to 12 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 www.bloodcenter.org/update.
About ImpactLife
ImpactLife is a not-for-profit community organization providing blood services to more than 120 hospitals and emergency medical service providers in Illinois, Iowa, Missouri, and Wisconsin, as well as resource sharing partners across the country. Services extend from southcentral Wisconsin to St. Louis, Missouri and from Danville, Illinois to Chariton, Iowa. (See a map of the ImpactLife service region.) 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.
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Additional Resources
PLEASE NOTE: In reviewing initial news coverage of the FDA’s Jan. 27 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 more clear to use specific language from the FDA:
- The current donor history questionnaire would 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, would 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 would 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.
Tags
- donor eligibility
- fda
- fda guidance