Small Increase in Blood Donor Deferrals Found When MSM Use Individual Risk Assessment

The FDA’s elimination of the 3-month deferral recommendation for men who have sex with men (MSM) when they wish to donate blood could lead to a slightly increased rate of deferrals for blood donations, according to a study published in Transfusion.¹

The FDA’s blood donor deferral policy was to disallow any MSM who had a sexual partner since 1977 as a means to prevent blood with HIV from being used in healthy patients. This policy, which lasted until 2015, was thought to be discriminatory by some and with improved HIV testing became increasingly unnecessary. The FDA changed this policy in 2023 to instead allow individual risk-based assessment rather than deferrals of all MSM.² Potential donors who report having a new sexual partner or more than 1 sexual partner in the past 3 months are deferred for donations. This study aimed to estimate how this new policy would change the number of deferrals for blood donations in the US.¹

Patient who donated blood | Image credit: LIGHTFIELD STUDIOS - stock.adobe.com

This study was conducted through 2 analyses. The first analysis was a blood donor deferral model that included literature on donors and sexual behaviors to estimate blood donation deferral. The second analysis used data from the 2022 US National Survey of Sexual Health and Behavior (NSSHB) that included questions about specific sexual behavior in patients who had donated blood previously.

The Transfusion-Transmissible Infections Monitoring System (TTIMS) was used to obtain 2021 blood donor data for the first analysis, which included the age and sex of all blood donors. The TTIMS represents the data of approximately 60% of all donors. A donor was considered deferred if they had reported sexual partner risk and anal sex within the previous 3 months. A computational model was used to collect and include data on the donors and their sexual behavior. The National Health and Nutrition Examination Survey was also used to collect data on sexual behavior, but the information was for the past year; therefore the researchers assumed an even distribution of sexual partners over the course of the year.

The second analysis used the sexual behavior questions and the time period of 3 months in the NSSHB that was conducted in 2022. Participants were also asked about past blood donations and whether they were currently a blood donor. The answers to the survey questions were used to create model estimates.

Both analyses found that the mean value of deferred donors was 1.2% of the overall percentage of blood donors in the US. The CIs were different but overlapping for both analyses. The 2 analyses also had similar rates of new or multiple partners at just above 6% and rates of anal sex at close to 20%. Both analyses having similar proportions indicates that both models were effective in the estimations.

There were some limitations to the models included in the study. Direct statistics on proportions of the population that have had new or multiple sex partners were not provided by the data included in the first analysis. The data on questions about sexual behavior in the previous 3 months had to be combined by gender to avoid small sample sizes in the second analysis, which prevented looking for associations due to gender or sex.

The researchers concluded that the models were able to accurately predict the increase in blood donor deferrals with the policy change by the FDA. The increase in deferrals overall should not affect blood availability, however. Future studies should investigate whether the increase of deferrals by 1.2% can be made up through an increase in the number of donors who may perceive the new policy as being more inclusive.

References

1. Whitaker BI, Huang Y, Gubernot D, et al. Modeling US blood donor deferrals under a policy of individual risk assessment for HIV risk sexual behavior. Transfusion. Published online June 12, 2024. doi:10.1111/trf.17916
2. FDA finalizes move to recommended individual risk assessment to determine eligibility for blood donations. News release. FDA; May 11, 2023. Accessed June 12, 2024. https://www.fda.gov/news-events/press-announcements/fda-finalizes-move-recommend-individual-risk-assessment-determine-eligibility-blood-donations