April 2, 2020 — Update Regarding New FDA Guidance
This morning, the FDA issued an updated guidance regarding blood donation deferrals for a number of risk factors, including travel to malaria-risk regions, tattoos, and risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) and HIV (which includes guidance around men who have sex with men). A few of the key changes include the following:
- Deferral for MSM decreased from 12 months to 3 months
- Deferral for travel to malaria risk areas decreased from 12 months to 3 months
- Removal of the deferral for geographic risk of vCJD for U.S. military bases in Europe (excluding 3 months or more in U.K. from 1980-1996 and 5 years or more in France or Ireland from 1980-2001).
We are grateful that the FDA is looking seriously at policies that affect the blood supply and while we are not able to implement this update immediately, are working to adapt our policies and procedures to the new guidance as soon as logistically possible. Learn more at stanfordbloodcenter.org/fda-releases-updated-deferrals.
Explaining the MSM Deferral
Due to FDA policies, men who have had sex with another man* in the past year will be deferred from donation for one year due to an increased risk of acquiring HIV infection.
Stanford Blood Center’s mission is to provide a safe and adequate blood supply to the local hospitals that we serve. The U.S. Food and Drug Administration (FDA) and AABB (formerly American Association of Blood Banks) set criteria for blood donor eligibility at the national level. State law dictates that all blood donor centers must adhere to these standards in screening potential donors. The intent of these standards is to maximize the safety of the blood supply; the standards are not intended to send a message to any individual regarding his or her infectious disease status. The blood center in no way endorses homophobia or racial stereotypes.
All blood centers in the U.S. perform a variety of tests for infectious agents, including two tests for HIV. For every infectious agent, there is a “window-period” (delay) between the time of exposure and the time that a laboratory test is able to detect evidence of infection in a person’s blood. During this “window-period,” donor questioning for potential exposure to the infectious agent serves as the only protection of the blood supply. This is why the FDA requires all blood centers to question donors about activities that are associated with an increased risk of exposure to infectious agents. The FDA requires the use of broad donor screening questions that select a low-risk donor population. These questions are developed by the AABB Donor History Task Force. The AABB Donor History Task Force works with the FDA on incorporating new FDA guidance into the questionnaire as appropriate.
In order to capture this window period, the FDA selected the 12-month deferral, based on several years of research, to provide adequate time for the detection of infected individuals. Stanford Blood Center strongly supports ongoing efforts by AABB, America’s Blood Centers, and the American Red Cross to work with the FDA to gather additional scientific risk data to assist the FDA in determining whether donor-screening alternatives based on individual behaviors are appropriate and feasible at this time.
*Please note that nonbinary individuals may be affected by the MSM deferral as well. If you have any questions, please call our Resource Nurse at 650-725-7336.
Stanford Blood Center Policy
Based on the FDA’s 2015 recommendation, which can be found at fda.gov, Stanford Blood Center changed the MSM deferral from an indefinite deferral to a 12-month deferral. Although this change does align the MSM donor deferral period with those for other activities that may pose a similar risk of transfusion-transmission infection, Stanford Blood Center strongly supports additional research to determine if individual risk assessment is an effective and safe alternative for donor screening. Stanford Blood Center encourages the FDA to further evaluate deferral criteria for MSM and ensure the use of science-based deferrals that are fair and consistent among blood donors while maintaining the safety of the blood supply.
Blood Donor Reentry
If you have been deferred at Stanford Blood Center for MSM activity, and you have not had sexual contact with another man or nonbinary individual in the last 12 months and would like to be reinstated for community blood donations, please contact our Medical Services department at 650-723-2597 before your donation appointment. Since the reinstatement process can take several days to complete, clearance must be completed prior to your donation appointment.