The FDA requires all blood centers to question donors about activities that are associated with an increased risk of exposure to infectious agents. According to statistics from the public health service, men who have sex with men (MSM) continue to represent a population at increased risk of acquiring HIV infection. Men may donate 12 months after last sexual contact with another man. Women may donate 12 months after last sexual contact with a man who had sexual contact with another man.
Explaining the 12-Month MSM Deferral
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. However, there is no 100 percent reliable test for every infectious disease that can be transmitted through blood.
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.
While testing has greatly improved, it is not 100% effective at detecting infectious diseases in donors with very early infection. Based on several years of research, the FDA selected the 12-month deferral to provide adequate time for the detection of infected individuals. At present, there are insufficient scientific data available to determine whether it is safe to rely on individual behavioral risk factors when determining donation eligibility. AABB, America’s Blood Centers, and the American Red Cross continue to work with the FDA to gather additional scientific risk data to assist the FDA in determining whether further changes are warranted in the future. Stanford Blood Center supports these efforts.
FDA Statement on Blood Donor Deferral Policy for Men Who Have Sex with Men
On December 21, 2015, the U.S. Food and Drug Administration (FDA) released revised guidance regarding deferral criteria for men who have sex with men (MSM), changing its blood donation policy from an indefinite deferral to 12 months since the last sexual contact with another man.
To read the full FDA final guidance, visit FDA.gov.
Stanford Blood Center Policy
As a member of America’s Blood Centers, Stanford Blood Center supports the recommendation to change the indefinite deferral for MSM to a 12-month deferral as recommended in the final guidance. As stated in a joint statement released in December 2015 by AABB, America’s Blood Centers, and American Red Cross, “This policy change aligns the MSM donor deferral period with those for other activities that may pose a similar risk of transfusion-transmissible infections.” Stanford Blood Center also supports the FDA’s ongoing effort of gathering additional scientific risk data to determine whether further changes to the deferral policy are warranted in the future.
As an FDA-regulated and AABB-accredited organization, Stanford Blood Center adheres to current policies, rules and regulations, as well as best practices in the industry. Maintaining a safe and available blood supply continues to be our highest priority.
Stanford Blood Center implemented the FDA’s revised MSM guidance on December 29, 2016. This implementation required significant changes to our operations, including updating donation database systems, procedures and training.
This is an industry-wide change. Blood centers across the country have gone through the same process of planning and implementation, though exact implementation dates may differ. We appreciate the community’s ongoing partnership as we planned for implementation.
If you have been deferred at Stanford Blood Center for MSM activity, and you have not had sexual contact with another man 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.