Explaining the 12 Month MSM Deferral
Read about the December 2015 guidance on the FDA's 12 month MSM deferral policy.
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.