The Food and Drug Administration (FDA) has issued a draft guidance for blood establishments that collect blood or blood components with recommended revisions to the donor deferral period for men who have sex with men (MSM).
Beginning in 1985, the FDA recommended that blood establishments indefinitely defer male donors who have had sex with another male, even one time, since 1977 due to the strong clustering of AIDS illness in the MSM community and the subsequent discovery of high rates of HIV infection in that population. In 1992, a blood memo was issued with the current recommendations regarding the indefinite deferral for MSM along with indefinite deferrals for other persons with behaviors associated with high rates of HIV exposure such as commercial sex workers (CSW), intravenous drug users (IDU), and certain individuals with other risk factors. However, the use of donor education material, specific deferral questions, and advances in HIV donor testing have reduced the risk of HIV transmission from blood transfusion to a current estimated residual risk of approximately 1 in 1.47 million transfusions.
The FDA initially announced a recommended change to the blood donor deferral period for MSM from indefinite deferral to one year since last sexual contact with another man in December 2014. The new recommendations apply to the collection of blood and blood components, including Source Plasma. The draft guidance will be open for public comments for 30 days; when finalized, the new “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” will replace the previous recommendation from 1992. The indefinite deferral recommendations will not be changed for other high-risk groups.
Blood establishments will be able to implement changes to the blood donor deferral for MSM after the final guidance has issued and standard operating procedures for the facility have been reviewed and approved. The FDA will monitor the outcome of the proposed recommended change to assure that blood safety is maintained before considering any further policy change.
For more information call (888) 463-6332 or visit FDA.gov.