29/30 November 2023
The emergence of acquired immunodeficiency syndrome (AIDS) in the early 1980s and the realisation that it could be transmitted through blood and blood products had a profound impact on the blood system in the United States. Although the disease was initially associated with male-to-male sexual contact, it was soon discovered that AIDS was also transmitted through the transfusion of blood products and through the infusion of clotting factor concentrates in persons with haemophilia. Subsequently, it was found that AIDS can also be associated with heterosexual transmission - e.g. through commercial sex work and intravenous drug use. The findings on the risk factors for AIDS were the basis for the first blood donation deferral policy in 1983, which at the time was the only way to reduce the risk of AIDS transmission through the transfusion of blood products. In 1984, it became known that AIDS was linked to the virus now known as HIV, which led to the development of donor screening tests.
Notably, there is currently an additional outbreak of respiratory disease caused by a novel coronavirus. The virus has been named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the disease it causes has been named Coronavirus Disease 2019 (COVID-19). On 31 January 2020, the Department of Health and Human Services (HHS) declared a public health emergency related to COVID-19 and mobilised the operational divisions of HHS. In addition, on 13 March 2020, the President declared a national emergency in response to COVID-19. As a result of this public health emergency, there is a significant shortage of blood supply in the United States that early implementation of the recommendations in this guide can help address (although the recommendations generally apply beyond the COVID-19 emergency). For this reason, this revised guidance is being implemented without prior public comment, as the FDA has determined that prior public participation is not feasible or appropriate for this guidance.
With the revised guidance document, the FDA recommends blood establishments that collect blood or blood components - including source plasma - to defer donations for individuals at increased risk for human immunodeficiency virus (HIV) transmission. The recommendations also include revising donor education materials, donor history questionnaires and collateral materials, as well as donor requalification and product management procedures. The recommendations reflect current thinking on persons at increased risk of transmitting HIV infection. Based on the review of available scientific evidence, the FDA recommends removing the screening questions specifically for men who have sexual contact with men (MSM) and for women who have sexual contact with MSM. Instead, the FDA recommends screening donor eligibility using the same individual risk-based HIV risk questions for each donor, regardless of gender or origin.
The May 2023 guidance replaces the August 2020 guidance entitled "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products". Based on careful evaluation of the available data, the FDA anticipates that implementation of these revised recommendations will not have an adverse impact on the safety of the blood supply. In addition, early implementation of the recommendations may help address a significant shortage of blood products due to a current and ongoing public health emergency.
For more information, see the original document "Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products".