Individual Donor Assessment
The U.S. Food and Drug Administration (FDA) announced its individual donor assessment final guidance, which for the first time in 40 years, evaluates blood donor eligibility regardless of gender or sexual orientation while maintaining the safety of the blood supply.
Vitalant implemented the Individual Donor Assessment on Aug. 21, 2023, and looks forward to welcoming more blood donors to help save lives.
|OLD FDA GUIDANCE|
|FDA’s Men Who Have Sex with Men (MSM) guidance requires gay and bisexual men to wait three months following their last sexual contact with another man.|
|NEW FDA GUIDANCE|
|All potential donors are now screened using a series of questions that assess individual risk of HIV, regardless of gender or sexual orientation.|
Maintaining the Safety of the Blood Supply
Vitalant’s top priority is maintaining the safety of the blood supply for patients. The donor history questionnaire is just one part of a multi-step process.
Following donation, all blood undergoes roughly a dozen tests for the presence of transfusion-transmitted infectious diseases, including HIV, Hepatitis B, Hepatitis C, and Syphilis. These multiple layers of safety ensure donated blood remains safe for the millions of individuals who rely on blood transfusions each year.
The data from countries that have already implemented this change – including Canada and the United Kingdom – have shown using the individual donor assessment approach does not put the safety of the blood supply at risk.
As part of Vitalant’s commitment to safety, we are one of four blood centers to participate in the Transfusion Transmissible Infections Monitoring Systems (TTIMS), which continually evaluates U.S. blood safety. Vitalant also served as the lead research organization and coordinator of the ADVANCE Study, which evaluated the effectiveness of an individual risk assessment as an alternative to the MSM guidance while maintaining the safety of the blood supply. The FDA cited results from both TTIMS and the ADVANCE Study in its final guidance.