The US Food and Drug Administration (FDA) has finalised recommendations for evaluating blood donor eligibility by leveraging a set of individual risk-based questions to lower the risk of transfusion-transmitted human immunodeficiency virus (HIV).
According to FDA, the set of questions will be similar for every donor, irrespective of sexual orientation, sex, or gender.
The blood establishments can now implement these FDA recommendations by updating their donor history questionnaires and procedures.
The latest policy is based on the available scientific evidence and aligns with policies implemented in nations like Canada and the UK.
FDA expects the updated policy will potentially increase the number of people eligible to donate blood, maintaining necessary measures to protect the blood supply’s safety.
The suggestions are in line with the course of action proposed in January. To complete these recommendations rapidly, the FDA worked carefully to analyse and consider all opinions received by the organisation.
FDA Centre for Biologics Evaluation and Research director Peter Marks said: “The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products.
“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community.
“The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”
According to the final guidance, all prospective blood donors will respond to a series of individual, risk-based questions to determine eligibility for blood donations.
The recommendations deferred the people who take medications to treat or prevent HIV infection.
The US health regulator expects that the implementation of an individual risk-based approach will not affect the safety or availability of the blood supply in the US.
FDA has carefully reviewed data from countries with similar HIV epidemiology, surveillance data received from the Transfusion Transmissible Infections Monitoring System, performance feature of nucleic acid testing for HIV and many more.
