14/15 December 2023
On 1 August, the U.S. Food and Drug Administration (FDA) published the updated version of their "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria". It is the update of the version from August 2013.
The issue announces that it incudes:
Independent of the fact that the transfusion transmitted Malaria occurs rarely, there is a risk and it is a concern in transfusion medicine to reduce the risk. In the absence of a licensed test for donor screening, the measure used to reduce transfusion-transmitted malaria in the United States has been the deferral of donors who have had a malaria infection or had a possible exposure risk to malaria. Accurate identification of donors with the potential to transmit malaria depends on the donor exposure history obtained during the donor interview, which may be facilitated through use of a donor questionnaire.
The Guideline provides the blood establishments with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria.
For more details please read the complete Guideline Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria.