Updated FDA Guidance for Donor Questioning related to Transfusion-transmitted Malaria

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

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:

• "Updates to recognize revisions to certain flow charts contained in the accompanying materials for the Full-Length Donor History Questionnaire (v.1.3 dated May 2008) and Abbreviated Donor History Questionnaire (v.1.3 dated December 2012) prepared by the AABB Donor History Task Force, as acceptable for use in screening donors of blood and blood components for risk of malaria (see new section VI).
• Revised recommendations in section VII on how licensed establishments must report the implementation of the recommendations contained herein to FDA. "

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.