Transmission of Malaria by Blood Donors - FDA updates Guidance Document

Back in 2013, the FDA published a guidance document entitled "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria". The FDA stated at the time:

"Despite the fact that transmission of malaria through transfusions is rare, there is a risk, and it is a concern of transfusion medicine to reduce the risk. In the absence of an approved test for donor screening, the measure to reduce transmission of malaria through transfusions in the United States has been to exclude donors who have had a malaria infection or who may be at risk of malaria. The precise identification of donors who may transmit malaria depends on the donor's exposure history, which is obtained through questioning of the donor and can be facilitated by using a donor questionnaire."

This guidance was then updated in 2014 and 2020. The change in 2020 was in response to the urgent and immediate need for blood and blood components during the COVID-19 pandemic. The recommendations in the April 2020 guidance were based on the FDA's assessment of available scientific and epidemiological data on the malaria risk and on data from FDA-approved pathogen reduction devices for transfusion purposes. As outlined in the April 2020 guidance, the FDA believed that implementation of the revised recommendations would not have adverse effects on the safety of the blood supply and that early implementation of the recommendations could help alleviate the significant blood shortage that had occurred as a result of the COVID-19 pandemic.

Current status

At the time of the release of the April 2020 guidance, the FDA announced that it would release a revised guidance after the current pandemic situation had ended. Therefore, the revised guidance is now being released to reflect the current considerations of the FDA. The guidance includes the following sections:

I. INTRODUCTION
II. BACKGROUND
III. DEFINITIONS
IV. RECOMMENDATIONS
A. Donor History Questionnaire
B. Donor Deferral
C. Product Retrieval and Quarantine, and Notification of Consignees of Blood and Blood Components
D. Product Disposition and Labeling
V. IMPLEMENTATION OF RECOMMENDATIONS
VI. REFERENCES
APPENDIX

The FDA states that the recommendations for screening blood donors for malaria risk and for conducting pathogen reduction for certain blood components are based on current epidemiological data on malaria and the risk of TTM, and also take into account the availability of FDA-approved pathogen reduction devices.

Further information can be found on the FDA Website under  "Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria"