FDA Worried Your Blood Transfusion Might Come With Malaria
Published Date: 1/16/2025
Notice
Summary
The FDA is rolling out new draft rules to help blood banks better spot and stop malaria from sneaking into blood donations. Blood centers will start using special tests to check donors who might have malaria, making transfusions safer for everyone. If you’re involved in blood collection, get ready to share your thoughts by March 17, 2025, before these changes become official!
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Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Selective NAT Testing for At‑Risk Donors
The FDA’s draft guidance recommends that blood establishments selectively test donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species. This recommendation applies to the collection of Whole Blood and blood components and is intended to replace the December 2022 recommendations when finalized.
Reduced Risk of Transfusion‑Transmitted Malaria
If blood donations from donors at risk for malaria are selectively tested with an FDA-licensed donor screening NAT for Plasmodium species, transfusion recipients should face a lower risk of transfusion-transmitted malaria (TTM). The draft guidance is intended to supersede the December 2022 recommendations if finalized.
Source Plasma Collections Are Exempt
The draft guidance does not recommend screening Source Plasma donors for malaria risk factors because Source Plasma undergoes manufacturing steps that remove or inactivate pathogens and licensed plasma derivatives from Source Plasma have not transmitted malaria. The guidance’s recommendations apply to Whole Blood and blood components, except Source Plasma.
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