Bacterial Mitigation Strategies, the FDA Guidance and Implications for Blood Centers and Transfusion Services

The FDA released their guidance, Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, in September 2019, since updated in December 2020, with an implementation date of October 2021. Due to their room temperature storage requirements which foster bacterial growth, platelets are more likely than any other blood product, to result in a septic transfusion reaction, leading to considerable patient morbidity and mortality. These storage requirements also limit shelf life to 5-days, contributing to a labile platelet inventory. The guidance is intended to enhance both safety and availability of platelet products. Numerous strategies, including traditional culture-based methods, rapid tests and pathogen reduction technology, have been approved to reduce the risk of septic transfusion reactions. Each strategy has implications for every step in the life of a unit of platelets, from collection to manufacturing and distribution to transfusion. Safety features, feasibility, cost, and impact to platelet availability are factors that influence strategy selection for both blood collectors and transfusion services.

 

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