FDA’s safety standards

FDA guidance to mitigate bacterial contamination in platelet components

The FDA released the final version of the guidance to mitigate bacterial contamination in platelet components on September 30, 2019. The document describes multiple strategies which can be used to mitigate the sepsis risk associated with platelet transfusions. The strategies include pathogen inactivation, Large Volume Delayed Sampling (LVDS), and various primary with secondary testing strategies, almost all of which require aerobic/anaerobic bottles.

The guidance document strongly recommends the implementation of additional safety measures to reduce bacterial contamination risks for platelets, proposing pathogen reduction technology as one of the options.

Source:
"Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion | Guidance for Industry" U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics, Evaluation and Research, September 2019.