Countdown to Guidance
FDA Bacterial Guidance October 2021October 2021 is the FDA Guidance1 deadline to implement a bacterial risk control strategy to enhance the safety and availability of platelets.
Pathogen reduction is the ONLY strategy recommended by FDA Guidance that mitigates transfusion-transmitted-infection (TTI) risk beyond bacteria.
Additional Resources
Cerus Webinar Replay: Patient Safety and FDA Platelet Bacterial Guidance Compliance with Dr. Richard Benjamin (Cerus Corporation)
Cerus Webinar Replay: A Software Model to Estimate the Cost and Shelf Life Implications of New Platelet Technologies with Dr. Laura Pizzi (Rutgers University)
Podcast: Preparing our Blood Supply for the Nest Pandemic with Dr. Susan Stramer (American Red Cross)
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There is no pathogen inactivation process that has been shown to eliminate all pathogens.
Refer to the package insert for more information.
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Dec 2020.
Refer to the package insert for more information.
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Dec 2020.