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Countdown to Guidance

FDA Bacterial Guidance October 2021

October 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.

Choose the proactive guidance strategy that goes beyond bacteria.

The INTERCEPT® Blood System for Platelets, Pathogen Reduction System.

Ask your transfusion service what their plan is to meet the October 2021 deadline for the FDA bacterial guidance for platelets.


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.