AM20-28-Bundle: Implementing the FDA Guidance for Industry of Platelets: Bacterial Risk Control Strategies from a Blood Center and Transfusion Service Perspective

The Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion was issued September 2019 with an 18-month implementation time frame.

This session will address the implementation steps taken at a large metropolitan hospital, and a major organization that includes five blood centers.

It will include the questions asked, decisions made, challenges that were overcome, and the regulatory steps taken to implement. It will address the different options to comply with the FDA Guidance, hospital customers concern and final outcomes.