AM20-28-Bundle

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

Date
October 4, 2020

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.

Learning Objectives

  • Illustrate the steps taken at a large metropolitan hospital to know what the hospital must do to adhere to the guidance and know what they are receiving from their multiple blood suppliers. Discuss how they will know if the product has a 5-day expiration or requires secondary testing. Discuss how they will decide to go with Pathogen Reduced platelets and if they will be readily available.
  • Discuss how to implement the guidance at a multiple facility blood center system. A system with multiple collection systems.
  • Predict how to determine what your customers preferences are while planning what products to produce.
  • Discuss all regulatory steps taken to implement the guidance including questions asked of the FDA.

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