Resources to Prepare for FDA Final Guidance Deadline on Bacterial Mitigation in Platelets
On September 30, 2019, the FDA released the Final Guidance “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion”
(“Final Guidance”). In December 2020, the FDA updated its Final Guidance and extended the deadline for implementation from March 31, 2021 to October 1, 2021. Since the announcement and subsequent deadline extension, Vitalant has worked collaboratively with our hospital partners on substantial planning for implementation of this Final Guidance.
Below are resources to help you prepare for implementation as well as previous communications on this topic from Vitalant.
Vitalant's Bacterial Mitigation Final Guidance Cutover Packet for Hospitals
Bacterial Mitigation Final Guidance Cutover Packet for Hospitals
Additional Resources to Assist with Implementation of Vitalant's Compliance Plan
Previous Communications from Vitalant