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
 

• ISBT Codes and Available Labels
• Cerus Coding and Billing Information: INTERCEPT platelet and plasma products administered in the outpatient setting
• Psoralen Treated Platelet Administration
• Cerus PRT: Implementation Guide for Hospitals
• Cerus PRT: Reducing the Risk of Cytomegalovirus (CMV) Transfusion Transmission
• Cerus: Methodologies for Reducing the Risk of TA-GVHD from Platelet Transfusions

Previous Communications from Vitalant
 

• May 2021 Update from Vitalant on Final Guidance (serving as 30-day notice of compliance plan rollout)
• September 2020 Update from Vitalant on Final Guidance
• February 2020 Update from Vitalant on Final Guidance