The introduction and inspiration from US FDA guidance: bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Abstract

Room temperature stored platelets are associated with a higher risk of sepsis and related fatality. The risk of bacterial contamination of platelets is a leading risk of infection from blood transfusion. U.S. Food and Drug Administration recently issued a guidance on bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. The prevention and control strategies in the guidance would be informative and instructive for further development of risk control strategies of platelet bacterial contamination in China.

Keywords

• platelets
• room-temperature storage
• bacterial contamination
• risk control
• guidance