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
10.13303/j.cjbt.issn.1004-549x.2025.01.025
- VernacularTitle:美国FDA血小板细菌污染风险控制指引主要内容和启示
- Author:
Ningjie ZHANG
1
;
Yuanqing YANG
1
;
Yuanpei ZHU
1
;
Yongjun WANG
1
;
Yongjian GUO
2
,
3
Author Information
1. The Second Xiangya Hospital, Central South University, Changsha 410011, China
2. Fujian Provincial Blood Center, Fuzhou 350004, China
3. Sub-Committee of Blood Standards, National Committee of Health Standards, Beijing 100083, China
- Publication Type:Journal Article
- Keywords:
platelets;
room-temperature storage;
bacterial contamination;
risk control;
guidance
- From:
Chinese Journal of Blood Transfusion
2025;38(1):142-148
- CountryChina
- Language:Chinese
-
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.
