美国FDA血小板细菌污染风险控制指引主要内容和启示  

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

作　　者：张宁洁[1] 杨源青 朱远裴 王勇军[1] 郭永建[2,3] ZHANG Ningjie;YANG Yuanqing;ZHU Yuanpei;WANG Yongjun;GUO Yongjian(The Second Xiangya Hospital,Central South University,Changsha 410011,China;Fujian Provincial Blood Center,Fuzhou 350004,China;Sub-Committee of Blood Standards,National Committee of Health Standards,Beijing 100083,China)

机构地区：[1]中南大学湘雅二医院输血科,湖南长沙410011 [2]福建省血液中心,福建福州350004 [3]国家卫生健康标准委员会血液标准专业委员会,北京100083

出　　处：《中国输血杂志》2025年第1期142-148,共7页Chinese Journal of Blood Transfusion

摘　　要：室温保存血小板细菌污染所致输血相关脓毒症和死亡的风险较高,已成为输血相关感染的首位原因。美国FDA最近发布的《血液采集机构和输血服务机构实施细菌风险控制策略提高输注用血小板的安全性和可及性的指引》提供了多种防控策略,供美国血液采集机构和输血服务机构选择应用。美国FDA的这些防控策略对于我国进一步建立血小板细菌污染风险控制策略颇具参考和借鉴价值。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.

关 键 词：血小板 室温保存 细菌污染 风险控制 指引 

分 类 号：R457.1[医药卫生—治疗学] R331.143[医药卫生—临床医学]