目的:探讨建立医学装备安全风险管理体系的新路径.方法:研究国家制定的"医疗器械临床使用安全管理规范"(试行)和"三级综合医院评审标准实施细则(2011版)"第六章(医院管理)第9条(医学装备管理)评审标准.结果:根据国家相关政策以及有关评审标准提出风险控制的"四关"管理模型,并建立一套行之有效的医学装备安全风险管理体系.结论:医学装备安全风险管理体系的建立有助于保障医院医疗质量与安全,并可为医学装备临床使用安全风险管理提供参考.%Objective:To explore the establishment of medical equipment safety risk management system new pathways.Methods: By studying the "Medical Device Clinical use of safety management practices" (Trial) and the "three general hospital accreditation standards Implementing Rules (2011 Edition)" Chapter VI (hospital management) Article 9 (Medical Equipment Management) accreditation standards.Results: Risk control made in accordance with relevant national policies and related evaluation criteria "four off" management model, and to establish an effective risk management system of medical equipment safety.Conclusion: The establishment of medical equipment safety risk management system helped to ensure medical quality and safety, to provide reference for the clinical use of medical equipment to explore the system security risk management through.
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