医学装备质量安全风险管理全面分析.pdfVIP

中国医学装备2014年10月第11卷第10期 China Medical Equipment 2014 October Vol .11 NO.10 管理论坛 医学装备质量安全风险管理全面分析 ① 尤 良 [文章编号] 1672-8270(2014)10-0101-04 [中图分类号] R197.39 [文献标识码] A [摘要] 目的： 方 全面分析医学装备质量安全风险管理，避免和减少医学装备临床使用安全风险。 法：医学装备的设计、制造、管理和使用者均需从系统安全性的角度来认识其在诊疗过程中可能 会出现的安全性问题，从风险分类、评估和形成原因等多方面进行分析及制定预防措施。结果： 通过对医学装备的质量与安全风险进行管理，采取相应的措施预防安全风险的发生，避免和减少 了安全风险形成因素的影响。结论：医学装备质量与安全风险问题涉及到许多复杂因素，必须对 医学装备存在的质量与安全风险全面分析、认真评估并加强管控。 [关键词] 医学装备；质量安全风险；全面分析 DOI: 10.3969/J.ISSN.1672-8270.2014.10.034 Medical equipment risk management comprehensive analysis of quality and safety/ YOU Liang// China Medical Equipment,2014,11(10):101-104. [Abstract] Objective: The medical equipment safety risks were avoided and reduce in 作者简介 clinical use. Methods: The security issues to may occur in the process of clinical diagnosis 尤良,男,(1953- ) , and treatment must be recognized on the multiple links of the medical equipment design, manufacture, management, and the user from the perspective of system security. From the 硕士，高级工程师。重 causes of the formation of risk classification, risk assessment, and risk several aspects were 庆市医疗设备质量检测 analyzed, and work out preventive measures. Results: through the medical equipment quality 管理所所长、中国医学 and safety risk management, take appropriate measures to prevent the happening of the 装备协会理事，从事医 security risks, the influence of the safety risk factors is avoided and reduced. Conclusion: 学装备管理工作。 the medical equipment quality and safety risk problem involves many complicated factors, It must be strengthened the quality safety risk of the medical equipment comprehensive analysis, evaluation, management and control. [Key words] Medical equipment; Quality and safety risk; Comprehensive analysis [First-author’s address] Chongqing Institute for Medical Equi