基于失效模式与效应分析的放射治疗实施过程风险研究  

Risk Analysis of Radiotherapy Implementation Process Based on Failure Mode and Effect Analysis

作　　者：江明尹 王琳琳[1] 高佳琦[1] 胡梦雅 李勤[2] 彭振军[2] 冯庆敏[1] 张叙天[1] 张强[1] 刘胜林[1] JIANG Mingyin;WANG Linlin;GAO Jiaqi;HU Mengya;Li Qin;PENG Zhenjun;FENG Qingmin;ZHANG Xutian;ZHANG Qiang;LIU Shenglin(Biomedical Engineering Lab,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,430022;Cancer Center,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,430022)

机构地区：[1]华中科技大学同济医学院附属协和医院生物医学工程研究室,武汉市430022 [2]华中科技大学同济医学院附属协和医院肿瘤中心,武汉市430022

出　　处：《中国医疗器械杂志》2019年第3期230-234,共5页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划项目(2016YFC0106700,2016YFC0106702)

摘　　要：目的提供放射治疗实施过程风险评估方法,发现治疗实施流程可能存在的风险,提出降低或预防这些风险的管控措施。方法组建多中心专家评估团队,绘制了治疗实施过程流程图,通过专家团队对流程图中每个支步骤展开失效模式分析,汇总分析结果并进行RPN(风险优先序数)评分,最终获得整个流程风险的量化评估结果。结果失效模式中共获得106个失效模式,风险评估获得RPN(前20%)高危风险模式22个和严重度S(≥8)高危风险模式27个,失效原因多为人为差错或软硬件故障。结论失效模式与效应分析可以较好的用于放疗实施过程的风险评估,为放疗领域的风险管控提供了新的评估工具。Objective Providing a risk assessment method for the implementation of radiotherapy to identify possible risks in the implementation of the treatment process,and proposing measures to reduce or prevent these risks.Methods A multidisciplinary expert evaluation team was developed and the radiotherapy treatment process flow was drawn.Through the expert team,the failure mode analysis is carried out in each step of the flow chart.The results were summarized and the RPN(risk priority ordinal)score was obtained,and the quantitative evaluation results of the whole process risk were obtained.Results One hundred and six failure modes were obtained,risk assessment of RPN(20%)high risk failure model are 22 and severity S(≥8)high risk failure model are 27.The reasons for the failures were man-made errors or hardware and software failures.Conclusion Failure mode and effect analysis can be used to evaluate the risk assessment of radiotherapy,and it provides a new solution for risk control in radiothera py field.

关 键 词：失效模式与效应分析 放射治疗 风险分析 

分 类 号：R197.39[医药卫生—卫生事业管理]