医疗设备临床应用风险评价指标体系的建立  

Establishment of the evaluation indicator system on clinical risk exposure of medical devices

作　　者：魏建新[2] 程菊[1] 冯庆敏[1] 张强[1] 刘胜林[1] 

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430022 [2]石河子大学医学院第一附属医院医学工程部

出　　处：《中华医院管理杂志》2016年第2期135-138,共4页Chinese Journal of Hospital Administration

基　　金：国家卫生和计划生育委员会医政医管局课题

摘　　要：目的从医疗机构角度构建一套科学的、全面的、可操作的医疗设备临床应用风险评价指标体系，以便为医疗机构开展医疗设备风险管理活动提供参考和帮助。方法通过文献分析、专家访谈拟定指标体系草案。遴选20位专家学者组成专家组，采用德尔菲法对初拟指标体系进行两轮专家咨询。使用专家的积极程度、权威系数、和谐系数检验本次专家咨询的可靠性，并且对指标体系进行了信效度检验。结果两轮咨询问卷回收率分别为90％、100％，两轮专家咨询后，专家意见已基本集中，最终确定的指标体系包涵4个一级指标、14个二级指标、48个三级指标，且信效度较好。结论专家意见比较协调，结果可取，说明构建的医疗设备临床应用风险评价指标体系可以作为医疗设备使用风险的评价工具。Objective To build a scientific, comprehensive, operable evaluation indicator system on clinical risk exposure of medical devices from the perspective of medical institutions. It can provide reference and help for medical institutions to carry out medical device risk management activities. Methods Through literature analysis and expert interview, the draft index system was proposed. Select 20 experts and scholars to form a panel of experts. A 2-rounds Delphi survey was made on the proposed indicators. The reliability of this expert consultation was tested by the response rate, the authority coefficient and concordance coefficient of experts. Results The response rates of the 2 rounds were 90%, 100% respectively. After two rounds of expert consultation, expert opinion has been basically concentrated. Ultimately, an index system comprising 4 first-level, 14 second-level, and 48 third-level was built. Conclusion The expert consultation has achieved reliable results. The evaluation indieator system on the clinical application risk of medical device can be used as an evaluation tool for medical device.

关 键 词：德尔菲法 医疗设备 临床应用 风险评价 指标体系 

分 类 号：R197.39[医药卫生—卫生事业管理]