基于德尔菲法与层次分析法对在用医疗器械质量管理评价指标体系的构建与应用研究

Study on the construction and application of evaluation index system of quality management of used medical device based on Delphi method and AHP

目的:建立质量管理评价指标体系,用于评价医疗机构医疗器械质量管理工作。方法:基于文献分析,从国内主流医疗机构的医疗器械管理流程,构建医疗器械质量管理的初级指标体系;采用德尔菲法确立指标体系,并运用层次分析法和百分位权重法计算指标权重,构建评价模型,评价湖北省40家三级医疗机构2016年医疗器械质量管理工作和7家二级医疗机构2017年医疗器械质量管理工作。结果:确立医疗器械质量管理评价指标体系,其中一级指标4个,二级指标17个,三级指标45个,依据权重对各项指标赋分,增加指标注释和评分细则。47家医疗机构应用该评价体系评价结果显示,40家三级医疗机构条件指标和结果指标得分率较高、过程指标得分率较低,7家二级医疗机构各项指标平均得分均不高。结论:质量管理评价指标体系具有较好的可操作性和区分度,适用于医疗机构的医疗器械质量管理评价。

Objective： To establish a evaluation index system of quality management of medical devices so as to evaluate the quality management of medical devices of medical institutions. Methods： Based on the literature analysis, the primary index system of quality management of medical devices was constructed from the management process of medical device of domestically main medical institutions. Delphi method was adopted to establish index system. And analytic hierarchy process（AHP） and percentile weight method were applied to calculate index weight, and construct evaluation model, and evaluate situations of quality management of medical devices of 40 three-grade medical institutions in 2016 and 7 two-grade medical institutions in 2017 of Hubei province. Results： A evaluation index system of quality management of medical device, which included 4 one-grade indexes, 17 two-grade indexes and 45 three-grade indexes, was established, and each index was allocated score according to weight. And index annotation and detailed grading rule were added in the system. The application results of this evaluation system in 47 medical institutions showed that the scores of condition indicators and result indicators of 40 three-grade medical institutions were higher, and the scores of process index of these organizations were lower, and all of the average scores of various index of 7 two-grade medical institutions were not high. Conclusion： The evaluation index system of quality management has strong operability and distinction, and it is suitable to evaluate the quality management of medical devices of medical institutions.