医疗器械质量控制管理评价体系的构建与应用

Construction and Application of Evaluation Index System of Quality Management of Medical Device

目的为加强三甲综合性医院医疗器械使用管理,推进医疗器械质量控制管理,科学评价公立医院的医疗器械质量管理工作。方法基于专家咨询、文献分析、问卷调研法和灰色多层次评价法,拟定医疗器械质量管理评价指标体系,再分配指标权重,形成医疗器械质量控制管理评价模型。结果构建三级层次结构的三甲综合性医院医疗器械质量控制管理评价模型,分设一、二、三级指标,着眼于医疗器械全生命周期的管理实践展开评价。6家三级医疗机构运用此评价体系评价2018年医疗器械质量控制管理工作,结果显示采购质量得分较高,使用质量得分较低。结论医院医疗器械质量控制管理评价指标体系方法科学,功能明确,指标设置合理,能有效利用指标体系开展三甲综合性医院医疗器械质量控制管理评估工作。

Objective In order to strengthen the use management of medical device in tertiary class A general hospitals,promote the quality control management of medical device,and evaluate the quality management of medical device in public hospital scientifically.Methods Based on expert consultation,literature analysis,questionnaire research method and grey multi-level evaluation method,the evaluation index system of medical device quality management was drawn up,and the index weight was redistributed to form the evaluation model of medical device quality control management.Results The evaluation model of medical device quality control management in tertiary class A general hospitals was constructed,and the first,second and third-level indexes were set up to evaluate the management practice of the whole life cycle of medical devices.Conclusion The evaluation index system of medical device quality control management in hospital is scientific,with clear function and reasonable index setting,and it can effectively use the index system to carry out the evaluation work of medical device quality control management in tertiary class A general hospitals.