医疗器械不良事件监测评价体系研究

Evaluation System of Adverse Events Surveillance on Medical Device

目的提高医疗器械不良事件监测评价水平,为管理决策部门制定相应政策提供参考。方法选取指标制定指标体系,进行权重测算及数据预处理,提出监测策略。结果以2017年不良事件监测工作为实证,总评分为84.056分,基本符合不良事件监测报告工作的客观实际。结论本研究可评价医疗器械不良事件监测水平,对于推进和改善不良事件监测工作,提高合理用械水平具有指导意义。

Objective This study aims to improve the standards of adverse events surveillanceon medical device, and provide reference for the regulatory agency to formulatecorresponding policies. Methods Selecting indicators to develop a measuring system, performing weight based measurement and data preprocessing, and proposing monitoring strategies. Results The 2017 adverse event monitoring work was used asempirical evidence. The total score measures at 84.056 points, which met the basic objective reality of the adverse event monitoring report. Conclusion This study can evaluate the quality of adverse events monitoring work in medical devices, and the information can be used to guide future work to improve the monitoring of adverse events and promote the level of rational medical instrument use.