基于MDR的风险防控体系构建及应用效果评价

Construction and Application Effect Evaluation of Risk Prevention and Control System Based on MDR

目的分析六年来医院医疗器械不良事件报告(Medical Device Reporting,MDR)发生的特点及风险防控体系运用的效果评价,降低使用风险,提升医院品质。方法采用回顾性分析方法,对医院2014-2019年上报的689例MDR进行资料回顾和综合统计分析。结果通过MDR风险防控体系构建的运用和器械使用风险的有效干预,MDR数量逐年上升,严重和群发事件逐年下降。利用SPSS 19.0统计软件进行卡方检验,P<0.05差异有统计学意义。结论风险防控体系构建的运用,提高了医务人员的积极性,对有效防范医疗风险,最大限度保障患者和医务人员的安全发挥着重要作用。

Objective To analyze the characteristics of the medical device reporting(MDR)over the past six years and evaluate the effect of risk prevention and control system application,so as to reduce the risk and improve the quality of treatment in the hospital.Methods Retrospective analysis was performed on 689 cases of MDR reported by the hospital from 2014 to 2019.Results The number of MDR increased year by year and the number of serious and mass incidents decreased with each passing year through the application of MDR risk prevention and control system and the effective intervention on the risk of instrument use.The c2 test(SPSS 19.0)was used to analyse the statistical significance of differences and P<0.05 difference was obtained.Conclusion The application of risk prevention and control system improves the enthusiasm of medical staff.More than that,it plays an important role in preventing medical risks effectively and ensuring the safety of patients and medical staff.