风险管理优化在医疗器械管理中的有效性研究

Research on the Effectiveness of Risk Management Optimization in Medical Device Management

目的探究风险管理优化在医疗器械管理效果中的有效性。方法以2020年6月至2021年6月的1800件医疗器械为研究对象,对对照组实施常规管理,对实验组通过划分风险等级、成立风险管理小组、规范管理内容等实施风险管理优化。通过评价管理前后的各项指标分析风险管理优化的效果。结果实施风险优化管理后,器械指标完善率、安全性能、清洁质量及包装质量合格率高于管理前,且差异具有统计学意义(P<0.05);器械缺陷发生总率则低于对照组,且差异具有统计学意义(P<0.05)。结论风险管理优化可有效提高医院医疗器械管理质量,对保障医疗器械的安全、有效运行,降低医疗器械缺陷发生风险有重要作用。

Objective To explore the effectiveness of risk management optimization in the effect of medical device management.Methods Taking 1800 medical devices from June 2020 to June 2021 as the research objects,routine management was implemented for the control group,and risk management optimization was implemented for the experimental group by dividing risk levels,establishing a risk management team,and standardizing management content and so on.The effect of risk management optimization was analyzed by evaluating various indicators before and after management.Results After the implementation of risk optimization management,the improvement rate of device indicators,safety performance,cleaning quality and packaging quality qualification rate were higher than those before management,and the difference was statistically significant(P<0.05).The total incidence of device defects was lower than that of the control group,and the difference was statistically significant(P<0.05).Conclusion Risk management optimization can effectively improve the quality of hospital medical device management,and play an important role in ensuring the safe and effective operation of medical devices and reducing the risk of medical device defects.