风险管理对医院医疗器械管理质量影响的研究

Study on the effect of risk management on the management quality of medical device in hospital

目的:研究风险管理对医院医疗器械管理质量的影响,以保障医疗器械的使用安全。方法:选取医院在用的3000件医疗器械,根据设备使用时间的不同,将2017年1月至2018年1月期间使用的1494件医疗器械纳入对照组,将2018年2月至2019年2月期间所使用1506件医疗器械纳入研究组。对照组采用常规性医院管理模式,研究组在对照组基础上融合应用风险管理模式,对比分析两组医疗器械安全性能、清洁质量和包装质量,以及器械各指标完善程度和器械缺陷发生率。结果:研究组器械的安全性能、清洁质量和包装质量均优于对照组,其差异有统计学意义(x^2=59.329,x^2=20.527,x^2=69.427;P<0.05);研究组器械的标识、警示内容、操作流程和维护保养流程指标完善程度优于对照组,其差异有统计学意义(x^2=10.266,x^2=10.031,x^2=10.865,x^2=9.904;P<0.05);研究组器械的类别错误、功能不全、器材遗失和功能损坏4项合计器械缺陷发生率明显低于对照组,其差异有统计学意义(x^2=5.026,P<0.05)。结论:融合应用风险管理模式可强化医院医疗器械管理,增强器械安全性能,降低器械缺陷发生率,为患者诊疗安全提供保障。

Objective:To explore the effect of risk management on the management quality of medical device in hospital.Methods:The using 3000 medical devices in hospital were selected and were divided into study group and control group(1500 cases in each group)according to different stages.1494 medical devices that were used during January 2017 and January 2018 were divided into control group and 1506 medical devices that were used during February 2018 and February 2019 were divided into research group.The control group adopted the conventional management mode of hospital,and the research group applied risk management mode on the basis of control group.The safety performance,cleaning quality and packaging quality of medical devices,and the improved degree of each indicator of device and the incidence of device defect between the two groups were compared.Results:The safety performance,cleaning quality and packaging quality of the devices of research group were significantly better than those of control group(x^2=59.329,x^2=20.527,x^2=69.427,P<0.05),respectively.And the improvement of the indicators such as the device identification,warning content,operation process and maintenance process of research group was significantly better than those of control group(x^2=10.266,x^2=10.031,x^2=10.865,x^2=9.904,P<0.05),respectively.The total incidence of four defects included category error,insufficiency,material loss and functional damage of study group was significantly lower than that of control group(x^2=5.026,P<0.05).Conclusion:The integrated application of risk management mode can strengthen the management of medical devices of hospital,and enhance the safety performance of devices,and reduce the incidence of device defects,and provide guarantee for the safety of diagnosis and treatment of patients.