对在用医疗器械实施风险管理的思考

Consideration of Risk Management of Medical Devices in Use

目的:分析思考对在用医疗器械实施风险管理的应用效果。方法:选择2018年1月~2019年12月本院的120件在用医疗器械作为研究对象,并分为观察组(60件,接受风险管理)和对照组(60件,接受常规管理)。结果:对比两组医疗器械经管理后的相关质量、各指标完善情况、不良事件发生情况,对照组安全性能88.33%、清洁质量80.00%、包装质量90.00%;观察组安全性能98.33%、清洁质量95.00%、包装质量100.00%,观察组管理质量更好,差异均有统计学意义(P<0.05)。对照组标识81.67%、操作流程85.00%、警示内容83.33%、维护流程80.00%;观察组标识95.00%、操作流程96.67%、警示内容96.67%、维护流程93.33%,观察组各指标完善情况更好,差异均有统计学意义(P<0.05)。对照组总不良事件发生率28.33%;观察组总不良事件发生率10.00%,差异均有统计学意义(P<0.05)。结论:对在用医疗器械实施风险管理,可有效提升器械使用的安全性,提升其管理质量,确保其严格按管理流程实施相关的维修、使用,有效延长器械使用周期,减少器械受损程度。

Objective:To analyze the application effect of risk management on medical devices in use.Methods:120 cases of medical devices in use in our hospital from January 2018 to December 2019 were selected as the research objects,and the patients were divided into observation group(60 cases received risk management)and control group(60 cases received routine management).Results:The related quality,improvement indexes and adverse events of two groups after management were compared.In the control group,the safety performance was 88.33%,the cleaning quality was 80.00%,and the packaging quality was 90.00%;In the observation group,the safety performance was 98.33%,the cleaning quality was 95.00%,and the packaging quality was 100.00%.The quality of management in the observation group was better,and the difference was statistically significant(P<0.05).In the control group,the identification was 81.67%,operation process was 85.00%,warning content was 83.33%,maintenance process was 80.00%;In the observation group,the identification rate was 95.00%,the operation process was 96.67%,the warning content was 96.67%,and the maintenance process was 93.33%,the improvement of each index in the observation group was better,and the difference was statistically significant(P<0.05).The total incidence of adverse events in the control group was 28.33%,and that in the observation group was 10.00%,the difference was statistically significant(P<0.05).Conclusion:The implementation of risk management on medical devices in use can effectively improve the safety and management quality of medical devices,ensure the implementation of relevant maintenance and use in strict accordance with the management process,effectively extend the use cycle of devices and reduce the damage degree of devices.