医疗器械三级质量控制管理体系在临床疑似不良事件管理中的应用研究

Application of three-level quality control management system in medical device suspected adverse event tracking

目的:构建医疗器械三级质量控制管理体系,探讨其在临床疑似不良事件管理中的应用效果。方法:选取医院临床在用的1830台(套)医疗器械,按照管理模式将其分为对照组[896台(套)]和观察组[934台(套)],对照组采用常规管理,观察组采用三级质量控制管理,根据风险分析要素和评估值,将其分为高风险、中风险和低风险3类,制定一级管理持证上岗、二级管理培训考核和三级管理常规检查制度。对比两组器械临床服务质量、不良事件控制效果和器械使用相关人员业务能力的差异性。结果:观察组因器械设计、操作使用、运行环境、技术保障和部件老化等原因发生故障的频次低于对照组,差异有统计学意义(t=4.979,t=6.268,t=7.697,t=5.156,t=3.265;P<0.05);疑似不良事件上报率、及时率、有效率、数据规范度和处理效率高于对照组,差异有统计学意义(χ^(2)=10.040,χ^(2)=36.247,χ^(2)=9.053,χ^(2)=4.787,χ^(2)=14.332;P<0.05);器械使用相关工人员持证上岗率、培训考核优秀率和常规检查合格率好于对照组,差异有统计学意义(χ^(2)=4.112,χ^(2)=13.832,χ^(2)=6.197;P<0.05)。结论:三级质量控制管理体系能规范器械不良事件上报流程,提升不良事件处理效率,保障医疗器械运行质量,提升器械使用相关人员业务能力。

Objective:To establish a three-level quality control management system for medical devices and explore its application value in clinical suspected adverse event tracking.Methods:1,830 pieces(sets)of medical devices used in clinical treatment by the hospital were selected and divided into control group 896 pieces(sets)and observation group 934 pieces(sets)based on the management model.The control group adopted conventional management,and the observation group adopted three-level quality control management.According to the factors of risk analysis and evaluation value,the observation group was divided into high risk,medium risk and low risk.The rules on working with certificate of the management at Level 1,training and examination of the management at Level 2 and regular inspection of the management at Level 3 were established.The differences of clinical service quality,adverse event control effect and relevant professional ability between the two groups were compared.Results:The failure frequency of medical equipment design,operation,operating environment,technical support and component aging in the observation group was lower than that in the control group,and the difference was statistically significant(t=4.979,t=6.268,t=7.697,t=5.156,t=3.265;P<0.05);the reporting rate,timeliness rate,effective rate,data normalization and processing efficiency of suspected adverse events in the observation group were higher than those of the control group,and the difference was statistically significant(χ^(2)=10.040,χ^(2)=36.247,χ^(2)=9.053,χ^(2)=4.787,χ^(2)=14.332;P<0.05);the working with certificate,excellent rate of training and examination,and qualified rate of routine examination of the relevant medical staff in the observation group were better than those in the control group,and the difference was statistically significant(χ^(2)=4.112,χ^(2)=13.832,χ^(2)=6.197;P<0.05).Conclusion:The three-level quality control management system can standardize the reporting process of adverse events,improve the efficiency of handling adverse event,and ensure the operation quality of medical devices,and enhance the professional competence of medical staff.