血液透析器械不良事件主动监测模式研究

Study on active monitoring model of adverse events in hemodialysis device

目的:通过开展医疗器械不良事件主动监测,探索不良事件监测上报新模式。方法:选取医院进行血液透析治疗的230例患者使用的血液透析器械为研究资料,通过登记调查法,实施监测人员业务培训、监测对象宣传教育、收集主动监测表、质量控制体系的构建实施和监测信息反馈等方法,对医院在用血液透析类器械进行6个月的使用情况主动监测。结果:研究中共发现274例不良事件,总体发生率为1.8626%;6个月的不良事件占比分别为1.34%、1.32%、2.67%、1.36%、2.94%和1.31%;不良事件中267例为低血压病例,其主要原因为患者因素、医护人员因素和其他不可控因素;主动监测实施后,医院医疗器械不良事件上报数量及质量明显提升,风险管理与主动监测意识显著增强。结论:开展医疗器械不良事件主动监测,发挥医疗机构报告主渠道作用,可提升公众用械安全,对医疗器械生产及上市后风险控制有一定指导和借鉴意义。

Objective:To explore a new mode of monitoring and reporting adverse events by carrying out active monitoring for adverse events of medical devices.Methods:The used hemodialysis devices of 230 patients who underwent hemodialysis treatment in hospital were selected as research materials.Through registration survey method to implement business training for supervise personnel,publicity and education of monitoring objects,the collection of active monitoring list,establishment and implementation of quality control system,the feedback of monitoring information and others,so as to carry out active monitoring for service situation of using hemodialysis devices of hospital in 6 months.Results:A total of 274 adverse events were found in the study,and the overall incidence of adverse events was 1.8626%.The proportion of adverse events in each month of 6 months was 1.34%,1.32%,2.67%,1.36%,2.94%,1.31%,respectively.Among the adverse events,267 cases were hypotension which were mainly caused by patient factors,medical personnel factors and other uncontrollable factors.After active monitoring was implemented,the number and quality of reported adverse events of medical devices in hospital were significantly improved,and the awareness of risk management and active monitoring of medical personnel was significantly enhanced.Conclusion:The implementation of active monitoring of adverse events of medical devices can full play the role of medical institutions as main channel for reporting adverse events,and can improve the safety of public devices.It has a certain guiding and reference significance for the production and post-marketing risk control of medical devices.