基于医疗器械不良事件报告分析的医院监测管理流程优化

摘要

Objective:To establish monitoring process for adverse event of medical instrument and analyze relative adverse event so as to decrease occurrence rate of adverse event of medical instrument and ensure the use safety of paramedics and patients.Methods:Through established monitoring process for adverse event of medical instrument and analyzed reason of adverse events, the monitoring strategy for adverse event was specifically proposed to guide the practical work.Results: The relevant management measurements was proposed based on the reasons of adverse event which appeared in the use process of medical instrument, and these measurements had reference effect for monitoring of adverse event of medical instrument.Conclusion: The medical engineering department should combine the occurrence situation of adverse event of medical instrument to normatively manage medical instrument, and establish long effect management mechanism so as to enhance management level for medical instrument, and to decrease occurrence rate of adverse event of medical instrument, and to ensure the use safety of medical staffs and patients.%目的:建立医疗器械不良事件监测流程,并对不良事件进行分析,降低医疗器械不良事件发生率,保障医务人员和患者用械安全.方法:通过建立医疗器械不良事件监测流程,对医疗器械不良事件原因进行分析,有针对性地提出医疗器械不良事件的监管策略.结果:针对医疗器械使用过程中出现的不良事件原因,提出相应的管理措施,对医疗器械不良事件监测工作起到借鉴作用.结论:医学工程科应结合医疗器械不良事件发生情况,有针对性地加以规范管理,并建立长效管理机制,提高医疗设备管理水平,降低医疗器械不良事件发生率,保障医务人员和患者的用械安全.