【摘要】 目的:探讨医疗器械不良事件处理方法和管理在医院医疗器械监督管理中的应用。方法:分析评估医院上报的3例典型医疗器械可疑不良事件,详述处理经过与跟踪反馈的改进效果。结果:总结了由此3个案例引发的医疗器械不良事件管理改进要点。结论:医疗器械使用单位只有不断加强对医疗器械不良事件的管理,在发生医疗器械不良事件后及时评价、追溯及处理,才能不断提高器械管理水平,保障医疗器械使用安全。更多还原

【Abstract】 Objective To sum up the handling methods and management effectiveness of medical device adverse events(MDAE). Methods Three recent typical cases of MDAEs in the hospital were studied and evaluated, and detailed processing and improvement feedback were recorded. Results Several management improvement points were summarized according to these cases in order to avoid the recurrence of similar adverse events. Conclusion The hospital must continue to strengthen the management, prompt evaluation, review and processing of MDAEs when MDAE happens to improve medical equipment management.更多还原