医疗器械不良事件监管探讨  

Discussion on the Monitoring of Medical Device Adverse Event

作　　者：房坤 胡淑婷 陈玉俊 徐国庆 沈爱宗 

机构地区：[1]安徽医科大学附属省立医院物流中心,合肥市230001

出　　处：《中国医疗器械杂志》2016年第6期445-447,共3页Chinese Journal of Medical Instrumentation

基　　金：安微省高等学校省级质量工程项目:(2015jxm783;2014jyx766);安徽医科大学青年教师教学研究项目(JYxm2015137);安徽中医药大学研究生教育综合改革项目(2014YJG007)

摘　　要：目的分析医疗器械不良事件现状,探讨临床医学工程师在医疗器械不良事件监测中的职能作用。方法通过介绍各部门人员在医疗器械不良事件监测中的职能作用,明确临床医学工程师和医护人员的技术要求和管理职责。结果加强临床医学工程师在医疗器械不良事件监测中的职能作用,是预防医疗器械不良事件的有效措施。结论充分发挥临床医学工程师在医疗器械不良事件监测中的职能作用,对提高医疗器械使用质量和确保患者安全具有重要意义。Objective Analyzing the status of medical device adverse events, the function of the clinical medical engineers in medical device adverse event monitoring was investigated.Methods Through introducing the functions of the various departments in the medical device adverse event monitoring, the technical requirements and management responsibilities of clinical medical engineer and medical staff were defined. Results Enhancing the function of clinical medical engineers in medical device adverse event monitoring,which is an effective measure to prevent medical device adverse events.Conclusion Play the functions of clinical engineers in the medical device adverse event monitoring, which is significant to improve the using quality of medical devices and to ensure patient safety.

关 键 词：医疗器械 不良事件监测 临床医学工程师 职能作用 

分 类 号：R197.39[医药卫生—卫生事业管理]