医院可疑医疗器械不良事件监测与上报管理  

Monitoring and Reporting Management of Suspected Medical Device Adverse Events

作　　者：韩晶晶 佟晓城 HAN Jing-jing;TONG Xiao-cheng(Weifang Hospital of Traditional Chinese Medicine,Shandong Weifang 261041)

机构地区：[1]潍坊市中医院,山东潍坊261041

出　　处：《中国医疗器械信息》2025年第1期77-79,共3页China Medical Device Information

摘　　要：作为现代医疗科学技术体系形成与发展的产物,医疗器械不仅在医院诊治中发挥着重要作用,在健康者健康保健与疾病预防中也发挥着同等重要的作用。在我国社会经济飞速发展的大环境下,我国的医疗器械水平得到了飞速的发展,在当前疾病诊疗与健康保健中已经发挥出了非常重要的作用。医疗器械是直接或间接应用在人体上,长时间的操作应用不可避免会出现功能退化、设备故障的问题,不仅会对医疗结果应用准确性带来影响,同时也会危及患者的生命安全,大大增加医疗安全事故的发生概率,为此需开展可疑医疗器械不良事件的监测与上报工作,及时解决安全隐患问题。论文以医疗器械不良事件发生为切入点,探究可疑医疗器械不良事件监测与上报管理的措施,以期保护人民群众的用械安全,促进医疗事业的可持续健康发展。As the product of the formation and development of modern medical science and technology system,medical devices not only play an important role in the diagnosis and treatment of hospitals,but also play an equally important role in the health care and disease prevention.In the environment of the rapid development of China’s social economy,the level of medical devices in China has been rapidly developed rapidly,which has played an extremely important role in the current disease diagnosis and treatment and health care.medical equipment is directly or indirectly applied on the human body,long time operation application will inevitably appear function degradation,equipment failure problem,not only affect the medical results application accuracy,but also can endanger patients’life safety,greatly increase the chance of medical safety accidents,therefore for suspicious medical device adverse event monitoring and reporting,timely solve the safety problem.The paper takes the occurrence of medical device adverse events as the starting point to explore the measures of monitoring and reporting management of suspicious medical device adverse events,in order to protect the people’s safety of people’s devices and promote the sustainable and healthy development of medical undertakings.

关 键 词：医院可疑医疗器械不良事件 监测上报 管理 

分 类 号：R197.39[医药卫生—卫生事业管理]