3例氧气湿化装置产品临床使用不良事件的风险研究  

Study on the Risk of Clinical Adverse Event in 3 Cases of Oxygen Humidification Device

作　　者：尹建兵 王雯 沈坚萍 YIN Jian-bing;WANG Wen;SHEN Jian-ping(Zhejiang Medical Device Adverse Event Monitoring Center Zhejiang Hangzhou 310009;Shaoxing Drug Adverse Reaction Monitoring Center Zhejiang Shaoxing 312000)

机构地区：[1]浙江省医疗器械不良事件监测中心,浙江杭州310009 [2]绍兴市药品不良反应监测中心,浙江绍兴312000

出　　处：《中国医疗器械信息》2018年第11期42-43,157,共3页China Medical Device Information

摘　　要：目的:随着生活水平的提高,吸氧者的氧气加湿需求也日趋增长,但随之而来的加湿吸氧类医疗器械产品发生的可疑不良事件报告数也日趋增加。方法:通过对我省2017年年底集中发现的3例该类产品不良事件的临床调研、文献资料检索、汇总研究和分析。结果:对该类器械产品常见可疑不良事件的发生从产品质控技术参数设定充分性、产品使用说明书和标签编写全面性、产品包装警示标识必要性三方面进行详细阐述。结论:提出氧气湿化装置类医疗器械产品临床使用风险控制的建议。Objective： With the improvement of living standards, oxygen humidifying demand for oxygen inhaler is also increasing, but the number of suspicious adverse event reports that followed the humidified oxygen inhalation medical devices is increasing. Methods： The clinical investigation, literature search, summary research and analysis of 3 cases of adverse events of this kind were found by the end of 2017 in our province. Results： Three aspects of the common suspicious adverse events of this kind of equipment are described in detail from three aspects： the adequacy of the product quality control technical parameters, the comprehensiveness of the product instructions and labels, the necessity of the product packaging warning signs. Conclusion： Common risk control suggestions for clinical use of medical devices in oxygen humidification devices.

关 键 词：医疗器械 不良事件 风险点 氧气湿化装置 

分 类 号：TH789[机械工程—仪器科学与技术]