隐形眼镜护理液伤害事件分析模型及定性研究  

The Analytical Model and the Qualitative Investigation of Injured Event for Contact Lenses Care Solution

作　　者：潘蕾 文强 王军 杨乐[4] 高菁 余永强 常璐 孟刚[4] 

机构地区：[1]江西省ADR监测中心,南昌330046 [2]重庆市ADR监测中心,重庆400014 [3]云南省ADR监测中心,昆明650101 [4]国家食品药品监督管理局药品评价中心,北京100045 [5]新疆ADR监测中心,乌鲁木齐830002

出　　处：《中国医疗器械信息》2008年第8期53-56,共4页China Medical Device Information

摘　　要：目的:对隐形眼镜护理液伤害事件进行事件分析,为医疗器械伤害事件分析提供工程学基础。方法:对隐形眼镜护理液伤害事件建立伤害事件分析模型并开展定性研究。结果:角膜损伤与病原体的存在是导致隐形眼镜护理液伤害的两个必要条件,人的使用是重要因素。结论:建立伤害分析模型,演绎隐形眼镜护理液伤害事件的发生原理,从而系统提出导致隐形眼镜护理液伤害事件的主次原因,为医疗器械伤害事件分析提供了方法和工具。明确提出危害分析中人的因素不可或缺,并为避免同类事件的反复发生提出了干预措施的建议。Object： Analyzing the medical device adverse events by contact lenses care solution, to providing the engineering foundation for the ADR and MDAE. Methods： Establishing the analytical model of the injured invent, then conducting the qualitative investigation to do the invalidation by contact lenses care solutions. Results： The corneal injury is the uppermost injury that caused by contact lenses care solutions, but the key is the using ways of people. Conclusion： This research use the analyzing of the reasons in these injured invents, establishing the analytical model, the research re-creates the occurrence and the consequence of the injured invents, thus provides the feasible control measure to manage and supervise for government.

关 键 词：隐形眼镜护理液 伤害模型 定性研究 

分 类 号：R197.39[医药卫生—卫生事业管理]