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一次性使用湿化瓶不良事件处理的全流程控制实践

             

摘要

一次性使用湿化瓶作为医院临床病人吸氧过程中对氧气进行湿化的常规耗材,具有使用面广、使用量大、操作方便等特点,在我院临床使用量极大,其使用的安全性一直备受我院相关部门的关注.近年来我院临床陆续发生了一次性使用湿化瓶在使用中发生爆裂的事件,为保证临床治疗时病人的安全,遵循JCI持续改进原则,在此次事件发生后我院设备管理部门立即组织力量深入调研,根据风险等级启动召回程序,分析故障原因并从模具、生产工艺等方面对设备进行改进.本文对此次事件的全流程控制和应对做了回顾,并提出了进一步的改进措施.%Disposable humidifying bottle is conventional clinical consumable which is used for oxygen humidification in the course of oxygen inhalation, and it has the characteristics of widely use, large amount of use, easy operation. Due to its large amount use in our hospital, the safety use of which obtained much attention by related departments. In recent years, there were several disposable humidifying bottle burst events in succession. In order to ensure the safety of patients during clinical treatment and following the JCI principle of continuous improvement, medical device management department in our hospital organized forces to investigate these events immediately, started the recall process according to the level of risk, analyzed cause of the fault and improved the equipment from the aspects of mould and production process. We reviewed the whole process control of this adverse event in this paper, and proposed further improved measures.

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