一次性使用湿化瓶不良事件处理的全流程控制实践
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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.
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.
引文
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[2]刘少杰.浅析计量检测在保证医疗设备质量中所起的作用[J].科技创新与应用,2015(20):296.
[3]郑盘根,郜宝成.浅谈医疗设备的科学管理[J].总装备部医学学报,2010,(3):132-133.
[4]汤黎明,吴敏,陈锐华.医院医疗设备企业化管理探索[J].医疗卫生装备,2007,28(9):46-47,50.
[5]杨晓慧.医疗设备风险评估与安全管理[J].健康界,2012,9(4):36-38.
[6]国家食品药品监督管理局.医疗器械监管技术基础[M].北京:中国医药科技出版社,2008.
[7]郑骏,陈斯尧.JCI体系中医疗设备风险管理的实践和探讨[J].中国医疗设备,2014,29(6):78-80.
[8]谢松城.医疗器械临床使用风险及其对护理质量的影响[J].中国护理管理,2010,10(10):5-7.
[9]Clark T,Perron E.临床工程指引--医疗仪器设备临床应用分析评估[M].北京:中国计量出版社,2009.
[10]范明利,范兴.对在用医疗设备的质量控制的几点具体做法[J].现代科学仪器,2010,(5):138-139.
[11]Claycamp HG,Rahaman F,Urban JM.The reliability-quality relationship for quality systems and quality risk management[J].PDA J Pharm Sci Technol,2012,66(6):512-517.
[12]GB/T 7826-87,系统可靠性分析技术-失效模式和效应分析(FMEA)程序[S].2009.
[13]中华人民共和国卫生部,医疗器械召回管理办法(试行)(卫生部令第82号)[S].2011.
[14]周琳,陈奕霖,梁庆宇.FMEA与RCA在骨科风险管理中的综合应用[J].成都医学院学报.2012,7(2):166-169.
[15]米永巍,李怡勇,郭赤.医疗设备质量控制体系的建立与实施[J].中国医疗设备,2010,26(11):94-96.
[16]国家食品药品监督管理局.《医疗器械不良事件监测和再评价管理办法(试行)》(国食药监械[2011]425)[S].2011.
[17]赵燕,郑立,王刚,等.医疗器械召回典型案例研究[J].中国药物警戒,2011,8(12):722-724.
[18]Karaarslank.Joint commission on international accreditation workshop:planning,development and provision of laboratory services[J].Clin Biochem,2009,42(4):284-287.