摘要
多参数监护仪是医院最常用的一种急救类设备,其安全性和有效性直接关系到患者的安全和健康。本文试图在国内外现有标准的基础上探索建立一种多参数监护仪的安全管理标准,通过制定安全管理体系、管理制度质量控制以及性能检测等方法规范在用多参数监护仪日常管理,以提高在用多参数监护仪的临床使用质量,保证其安全性、有效性。通过上述方法,增强了多参数监护仪质量控制与安全管理的可操作性,进一步明确临床多参数监护仪使用、监督管理的内容和要求,为医疗机构落实总局第18号令中提出的加强医疗器械使用质量监督管理要求打下坚实基础。
Multi-parameter monitor is the most commonly used one kind of emergency equipment in hospital,its safety and effectiveness is directly related to the patient's safety and health.This article attempted to establish a multi-parameter monitor standard of safety management based on the standards at home and abroad,the daily management of multi-parameter monitor was formulated by the safety management system,quality control of management system and performance test,to improve the clinical using quality of multi-parameter monitor,to ensure its security,effectiveness.Through the above methods,the operability of quality control and safety management of multi-parameter monitor was enhanced,and the content and requirements of multi-parameter monitor were further clarified,to lay a solid foundation for the medical institutions to implement the requirements of the eighteenth order issued by the general administration to strengthen the supervision and management of the quality of medical devices.
作者
郭智利
GUO Zhili(Office,Inner Mongolia Autonomous Region Population and Development Research Centre,Hohhot Inner Mongolia 010017,China)
出处
《中国卫生标准管理》
2018年第16期8-10,共3页
China Health Standard Management
关键词
多参数监护仪
安全管理
标准
使用质量
性能检测
安全性
有效性
multi-parameter monitor
safety management
standards
usage quality
performance test
safety
effectiveness