摘要
目的:中华护理学会消毒供应护理专业委员会对全国435家三级甲等医疗机构的消毒供应中心消毒与灭菌设备的产品使用说明书内容进行调查和分析,调查内容依据国家食品药品监督管理总局于2014年6月27日颁布《医疗器械说明书和标签管理规定》的相关条款设计并下发调查问卷。方法:调查问卷和现场调研。结果:发现其中191家医院的国产清洗、消毒设备和185家医院的进口清洗消毒设备,255家医院的国产压力蒸汽灭菌设备和132家医院的进口压力蒸汽灭菌设备的产品使用说明书合格率基本持平,其中完全符合国家食品药品监督管理总局《医疗器械说明书和标签管理规定》的设备占调研总比86%。结论:分析本次调查结果,发现厂家提供给医院的说明书存在以下问题:说明书主要未及时跟随产品升级而及时更新;说明书中产品配件的使用年限说明不清晰;进口设备产品说明书译文与原文有出入;产品安装和使用说明的细节描述不详细,给使用者造成不便。
Objective： The Professional Committee of disinfection and supply nursing of the Chinese Nursing Association investigated and analyzed the contents of the product instructions of disinfection and sterilization equipment in 435 disinfection and supply centers of third-class frst-class medical institutions in China. Methods： Questionnaires were designed and sent out according to the relevant provisions of the Regulations on Administration. Methods： Questionnaires and feld investigations were conducted. Results： 191 hospitals had domestic cleaning and disinfection equipment and 185 hospitals had imported cleaning and disinfection equipment, 255 hospitals had domestic pressure steam sterilization equipment and 132 hospitals had imported pressure steam sterilization equipment. Conclusions： The qualifed rate of the product instructions was basically the same, among which 86% of the equipment fully conformed to the State Food and Drug Administration＇s ＂Regulations on the Management of Instrument Instruments and Labels＂ accounted for. It is necessary to update the specifcations, to clarify the service life of the product parts in the specifcations, to translate the product specifcations of imported equipment into diferent versions, and to describe the details of the product installation and use specifcations in detail, thus causing inconvenience to the users.
作者
王瑾
钱黎明
张青
WANG Jin;QIAN Li-ming;ZHANG Qing(Beijing Anzhen Hospital,Beijing 100029;Shanghai Ruijin Hospital,Shanghai 200025;Peking Union Medical College Hospital,Beijing 100005)
出处
《中国医疗器械信息》
2018年第19期50-52,共3页
China Medical Device Information
关键词
CSSD
医用消毒与灭菌设备
产品使用说明书
CSSD （central sterile supply department）
medical disinfection and sterilization equipment
IFU
