摘要
以2022年1月至2023年10月南京市6家医疗机构(涉及5个品牌)上报的一次性使用导尿包不良事件为数据来源,分析了一次性使用导尿包在产品设计、生产制造、运输储存、临床使用等环节的风险信号,指出了在产品包装、有效期、说明书、灭菌工艺、操作使用等方面存在的问题,并对生产经营企业、医疗机构、监督管理部门提出了风险管控建议,为一次性使用导尿包全生命周期的风险管理提供了参考。
The risk signals of the disposable urethral catheter set during the links of product design,production and manufacturing,transportation and storage and clinical use were analyzed with the adverse events of the disposable urethral catheter sets from 5 brands reported by 6 medical institutions in Nanjing from January 2022 to October 2023 as the data source.The problems were pointed out in packaging,expiration date,instruction manual,sterilizing process and use.Some suggestions for risk management and control were proposed for production and operation enterprises,medical institutions and supervision and management departments.References were provided for risk managment for the disposable urethral catheter set.
作者
陈伟伟
李莉
王贞媛
CHEN Wei-wei;LI Li;WANG Zhen-yuan(Affiliated Hospital of Nanjing University of Chinese Medicine,Jiangsu Province Hospital of Chinese Medicine,Nanjing 210008,China;Nanjing Institute for Food and Drug Control,Nanjing 211198,China)
出处
《医疗卫生装备》
2025年第9期88-92,共5页
Chinese Medical Equipment Journal
关键词
医疗器械不良事件
一次性使用导尿包
风险信号
风险管理
medical device adverse events
disposable urethral catheter set
risk signal
risk management
