Medical device adverse event monitoring-based analysis and suggestions on risk signals for disposable urethral catheter set
10.19745/j.1003-8868.2025168
- VernacularTitle:基于医疗器械不良事件监测的一次性使用导尿包风险信号分析及建议
- Author:
Wei-wei CHEN
1
;
Li LI
;
Zhen-yuan WANG
Author Information
1. 南京中医药大学附属医院(江苏省中医院),南京 210008
- Publication Type:Journal Article
- Keywords:
medical device adverse events;
disposable urethral catheter set;
risk signal;
risk management
- From:
Chinese Medical Equipment Journal
2025;46(9):88-92
- CountryChina
- Language:Chinese
-
Abstract:
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.[Chinese Medical Equipment Journal,2025,46(9):88-92]
