中国药业2026，Vol.35Issue(10)：23-26,4.DOI:10.3969/j.issn.1006-4931.2026.10.005
冲吸式口护吸痰管不良事件分析及风险控制建议
Analysis of Adverse Events and Risk Control Recommendations of Irrigation-Suction Oral Care Suction Catheters
摘要
Abstract
Objective To provide a reference for the safe clinical application of irrigation-suction oral care suction catheters.Methods Medical device adverse event(MDAE)reports of irrigation-suction oral care suction catheters reported by Guangdong Province and collected by the National Monitoring Information System from January 1,2018 to December 31,2024 were retrieved.Descriptive statistical method analyze was used to analyze the adverse event reports,including the intended therapeutic use,department of application,causes of device failure,and manifestations of injury.Meanwhile,a literature analysis was performed on high-risk adverse events,and corresponding risk control recommendations were proposed.Results A total of 58 MDAE cases involving irrigation-suction oral care suction catheters were included.According to the intended therapeutic use,38 cases(65.52%)were used for oral care and 20 cases(34.48%)were used for respiratory tract sputum aspiration.Among them,45 cases(77.59%)clearly recorded the department of application,mainly concentrated in the intensive care unit(27 cases,46.55%).The primary cause of device failure was brush head detachment(42 cases,72.41%).The predominant manifestation of harm was no obvious injury(37 cases,63.79%).All recorded injuries were caused by brush head detachment,mainly manifested as accidental ingestion/aspiration(10 cases,17.24%)and asphyxiation(8 cases,13.79%).The causes of brush head detachment could be classified into quality problems/design defects(32 cases,76.19%)and unconscious biting-off by patients(10 cases,23.81%).Conclusion Brush head detachment is the main risk of adverse events associated with irrigation-suction oral care suction catheters,and unconscious biting-off by patients is the primary injury-inducing factor.It is recommended that clinical operations showld be standardized.Manufacturers should optimize product instructions and product design from the source and improve product quality to ensure the safety of such medical devices in clinical use.关键词
冲吸式口护吸痰管/医疗器械不良事件/刷头脱落/风险控制/使用安全Key words
irrigation-suction oral care suction catheter/medical device adverse event/brush head detachment/risk control/use safety分类
医药卫生引用本文复制引用
左丽,余启浩,钟天华,赖舒坤..冲吸式口护吸痰管不良事件分析及风险控制建议[J].中国药业,2026,35(10):23-26,4.基金项目
广东省药品监督管理局科技创新项目[2024TDB47]. （）
