冲吸式口护吸痰管不良事件分析及风险控制建议OA
Analysis of Adverse Events and Risk Control Recommendations of Irrigation-Suction Oral Care Suction Catheters
目的 为临床安全使用冲吸式口护吸痰管提供参考.方法 收集国家医疗器械不良事件监测信息系统 2018 年 1 月 1 日至2024 年 12 月 31 日收到的广东省内上报的冲吸式口护吸痰管的医疗器械不良事件(MDAE)报告.采用描述性统计法分析纳入的不良事件报告,包括患者预期治疗用途、使用科室、器械故障原因、伤害表现等,同时对高风险不良事件进行文献分析,并提出风险控制建议.结果 共纳入涉及冲吸式口护吸痰管的 MDAE 报告 58 例.按患者预期治疗用途,包括用于口腔护理 38 例(65.52%),呼吸道取痰20 例(34.48%).明确记录使用科室者 45 例(77.59%),以重症监护室为主(27 例,46.55%).器械故障原因以刷头脱落为主(42 例,72.41%).伤害表现以无明显伤害为主(37 例,63.79%),出现的伤害均为刷头脱落所致,主要为误吞误吸(10 例,17.24%)和窒息(8 例,13.79%).刷头脱落原因可归为质量问题/设计缺陷(32 例,76.19%)和患者无意识咬脱(10 例,23.81%).结论 刷头脱落是冲吸式口护吸痰管不良事件的主要风险,患者无意识咬脱为其主要致伤因素.建议临床规范临床操作,生产商从源头优化产品说明书和产品设计,提升产品质量,保障此类医疗器械使用安全.
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.
左丽;余启浩;钟天华;赖舒坤
广东省深圳市药物警戒和风险管理研究院,广东 深圳 518000广东省深圳市药物警戒和风险管理研究院,广东 深圳 518000广东省深圳市药物警戒和风险管理研究院,广东 深圳 518000广东省深圳市药物警戒和风险管理研究院,广东 深圳 518000
医药卫生
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
irrigation-suction oral care suction cathetermedical device adverse eventbrush head detachmentrisk controluse safety
《中国药业》 2026 (10)
23-26,4
广东省药品监督管理局科技创新项目[2024TDB47].
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