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杨 飞,刘 斌,孙 凤,陶庆梅,徐荣彬,杨 俊,翟 伟,钟 蕾,刘东红.中频电疗仪使用不良事件发生率及相关因素[J].中国康复医学杂志,2017,(9):1006~1011
中频电疗仪使用不良事件发生率及相关因素    点此下载全文
杨 飞  刘 斌  孙 凤  陶庆梅  徐荣彬  杨 俊  翟 伟  钟 蕾  刘东红
北京市药品不良反应监测中心,北京,100054
基金项目:北京市科学技术委员会2013年第一批绿色通道项目(Z131100005613032)
DOI:
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摘要:
      摘要 目的:调查中频电疗仪临床使用过程中不良事件发生情况及其影响因素。 方法:对北京市8家医疗机构63台中频电疗仪进行为期2个月的医疗器械不良事件横断面调查,同时收集设备情况、维护情况、患者特征、操作情况、设备运行情况等相关因素,用logistic 回归模型进行单因素分析和多因素分析。 结果:收集调查表3075人次,其中出现中频电疗仪医疗器械不良事件55人次,百分比为1.8%。按损坏或无法使用来进行电极板更换,相比按使用时间更换电极板的风险更高OR=7.383,95%CI:1.661—32.819,P=0.009;对于导电橡胶电极板来说,电极板下不使用衬垫对比使用来讲,风险增加3.966倍, 95%CI:1.707—9.215,P=0.001;不配合药物治疗更安全,OR=0.307, 95%CI:0.148—0.636,P=0.001。 结论:设备情况、维护情况、患者特征、操作情况、设备运行情况等是中频电疗仪医疗器械不良事件发生主要影响因素,提出风险控制建议,提高中频电疗仪使用安全性,保障患者治疗安全。
关键词:中频电疗仪  医疗不良事件  临床使用安全性
Incidence and related factors of administration events in intermediate frequency electrical therapy    Download Fulltext
Beijing Center for ADR Monitoring, Beijing, 100054
Fund Project:
Abstract:
      Abstract Objective: To investigate the incidence and related factors of medical device administration events (MDAE) with intermediate frequency electrical stimulator's. Method: The medical device administration events’ prevalence survey of 63 intermediate frequency electrical stimulation in 8 hospitals in Beijing was conducted in two month,. Device state, maintenance situation, patients’ physical characteristics, clinic operation situation and running state were recorded, then the logistic regression models were used for single factor and multifactor analysis. Result: In the collected 3075 records, 55 cases of MDAE happened, the percentage was 1.8%. Replacing the electrodes based on damage or unusable was more dangerous than those based on using time, OR=7.383, 95%CI:1.661—32.819,P=0.009;.Non-using moist mat under the electrodes was 3.966 times more dangerous than those using ones, 95%CI: 1.707—9.215,P=0.001. Using the electrodes without liquid medication was safer, OR=0.307, 95%CI:0.148—0.636,P=0.001. Conclusion: Related factors of intermediate frequency electrical stimulator’s administration events (MDAE) were found, and risk control suggestions were proposed in this work. These will improve the clinic use security, and guarantee the patients' life safety in intermediate frequency electrical therapy.
Keywords:intermediate frequency electrical stimulator  medical device administration events  clinic use security
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