中频电疗仪使用不良事件发生率及相关因素

发布时间：2018-06-24 05:03

本文选题：中频电疗仪 + 医疗不良事件　；参考：《中国康复医学杂志》2017年09期

【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。
[Abstract]:Objective: to investigate the incidence and influencing factors of adverse events in the course of clinical use of medium frequency electrotherapy instrument. Methods: a 2-month cross-sectional survey of 63 media-frequency electrotherapy devices in 8 medical institutions in Beijing was carried out, and the equipment, maintenance, patient characteristics and operation were collected at the same time. The single factor analysis and multi-factor analysis are carried out by logistic regression model. Results: 3075 questionnaires were collected, among which 55 cases (1.8%) of medical equipment adverse events occurred with medium frequency electrotherapy instrument. The risk of replacing the electrode plate by damage or unavailability is higher than the risk of replacing the electrode board by the time it is in use, and the risk of replacing the electrode board is higher than that of the replacement electrode board by the time it is used, and there is a higher risk of replacing the electrode board by 7.383C95: 1.661-32.819P0. 009; for the conductive rubber electrode board, no gasket is used under the electrode plate. Risk increases by 3.966 times and 95% CI: 1.707-9.215m P0. 001. it is safer not to cooperate with drug therapy in 0.307 and 95CI: 0.148-0.636P0. 001. Conclusion: the equipment condition, the maintenance condition, the patient characteristic, the operation condition, the equipment operation condition are the main influencing factors of the medical equipment adverse events of the medium frequency electrotherapy instrument, puts forward the risk control suggestion, improves the use safety of the medium frequency electric therapy instrument. To ensure the safety of treatment.
【作者单位】：北京市药品不良反应监测中心;北京大学医学部公共卫生学院;北京肿瘤医院;北京大学儿童青少年卫生研究所;
【基金】：北京市科学技术委员会2013年第一批绿色通道项目(Z131100005613032)
【分类号】：R197.39

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