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一次性使用心电电极在临床动态心电图监测中发挥重要作用,但易引起皮肤过敏不良事件。本文结合宝山区不良反应监测中心调查处理的10例一次性使用心电电极致皮肤过敏不良事件,从患者源性、器械源性、医疗源性和产品质量四个方面浅析一次性心电电极致皮肤过敏的风险因素。结合风险管理原理提出此类不良事件风险的防控措施,为确保一次性使用心电电极安全有效使用提供参考,为提高医疗器械不良事件监测和风险管理水平提供参考。
One-time use of ECG electrodes in clinical monitoring of Holter monitoring plays an important role, but can easily lead to skin allergy adverse events. In this paper, 10 cases of skin allergy-induced adverse events caused by one-time use of ECG electrodes were investigated in Baoshan District Adverse Reaction Monitoring Center. One-off ECGs were analyzed from four aspects: patient source, equipment source, medical source and product quality Extreme skin allergy risk factors. Combined with the risk management principle, the prevention and control measures of such adverse events risks are put forward to provide a reference for ensuring the safe and effective use of ECG electrodes in one-time use and provide a reference for improving the monitoring and risk management of medical device adverse events.