关键词: 一次性心电电极, 皮肤过敏, 医疗器械不良事件, 风险因素及分析, 风险防控

Abstract: Objective Combined by the risk management principle, some advices are given to ensure safe and effective clinical use of disposable ECG electrode and also in order to improve level of medical device adverse event monitoring and its risk management. Methods Based on the investigation of 10 cases of skin allergic damage caused by disposable ECG electrode, combined by both foreign and domestic clinical researches as well as such MDAE recorded in FDA MAUDE database, brief risk factor analysis was carried out from four risk aspects according to MDAE legal definition. Results Risk factors related to skin allergic damage caused by disposable ECG electrode include objective factors such as patient's own factor and product intrinsic property factor, as well as erasable factors such as medical factor and product quality factor. Conclusion A full time control involving preventive measurement, process control and timely disposal should be taken to reduce the incidence and extent of damage caused by disposable ECG adverse event.