一次性心电电极致皮肤过敏的分析及思考_陆逸雁.pdf

中国药物警戒第11 卷第11 期 2014 年11 月 November, 2014, Vol.11, No.11 中图分类号：R197.39 文献标识码：A 文章编号：1672- 8629 （2014）11- 0687- 06 一次性心电电极致皮肤过敏的分析与思考 * 陆逸雁 崔文波 （上海市食品药品监督管理局宝山分局，上海200439） 摘要：目的依据风险管理原理提出一次性心电电极不良事件风险的防控措施，为确保一次性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。方法根据宝山区不良反应监测中心调查处理 10例一次性心电电极致皮肤过敏不良事件，结合国内临床研究文献、国外不良事件报道以及美国MAUDE 数据库不 良事件报告，从医疗器械不良事件的定义出发分析一次性心电电极致皮肤过敏的风险因素。结果一次性心电电极不 良事件的风险因素包含了患者源性、器械源性客观风险，以及医疗源性和产品质量可排除风险。 应采取使用前预 结论 防、使用中控制、使用后及时处置的防控措施降低一次性心电电极引起皮肤过敏不良事件的发生率及其损害程度。 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 关键词： Analysis and Discussion on Skin Allergy Caused by Disposable Electrocardiogram Electrode LU Yi-yan CUI Wen-bo* (Baoshan Branch of Shanghai Municipal Food and Drug Administration Shanghai 200439, China) 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 patients 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 adve