婴儿培养箱产品不良事件探讨

      Study on Adverse Events of Infant Incubator Products

      • 摘要: 目的 探讨和研究浙江省范围内出现的国家三类医疗器械产品婴儿培养箱的临床使用产生不良事件的风险。方法 运用半定量矩阵分析法将浙江省内从2018年8月至2019年8月期间发生的与婴儿培养箱产品相关的不良事件表现进行风险分析。结果 通过对213例婴儿培养箱产品不良事件的风险分析,评估该产品在实际临床应用中的风险点及程度。结论 通过评价结果对生产企业、医疗机构提出相关建议,降低产品使用风险防止该产品使用过程中严重不良事件的重复发生和蔓延。

         

        Abstract: Objective To investigate the risk of adverse events in the clinical use of infant incubators of three kinds of national medical devices in Zhejiang Province. Methods Semi-quantitative matrix analysis was used to analyze the risk of adverse events related to incubator products in Zhejiang province from August 2018 to August 2019. Results Through the risk analysis of 213 cases of adverse events of infant incubator product, the risk point and degree of the product in practical clinical application were evaluated. Conclusion Through the evaluation results of the production enterprises, medical institutions put forward relevant recommendations to reduce the risk of product use to prevent the recurrence of serious adverse events in the use of the product and spread.

         

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