中国药物警戒 ›› 2016, Vol. 13 ›› Issue (8): 503-504.

• 安全性评价与合理用药 • 上一篇    下一篇

呼吸机可疑不良事件监测与风险分析

郑立佳, 赵燕*, 董放   

  1. 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2016-09-14 修回日期:2016-09-14 出版日期:2016-08-20 发布日期:2016-09-14
  • 通讯作者: 赵燕,女,硕士,医疗器械不良事件监测。

Medical Device Adverse Events Monitoring and Risk Analysis on Ventilators

ZHENG Li-jia, ZHAO Yan*, DONG Fang   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2016-09-14 Revised:2016-09-14 Online:2016-08-20 Published:2016-09-14

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摘要： 目的 加强对呼吸机产品的监管,为确保呼吸机的安全正确使用提供参考。方法 通过介绍呼吸机的分类、临床使用现状、常见可疑医疗器械不良事件及原因分析,从设计因素、使用因素、患者自身因素几个方面分析了呼吸机常见风险因素,并提出初步风险控制建议。结果 产品设计不合理以及使用不当是呼吸机常见风险因素。结论 为控制呼吸机风险,生产企业应改进产品设计,使用人员应加强培训,熟悉操作方法 。

关键词: 呼吸机, 医疗器械不良事件监测, 风险因素, 分析

Abstract: Objective To strengthen the monitoring of ventilators, and ensure the correct and safe use of the products. Methods By introducing the classification,common use, suspected medical device adverse event (MDE) and analyzed of the MDE causes of ventilators, the risk factors of ventilators were anlyzed. The analysis of the risk factors was based on three aspects, including design factors, use factors and patients factors. Some advices to the risk control were suggested. Results The unreasonable design of products and improper use were the common risks about ventilators. Conclusion Manufacturers need to improve the product design, operators need to improve training to control the risks of ventilators.

Key words: ventilator, medical device adverse events monitoring, risk factor, analysis

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