呼吸机可疑不良事件监测与风险分析  

Medical Device Adverse Events Monitoring and Risk Analysis on Ventilators

作　　者：郑立佳[1] 赵燕[1] 董放[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2016年第8期503-504,共2页Chinese Journal of Pharmacovigilance

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。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.

关 键 词：呼吸机 医疗器械不良事件监测 风险因素 分析 

分 类 号：R994.11[医药卫生—毒理学]