373例国外医疗器械召回事件分析及启示

Analysis and enlightenment of 373 cases of medical device recalls in foreign countries

介绍了对缺陷医疗器械产品实施召回的必要性,从产品分类、召回原因归类及主要风险产品召回原因等方面分析了2011—2020年美国食品药品监督管理局、英国药物和保健产品管理局、加拿大卫生部、澳大利亚治疗产品管理局官方网站发布的373例与医疗器械自身关联性较大的召回事件。针对目前国内主动召回的现状提出了一些建议,为国内开展上市后医疗器械风险研判和生产企业设计研发同类产品时识别风险因素提供了参考,同时也为医疗器械的临床使用提供了警示。

The necessity of implementing recalls for defective medical device products was introduced,and 373 cases of recalls from 2011 to 2020 released by the official websites of the US Food and Drug Administration,the UK Medicines and Healthcare Products Regulatory Agency,Health Canada and the Australian Therapeutic Goods Administration were analyzed in terms of product classification,categorization of recall reasons and the main risk product recall reasons.Some suggestions were made for the current status of active recalls in China,which provided references for conducting post-market medical device risk studies in China and for identifying risk factors when manufacturers designed and developed similar products,as well as providing a warning for the clinical use of medical devices.