Abstract:Objective Through the statistics of medical device recall in the first half of 2018 and the analysis of it, to explore the trends
in the policies and the status quo of the industry indicated by various statistical results. Methods The collected medical device recall
information was analyzed by means of comparison, weight removal, selection of key information and classification statistics. Results
The results shown that the quantity of medical device recall incidents in 2018 was on the rise, the first-level recall was slightly
increased, and the quality and design issues were still the main reason for the recall, the number of medical equipment recall events
was the most, and the recall consciousness of domestic medical device enterprises was relatively weak. Conclusion Medical device
enterprises should pay attention to the improvement of product quality and service, and domestic medical device manufacturers
should have correct attitude towards recall. Meanwhile, medical institutions should pay attention to the recall information in time to
reduce the risk of using medical devices.
张倩,冯靖祎,吕颖莹,孙静,叶秋萍. 2018年上半年医疗器械召回情况探讨[J]. 中国医疗设备, 2018, 33(12): 151-153.
ZHANG Qian, FENG Jingyi, LV Yingying, SUN Jing, YE Qiuping. Analysis of Medical Device Recall in the First Half of 2018. China Medical Devices, 2018, 33(12): 151-153.