Analysis on medical device recall from 2010 to 2018 in China
ZHANG Huan1 HONG Yuan2 HE Yuqing2 ZHANG Lei3 CHEN Qi4 YAO Wen5 LIU Liping2
1.Department of Parmacy, Kangda College of Nanjing Medical University, Jiangsu Province, Lianyungang 222000, China;
2.Department of Clinical Pharmacy, School of Pharmacy, Nanjing Medical University, Jiangsu Province, Nanjing 211166, China;
3.Jiangsu Hengrui Pharmaceutical Co., Ltd, Jiangsu Province, Wuxi 214000, China;
4.Department of Finance, Sanjiang University, Jiangsu Province, Nanjing 210012, China;
5.Department of Humanities and Management, Kangda College of Nanjing Medical University, Jiangsu Province, Lianyungang 222000, China
Abstract：Objective To explore the status quo of medical device recall in China and to make recommendations for reference. Methods All information were collected in “Medical Device Recall” section of the official websites of China Food and Drug Administration (CFDA) and National Medical Products Administration (NMPA) from May 2010 to December 2018. Excel method was used for classification analysis in terms of number of recalls, reasons, levels, methods, equipment classification, country of origin, and manufacturing enterprises. Results The total number of effective medical device recalls was 1533 cases, all of which were active recalls, including 1251 cases of imported instruments (81.60%) and 282 cases of domestic instruments (18.40%). The main recall reasons were design defects in 349 cases (22.77%) and manufacturing defects in 752 cases (49.05%). 48 cases (3.13%) were recalled with first level, 379 cases (24.72%) with second level, while 740 cases (48.27%) with third level, and 366 cases (23.87%) with un-indicated recall level. The number of Clinical analytical instruments recalls was 403 cases (26.29%), which was the largest number in category of devices recalls. 18 countries were involved in the recall process, while the top 3 were USA, China and Germany. Conclusion The recall regulation has achieved remarkable results, however, the system still needs to be standardized to improve the scientific and efficient supervision system.
张焕1 洪源2 何宇卿2 张雷3 陈其4 姚雯5 刘利萍2. 2010～2018年我国医疗器械召回情况分析[J]. 中国医药导报, 2020, 17(2): 48-51.
ZHANG Huan1 HONG Yuan2 HE Yuqing2 ZHANG Lei3 CHEN Qi4 YAO Wen5 LIU Liping2. Analysis on medical device recall from 2010 to 2018 in China. 中国医药导报, 2020, 17(2): 48-51.
2020, Vol. 17 
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