Abstract：Objective To provide references for further research by analyzing the current research status and hotspots in the field of
adverse events of medical devices in China. Methods Searched all literatures related to adverse events of medical device in the China
national knowledge internet (CNKI) from January 1, 1915 to October 28, 2020. By using the analysis and retrieval function of CNKI,
combined with the visual analysis function of CiteSpace 5.1.R6 SE, this paper analyzed the research situation in this field from the
aspects of the number of articles, authors, institutions, and keywords. At the same time, the keyword knowledge map was drawn, the
research hotspots and development process of this field were further analyzed through cluster analysis and sudden detection. Results
A total of 951 articles were included. The analysis results showed that the overall trend of the study was stable. Zhang Sumin’s team
and Zhao Yan’s team from national center for adverse drug reaction monitoring center, Yin Jianbing’s team from Zhejiang center
for medical device adverse event monitoring and safety research, Zhai Wei’s team from Beijing adverse drug reaction monitoring
center, Huang Lin’s team from Shandong adverse drug reaction monitoring center, and Qu Tingting’s team from Dalian adverse drug
reaction monitoring center played an important role in this field of research. Research hotspots included adverse event monitoring
of orthopedic implants and other medical devices, the role of health care workers in adverse event monitoring of medical devices,
the prevention and management of adverse event risk of medical devices, reports of adverse events during clinical trials of medical
devices, risk control of implantable medical devices (intrauterine device, Urinary catheters, etc.) adverse events, safety and quality
control of medical consumables, data analysis of adverse event reports of medical devices after listing, standardized management of
medical device, research on recycling management of sterile medical devices, monitoring mode of adverse events of medical devices
in prefecture-level monitoring institution. Conclusion The research trend in this field is stable, and the research team is mainly based
on monitoring institutions, focusing on the work norms of medical device adverse events and the risk points of a few typical cases.
魏芬芳，吴建茹，吴文宇. 应用CiteSpace对医疗器械不良事件研究文献的可视化分析[J]. 中国医疗设备, 2021, 36(12): 122-126.
WEI Fenfang, WU Jianru, WU Wenyu. Visual Analysis of Research Literature About Adverse Events of
Medical Devices by Using CiteSpace. China Medical Devices, 2021, 36(12): 122-126.
