基于文献计量可视化的我国医疗器械风险监控研究

Research on Risk Monitoring and Control of Medical Devices in China Based on Bibliometrics

目的:对我国医疗器械风险监控领域的研究现状、热点与前沿趋势进行分析,促进法规、制度以及行业标准的进一步完善,推动医疗器械行业的可持续健康发展,并为后续研究提供参考。方法:利用Excel 2010、VOSviewer 1.6.16和Citespace 3.8.R6对我国近20年医疗器械风险监控研究领域的852篇文献进行发文量、作者及机构的合作关系、关键词聚类、突现词分析等知识图谱构建及文献特征分析。结果:我国医疗器械风险监控研究起步较晚,但已逐步发展成前景可观的新兴研究领域。核心作者团队和合作研究机构网络初步形成,产学研合作关系仍不紧密,高校和科研院所的参与度不高。基于风险信号识别、风险评价等科学监管方法研究、融合人工智能等先进技术的风险管理工具研发将成为未来该研究领域的新热点。结论:医疗器械风险监控已经成为提升行业技术水平,保障行业可持续发展的重要影响因素,应加大培养具备科学监管理念的风险监控人才,促进相关法规、管理制度以及行业标准的进一步完善。

Objective:To analyze the current situation,hot spots and frontier trends of research in the field of medical device risk monitoring in China,to promote further improvement of regulations,systems and industry standards,to promote the sustainable and healthy development of the medical device industry,and to provide reference for subsequent research.Methods:Using Excel 2010,VOSviewer 1.6.16 and Citespace 3.8.R6,we conducted knowledge graph construction and literature feature analysis on 852 documents in the field of medical device risk monitoring research in China in the past 20 years in terms of the number of articles issued,the partnership of authors and institutions,keyword clustering,emergent word analysis,etc.Results:Medical device risk monitoring research in China started late,but has gradually developed into a promising emerging research field.The core author team and the network of cooperative research institutions are initially formed,and the cooperation relationship between industry,academia and research is still not close,and the participation of universities and research institutes is not high.The research and development of risk management tools based on scientific supervision methods such as risk signal identification and risk assessment,and the integration of advanced technologies such as artificial intelligence will become new hot spots in this research field in the future.Conclusion:Medical device risk monitoring has become an important factor in improving the technical level of the industry and ensuring the sustainable development of the industry.We should increase the training of risk monitoring talents with scientific supervision concepts and promote the further improvement of relevant laws and regulations,management systems and industry standards.