基于文献计量的国内医疗器械质量研究分析

The Analysis of Domestic Medical Device Quality Research Based on Bibliometrics

医疗器械质量与医疗质量密切相关。该研究通过综合应用VOSviewer和CiteSpace软件对2008-2023年以医疗器械质量为主题的学术文献进行可视化分析,主要包括发文量、作者、机构和关键词等主题的研究情况,探讨国内医疗器械质量领域的研究热点和发展趋势。通过分析中国知网(CNKI)数据库中文献数据表明,国内医疗器械质量领域文献发表量近年保持在较高水平,但研究人员和机构间的合作需进一步加强。研究热点围绕影响医疗器械质量的各个环节在2017年前后有较大改变,从医疗器械质量的控制和清洗转变为更趋向于精细化管理并达到预期效果,注重管理体系和规范的制定,综合考虑风险管理和经济管理,以及引入人工智能、开展临床试验等方式方法。鉴于医疗器械质量涉及面广,因此在开展研究时将有更多的(学)校-(医)院-企(业)合作,同时在涉及的技术领域趋向智能化和临床试验,管理方面则更精细化。

The quality of medical devices is closely related to the medical quality of patients.In this study,VOSviewer and CiteSpace software were comprehensively applied to visually analyze the academic literature on the topic of medical device quality from 2008 to 2023,including the number of publications,authors,institutions and keywords,and to explore the research hotspots and development trends in the field of medical device quality.The analysis of literature data in CNKI database showed that the number of publications in the field of medical device quality was relatively high in recent years,but cooperation between researchers and institutions needed to be further strengthened.The research hotspots around all aspects affecting the quality of medical devices have changed greatly before and after 2017,shifting from quality controlling and cleaning medical device to more refined management and achieving expected results,focusing on the development of management systems and standards,comprehensively considering risk management and economic management,as well as introducing artificial intelligence,conducting clinical trials and other methods.With the wider coverage of medical device quality,there will be more cooperation between universities,hospitals,and enterprises in conducting research.At the same time,the technology involved will tend towards intelligence and clinical trials,and management will be more refined.