医学装备风险管理文献的计量研究

目的:计量我国近10年的中文期刊医学装备风险管理研究文献,分析医学装备风险管理现状及热点领域。方法:检索万方、中国知网(CNKI)及维普数据库(2003-2012年)及追溯参考文献采集文献,运用文献计量学和文献评阅分析研究医学装备风险管理现状及热点领域。结果:检索出中文期刊文献331篇,刊登在114种期刊,其中中国科技论文与引文数据库(CSTPCD)收录期刊169篇,中国科技期刊要目总览(PKU)收录期刊34篇,中国科学引文数据库(CSCD)收录期刊16篇,Medline收录期刊17篇;发文量≥5篇的作者有8位;综述类文献203篇,研究论著文献128篇,基本呈逐年上升趋势。结论:我国医学装备风险管理研究的热点领域主要集中在对在用医学装备的风险评估、风险控制、安全管理以及监管部门对医疗器械不良事件的分析研究。

Bibliometric study for literatures of medical device risk management

[Abstract] Objective： To investigate the bibliometric parameters in literatures of medical device risk management and safety management on the China journals in Chinese in recent 10 years and analyze current situation and research focuses. Methods： We sampled the literatures from WanFang, CNKI and VIP databases （2003 to 2012） and date mining for the references, analyzed the research hotspot by the bibliometrics and literature review. Results： A total of 331 Chinese papers published in 114 kinds of China journals in Chinese were searched, basically increasing gradually, included 169 papers from CSTPC journals, 34 papers from PKU journals, 16 papers from CSCD journals, andl7 papers from Medline. The first-author who published 5 papers and above has 8 persons, review have 203 papers, the articles have 128 papers. Conclusion： The hotspot in the field of risk management of medical device in China mainly focus on risk assessment, risk control and safety management in applications, and analysis for medical device adverse events by organizations of supervision and administration. [Key words] Risk management; Safety management; Medical device; Bibliometrics