【摘要】 目的分析国际医疗器械风险管理研究的现状及热点领域。方法计算机检索2002~2011年PubMed收录医疗器械风险管理相关文献,提取主题词等信息,运用文献计量学方法、书目信息共现分析系统(BICOMB)、图形聚类工具包(gCluto)进行文献计量分析,对高频主题词词篇矩阵进行聚类可视化分析。结果共检出文献7 073篇,发表论文数呈逐年上升趋势;发文量(第一作者发表论文数量)居前3位的国家分别是美国、英国和德国,中国位列第12位;期刊载文量前3位的国家为美国、英国和荷兰,中国位列第22位;发文量≥50篇的期刊有20种,均为临床医学类期刊;发文量≥5篇的作者有33人,最多为18篇。总共截取高频主题词124个,聚类分析聚为6类,0~4类为心脏瓣膜等假体、冠状血管支架、外周血管支架、植入式除颤器等生命支持设备、外科修复术用皮瓣及最小侵伤外科用腹腔镜等器材的风险报道、风险分析、风险评估及方法学专题研究;5类集中在以防控医疗器械不良反应、医疗失误、职业暴露、设备故障为基础的安全管理、风险控制、组织实施等有关研究。结论国际医疗器械风险管理研究文献发表呈逐年上升的趋势,多数论文刊登在临床医学类期刊上;研究热点聚焦在血管成形术、人工假体置换、整形、微创等外科及危重医学、放射诊断与治疗等领域的风险评估、安全管理、质量改进等方面,以植入性、生命支持、有创性和辐射性医疗器械为主要研究对象;研究特点为医疗器械风险管理与临床诊疗应用的安全有效、质量保障体系紧密结合。更多还原

【Abstract】 Objective To analyze the current situation and international research focuses on the study of medical device risk management. Methods To retrieve medical device risk management literature information cited from 2002 to 2011 in PubMed such as high-frequency MeSH; analyze current situation and research focuses of medical device risk management by using bibliometrics, bibliographic item co-occurrence matrix builder(BICOMB), and graphical clustering toolkit(gCluto) for quantitative analysis, high-frequency MeSH term papers cluster visualization analysis. Results A total of 7 073 published studies were retrieved, basically suggesting a gradually increasing trend of the number of published papers. h e top 3 numbers of i rst authors’ papers referred to three countries: the United States, Britain and Germany, while China ranked twelt h. h e top 3 numbers of journal articles referred to the United States, Britain and Holland, while China ranked twenty-second. Twenty journals published more than 50 papers, and all these journals were clinical journals. h irty-three authors published no less than 5 papers, with the maximum of 18 articles. Totally, there were 124 highfrequency MeSHs. h e high-frequency MeSHs were classii ed into 6 categories by using double cluster analysis: kinds 0 to 4 included risk report, risk analysis, risk assessment and methodology of heart valve prosthesis, coronary stents, peripheral vascular stents, implantable dei brillators and other life support device, surgical repair surgical l aps and minimal invasion surgical device such as laparoscopy; kind 5 focused on safety management, risk control, organization and implementation and other related research based on prevention and control of medical device adverse reaction, medical errors, occupation exposure, and equipment failure. Conclusion h e analysis on international literature on medical device risk manage-ment basically shows a gradually increasing trend; most studies published in the clinical medicine journals; research focus on risk assessment, safety management and quality improvement in the application such as angioplasty, artii cial prosthesis replacement, plastic surgery, minimally invasive surgery and critical care medicine, and radiology diagnosis and treatment; implantable, life-supported invasive and radiological devices as the main research subject; and characteristics include closely combination between medical device risk management and the application of safe and ef ective, quality improvement systems for clinical diagnosis and treatment.更多还原