ObjectiveTo analyze the current situation and international research focuses on the study of medical device risk management. MethodsTo 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. ResultsA total of 7 073 published studies were retrieved, basically suggesting a gradually increasing trend of the number of published papers. The top 3 numbers of first authors' papers referred to three countries: the United States, Britain and Germany, while China ranked twelfth. The 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. Thirty-three authors published no less than 5 papers, with the maximum of 18 articles. Totally, there were 124 highfrequency MeSHs. The high-frequency MeSHs were classified 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 defibrillators and other life support device, surgical repair surgical flaps 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. ConclusionThe analysis on international literature on medical device risk management 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, artificial 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 effective, quality improvement systems for clinical diagnosis and treatment.