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.
Objective By reviewing and analyzing the experiences and lessons of American hurricane risk management, this study aims to explore the possible application of constructing the system for medical risk management in China. Methods We searched the EI database (1969 to 2005), OVID database (1966 to 2005), Superstar electronic library and some websites such as Federal Emergency Management Agency (FEMA), National Oceanic and Atmospheric Administration (NOAA), and Centre for Disease Control and Prevention (CDC). The retrieved articles were screened independently by two reviewers according to the inclusion and exclusion criteria. The included articles were classified and the quality was ranked. Results Total of 227 articles and 1 book met the eligibility criteria. The articles related to risk prediction occupy 73.13%. The American hurricane database can be traced back to 1886. Disaster Relief Act was promulgated in 1950, and there were various types of policies for disaster risk management. The FEMA, set up in 1979, played a key role in disaster risk management. The precaution was announced according to the different levels of hurricane risk, and the forecasts were mainly made by NOAA. The American government and some non-governmental organizations were involved in hurricane emergent responses concerning both physical and mental health of the public. In addition, there were many methods to evaluate and predict hurricane risk. The main lessons from hurricane Katrina risk management lay inunderestimation of the risk and political discrimination. Conclusion There are both distinctive advantages and disadvantages in the present status of American hurricane risk management. As the monitoring and precaution system of medical risk management in China are still in an initial stage, we can learn the experience and lessons from American hurricane risk management to construct and run our system of medical risk management better.
Objective To provide some theoretical reference and practical guidance for the medical risk management and early warning of private medical institutions, and to improve the service level and social reputation of private medical institutions. Methods China National Knowledge Infrastructure, Wanfang, VIP, and Web of Science database were searched for literature on medical risk management of private medical institutions published from the dates of establishment of databases to July 31, 2023. CiteSpace software was used for analysis. The aspects of literature number, literature source, author-institution cooperation, keyword co-occurrence, keyword clustering and burst were analyzed. Results A total of 2 635 literature were detected. Among them, there were 1446 articles in Chinese and 1189 articles in English. Although domestic research started late, it covered a wide range of disciplines and research fields. The Chinese literature showed a growth trend in the medium term, but the growth trend was slower than that of foreign literature. At the same time, the cooperation network of foreign authors and institutions was closer than that of domestic ones, and the overall development was relatively insufficient. There were differences between domestic and foreign research hotspots in terms of disciplines and research contents. Conclusions It is necessary to strengthen the theoretical and practical research on medical risk management of private medical institutions, and accelerate the construction of risk management and early warning models suitable for the characteristics of private medical institutions in China. In the future, the emerging research fields such as moral hazard, emergency and internal control need to be deepened and expanded.
Objective To provide evidence for establishing a medical risk precaution and monitoring system in China by evidence-based evaluation of the medical risk monitoring and precaution system in Canada, including the current situation and corresponding prevention measures. Method According to the unified search strategy made by our research group, we searched relevant databases and official or government websites. We included articles about medical risk management, medical error and patient safety in Canada. The included articles were classified and the quality was ranked. Results A total of 15 articles were included, among which 10 were official documents (about 2/3) and 5 described research methods (about 1/3), mainly involving medical risk management or evaluation, medical error and patient safety. In 2002, Canada established its National Steering Committee on Patient Safety (NSCPS) and proposed the suggestions to integrate health care resources accross the country, build a patient safety system, and established the Canada Patient Safety Institution (CPSI) to improve patient safety. Canada revised the patient safety management system, collected and issued related information, strengthened doctor-patient communication, developed continuous education for medical staff, practiced the best medical behavior and model and improved lawsuit procedures. These activities have achieved great progress in practice. Conclusions What have been done in Canada will provide a guide for us to establish scientific patient safety system and promote public awareness of patient safety.
Objective Interpretation of the growing body of global literature on health care risk is compromised by a lack of common understanding and language. This series of articles aims to comprehensively compare laws and regulations, institutional management, and administration of incidence reporting systems on medical risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods?We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents. Results?A total of 146 documents were included in this study, including 2 laws (1.4%), 17 policy documents (11.6%), 41 guidance documents (28.1%), 37 reviews (25.3%), and 49 documents giving general information (33.6%). The United States government implemented one law and one rule of patient safety management, while the United Kingdom and Australia each issued professional guidances on patient safety improvement. The four countries implemented patient safety management policy on four different levels: national, state/province/district, hospital, and non-governmental organization. Conclusion?The four countries and one district adopted four levels of patient safety management, and the administration modes can be divided into an “NGO-led mode” represented by the United States and Canada and a “government-led mode” represented by the United Kingdom, Australia, and Taiwan.
This article introduced the structure and features of the medical safety and quality management system of New South Wales (NSW) of Australia. The system was funded by government with overall design, multi-sectors involvement, and explicit roles of government, hospitals, and independent third parties. The system also developed national and state-wide regulations, policies, standards and their certification. The NSW Health Incident Information Management System (IIMS), the guidelines and interventional programs were also established to decrease the medical risk and ensure the healthcare quality. This system will be used for reference to the national medical risk and quality management system of China.
Objective To evaluate evidence from American medical risk monitoring and precaution system (AMRMPS) which may affect the construction of Chinese medical risk monitoring and precaution system (CMRMPS). Methods We searched relevant databases and Internet resources to identify literature on AMRMPS, medical errors, and patient safety. We used the quality evaluation system for medical risk management literature to extract and evaluate data. Results In 1999, a report from the Institute of Medicine (IOM) not only showed the severity and cause of medical errors in America but also gave the solution of it. In 2000, the Quality Interagency Coordination Task Force (QuIC) was appointed to assess the IOM report and take specific steps to improve AMRMPS. After 5 years, a well-developed medical risk management system was established with the improvement in the public awareness of medical errors, patient safety, performance criteria of medical safety, information technology and error reporting system. There was still some weakness of this system in risk precaution and prevention. Conclusion The experience from AMRMPS can be used to establish the CMRMPS. Firstly, we should disseminate and strengthen the awareness of medical risk and patient safety in public. Secondly, we should establish hospital audit system which includes auditing of medical staff and course of medical risk in continuing and academic education. Thirdly, we should develop regulations and guidelines on health care, medical purchase and drug supply which will benefit in management of regular work. Fourthly, we should develop computer information system for hospital which will regulate the management without the disturbance from human. Lastly, we should emphasize outcome evaluations and strive for perfection during the process.