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 To comprehensively compare the methods and tools for medical risk management and assessment in the United Kingdom, the United States, Canada, Australia and Taiwan region (hereafter shortened as “four countries and one region”), so as to provide evidence and recommendations for medical risk management policy in China. Methods The official websites of the healthcare risk management agencies in these four countries and one region were searched to collect materials concerning healthcare risk management and monitoring, such as laws, regulatory documents, research reports, reviews and evaluation forms, then the descriptive comparative analysis was performed on the methods and tools for risk management. Results a) A total of 146 documents were included in this study, including 2 laws, 17 regulatory documents, 41 guidelines, 37 reviews and 49 documents about general information; b) The United Kingdom applied the integrated risk management; Australia and Taiwan adopted the classical risk management process, including risk identification, risk analysis, risk evaluation and risk control, while the United States and Canada mainly chose the prospective failure mode and effects analysis (FMEA) for clinical risk management; c) The severity of clinical risk was divided into five grades in the United Kingdom and Australia, and six in Taiwan, respectively. The frequency of medical risk was divided into five grades with four grade responses in above two countries and one region; and d) There were almost the same processes and tools about Root Cause Analysis (RCA), but a little difference in the objects of analysis in these four countries and one region. Conclusion?There are three models of risk management with the same assessment tools in these four countries and one region: the prospective risk assessment, the retrospective assessment based on occurred incidents and the integrated risk management. Although the grading of risk is similar, the definition of grading is different in the United Kingdom, Australia and Taiwan. The methods and processes of analyses on the adverse events are almost the same in these four countries and one region.
Objective To analyze the policy and guideline, the institutional management and the operation mechanism of ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods Such databases as PubMed, EMBASE, The Cochrane Library were searched to include the literatures such as the guideline documents and the research reports on ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan; the institutional management and the operation mechanism of the risk management in the above four countries and one area were comprehensively analyzed, and especially the UK model was highly emphasized. Results A total of 31 literatures were included, including 1 guideline, 5 reviews, 2 investigative reports and 23 research documents. The United Kingdom guided the ICU risk management in forms of the standard and the guideline, formulated a clear tool of event classification and corresponding response mechanism. The United States learned from Australia’s experience and established the ICU safety reporting system; both of them regarded ICU as one part of the medical risk management and set up a special management column. Conclusion The ICU risk management with the independent report system in the United Kingdom is brought into the scope of national patient safety management, and is regarded as the relative complete system at present. In Australia and the USA, the national institutions are in charge of setting up the research projects of ICU risk management; the industry associations and the non-governmental organizations lead the risk research; and the experimental units popularize gradually after self-application.
Objective To investigate the regulations and implementation effect for high-risk drugs of the FDA and MHRA on the basis of natalizumab, and to provide references for the risk regulation of the innovative drugs and high-risk drugs of China. Methods We searched MEDLINE, EMBASE.com, the official website of Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the marketing/withdrawal and risk regulation information of natalizumab as well as the relevant information of drug marketing/withdrawal and approval track. Results (1) Natalizumab was initially approved by the FDA through accelerated approval in November, 2004 with the phase three clinical trial still being conducted. But in February 2005, it was withdrawn after 3 patients developed PML. FDA resumed its marketing under a specially restricted distribution program called the Touch Prescribing Program in March, 2006. (2) Natalizumab was marketed in the European Union in April 2006. No cases of PML have been reported in the UK for this drug. (3) To speed the development of drugs that treat serious diseases, the FDA developed 3 distinct and successful approaches to make such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. The proportion of new molecular entity and new biologic approved by fast tract were 45% and 74%, respectively between 2002 and 2009. (4) Drug regulation of MHRA contained: Yellow Card Scheme, Black Triangle products, Download Drug Analysis Prints (DAPs), and Defective Medicines Report Centre (DMRC). Self-reporting and monitoring system were fairly perfect, thus they can fulfill the close monitoring for high-risk drugs under the existing conditions and then realize the risk-minimization. Conclusion (1) The risk-minimization program of FDA for high-risk drugs is effective, and plays a role in the policy support for the researching and marketing of irreplaceable innovative drugs. (2) The risk regulation for high-risk drugs of MHRA is integrated into drug regulation program and enforces hierarchical management, and acquires risk-minimization effect. (3) We should learn from the policy and operational experience for the international new molecular entity and new biologic on the re-evaluation for innovative drugs and high-risk drugs. Combined with drug specific characteristics, evaluation indicators and criteria are developed base on evidence, risk management system and mechanism for innovative drugs are established and improved, and policy and administration security for the safety application of innovative drugs and high-risk drugs are provided.
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 reference for medical risk management by systematically reviewing the hterature on aviation risk management abroad. Methods We searched the SCOPUS database and related websites, and handsearched related journals, for literatures on the history, experience, and models of aviation risk management, and their relationship to medical risk management. Rationale and method of evidence-based science were used to appraise and analyze the included hterature. Results Aviation and medical industry were both with the characteristics of high technology, high risk, and high professional. The aviation risk management system including the unique information reporting system, risk analyzing tools and models covered the whole process of information collecting, analyzing and managing, and with the emphasis on systematical construction. Conclusions Medical risk management in China should base on its own characteristics, taking the following experiences from aviation risk management into account： （1） establishing incident and shght ~fistake reporting system, with management mechanism and legal support. Pilot experiments should be practiced in high-risk department; （2） developing a training model hke Crew Resources Management（ CRM）, emphasizing non-technical skills training; （3） reinforcing staff and environment management for the control of human-origin risk; （4） constructing database for better information collection and analysis, developing and using perspective analyzing tools; （5） assessing the safety culture of medical organization with the tools used by aviation industry, and taking the experience of aviation safety culture construction.
Objective To analyze experiences of medical risk management in the United Kingdom so as to explore the possible application for the construction of a Chinese medical risk monitoring and early warning system. Methods We searched Engineering Information, SCI and SSCI, EMBASE, SCOPUS with 100% MEDLINE, VIP, CNKI, and government or official websites. This search was conducted in Jan. 2006. We included articles about medical risk, patient safety and medical errors in the UK. Languages of articles were limited either in English or in Chinese. Results Eleven articles were included, of which 9 article are evidence of level B (about 80%) and the other 2 are evidence of level C (about 20%). The report of “An Organization with a Memory” revealed the severity of medical errors and adverse events in the UK in 2000, and subsequently Minister Blair announced a five-year reform program for NHS. Within 7 years of reform, NHS budget has been increased from £33 billion to £674 billion,(check numbers-doesn’t sound correct) the National Patient Safety Agency (NPSA) and the New National System for learning from adverse events and near misses have been established, a series of practicable measures aimed at ensuring patient safety, preventing medical risk and improving healthcare quality have been implemented, all of which have effectively resolved many problems that perplexed the government and public, such as patients waiting time, range of NHS service, the availability of medical facility and mortality induced by high-risk diseases. Conclusion There are both advantages and disadvantages in the present status of the UK medical risk management. Both of them will provide a guide to prevent medical risk, improve healthcare quality and to realize the ultimate goal that everybody could share healthcare sources fairly and safely in our country.
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.
Objective To provide information for the establishment of a medical risk monitoring and precaution system in China, by reviewing and analyzing the current status of medical risk management system and preventative measures in New Zealand, Methods We searched EI (1969-2006), SCI and SSCI (1975-2006), EMBASE (1966-2006), SCOPUS (included 100% MEDLINE) (1960-2006), VIP (1989-2006), CNKI (1979-2006) and relevant official and governmental websites. This search was conducted in January 2006 and articles about medical risk management and prevention were collected. Results We included 10 articles involving medical adverse events, patient safety and medical litigation. New Zealand took many measures in order to prevent medical error and improve medical quality, including strengthening medical practice standards, doctor-patient communication, safety awareness and promoting informationization of hospitals. New Zealand also revised “The Health Practitioners Competence Assurance Act” and improved medical litigation to form an appropriate law environment. Conclusions New Zealand has taken many measures and established a medical risk management system to prevent medical risk. Some issues of particular relevance to China include building corresponding medical litigation and relevant laws and regulations.
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.