After signs of risk have been happened in risk management of medical equipment at present, reports are taken step by step. So there is a report not timely, incomplete information, it is difficult to monitor, and many other problems. With the improvement of risk management requirements; the development of the information technology s apply, and increasing sources of information used for risk early warning analysis. This paper analyzes the requirement of risk management, and proposes a total solution of enterprise risk early warning based on EAI. It will make managers accurately and fully grasp the risks, find risk signs timely, speed up the response to risk.
Materials Management, Hospital ; Risk Management

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.
Accreditation ; Risk Management

Globally, airlines are dedicated to achieving higher standards of Flight Safety. They have therefore developed and applied programs such as CRM, LOFT, Risk Management and Threat and Error Management. Despite these efforts, Commercial aircraft accidents continue to occur. Accident statistics over the last 40 years show that mechanical or maintenance related accidents comprise only 15% of the total, and have been decreasing. Accidents attributable to flight crew, however, are about 65% of the total, and show little trend towards reduction (Boeing, 2003). So there is much continuing effort to reduce these kinds of accidents. Additionally, many researchers world-wide are developing and applying programs which are focused on Human Factors. This study analyzes both the factors affecting flight crew and the results obtained from research conducted in Korea.
Aircraft ; Humans ; Korea ; Risk Management

Based on the research of risk assessment of medical equipment safety and operation to formulate evaluation criteria and methods of how to use the practical management work. Objective to evaluate the practical method is to use and the risk of adverse events of medical equipment in operation risk in order to find the risk, control risk, ensure safety in time, so that Improve the level of risk management of medical equipment.
Equipment Safety ; Humans ; Risk Assessment ; Risk Management

A number of absurdities surrounding the humidifier disinfectant (HD) incident may have occurred because 1) a judicial system operates on the underlying false assumption that the involved parties are equals in knowledge, information and resource mobilization capabilities, regardless of respective real status as company or individual; 2) there is a lack of a system that mandates a company to prevent and actively manage possible catastrophes; 3) the regulatory scheme makes companies believe that as long as they are complying with the existing regulations, they have satisfied all of their responsibilities. I believe that this issue is an opportunity to bring about changes in the judicial redress system, the system of internal management of manufacturers, and the regulatory system of the government. The following regulation amendments are needed to move towards the changes stated above. First, legislation relating to victim relief that is applicable to the HD incident must be established. Second, a risk management system must be formed within the manufacturing company and to this end an institutional environment for the system must be established within regulatory framework. Furthermore, legislation must be passed that could punish companies themselves that have caused severe damage to individuals because they had failed to take necessary actions to avoid foreseeable harm. Finally, the framework of regulation must be changed so that the company, who has the necessary information regarding the product and the component chemicals used in the product, must self-directed experiment and assessment of the safety of their own products.
Humidifiers* ; Risk Management ; Social Control, Formal

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.
China ; Equipment and Supplies ; Registries ; Risk Management

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
Needles ; Endoscopy ; Injections ; Risk Management ; Industry

Introduction: Accidents are unpredictable and sometimes unavoidable. Businesses such as shopping complexes need to follow safety protocols to ensure that nobody is hurt. The shopping complex should have preventive measures and an accident management team to offer efficient and timely treatment for these accident victims. Objective: This paper aims to identify problems experienced by the accident management team in dealing with accidents in a shopping complex. The report will also propose and implement solutions to all issues identified. Methods: Two action research cycles were conducted for this paper, with the results of the first action research flowing into the second action research cycle. Reeves et al.’s interprofessional teamwork framework addressed concerns related to teamwork. The data used in this action research came from journal entries, informal and formal one-on-one discussions, and discussions with each department. Results: The workflow for the current post-accident management activities was evaluated. The problems identified were grouped into 5: roles and responsibilities, procedures, knowledge transfer, logistics, and skills. The issues concerning the roles and responsibilities of each team member were addressed by realigning these with their current skills, training, and job description. The remaining and new problems were addressed by developing an accident management policy. Inclusions in the policy are protocols on transporting patients, communication and transportation procedures, letter of authorization (LOA) approval procedures, post-accident evaluation procedures, pre-accident recommendations, policy revision procedures to address organizational changes, changes in the job description or government regulatory mandates, and the evaluation of current skills in case training is needed. Conclusion Accident management requires a coordinated effort amongst all the team members, with members from different social and health specialties. Using Reeves et al.’s interprofessional teamwork framework, the team identified the problems and implemented solutions by realigning the roles and responsibilities of each team member and implementing an accident management policy that can improve preventive measures and improve post-accident responses.
policy development ; accountability ; action research ; risk management

The "Act on Overseas Medical Expansion and Foreign Patient Attraction Support"(legislation no. 13599), due to be enacted by the National Assembly during the general meeting on June 23, 2016, will give institutionalized support and fully recognize the efforts for medical tourism-that is, the overseas expansion of medicine and ingress of foreign patients. However, before jumping into medical tourism, the failures of previous ventures in this field must be analyzed. The absence of specific goals and strategies, insufficient planning and analysis of feasibility, the lack of international experience, and glocalization and marketing failures of previous projects are all areas in which improvement is advised. Further, overseas medical expansion is only possible when various considerations are examined, such as the influence on the domestic medical market, as well as plans for securing the management capacity to ensure economic feasibility and risk management of medical institutions.
Humans ; Marketing ; Medical Tourism ; Risk Management

Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management.
Equipment and Supplies ; standards ; Industry ; standards ; Risk Management