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

This paper analyzes emergency medical devices, and puts forward the types of risk management mode, risk analysis, risk assessment (including the risk score calculation), and risk control points. Emergency medical equipment which has the high risk and is directly related to the patient's life safety, should be taken seriously.
Emergency Medicine ; instrumentation ; Equipment Safety ; Risk Assessment ; Risk Management ; Safety Management ; organization & administration

BACKGROUND: Construction industry is among the most hazardous industries, and needs a comprehensive and simple-to-administer tool to continuously assess and promote its health and safety performance. METHODS: Through the study of various standard systems (mainly Health, Safety, and Environment Management System; Occupational Health and Safety Assessment Series 180001; and British Standard, occupational health and safety management systems-Guide 8800), seven main elements were determined for the desired framework, and then, by reviewing literature, factors affecting these main elements were determined. The relative importance of each element and its related factors was calculated at organizational and project levels. The provided framework was then implemented in three construction companies, and results were compared together. RESULTS: The results of the study show that the relative importance of the main elements and their related factors differ between organizational and project levels: leadership and commitment are the most important elements at the organization level, whereas risk assessment and management are most important at the project level. CONCLUSION: The present study demonstrated that the framework is easy to administer, and by interpreting the results, the main factors leading to the present condition of companies can be determined.
Construction Industry ; Leadership ; Occupational Health* ; Risk Assessment ; Safety Management

Consumer Product Safety ; Food ; Food Safety ; Risk Assessment ; Safety Management ; methods

Safety and effectiveness of medical devices is a focus of people's attention, which is also a central work for the government's administration. Carrying out safety standards of medical devices, implementing the quality system standards and risk management standards are supplemented with each other. The risk management is an indispensable part to the quality management system of medical devices.
Equipment Failure Analysis ; Equipment Safety ; methods ; standards ; Equipment and Supplies ; standards ; Humans ; Product Surveillance, Postmarketing ; methods ; Risk Assessment ; Risk Factors ; Risk Management ; Safety Management

By analysis on the risk management regulations and the situation of medical device after the product on the market, information list of problems and risk analysis process of the production and after-production were described, simultaneously, the suggestions were put forward to risk management after the product on the market, with the aim of providing reference for manufacturers and administrators.
Equipment Safety ; Product Surveillance, Postmarketing ; Risk Management

This study compared the predictive models for the growth kinetics of Staphylococcus aureus in ham rice balls. In addition, a semi-quantitative risk assessment of S. aureus on ham rice balls was conducted using FDA-iRISK 4.0. The rice was rounded with chopped ham, which was mixed with mayonnaise (SHM), soy sauce (SHS), or gochujang (SHG), and was contaminated artificially with approximately 2.5 log CFU·g⁻¹ of S. aureus. The inoculated rice balls were then stored at 7℃, 15℃, and 25℃, and the number of viable S. aureus was counted. The lag phases duration (LPD) and maximum specific growth rate (SGR) were calculated using a Baranyi model as a primary model. The growth parameters were analyzed using the polynomial equation as a function of temperature. The LPD values of S. aureus decreased with increasing temperature in SHS and SHG. On the other hand, those in SHM did not show any trend with increasing temperature. The SGR positively correlated with temperature. Equations for LPD and SGR were developed and validated using R² values, which ranged from 0.9929 to 0.9999. In addition, the total DALYs (disability adjusted life years) per year in the ham rice balls with soy sauce and gochujang was greater than mayonnaise. These results could be used to calculate the expected number of illnesses, and set the hazard management method taking the DALY value for public health into account.
Hand ; Kinetics ; Methods ; Public Health ; Risk Assessment ; Safety Management ; Soy Foods ; Staphylococcus aureus ; Staphylococcus

While the ability to develop nanomaterials and incorporate them into products is advancing rapidly worldwide, understanding of the potential health safety effects of nanomaterials has proceeded at a much slower pace. Since 2008, Korea Food and Drug Administration (KFDA) started an investigation to prepare "Strategic Action Plan" to evaluate safety and nano risk management associated with foods, drugs, medical devices and cosmetics using nano-scale materials. Although there are some studies related to potential risk of nanomaterials, physical-chemical characterization of nanomaterials is not clear yet and these do not offer enough information due to their limitations. Their uncertainties make it impossible to determine whether nanomaterials are actually hazardous to human. According to the above mention, we have some problems to conduct the human exposure risk assessment currently. On the other hand, uncertainty about safety may lead to polarized public debate and to businesses unwillingness for further nanotechnology investigation. Therefore, the criteria and methods to assess possible adverse effects of nanomaterials have been vigorously taken into consideration by many international organizations: the World Health Organization, the Organization for Economic and Commercial Development and the European Commission. The object of this study was to develop risk assessment principles for safety management of future nanoproducts and also to identify areas of research to strengthen risk assessment for nanomaterials. The research roadmaps which were proposed in this study will be helpful to fill up the current gaps in knowledge relevant nano risk assessment.
Commerce ; Cosmetics ; Hand ; Humans ; Korea ; Nanostructures ; Nanotechnology ; Risk Assessment ; Risk Management ; Safety Management ; Uncertainty ; United States Food and Drug Administration ; World Health Organization

OBJECTIVES: This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. METHODS: Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. RESULTS: Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. CONCLUSIONS: We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.
Electronic Health Records* ; Equipment Safety* ; Hospital Information Systems ; Korea ; Patient Safety ; Risk Management ; Safety Management

PURPOSE: This was a descriptive research study to examine the patient safety risk factors and the level of safety management of nurses in emergency service, hospitals and to analyze the relationship between the two factors. METHOD: Data for analysis were collected from 232 nurses in emergency service, hospitals in Busan and Gyeongnam from July 30 to September 7, 2013. Data were analyzed using descriptive statistics, t-test, one-way ANOVA, and Pearson correlation coefficients. RESULTS: Therapeutic agents showed the highest risk level. The prevention of transfusion errors showed the highest performance. As the nurses were working in regional emergency medical centers and received education more than 7 sessions on patient safety, they readily recognized the riskiness of the safety risk factors. In addition, as the nurses were older than 40, married, having more education about safety and understood the incident report registration system well, they performed safety management better. There were significant correlations between perception of the patient safety risk factors and performance for safety management. CONCLUSION: Nurses in emergency service, hospitals should try to improve safety management to reduce the risk factors shown to be higher based on the results and ensure the patient safety.
Busan ; Education ; Emergencies* ; Patient Safety* ; Risk Factors* ; Safety Management*