• Journal of the Korean Institute of Gas
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• v.13 no.1
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• pp.52-60
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• 2009

This study reflects the concept of risk-based design to present a systematic design means and a method to adjust regulations and standards towards a more reliable direction within the current law. In order to enhance the early design concentration and level in the part of safety design, a new Advanced Safety Analysis Table (ASAT) was developed to provide information on the systematized safety design element from the early design phase. Furthermore, a guideline was put forth about the selection of a safety device according to process trouble, on the basis of the ASAT. To apply the proposed ASAT and the selection method of a safety device according to process troubles, the ASAT was executed for the PGC (Process Gas Compressor) of the NCC (Naphtha Cracking Center), and the result of selecting the safety device was analyzed according to process trouble.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Journal of the Korean Society of Safety
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• v.32 no.1
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• pp.121-127
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• 2017

Recently, many patients in a hospital are threatened life by fire disaster. Because many patients like vulnerable people have more evacuation problem than ordinary person. So a patient who can escape by oneself with walking assistance device like crutches or wheelchair and another patient who can't escape by oneself are should be supported safety technologies and service. Earlier research of 'hospital evacuation' led by actual experiments or computer evacuation simulation. Actual experiment is effective to gain credibility of result but it is difficult for patients to experiment repeatedly and it requires consideration for spatial problem and economic problems. Although computer evacuation simulation have been used to solve these problems, almost have concluded only results based on velocity without evacuation device. In this study, evacuation results with support device application or not are analysed used by computer evacuation simulation based on MAS(Multi Agent System). As a result, it is drawn through proof of efficiency of evacuation device in the vertical space like stairs that can improve the evacuation plan for vulnerable people in the hospital.

• Journal of Biomedical Engineering Research
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• v.36 no.5
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• pp.162-168
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• 2015

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.9 no.6
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• pp.135-139
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• 2009

In order to cope with safety issues regarding fisher vessels, a device is required with the real-time monitoring for the safety and risk factors for a capability of informing and alerting function. In embedded modules, there is a trouble that we should design device drivers and application programs for usage of the multi-function sensors in order to detect risk factors. In this paper, we designed hardware circuit and implemented control program of the sensor part using PIC18F, in order to control and process the input and output data of multi-function sensors without device drivers and application programs. We confirmed the operation of multi-function sensor module to generate output data according to sensor operation.

• Journal of Industrial Convergence
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• v.17 no.4
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• pp.125-129
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• 2019

With the growing number of people using bicycle, the number of bicycle accidents also has been increasing. It is said that bicycle accident can be reduced up to 11%~44% when riding a bicycle if LED light is used. The headlight of the bicycle makes exposure effect to the opposite side of bike rider while taillight makes exposure effect to the rear bike rider for improving safety. Bicycle safety device capable of displaying a change of direction by LED is implemented in this study in response to control button signal. This signal makes LED light which is installed in pedal and wheel of bicycle as a module type emitting or flickering during the fixed hour. Bicycle auxiliary device in pedal which is able to improve safety using LED when bikers are riding a bike at night is developed in this study. Bicycle safety device applying wireless communication technology will be expected alternative technology in the future to solve a social problem such as energy, environment, and safety.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.11 no.4
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• pp.287-297
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• 2017

This exploratory study aimed to explore the perception (knowledge and attitude) and behaviors of medical personnel regarding medical device safety and to identify the differences in results linked with the type of their task. A questionnaire was administered to medical personnel working at a tertiary care hospital with 900 beds in Incheon, Korea, and 220 completed questionnaires were used for analysis. The results revealed that the majority of the medical personnel perceived the potential risk involved in different types of medical devices they use and stated that they need training programs for safe use of medical devices. Concerning the perception regarding medical devices across different positions within the hospital, it was found that the residents had a low awareness about safety issues, although the medical services they handled involve high risks, thereby calling for safety training. Further nationwide studies are needed to improve the quality and validity of data and eventually to provide important information required by policy makers and academicians to manage medical device safety.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• Safety and Health at Work
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• v.8 no.1
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• pp.59-66
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• 2017

Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.