• Journal of the Korean Society of Safety
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• v.33 no.3
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• pp.27-32
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• 2018

Nowadays, to prevent electrical accidents in Korea, inspectors directly performed checking general electrical facilities as a cycle from every one to three years. It is difficult to presuppose an omen because intact conditions of electrical equipments are not kept at the time of inspection. In this paper, in order to ensure effectiveness of an online basis electric inspection, we developed an electrical safety IoT system using LoRa communication technology to enable monitoring mainly electrical safety components such as overcurrent, overvoltage, resistive leakage current, and power. Then we proposed a method for verifying performances of the prosed electrical safety IoT system. Resistive leakage currents are calculated by using difference of phase between voltages and currents. We verified that average errors are 0.97%, which reference goal is ${\pm}5%$ for a device, through reliability test according to conditions. Results of this research can be used as basic study materials to develop technologies for measuring three phase leakage current and for implementing public electrical safety. platform.

• Journal of Korean Neurosurgical Society
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• v.59 no.5
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• pp.521-524
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• 2016

Use of the Pipeline embolization device (PED) has increased based on studies about its safety and effectiveness, and new reports that describe perior postprocedural complications are now emerging. We report a rare periprocedural device-related complication that occurred during endovascular treatment with the pipeline embolization device for a dissecting aneurysm on the vertebral artery. A 55-year old woman was admitted due to left medullary infarction, and angiography showed a fusiform dilatation in the left vertebral artery that was suspicious for dissecting aneurysm. Endovascular treatment with PED was planned. Under general anesthesia, the procedure was performed without significant problems and a PED was deployed in an appropriate position. However, in the final step of the procedure, the distal tip of the PED delivery wire became engaged within a small branch of the posterior cerebral artery and fractured. Fortunately, imaging studies after the procedure revealed neither hemorrhagic nor ischemic stroke, and the patient recovered without neurological morbidities except initial symptoms.

• Journal of the Korean Society of Safety
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• v.30 no.4
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• pp.64-72
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• 2015

The purpose of this study is to study the safety of a small LPG storage tank with a capacity less than 3 ton when it is exposed to an external fire. First, simulation studies were carried out using ASPEN Plus and PHAST to demonstrate that overpressurization in the tank can be relieved by discharging the LPG through an adequately sized safety valve, but the release may lead to the secondary risk of fire and explosion around the tank. Next, the temporal variations of the temperatures of the lading and tank wall were obtained using AFFTAC, which showed that the tank wall adjacent to the vapor space could be overheated in about 11 min to such a point that the weakened strength might cause a rupture of the tank and subsequent BLEVE. The consequences of the BLEVE were estimated using PHAST. Finally, several practical measures for preventing the hazards of overheating were suggested, including an anti-explosion device, sprinkling system, insulation, heat-proof coating, and enhanced safety factor for tank fabrication. The effectiveness of these measures were examined by simulations using AFFTAC and ASPEN Plus.

• The Korean Journal of Health Service Management
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• v.11 no.4
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• pp.189-202
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• 2017

Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.503-515
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• 2022

Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

• Journal of Biomedical Engineering Research
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• v.44 no.5
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• pp.315-323
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• 2023

The objective of this study is to identify the selective application targets for reporting on details of supply of class 1 and 2 medical devices as part of the improvement of the reports on details of supply of medical device system, and to analyze its effectiveness. Therapeutic materials covered by health insurance and secondhand medical devices were chosen based on the transparency of health insurance coverage and the management of medical device distribution. As a result, approximately 85% of groups can be excluded from the reporting requirements compared to reporting all items under Class 1 and 2 medical devices. This is expected to enhance the efficiency of supply reporting tasks. Additionally, the information on supply details managed by the regulatory authority can be utilized for statistical analysis and periodic monitoring, serving as fundamental data for the development of medical device-related policies and research in the field of medical devices.

• Journal of the Korean Society of Safety
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• v.32 no.6
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• pp.81-88
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• 2017

This study deals with the optimal design of a hybrid control system composed of a combination of active control system and passive control system for effective seismic performance improvement of two adjacent structures. The proposed hybrid control system adopts a configuration of installing an active control device in one building and connecting two adjacent structures with a passive control device so that the one-side active control force can be bi-directionally applied to both buildings through the passive connecting devices. In order to derive the optimal performance of the proposed system, the design parameters of the passive and active control systems were searched using the genetic algorithm. Numerical simulations of 10-story and 8-story buildings have been performed to verify the effectiveness of the proposed technique. For the purpose of comparison, the conventional independent control system with two identical active control systems being installed separately for each structure was also optimally designed and its seismic response has been evaluated as well. From the comparative results of the two control systems, it is demonstrated that the proposed hybrid control system requires larger control force for its one-side active control device than the conventional independent control system does for each of both-side active devices, but quite less than the total control force required for both-side devices of the independent control system, while maintaining similar seismic performance. Therefore, the proposed system is more economical and reliable than the conventional independent control system with two identical active devices.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• The Journal of Health Technology Assessment
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• v.6 no.2
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• pp.142-147
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• 2018

Objectives: The purpose of this study is to evaluate the safety and effectiveness of Robot-Assisted Brain Stereotactic Surgery with a systematic review. Methods: Electronic literature was searched using KoreaMed, Ovid-MEDLINE, Ovid-EMBASE, and Cochrane Library on 6th April 2017. Two authors screened 1218 citations. Duplicated articles of 456 excluded, the remaining 762 articles were reviewed with title and abstract. Results: A total of 8 studies were selected in this review. The device used in all studies was $ROSA^{TM}$. In one cohort study comparing the intervention ($ROSA^{TM}$) with the control (conventional stereotactic surgery), hematoma was reported no significant difference between groups. In six descriptive studies, one study reported hematoma 10% (10/100) and temporary nerve impairment 6% (6/100) using the ROSA; while five descriptive study did not report any complications. In one cohort, the localization precision were 1.2 mm in the intervention group and 1.1 mm in the control group; the localization success rate as 78.2% in the intervention group and 76.2% in the control group in one cohort; and the average time for surgery as 130 min for the intervention group and 352 min for the control group in one cohort. Four studies reported the localization success rate as 100%; two out of three articles reported the overall time for surgery as 56 min and 90 min, while one article reported the time as less than one hour in 50% of patients (50/100); two articles reported in epilepsy patients, the condition after the surgery was Engel level I in 66.2%, 75% patients, Engel level II-III in 25%, 26.5% patients, and Engel level 4 in 7.3% patients. Conclusion: Robot-Assisted Brain Stereotactic Surgery is a safe and accurate technique that can significantly reduce the time for the brain stereotactic surgery. However, further studies are needed to generalize the results.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.8 no.2
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• pp.79-88
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• 2014

In Republic of Korea, there are considerable vulnerability in electrical stimulating swallowing-assist equipments even though they are professional medical equipments and have high penetration rate with heavy frequency of use. Therefore, in this article, we developed Device Management and Safety Diagnosis Manual for Electrical Stimulating Swallowing-Assist Equipments system. For achieving this, we collected and analysed international standard data from international organizations like International Electrotechnical Commission(IEC). After literature reviews, we build maintenance worksheet and equipment procedure manual for electrical stimulating swallowing-assist equipments according to evidences we collected. These manual and protocol would be used as standard process and contribute to sustain accuracy, effectiveness of the devices, also decrease failure rate and assist to save medical documents.