• Proceedings of the Korea Information Processing Society Conference
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• 2017.04a
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• pp.605-608
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• 2017

최근에는 의료기기의 구성 요소 중 소프트웨어의 기능과 역할이 커지면서 의료기기 소프트웨어의 비중이 높아지고, 의료기기의 사용자의 생명과 안전에 직결되는 특성으로 인해 의료기기 소프트웨어 위험관리의 중요성은 더욱 강조되고 있다. 이를 위해 여러 표준들은 위험관리를 위한 다양한 요구사항들을 제시한다. 그러나 의료기기 소프트웨어 개발생명주기의 각 단계에서 수행되어야하는 위험관리 항목들은 분류되어있지 않다. 이로 인해 개발자들은 의료기기 개발 중에 직접 표준들의 연관성을 분석하여 위험관리 활동을 수행해야하는 어려움을 겪고 있다. 따라서 본 논문에서는 위험관리 프로세스의 항목들을 추출하고 PEMS(Programmable Electrical Medical System) 개발생명주기와 대응시켜 연관성을 분석하고, 이를 통해 의료기기 소프트웨어의 개발 중 효과적이고 체계적인 위험관리를 가능하게 한다.

• KIPS Transactions on Software and Data Engineering
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• v.6 no.12
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• pp.543-548
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• 2017

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2012.10a
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• pp.495-497
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• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• Journal of the Institute of Electronics and Information Engineers
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• v.52 no.1
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• pp.140-147
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• 2015

In this study, medical devices safety information reporting system was designed to manage medical devices for the efficient management of in-hospital adverse events. The current management of medical device adverse event reporting regulations and the legal status of the system and procedures for identifying the system were reviewed. MSF/CD(Microsoft Solution Framework/Component Design) was applied to the system design. Through this study, we can understand medical devices management including the notice provisions of the Ministry of Food and Drug Safety for medical devices safety information reporting. We also expect this study will help to improve patient safety and the effective management of medical equipment, and contribute to activating medical devices safety information reporting.

• Proceedings of the Korea Information Processing Society Conference
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• 2006.11a
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• pp.571-574
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• 2006

2006년 5월 국제전기기술위원회(International Electrotechnical Commission, IEC) TC62(의료용전기기기기술위원회) SC62A(의료용전기기기 공통특성에 관한 세부분과위원회)에서 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 62304, Ed.1을 제정하였다. 전체 내용은 크게 일반적인 요구사항(General requirements)과 소프트웨어 개발과 유지보수에 대한 프로세스(Software development & maintenance process)로 구성되어 있다. 그리고 소프트웨어 개발과 유지보수 프로세스가 진행되는 동안에 기본적으로 확보되어야 하는 소프트웨어 위험관리와 형상관리에 대한 프로세스 Software risk management & configuration management process)를 규정하고, 또한 문제 발생 시 이를 해결하기 위한 소프트웨어 문제 해결 프로세스(Software problem resolution process)를 규정하고 있다. 이는 기존의 정보통신 분야에서 사용되던 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과 외형상 많은 차이를 나타내고 있다. 이에 본 논문에서는 의료기기 소프트웨어의 생명주기 프로세스에 관한 국제규격인 IEC 652304를 분석하여 실제 의료용 소프트웨어 개발 및 유지보수 작업들이 어떠한 방식으로 이루어지는지를 분석하고, 또한 기존의 소프트웨어 생명주기 프로세스인 ISO/IEC 12207 규격과의 차이점을 비교 분석하여 본 규격에 대한 근본적인 활용 방안을 모색하고자 한다.

• 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.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.9 no.6
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• pp.145-152
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• 2014

This Study was done to estimate the availability of biological resistance analysis method in medical equipment companies in Korea, and if it is usefull in predicting risk of obesity and cardiovascular disease and managing of it, by means of comparing it with blood tests. Especially, we analyzed the correlation between circumference length and fat thickness of each site of body area, which are ones of among measurement values of the BIA. This study has the purpose to propose the use of BIA as basement of diagnosis for efficient management and assessment in the medical device industry in our country.

• Journal of Biomedical Engineering Research
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• v.40 no.1
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• pp.20-31
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• 2019

Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.

• 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.

• The Optical Journal
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• s.105
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• pp.27-29
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• 2006

레이저 광선이 가져다준 많은 장점과 편리함에 비하면 레이저의 위험성이라는 부정적인 요소가 차지하는 비중은 미미하다고 볼 수 있다. 그러나 우려되는 것은 레이저를 생산하거나 이용하는 공장의 작업장을 비롯하여, 수술 또는 치료용으로 사용하는 의료기관의 수가 지속적으로 늘어나고 있음을 감안할 때, 이러한 장소에서 레이저를 동작시키는 사용자를 포함한 주변사람이 레이저광선에 직접 또는 간접적으로 노출되어 사고를 당할 확률도 그만큼 높아지고 있다는 점이다.