• 대한방사선기술학회지:방사선기술과학
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• 제22권2호
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• pp.33-39
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• 1999

This paper included a data analysis of the unit of medical devices using mainternance recording card that had medical devices of unit failure mode, hospital of failure mode and MTBF. The results of the analysis were as follows : 1. Medical devices of unit failure mode was the highest in QC/PM such A hospital as 33.9%, B hospital 30.9%, C hospital 30.3%, second degree was the Electrical and Electronic failure such A hospital as 23.5%, B hospital 25.3%, C hospital 28%, third degree was mechanical failure such A hospital as 19.5%, B hospital 22.5%, C hospital 25.4%. 2. Hospital of failure mode was the highest in Mobile X-ray device(A hospital 62.5%, B hospital 69.5%, C hospital 37.4%), and was the lowest in Sono devices(A hospital 16.76%, B hospital 8.4%, C hospital 7%). 3. Mean time between failures(MTBT) was the highest in SONO devices and was the lowest in Mobile X-ray devices which have 200 - 400 failure hours. 4. Anverage failure ratio was the highest in Mobile X-ray devices(A hospital 31.3%, B hospital 34.8%, C hospital 18.7%), and was the lowest in Sono(Ultrasound) devices (A hospital 8.4%, B hospital 4.2%, C hospital 3.5%). 5. Failure ratio results of medical devices according to QC/PM part of unit failure mode were as follows ; A hospital was the highest part of QC/PM (50%) in Mamo X-ray device and was the lowest part of QC/PM(26.4%) in Castro X-ray. B hospital was the highest part of QC/PM(56%) in Mobile X-ray device, and the lowest part of QC/PM(12%) in Gastro X-ray. C hospital was the highest part of QC/PM(60%) in R/F X-ray device, and the lowest a part of QC/PM(21%) in Universal X-ray. It was found that the units responsible for most failure decreased by systematic management. We made the preventive maintenance schedule focusing on adjustement of operating and dust removal.

• 대한영상의학회지
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• 제81권4호
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• pp.863-885
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• 2020

의료기구들이 발달하면서 복부 및 골반 내에 이식되거나 거치되는 의료기구들이 다양해졌다. 흔하게 사용되는 기구들의 영상의학 소견은 영상의학과 의사들에게 매우 익숙하지만, 상대적으로 사용 빈도가 낮거나 새로운 형태의 기구들의 영상의학 소견은 잘 알려져 있지 않다. 또한 환자에 대한 임상정보가 제한적일 경우 이런 새로운 형태의 의료기구들은 잘못 해석되거나 놓치기 쉽다. 그러므로 복부 및 골반 내 의료기구들의 영상의학 소견을 인지하는 것은 기구들의 올바른 위치를 평가하고, 이와 관련된 합병증을 평가하는데 있어 매우 중요하다. 본 논문에서는 다양한 복부 및 골반 내 의료기구들과 이와 관련된 합병증의 영상의학 소견을 소개하고자 한다.

• 대한의용생체공학회:의공학회지
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• 제42권3호
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• pp.86-93
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• 2021

Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

• 대한의용생체공학회:의공학회지
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• 제40권1호
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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.

• 임상간호연구
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• 제16권2호
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• pp.69-84
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• 2010

Purpose: The purpose of this study was to identify the state of infection control in neonatal intensive care units (NICUs) including disinfection methods, disinfection cycles, and exchange cycles for medical devices and to suggest a basic framework which would help develop standardized infection control guidelines. Methods: From a list of NICU equipment developed from the NICUs in 4 tertiary hospitals, a structured questionnaire on 74 types of medical equipment was developed and sent to 31 hospitals by mail. The results were reviewed by panel of experts (56 persons), and analyzed for internal validity by a focus group (4 persons) using guidelines from the Centers for Disease Control and the Korean Hospital Nurses Association. Results: The results showed various methods, cycles, disinfectant levels for the disinfectants and exchange cycles in the medical equipment infection control of the 31 hospitals. The focus group developed a 66-item basic framework based on validity testing. Conclusion: From the results of this study, a framework of infection control standards for 66 types of medical equipment in the NICU was developed. It is suggested that further study be done to more precisely establish standard infection control guidelines for NICU medical equipment.

• 한국인터넷방송통신학회논문지
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• 제13권6호
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• pp.255-262
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• 2013

다양한 병원 정보 시스템 환경에서 서로 다른 인터페이스 규격을 가지는 의료기기들을 통합하기 위한 의료기기 통합 게이트웨이(MG, Medical Gateway)는 하나의 장비로 여러 의료기기들을 인터페이스 할 수 있기 때문에 기존의 PC를 게이트웨이로 사용하는 환경에 비해 관리의 효율성과 비용적인 측면에서도 많은 이득을 제공하고 있다. 그러나 MG를 통해 여러 의료기기들을 통합 한다 하더라도 데이터를 EMR 시스템과 연동하기 위해서는 각 병원시스템과 DB 구성에 따라 개별적인 프로그램이나 추가적인 시스템 도입이 필요하게 된다. 본 논문에서는 이러한 MG와 EMR 시스템간의 연동을 위한 표준기반의 메시지 규격을 설계하고 설계된 메시지를 처리할 수 있는 서버를 구현한다. 본 논문에서 제안한 메시지 규격과 서버는 환경이 서로 다른 병원에서도 MG와의 데이터 교환이 용이하게 하여 디지털병원 수출 프로젝트와 같은 국내의 선진 병원 구축 기술과 IT 기술을 해외에 수출하는 국가적인 프로젝트에 기여할 수 있다.

• 대한의용생체공학회:의공학회지
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• 제29권2호
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• pp.164-171
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• 2008

Recently, many of hospitals have hurried to computerize the resulting data from medical devices, in order to introduce Electric Medical Record(EMR). In terms of the linkage between medical devices and hospital information systems, however, many difficulties have arisen due to some reasons such as the variety of prescription input, the format difference of the resulting data sheet, and the interface difference between medical devices from different companies. To solve these problems, many researches on standardization of the resulting data of medical devices have been performed. In this study, the linkage between hospital information systems and resulting datum in Electrocardiogram(ECG) generating biosignal waveform was tested by applying Medical waveform Format Encoding Rules(MFER) Version 1.02, which has more advantages than existing global standard. MFER viewer, in addition, was made to display the resulting data on a screen. The MFER viewer was tested and compared to the existing Scalable Vector Graphics (SVG) Viewer. The results showed that this method is more effective in the interface the data storage and application, because of simplicity and easiness in data applications. And the results show that the MFER is convenience and effective for physician. It is considered that the role of MFER as the interface in biosignal waveform including Electrocardiogram medical devices would expand in the near future.

• 전자공학회논문지
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• 제52권1호
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• pp.140-147
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• 2015

본 연구는 의료기기법이 시행된 이래 의료기기 부작용등 안전성 정보관리를 위한 의료기기 안전성 정보 원내 보고 시스템 설계에 대한 연구이다. 본 연구는 현행 의료기기 부작용등 안전성정보 보고 관리에 대한 법적 규정 및 시스템에 대한 절차와 현황을 파악하고, MSF/CD(Microsoft Solution Framework/Component Design)설계방법론을 적용한 시스템 설계 방법을 적용하여 의료기기 안전성 정보 원내 보고 시스템 구축을 위한 설계를 하였다. 본 연구를 통해 우리나라의 부작용 등 안전성 정보 보고에 대한 식품의약품안전처 고시 규정을 포함한 의료기기 관리 제도를 파악하고, 좀 더 환자의 안전과 의료기기의 위험관리를 효과적으로 할 수 있는 의료기기 안전성 정보 원내 보고 시스템을 설계 및 구축함으로써 의료기기 부작용 등 안전성 정보 보고의 활성화에 이바지 할 수 있기를 기대한다.

• 재활복지공학회논문지
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• 제11권4호
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• pp.287-297
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• 2017

본 연구는 의료기기 안전성에 관한 의료인들의 인식(지식, 태도)과 행동에 관한 기초현황을 파악하여 보고, 직종 간 차이를 평가해보기 위한 탐색적 조사연구이다. 인천광역시에 소재한 900병상 규모의 상급종합병원을 대상으로 설문지를 배포하여 220명의 응답 자료를 분석에 사용하였다. 연구결과, 연구대상 의료인들은 대체적으로 의료기기 종류에 따른 잠재적 위험성에 대한 인식이 갖춰져 있고, 의료기기 안전성 교육의 필요성을 느끼고 있었다. 또한 의료진들의 직종 간 의료기기 안전성에 관한 인식의 차이를 살펴봤을 때, 등급 높은 의료기기를 주로 사용하지만 의료기기 안전에 관한 인식이 가장 낮은 전공의를 대상으로 하는 의료기기 안전교육의 필요성이 크다는 것을 알 수 있었다. 향후 전국규모의 연구를 통하여 자료의 질을 향상하고 결과의 수준을 높이며, 이를 바탕으로 의료기기 안전성 관리에 있어 정책적, 교육적 기반으로 활용할 필요가 있다.

• 비만대사연구학술지
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• 제2권1호
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• pp.17-24
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• 2023

Obesity is a major public health problem worldwide, with several methods having been proposed as a means of weight loss. If diet, exercise, and medication are insufficient, a healthcare professional may suggest weight loss treatments, including bariatric surgery or medical devices. Antiobesity medical devices are an option for patients who do not want to undergo bariatric surgery. Compared with bariatric surgery, medical devices have the advantage of being reversible and easier to operate. The U.S. Food and Drug Administration (FDA) regulates medical devices, including those used for weight loss and weight management. This article provides an overview of the FDA-regulated weight loss and weight management devices.