• Title/Summary/Keyword: Medical Device Management

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An ability test for the use of indirect radiographic unit (간접촬영용 X-선 발생장치 성능 평가)

  • Im, In-Cheol
    • Journal of radiological science and technology
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    • v.27 no.4
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    • pp.37-41
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    • 2004
  • Purpose : Raise ability cultivation in presence at a sicked business by performance management estimation of device through measurement. Also Learn a technology that measure exact tube voltage, exposure time, output dose. And it is to grasp photofluorography X-ray generator existing circumstances using at hospital. Material & Method : Investigated Photofluorography X-ray generator(inside, outside each 10) of 10 university hospitals using tube voltage, exposure time, output dose measuring instrument. Result : Photofluorography device that tube voltage correctness is incongruent by examination PAE decision came out 3, and at exposure time correctness examination 2 incongruent, Also 3 that calculate coefficient of variation about exposure in repeatability examination of exposure were incongruent. Inappropriate photofluorography device is 5 outside hospital(mobile unit) and the thing in hospital was 3 in 3 kind of efficiency test. It appeared high that photofluorography device outside hospital is more incongruent than thing in hospital. Conclusion : May ready situation that can offer patient medical service of good quality by radiation exposure reduction, image quality administration, retake decrease etc. by keeping performance of Photofluorography device. Therefore, is considered that need on-time efficiency test.

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A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device (저강도 초음파 치료기기의 안전성 및 성능평가 가이드라인 수립을 위한 연구)

  • Kim, Ju-Young;Kim, Jae-Young;Noh, Si-Cheol;Choi, Heung-Ho
    • 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.

e-Business Strategy of Healthcare Industry (보건의료산업에서의 전자상거래 가치 및 활성화 전략)

  • 이견직
    • Health Policy and Management
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    • v.11 no.3
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    • pp.102-120
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    • 2001
  • This paper examines the current situation and major impacts of e-business on healthcare industry: hospital, pharmaceutical, medical device and health-related internet sectors. Of the 137 samples collected with mail survey, the utilization rate of B2C e-commerce is 31.4% and B2B is 13.1%. And 74.5% of respondents remains the first development stage which represents the simple advertisement such as the one-way information offering. The key obstacle of expansion of health care e-commerce turns out to be the illogical and outdated medical-related law and institution. Finally, policy recommendations are proposed based on the evaluation of the current policy implemented by government.

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Analysis of Association between Risk Management Items and PEMS Development Life Cycle for Risk Management of Medical Device Software (의료기기 소프트웨어 위험관리를 위한 PEMS 개발생명주기 기반 위험관리 항목 연관성 분석)

  • Kim, DongYeop;Park, Ye-Seul;Lee, Jung-Won
    • 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.

Rehabilitation of spinal muscular atrophy: current consensus and future direction

  • Yi, You Gyoung;Shin, Hyung-Ik;Jang, Dae-Hyun
    • Journal of Genetic Medicine
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    • v.17 no.2
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    • pp.55-61
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    • 2020
  • Spinal muscular atrophy (SMA) is a neuromuscular disease that requires multidisciplinary medical care, including rehabilitation management. The emergence of a genetic therapy-based approach for SMA has markedly changed the disease course. Nonetheless, currently, updated physical therapy and rehabilitation are warranted for individuals with SMA in the era of gene therapy. In this review, we discuss the physical therapy and rehabilitation strategies currently performed for people with SMA, such as positioning and bracing, supported standing, management of musculoskeletal deformities, stretching, physical exercise training like aerobics and strengthening exercises, assistive devices, pulmonary rehabilitation, and dysphagia treatment.

The Relationship Between Renminbi Exchange Rate Fluctuations and China's Import and Export Trade

  • Renhong WU;Yuantao FANG;Md. Alamgir HOSSAIN
    • The Journal of Industrial Distribution & Business
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    • v.15 no.5
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    • pp.17-27
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    • 2024
  • Purpose: The renminbi (RMB) has appreciated alongside the elevation of China's economic status, leading to increased exchange rate volatility. Moreover, China's medical industry saw a surge in import and export trade volume, with trade related to epidemic prevention and control in the medical sector significantly increasing its share. The medical device trade, in particular, occupies a substantial portion of this trade. Research design, data and methodology: This paper focuses on the import and export value of medical devices in the medical industry as a case study to explore the impact of RMB exchange rate fluctuations on the import and export trade of the medical industry during the pandemic. Additionally, it investigates whether the import and export trade of the medical industry can be a contributing factor to the fluctuations in the RMB exchange rate. Results: Through an empirical study on the import and export values of medical devices in the medical industry over the past three years, as well as the RMB exchange rate, this paper establishes a VAR model and conducts a series of tests including stationarity tests and cointegration tests. Conclusions: The conclusion is that fluctuations in the RMB exchange rate have a long-term impact on China's medical industry's import and export trade.

A Study on the Adequacy Awareness of Computed Tomography Equipment Quality Control (전산화단층촬영장비 정도관리의 적정 인지도에 관한 연구)

  • Kim, Gyoo Hyung;Lim, Cheong Hwan;Kim, Ki Jeong
    • Journal of radiological science and technology
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    • v.42 no.1
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    • pp.31-37
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    • 2019
  • Investigate the adequacy awareness of accuracy control of CT apparatus Questionnaire survey and statistical analysis in the analysis according to age, there is a difference between familiarity with accuracy management items (F = 14.187, p<0.001) and necessity of accuracy control (F=8.109, p<0.001), depending on academic background and work history, There is a difference only in familiarity (F=5.103, p<0.05, F=13.394, p<0.001), and according to the scale of the medical institution analysis shows that if you are more interested than senior general hospital grade hospital grade or less It was analyzed. In order to advance the accuracy control level, we have introduced our comprehensive and efficient comprehensive and efficient integrated medical image quality management operation system of the whole medical image equipment including CT device, It is thought that it is necessary to develop human resources capable of doing.

Comparative Analysis of Vectorization Techniques in Electronic Medical Records Classification (의무 기록 문서 분류를 위한 자연어 처리에서 최적의 벡터화 방법에 대한 비교 분석)

  • Yoo, Sung Lim
    • Journal of Biomedical Engineering Research
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    • v.43 no.2
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    • pp.109-115
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    • 2022
  • Purpose: Medical records classification using vectorization techniques plays an important role in natural language processing. The purpose of this study was to investigate proper vectorization techniques for electronic medical records classification. Material and methods: 403 electronic medical documents were extracted retrospectively and classified using the cosine similarity calculated by Scikit-learn (Python module for machine learning) in Jupyter Notebook. Vectors for medical documents were produced by three different vectorization techniques (TF-IDF, latent sematic analysis and Word2Vec) and the classification precisions for three vectorization techniques were evaluated. The Kruskal-Wallis test was used to determine if there was a significant difference among three vectorization techniques. Results: 403 medical documents were relevant to 41 different diseases and the average number of documents per diagnosis was 9.83 (standard deviation=3.46). The classification precisions for three vectorization techniques were 0.78 (TF-IDF), 0.87 (LSA) and 0.79 (Word2Vec). There was a statistically significant difference among three vectorization techniques. Conclusions: The results suggest that removing irrelevant information (LSA) is more efficient vectorization technique than modifying weights of vectorization models (TF-IDF, Word2Vec) for medical documents classification.

Construction of Untact Monitoring System for image quality management of medical imaging devices (의료영상진단 기기 영상 품질 관리를 위한 비대면 모니터링 시스템 구축)

  • Kim, Ji-Eon;Lim, Dong Wook;Ju, Yu Yeong;No, Si-Hyeong;Lee, Chung Sub;Moon, Chung-Man;Kim, Tae-Hoon;Jeong, Chang-Won
    • Proceedings of the Korean Society of Computer Information Conference
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    • 2021.01a
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    • pp.45-46
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    • 2021
  • 의료영상이란 의료영상장비로부터 DICOM이라는 의료영상표준에 따라 저장되며, 의료영상관리 시스템인 PACS를 통해 관리된다. 이러한, 의료영상장비 ICT기술이 융합되어 급격하게 발전되고 있으며 다양한 의료영상장치가 개발되어지고 있다. 하지만, 기술력은 높아지고 있으나 개발된 의료영상장비로부터 촬영된 영상품질관리에 대한 문제점이 제기되고 있다. 이와 관련하여 다기관의 의료영상장비 개발과 해당 기기로부터 수집된 의료영상에 대한 품질을 관리할 필요성이 증가하고 있다. 따라서 코로나 19와 같은 상황에서 의료기기 개발 지원과 관리를 비대면 관리서비스 시스템 개발과 의료영상장치 개발 정도를 관리할 수 있을 뿐만 아니라 의료영상에 대한 품질까지 모니터링하여 및 개선 할 수 있는 시스템을 제안하고자 한다.

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The Safety Management for Compression Medical Device through the Quality Improvement Activities (질 향상 활동을 통한 사지압박순환장치의 안전관리)

  • An, Young-Jae;Kim, Kyu-Sung;Shin, Jeong-Ae;Lee, Hye-Ryun;Hwang, Kyu-Jung;Park, Ji-Young;Kim, Sae-Rom;Kang, Su-Kyung;Kwon, Dae-Gyu
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.11 no.2
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    • pp.125-132
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    • 2017
  • Intermittent pneumatic compression is frequently used for prophylaxis of deep vein thrombosis, however there is a lot of complains by frequent adverse event. In this paper, we analyzed the cause of adverse event and we tried to improve for the cause of machine, nurses, patients, system by diverse strategy. And we could improve the index of each cause, the rate of error was decreased finally. The proactive activity of quality improvement for medical device can contribute to decrease the error, that will improve the quality of medical service and achieve the safe medial culture.