• 제목/요약/키워드: Medical Device Management

검색결과 306건 처리시간 0.025초

시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로 (A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system)

  • 김병관;최영숙;김미선;양석조
    • 대한의용생체공학회:의공학회지
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    • 제41권1호
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    • pp.35-41
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    • 2020
  • In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

산재보험지정의원 요양급여적정성 종합관리지표 산출 및 적용방안 (The Comprehensive Management Indexes and Their Application Strategies for Appropriate Medical Care in Primary Care Clinics Under Workers' Compensation Insurance)

  • 방은주;최은숙;고영
    • 한국직업건강간호학회지
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    • 제17권1호
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    • pp.86-95
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    • 2008
  • Purpose: The objectives for this study are to produce the comprehensive management indexes and find their application strategies for appropriate medical care in primary care clinics under workers' compensation insurance. Method: Data of this study was workers' compensation insurance medical fees claim's data from July 2006 to June 2007. Data were analyzed using SAS 9.1 version by applying descriptive statistics and Pearson's correlation. The indexes such as costliness index(CI), standard medical fee were calculated based on the fourth revision of korean classification of diseases(KCD-4.). Results: The CI, visiting index(VI), outliers index(OI), and medical review adjustment percentage were positively correlated in the both inpatient and outpatient medical fees in primary care clinics under workers' compensation insurance. The major medical specialities were neurological surgery, general medicine, general surgery, rehabitational medicine, and orthopedic surgery. The CIs were slightly high in rehabitational medicine among major medical specialities. The CIs were mostly high in diagnosis, test, anesthesia, and rehabitational assistive device fees among major medical specialities. The CIs were slightly high in Kwangju, Daegu, Daejeon, and Busan districts among district management centers of Korea Workers' Compensation and Welfare Service. Conclusions: We suggest the continuous development of appropriate disease classification system and medical care quality indicators to successfully take root the comprehensive management for appropriate medical care under workers' compensation.

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의료정보처리를 위한 시스템 개선에 관한 연구 (A Study on Implementation of System Improvement for Medical Information Processing)

  • 유진호
    • 디지털융복합연구
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    • 제14권11호
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    • pp.283-288
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    • 2016
  • 본 연구는 IoT기반의 의료정보 처리를 위한 시스템 및 네트워크 기술 구현에 관련한 것이다. 본 연구의 구성환경은 IoT의 기본구성으로 센서노드, 게이트웨이, 서버노드의 구성이다. 센서노드로서의 의료단말이 게이트웨이에 연결요청을 하면 서버에 미리 등록된 의료장치일 경우 서버는 등록을 허가한다. 착용형 의료장치는 주기적으로 센싱정보를 수집하여 서버에 전달하고 서버는 이를 시각화하거나 미래사용을 위해 저장한다. 본 논문에서는 이에 필요한 전체 절차와 알고리즘을 기술하였고 소프트웨어 구조를 제안하였다.

급성 우심 부전의 집중 치료 (Intensive management of acute right heart failure)

  • 김기범;노정일
    • Clinical and Experimental Pediatrics
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    • 제50권11호
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    • pp.1041-1048
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    • 2007
  • Not a few patients in children and adolescents are suffering from right ventricular (RV) dysfunction resulting from various conditions such as chronic lung disease, left ventricular dysfunction, pulmonary hypertension, or congenital heart defect. The RV is different from the left ventricle in terms of ventricular morphology, myocardial contractile pattern and special vulnerability to the pressure overload. Right ventricular failure (RVF) can be evaluated in terms of decreased RV contractility, RV volume overload, and/or RV pressure overload. The management for RVF starts from clear understanding of the pathophysiology of RVF. In addition to correction of the underlying disease, management of RVF per se is very important. Meticulous control of volume status, inotropic agents, vasopressors, and pulmonary selective vasodilators are the main tools in the management of RVF. The relative importance of each tool depends on the individual clinical status. Medical assist device and surgery can be considered selectively in case of refractory RVF to optimal medical treatment.

한의학 전통 지식 데이터베이스 관리 시스템 현황 (Currently Provided Database Management System of Traditional Korean Medical Knowledge)

  • 김현호;임진웅;박영재;박영배
    • 대한한의진단학회지
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    • 제16권3호
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    • pp.23-32
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    • 2012
  • Objectives: The objective of this study is to investigate and valuate currently provided database management systems (DBMS) of traditional Korean medical knowledge. Methods: We searched DBMS on the web and smart device application markets (Apple App Store and Google Play Store). Key words for searching were 'traditional medicine', 'acupuncture', 'moxibustion', 'herbal medicine', and '한의학'. We looked into each DBMS to find out its scopes and limits, and each was valuated according to its functionality, accessibility, and utility. Results: 186 DBMS of traditional Korean medical knowledge were investigated and 91% of them were applications for smart devices. Almost all DBMS provided acupuncture and herb information, and a small amount of DMBS provided prescription and research paper information. Functionality, accessibility, and utility valuation were performed by using scoring system from 0 to 2. Mean values of functionality, accessibility, and utility were 0.86, 1.29, and 1.09. Conclusions: On the whole, high accessibility and low functionality were found, and various data-calculating functions were not implemented. Further researches and developments about traditional Korean medical knowledge DBMS are necessary to provide correct traditional Korean medical information and to support the studies about Korean medicine.

Management of Recurrent Paravalvular Leakage in a Very High-Risk Patient: A Case Report

  • Park, Sung Jun;Kim, Young Woong;Yoo, Jae Suk;Kim, Joon Bum;Lee, Jae Won
    • Journal of Chest Surgery
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    • 제48권1호
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    • pp.59-62
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    • 2015
  • Interventional device closure has emerged as a less invasive alternative to surgery in the management of paravalvular leakage. However, this procedure involves various problems such as a high probability of residual leakage or hemolysis. Here, we report a case of residual paravalvular leakage despite two attempts at interventional closure in a patient with a history of four previous mitral valve replacements. The fifth operation for the primary repair of paravalvular leakage was performed successfully. Careful evaluation before the procedure and specially designed devices are essential for the interventional treatment of paravalvular leakage. Surgery can be performed adequately in the management of paravalvular leakage even in high-risk patients.

심폐소생술 시 아이젤의 고정 방법에 따른 환기량의 변화 비교: 시뮬레이션 마네킨을 이용한 연구 (Comparison of changes in ventilation volume according to fixation method of I-gel during cardiopulmonary resuscitation: a study using a simulated manikin)

  • 김선태;신상열;최정우
    • 한국응급구조학회지
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    • 제25권3호
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    • pp.7-16
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    • 2021
  • Purpose: The I-gel device is Korea's most frequently used airway management method during pre-hospital cardiopulmonary resuscitation (CPR). This study aimed to compare changes in ventilation volume according to the fixation method with a simulated manikin. Methods: We placed I-gel into an advanced life support simulator and compared tape and band fixation conditions. CPR was performed according to the 2020 Korean CPR guidelines, using a mechanical chest compression device and an adult bag. The positional shift of I-gel and the ventilation volume of the simulated manikin were measured after performing CPR for 20 minutes. Five trials were carried out in each setting. Statistical analysis was carried out with SPSS 27.0. P < .05 was considered significant. Results: Positional shift after 20 minutes of CPR was as follows: tape fixation, 7.2 ± 0.2 mm; band fixation, no change, indicating a significant difference between the two groups (p=.003). The mean ventilation volume was tape fixation, 482.63 ± 30.84 mL; band fixation, 544.96 ± 22.98 mL, showing a significant difference (p=.002). Conclusion: When using the I-gel during pre-hospital CPR, using a band-type fixing device with elasticity rather than fixing the tape provides stable and appropriate ventilation by maintaining the fixed position.

개인용전기자극기 성능 및 안전성 평가 방법 연구 (A study on Evaluation Methods for Safety and Performance of Electrical Stimulations for Home Use)

  • 김산;장무영;황윤수;이기훈;허찬회;홍충만
    • 전자공학회논문지
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    • 제50권3호
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    • pp.187-202
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    • 2013
  • 선진국의 고령사회 도래 및 웰빙 확산, 중국, 인도 등 후발 공업국의 급성장에 따라 최근 전자의료기기시장이 크게 확대 되고 있다. 이중 다소비 생활밀착형 전자의료기기중 하나인 개인용전기자극기는 통증완화, 재활치료, 근육운동 등의 목적으로 사용되는 전기자극기로써 가정에서 개인적으로 사용하는 만큼 그 안전성 및 성능 확보는 사용자의 측면에서 매우 중요하다고 볼 수 있다. 그러나 현재 개인용전기자극기에 대한 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 따라서 본 연구에서는 국제수준에 부합하는 개인용전기자극기의 안전성과 성능을 평가하기위해 관련 국내외 규격을 검토하였고 시험항목, 기준 및 방법을 제안하였다. 또한 제안된 시험항목에 대한 시험검증을 통하여 최종적으로 국제 조화된 안전성 및 성능 평가 항목을 도출하였다. 본 연구 결과를 통하여 개인용전기자극기의 품질 및 안전성 향상을 도모함으로써 국내 전자의료기기산업의 국제 경쟁력 확보에 기여할 수 있을 것으로 기대된다.

모바일 기기를 이용한 통합 응급의료센터 관리 시스템 설계 (Design integrated emergency center management system with mobile device)

  • 백성현;장종욱
    • 한국정보통신학회:학술대회논문집
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    • 한국정보통신학회 2012년도 추계학술대회
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    • pp.414-417
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    • 2012
  • 최근 전문의 응급의료센터 당직을 규정하는 것을 골자로 응급의료법이 개정되면서 응급의료센터 시스템에 많은 변화가 생길 것 이다. 응급환자가 응급의료센터를 찾을 경우 응급실 근무의사 ${\rightarrow}$ 해당과 인턴 ${\rightarrow}$ 1 2년차 전공의(레지던트) ${\rightarrow}$ 3 4년차 레지던트를 거쳐야 전문의 진료를 받을 수 있던 것을 응급실 근무의사 ${\rightarrow}$ 해당과 당직전문의 진료 또는 호출로 그 절차가 간소화됐다. 문제는 이런 시스템을 하려면 모든 진료과목에 대해 당직전문의를 배치해야 한다. 하지만 모든 병원이 모든 진료 과목에 대해 전문의를 배치하는 것은 어렵다. 본 논문에서는 모바일 기기를 이용하여 사용자 근처의 응급의료센터가 있는 병원과 해당 병원이 어떤 전문의가 있는지와 병원의 정보와 응급실의 사용현황을 개정되는 응급의료법을 위해 통합 응급실 관리 시스템을 설계한다.

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국내 바이오산업의 지역별 분포특성과 혁신 활동 성과에 관한 연구: 수도권과 비수도권 지역을 중심으로 (A Study on the Regional Distribution Characteristics and Innovation Activity Performance of Bio-Industry in Korea: Focusing on Metropolitan and Non-metropolitan Areas)

  • 유민정;류규하
    • 대한의용생체공학회:의공학회지
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    • 제44권4호
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    • pp.225-241
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    • 2023
  • The study empirically analyzed the differences in industry distribution and innovation activity performance in the metropolitan and non-metropolitan areas of Korea's bio companies, which are highlighted as future growth engines. The main innovation activities of the bio industry, which are focused on science and technology and expressed with high uncertainty, were analyzed, centering on human resources, technology cooperation, and investment promotion. As a result of the analysis, the biomedical industry in the metropolitan area was found to have a high proportion, and bio foods, bio-based chemicals, and energy industries in the non-metropolitan area, respectively. Moreover, the innovation activity performances differed between the two regions. In particular, the notable characteristics included human resources, investment promotion, and technical cooperation with medical institutions in the metropolitan area with a high proportion of biomedical industries, and technology personnel exchange and cooperation with private research institutions in the non-metropolitan area, which has a high proportion of bio foods, bio-based chemicals, and energy industries. This study is significant in that it is the first study to compare and analyze the performance of innovative activities based on the distribution of industries in the bio-industry, focusing on human resources, technology cooperation, and investment promotion. In addition, after investigating the distribution status and competitiveness of the domestic bio-industry by region, it will analyze the status and characteristics of the domestic bio-industry and present policy implications to implement relevant promotion policy more efficiently.