위험관리기반의 성능관리 의료기기 선정 절차 수립 및 시험 항목 도출
Establish Selection Process of Performance Management Medical Devices and Test items Based on Risk Management
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초록
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.
Abstract
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.
참고문헌 (22)
- Establishment of post market quality control for performance and effectiveness of medical devices, "K.M. Lee", Korea Food & Drug Administration, 51~69 (2016)
- Ministry of Health and Welfare, "MEDICAL SERVICE ACT (Law No. 15716), Article 38", ~ (2018)
- Ministry of Health and Welfare, "ENFORCEMENT DECREE OF THE EMERGENCY MEDICAL SERVICE ACT (Law No. 14927)", ~ (2017)
- Food and Drug Administration (FDA), "Mammography Quality Standards Act Regulations", ~ (2004)
- Joint Commission International, "Joint Commission International Accreditation Standards for Hospitals, Fourth Edition", 195~ (2011)
- Medicines and Healthcare products Regulatory Agency, "MHRA Enforcement Strategy", 16~ (2010)
- Ministry of Health, Labour and Welfare, Japan, "Pharmaceutical Affairs Law", ~
- Ministry of Health and Welfare, "Regulations for the installation and operation of special medical equipment", ~ (2015)
- Ministry of Health and Welfare, "Regulations for the Safety Management of Diagnostic Radiation Generators", ~ (2017)
- Medical Institution Evaluation Certification Authority, "Medical Institution Certification Survey Standard(Large hospital:Hospitals and general hospitals over 300 beds)", 20~21 (2011)
- "Guideline for clinical examination quality control in Korea" (2013)[URL]
- Center for Devices and Radiological Health, "The Mammography Quality Standards Act Final Regulations: Preparing for MQSA Inspections; Final Guidance for Industry and FDA", Food and Drug Administration (FDA), ~ (2001)
- Ministry of Health, Labour, and Welfare, Japan, "Enforcement Decree of Pharmaceutical Affairs Law", ~
- Ministry of Health, Labour, and Welfare, Japan, "Enforcement Regulations of Pharmaceutical Affairs Law", ~
- Medicines and Healthcare products Regulatory Agency, "The Regulation on Accreditation and Market Surveillance", ~ (2010)
- United Kingdom Accreditation Service, "Imaging Services Accreditation Scheme (ISAS)", ~ (2016)
- Department of Health and Ageing (Australian Government), "Australian regulatory guidelines for medical devices, (ARGMD) Part 3-Post-market, Version 1.1", 292~326 (2011)
- Ministry of Food and Drug Safety, "Regulations on the classification of medical devices and items(No. 2018-83)", 26~187 (2018)
- "IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", 331~334 (2012)
- Ministry of Food and Drug Safety, "Medical Devices GMP (GIP) Self-Examination Guidelines", 3~6 (2007)
- Ministry of Food and Drug Safety, "Medical device manufacturing and quality control standards(No. 2016-156)", ~ (2016)
- International Electrotechnical Commission, "IEC 60601-2-24: Medical electrical equipment-Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers", 17~34 (2012)