국내 운반형인공호흡기 안전성 확보를 위한분류체계 및 평가기준 제안
A Proposal for a Classification System and Evaluation Standards for Ensuring the Safety of Transport Ventilator in Korea
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.
Abstract
Objectives : This study aims to present a new classification system using evaluation standards to ensure the safety of transport ventilators used in Korea. Due to the rapid advancement of technology, various types of ventilators have been developed and as the range of application increases, so does demand. With quick access to information and a growing economy, the technology used in Korean hospitals is equivalent to that of other countries; however, regulatory and safety consciousness are still lagging in Korea. Methods : Based on researching overseas cases, reference data and standards for improving the current system in Korea are proposed. Results : According to the review of transport ventilator use in Korea, it was found that concerns about safety is due to the absence of a standardized classification system for evaluating the safety and effectiveness of transport ventilators. Conclusions : In order to improve the safety of patients and the quality of medical care, it is essential to establish guidelines and assessment standards guaranteeing the safety of transport ventilators in Korea. Clear definitions and classifications for devices must precede the application of such standards. In addition, effective evaluation standards should be developed in order to resolve problems and improve upon the current system through continuous validation.
참고문헌 (24)
- B. Fanara, "Recommendations for the intra-hospital transport of critically ill patients", Critical Care, 14(3), pp.87~ (2010)
- S.R. Holets, "Should a portable ventilator be used in all in-hospital transports?", Respiratory Care, 61(6), pp.839~ (2016)
- J.P.N. Papson, "Unexpected Events during the Intrahospital Transport of Critically Ill Patients", Academic Emergency Medicine, 14(6), pp.574~577 (2007)
- HIRA, "Initial evaluation of ICU evaluation results!", pp.2~3 (2016), Health Insurance Review and Evaluation Center Press Release
- Ministry of Public Safety and Security, "Fire Safety Grant Tax Guideline", 12~15 (2015)
- Ministry of Public Safety and Security, "Government disaster safety management is improving", pp.1~2 (2016), Ministry of Public Safety and Security Press Release
- Ministry of Health and Welfare, "Air ambulance, ‘Doctor Helicopter’ Carries Over 5,000", pp.3~6 (2016), PeopleMinistry of Health and Welfare Emergency Medical Service Press Release
- Regulations on the classification of medical devices and items, "MFDS", 28~29, pp.MFDS Notification No.2017–6 (2017)
- IN-HOSPITAL TRANSPORT OF THE CRITICALLY ILL, "Department of Surgical Education", Orlando Regional Medical Center, 1~3 (2003)
- The Global Medical Device Nomenclature Agency, "GMDN User Guide", 11~29 (2010)
- Ventilation During Patient Transport: A Review of Clinical Effectiveness and Guidelines, "CADTH (Canadian Agency for Drugs and Technologies in Health)", Canadian Agency for Drugs and Technologies in Health, 1~ (2010)
- 이상희, "응급구조사의 업무스트레스와 근골격계 증상이 우울에 미치는 영향", 보건의료산업학회지, 9(4), pp.63~78 (2015), 보건의료산업학회
- C.W. Kerechanin, "Development of field portable ventilator systems for domestic and military emergency medical response", Johns Hopkins APL technical digest, 25(3), pp.215~ (2004)
- D.W. Chipman, "Performance comparison of 15 transport ventilators", Respiratory care, 52(6), pp.740~751 (2007)
- E. L'Her, "Bench-test comparison of 26 emergency and transport ventilators", Critical Care, 18(5), pp.1~14 (2014)
- N. Marjanovic, "A Comprehensive Approach for the Ergonomic Evaluation of 13 Emergency and Transport Ventilators", Respiratory Care, 61(5), pp.632~639 (2016)
- Medical device standard (Particular requirement 29, Ventilator, Facility use, "MFDS", 1~, pp.MFDS Notification No.2016-90 (2016)
- H.J. Kim, "Comparison of Climatic Environmental Test Standards of MIL-STD-810 and IEC Pub. 60068", Journal of Applied Reliability, 9(2), pp.81~91 (2009)
- Environmental Engineering Considerations and Laboratory Test, "Department of Defense, U.S.A.", 13~14, pp.MIL-STD-810G (2008)
- M.J. Rouse, "Mechanical ventilation during air medical transport: Techniques and devices", Journal of Air Medical Transport, 11(4), pp.5~8 (1992)
- D.R. Hess, "Essentials of mechanical ventilation", pp.3~23 (2005), KOONJA