A Proposal for a Classification System and Evaluation Standards for Ensuring the Safety of Transport Ventilator in Korea

국내 운반형인공호흡기 안전성 확보를 위한 분류체계 및 평가기준 제안

  • Kim, Ji-Hyun (Department of Medical Device Industry, Graduate School of Dongguk University) ;
  • Cho, Sung-Ku (Department of Industrial & System Engineering, Dongguk University)
  • 김지현 (동국대학교 대학원 의료기기산업학과) ;
  • 조성구 (동국대학교 산업시스템공학과)
  • Received : 2017.05.01
  • Accepted : 2017.11.29
  • Published : 2017.12.30


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.



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