원문정보
초록
영어
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.
목차
Ⅰ. 서론
1. 연구의 필요성
Ⅱ. 연구방법
1. 연구대상
2. 연구방법
Ⅲ. 연구결과
1. 성능에 따른 허가현황 비교
2. 품목별 적용규격 비교
3. 기준규격의 부재로 인한 품목분류의 오류 및 재분류 제안
Ⅳ. 고찰
1. 분류체계 - 품목분류 세분화
2. 분류체계 - 사용명칭의 통일
3. 평가기준 - 기준규격 수립
4. 평가기준 - 가이드라인의 설정
Ⅴ. 결론
REFERENCES