메뉴 건너뛰기
.. 내서재 .. 알림
소속 기관/학교 인증
인증하면 논문, 학술자료 등을  무료로 열람할 수 있어요.
한국대학교, 누리자동차, 시립도서관 등 나의 기관을 확인해보세요
(국내 대학 90% 이상 구독 중)
로그인 회원가입 고객센터 ENG
주제분류

추천
검색

논문 기본 정보

자료유형
학위논문
저자정보

이예진 (동국대학교, 동국대학교 대학원)

지도교수
남기창
발행연도
2019
저작권
동국대학교 논문은 저작권에 의해 보호받습니다.

이용수3

표지
AI에게 요청하기
추천
검색

이 논문의 연구 히스토리 (2)

초록· 키워드

오류제보하기
This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post market surveillance of medical device, which is a core component of quality management system is becoming more important. The post market surveillance of medical device not only improves the usability and functionality of the device, but also identifies new or growing risks due to the device. Globally, regulators encourage reporting of incidents relating to medical devices by consumers, patients, clinicians, and distributors of devices, but the rate of reporting remains low. APEC have established and operate post market surveillance systems for medical devices on the basis of IMDRF and GHTF guidelines. However, there are significant gaps in many aspects. It is important not only to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently in order to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post market surveillance. The results of the study showed that there was a considerable difference in the judgment on the starting point of patient use of medical devices. And different opinions were expressed according to the health impact from the event of the patients received, when the adverse event occurred, other regulations across countries, lack of understanding of the guideline, and personal knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchange international guidelines of the adverse event for domestic stakeholders. It can improve accuracy and reliability by reducing uncertainty and confusion about reporting and exchanging about medical device adverse events.

목차

제1장 서 론 1
제1절 연구의 배경 1
제2절 연구의 필요성 4
제3절 연구의 목적 5
제2장 본 론 6
제1절 의료기기 보고 및 국가 간 정보 교환 제도 현황 6
제2절 MDV(Medical Device Vigilance) 규제조화 10
제3절 연구 방법 19
제3장 결 과 27
제1절 설문조사 대상 분석 27
제2절 의료기기 사용시점에 대한 관점 분석 29
제3절 질문에 따른 사례별 이해관계자의 응답 분석 31
제4절 개인 응답과 그룹 토의 후 응답의 비교 분석 48
제4장 고 찰 및 결 론 55
참 고 문 헌 59
ABSTRACT 61

최근 본 자료

전체보기

댓글(0)

0