대여 의료기구 관리방안
- Type
- Research report
- Issued Date
- 2024-05
- Publisher
- 건강보험심사평가원
- Table Of Contents
- 제1장 서론 ········································································ 1
1. 연구 배경 ······························································································ 1
2. 연구 목적 ······························································································ 2
3. 연구 목적 ······························································································ 3
제2장 대여 의료기구 관리 현황 및 문제점 ········································································ 7
1. 대여 의료기구 현황 ················································································ 7
가. 수술용 대여 의료기구 ················································································· 7
나. 대여업체 ·································································································· 10
다. 수술용 대여 의료기구의 재처리 ·································································· 11
2. 대여 의료기구 관리 현황 ······································································· 15
가. 수입업자 ·································································································· 15
나. 임대업자 ·································································································· 17
다. 의료기관 ·································································································· 17
3. 대여 의료기구 관리상의 문제점 ······························································ 21
제3장 국내 및 미국의 재사용 의료기구 재처리 관리 규정 비교 ········································································ 25
1. 국내 ···································································································· 25
가. 재사용 의료기구 재처리 주체 ····································································· 25
나. 제조업자의 의료기구 재처리 관련 정보 제공(라벨링, 지침)에 대한 규정 ········· 26
다. 제조업자의 의료기구 재처리 방법 검증을 위한 규정 ··································· 29
라. 의료기구 재처리 관련 규정 또는 가이드라인 ················································ 29
마. 의료기기의 추적 ······················································································· 35
2. 미국 ···································································································· 41
가. 재사용 의료기구 재처리 주체 ····································································· 41
나. 제조업자의 의료기구 재처리 관련 정보 제공(라벨링, 지침)에 대한 규정 ········· 41
다. 제조업자의 의료기구 재처리 방법 검증을 위한 규정 ··································· 43
라. 의료기구 재처리 관련 규정 또는 가이드라인 ················································ 46
마. 의료기기의 추적 ······················································································· 48
3. 소결 ···································································································· 55
제4장 대여 의료기구 관리방안 ········································································ 61
1. 의료기기 허가․심사 시 재처리 지침 관련 규정 포함 ································· 62
2. 대여업체의 대여 의료기구 이력 관리 ······················································ 63
3. 의료기구 재처리 관련 규정 구체화 ························································· 65
4. 의료기관 인증평가 기준에 대여 의료기구 감염관리 규정 포함 ··················· 66
5. 의료기구 재처리 관련 감염 모니터링 및 감시 활동 강화 ·························· 72
제5장 결론 ········································································ 75
◾ 참고 문헌 ······················································································· 79
◾ 붙임 ······························································································· 85
- Publisher
- 건강보험심사평가원
- Location
- KOR
- Citation
- 조수진. (2024-05). 대여 의료기구 관리방안.
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