생체재료학회지 (Biomaterials Research)

  • 제16권1호
  • /
  • Pages.1-6
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  • 2012
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  • 1226-4601(pISSN)
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  • 2055-7124(eISSN)
한국생체재료학회 (Korean Society for Biomaterials)
권호 표지

재사용의료기기의 소재선택, 설계 및 평가

The Material Selection, Design and Evaluation of Reusable Medical Devices

  • 김동빈 (연세대학교 의과대학 의학공학교실) ;
  • 공석경 (한국산업기술시험원 의료기기그룹) ;
  • 유우진 (한국산업기술시험원 의료기기그룹) ;
  • 이미희 (연세대학교 의과대학 의학공학교실) ;
  • 유선국 (연세대학교 의과대학 의학공학교실) ;
  • 박종철 (연세대학교 의과대학 의학공학교실)
  • Kim, Dong-Bin (Department of Medical Engineering, Yonsei University College of Medicine) ;
  • Kong, Seok-Kyoung (Medical Device Group, Korea Testing Laboratory) ;
  • Yu, Woo-Jin (Medical Device Group, Korea Testing Laboratory) ;
  • Lee, Mi Hee (Department of Medical Engineering, Yonsei University College of Medicine) ;
  • Yu, Sun-Kuk (Department of Medical Engineering, Yonsei University College of Medicine) ;
  • Park, Jong-Chul (Department of Medical Engineering, Yonsei University College of Medicine)
  • 발행 : 2012.03.01
⟨ 이전 논문 다음 논문 ⟩

초록

The contamination of body contacting medical devices is the major hazard. As reusable medical devices (RMDs) are used repeatedly among many patients, especially, the problems of cross contamination due to the use of RMDs are being highlighted as a social issue at home and abroad. To solve this issue, active research and work is under progress including the issuance of new guidelines by competent governmental authorities such as the US Centers for Disease Control (CDC) and the US Food and Drug Administration (FDA). Although risk aspects of RMDs are significant such as cross contamination, the level of control systems and technologies to deal with it is relatively low. Therefore, it is necessary to introduce the scientific technical standards and management methodology for RMDs that consider the situation where they are repeatedly reused and reprocessed. This paper (1) analyzes the classification system of RMDs such as invasive critical devices(surgical instruments and laparoscopes, etc.), and mucous membrane or nonintact skin exposed semicritical devices(broncoscopes and aspirator tubes); (2) addresses the factors to be considered in the material selection and design of RMDs such as metals and polymers; (3) and suggests the validation and scientific evaluation methods of reprocessing for RMDs, focusing on cleaning.

키워드

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