DOI QR코드

DOI QR Code

3D 프린팅 기술의 의료기기 수리 적용에 대한 국내 규제 이슈 및 기술적 적합성 평가

Regulation Issues in Korea and Technical Feasibility Evaluation of 3D Printing-Based Medical Device Repair

  • 윤성욱 (양산부산대학교병원 의공학과) ;
  • 남경원 (양산부산대학교병원 의공학과)
  • Yun, Sung Uk (Department of Biomedical Engineering, Pusan National University Yangsan Hospital) ;
  • Nam, Kyoung Won (Department of Biomedical Engineering, Pusan National University Yangsan Hospital)
  • 투고 : 2020.02.06
  • 심사 : 2020.03.25
  • 발행 : 2020.04.30

초록

In large-scale hospitals, the department of biomedical engineering should always provide quick repair service for damaged medical devices to guarantee continuous patient treatment. However, in actual circumstances, there are so many time-consuming issues that delays device repair for weeks or even months; therefore, it is required to prepare alternative ways for quick repair service. In this study, we first mentioned about the regulation issues in Korea about the 3D printing-based medical device repair, and then introduced the results of our preliminary study that evaluated the feasibility of 3D printing-based medical device repair before real-field application. Results of the study demonstrated that, in all of the 23 cases, parts for repair that were manufactured by 3D-printing were successfully fixed and connected to the main body of the original device, and showed sufficient rigidity for protecting internal parts of the device. Considering the experimental results, medical device repair by applying 3D printing technology can be a promising alternative in cases when regular repair process is not available or takes too much time.

키워드

참고문헌

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