Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting

의료기기 이상사례 보고에 대한 국내 이해관계자의 관점 차이

  • 이예진 (동국대학교 대학원 의료기기산업학과) ;
  • 윤치호 (순천향대학교 부천병원) ;
  • 최수정 (순천향대학교 부천병원) ;
  • 강영준 (국립제주대학교 의과대학) ;
  • 김진국 (순천향대학교 부천병원) ;
  • 권범선 (동국대학교 일산병원) ;
  • 이유경 (순천향대학교 부천병원) ;
  • 남기창 (동국대학교 의과대학)
  • Received : 2019.07.19
  • Accepted : 2019.10.18
  • Published : 2019.10.31


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 not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently 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 phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.



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