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KMID : 1137820190400050171
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의공학회지
2019 Volume.40 No. 5 p.171 ~ p.178
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Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting
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Lee Ye-Jin
Yoon Chi-Ho
Choi Soo-Jeong
Kang Young-Joon
Kim Jin-Kuk
Kwon Bum-Sun
Lee You-Kyoung
Nam Ki-Chang
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Abstract
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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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KEYWORD
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Medical device, Adverse event, Medical device vigilance, National competent authority report, International medical device regulators forum
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