Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting |
Lee, Ye Jin
(Department of Medical Device Industry, Graduate School of Dongguk University)
Yoon, Chiho (Soonchunhyang University Bucheon Hospital) Choi, Soo Jeong (Soonchunhyang University Bucheon Hospital) Kang, Youngjoon (Jeju National University College of Medicine) Kim, Jin Kuk (Soonchunhyang University Bucheon Hospital) Kwon, Bum Sun (Dongguk University Ilsan Hospital) Lee, You Kyoung (Soonchunhyang University Bucheon Hospital) Nam, Ki Chang (Dongguk University College of Medicine) |
1 | Ministry of Food and Drug Safety. Regulations on management of medical device safety informations including side effect. MFDS; 2019. |
2 | Jang HJ, Choi YD, Kim NH. Design for a medical devices safety information reporting system for the hospitals. Journal of The Institute of Electronics and Information Engineers. 2015;52(1):140-7. DOI |
3 | Ministry of Food and Drug Safety. Guideline of medical device adverse event reporing. MFDS; 2018 |
4 | https://www.mfds.go.kr/brd/m_99/view.do?seq=41572. Accessed on 12 Jun 2019. |
5 | http://www.imdrf.org. Accessed on 20 Jun 2019. |
6 | International Medical Device Regulators Forum MC. IMDRF 'Strategic Plan 2020'. IMDRF; 2015. |
7 | Regulatory Harmonization Steering Committee. Roadmap to promote regulatory convergence for medical device vigilance. 2015. |
8 | Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review. Syst Rev. 2015;4(1):37. DOI |
9 | Lim JH, Kim KS, Kim SL, Kim YS, Lee HJ. Perception and behavior regarding the safety of medical devices among medical personnel at a tertiary care hospital. J Rehabil Welf Eng Assist Technol. 2017;11(4):287-97. DOI |
10 | Craig A, O'Meley P, Carter P. The need for greater reporting of medical device incidents. EMJ Innov. 2019;3(1):56-63. |
11 | Yoon CH, Nam KC, Lee YK, Kang YJ, Choi SJ, Shin HM, Jang HJ, Kim JK, Kwon BS, Ishikawa H, Woo E. Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases. J Korean Med Sci. 2019;34(39):e255. DOI |
12 | The Global Harmonization Task Force, Study Group 2. Medical devices post market surveillance: global guidance for adverse event reporting for medical devices. GHTF. 2006. |
13 | National Competent Authority Report Working Group. Medical devices: post-market surveillance: National Competent Authority Report exchange criteria and report form. IMDRF. 2017. |