Browse > Article
http://dx.doi.org/10.9718/JBER.2019.40.5.171

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)
Publication Information
Journal of Biomedical Engineering Research / v.40, no.5, 2019 , pp. 171-178 More about this Journal
Abstract
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.
Keywords
Medical device; Adverse event; Medical device vigilance; National competent authority report; International medical device regulators forum;
Citations & Related Records
연도 인용수 순위
  • Reference
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.