The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience & nbsp;
- Authors
- Choi, Soo Jeong; Nam, Ki Chang; Choi, Sooin; Kim, Jin Kuk; Lee, You Kyoung; Kwon, Bum Sun
- Issue Date
- Jul-2021
- Keywords
- Medical devices; Research design; Safety management
- Citation
- Health Policy, v.125, no.7, pp 941 - 946
- Pages
- 6
- Journal Title
- Health Policy
- Volume
- 125
- Number
- 7
- Start Page
- 941
- End Page
- 946
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/18732
- DOI
- 10.1016/j.healthpol.2021.04.017
- ISSN
- 0168-8510
- Abstract
- Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.& nbsp; (C)& nbsp;2021 Elsevier B.V. All rights reserved.
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- There are no files associated with this item.
- Appears in
Collections - College of Medicine > Department of Clinical Pathology > 1. Journal Articles
- College of Medicine > Department of Internal Medicine > 1. Journal Articles
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