The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience |
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| Authors: | Soo Jeong Choi Ki Chang Nam Sooin Choi Jin Kuk Kim You Kyoung Lee Bum Sun Kwon |
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| Institution: | 1. Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of Medicine, 170, Jomaru-ro, Bucheon 14584, Republic of Korea;2. Center for Medical Device Safety Information Monitoring, Soonchunhyang University Bucheon Hospital, 170, Jomaru-ro, Bucheon 14584, Republic of Korea;3. Department of Medical Engineering, Dongguk University College of Medicine, 27, Dongguk-ro, Ilsandong-gu, Goyang 10326, Republic of Korea;4. Center for Medical Device Safety Information Monitoring, Dongguk University Ilsan Hospital, 27, Dongguk-ro, Ilsandong-gu, Goyang 10326, Republic of Korea;5. Department of Laboratory Medicine and Genetics, Soonchunhyang University College of Medicine, 170, Jomaru-ro, Bucheon 14584, Republic of Korea;6. Department of Rehabilitation Medicine, Dongguk University College of Medicine, 27, Dongguk-ro, Ilsandong-gu, Goyang 10326, Republic of Korea;1. Pharmacotherapy Outcomes Research Center, College of Pharmacy, University of Utah, 30 S 2000 E, Salt Lake City, 84112, UT, USA;2. Population Informatics Lab, Texas A&M University, 212 Adriance Lab Rd, College Station, 77843, TX, USA;3. Laboratory of Health Economics & Management, Economics Department, University of Piraeus, Karaoli ke Dimitriou 80, 185 34, Piraeus, Greece;4. Department of Health Policy & Management, School of Public Health, Texas A&M University, 212 Adriance Lab Rd, 77843, College Station, TX, USA;5. University Regional General Hospital of Patras, University of Patras, 26504, Patras, Rion, Greece;6. Department of Social and Education Policy, University of Peloponnese, Damaskinou & Kolokotroni Str., 20100, Corinth, Greece;1. VIVE – The Danish Center for Social Science Research, Herluf Trolles Gade 11, København K, DK;2. Centre for Health Policy, Institute of Global Health Innovation, Imperial College London, SW7 2A London, UK;3. Danish Centre for Health Economics, University of Southern Denmark, J.B. Winsløws Vej 9B, Odense C, DK;4. Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230 Odense M, DK;1. Department of Economics, Faculty of Administrative Sciences, Hacettepe University, Turkey;2. Department of Economics, Faculty of Administrative Sciences, Ankara Hac? Bayram Veli University, Turkey |
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| 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. |
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