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http://dx.doi.org/10.9718/JBER.2020.41.1.35

A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system  

Kim, Byung Gwan (Department of Mechatronics Engineering, College of Engineering, Chungnam National University)
Choi, Young Sook (Ministry of Food and Drug Safety)
Kim, Mi Sun (National Institute of Food and Drug Safety Evaluation)
Yang, Seok-Jo (Department of Mechatronics Engineering, College of Engineering, Chungnam National University)
Publication Information
Journal of Biomedical Engineering Research / v.41, no.1, 2020 , pp. 35-41 More about this Journal
Abstract
In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.
Keywords
medical device; clinical evaluation; systematic literature review; safety and effectiveness; ophthalmic Electrosurgical system;
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Times Cited By KSCI : 2  (Citation Analysis)
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