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KMID : 1137820200410010035
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의공학회지
2020 Volume.41 No. 1 p.35 ~ p.41
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A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system
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Kim Byung-Gwan
Choi Young-Sook
Kim Mi-Sun
Yang Seok-Jo
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Abstract
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In this study, we examined whether the systematic literature review method used in the field of evidencebased 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.
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KEYWORD
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medical device, clinical evaluation, systematic literature review, safety and effectiveness, ophthalmic Electrosurgical system
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