대한의용생체공학회:의공학회지 (Journal of Biomedical Engineering Research)

  • 제41권1호
  • /
  • Pages.35-41
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  • 2020
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  • 1229-0807(pISSN)
  • /
  • 2288-9396(eISSN)
대한의용생체공학회 (The Korean Society of Medical and Biological Engineering)
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시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로

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

  • 김병관 (충남대학교 공과대학 메카트로닉스공학과) ;
  • 최영숙 (식품의약품안전처) ;
  • 김미선 (식품의약품안전평가원) ;
  • 양석조 (충남대학교 공과대학 메카트로닉스공학과)
  • 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)
  • 투고 : 2019.10.30
  • 심사 : 2020.02.15
  • 발행 : 2020.02.29
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초록

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.

키워드

참고문헌

  1. Medical Device Act, amended by act of the Korean Ministry of Food and Drug Safety, No. 16402 (April. 23, 2019).
  2. Regulation on Medical Device Approval Report Review, Etc: amended by ordinance of the Korean Ministry of Food and Drug Safety, No. 2019-103 (Nov 12, 2019).
  3. Ahn HS, K HJ. An introduction to systematic review. J Korean Med Assoc, 2014;57(1):49-59. https://doi.org/10.5124/jkma.2014.57.1.49
  4. Lee SH, Choi WJ. Systematic review for new health technology assessment. J Korean Med Assoc. 2012;55(3):279-291. https://doi.org/10.5124/jkma.2012.55.3.279
  5. https://emed.mfds.go.kr/#!CECAB01F010. Accessed on 5 June 2017.
  6. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta analyses: the PRISMA statement. J Clin Epidemiol, 2009;62:1006-1012. https://doi.org/10.1016/j.jclinepi.2009.06.005
  7. Wecker T, Neuburger M, Bryniok L, Bruder K, Luebke J, Anton A, Jordan JF. Ab Interno Trabeculectomy With the Trabectome as a Valuable Therapeutic Option for Failed Filtering Blebs. J Glaucoma. 2016;25(9):758-62. https://doi.org/10.1097/IJG.0000000000000492
  8. Bussel I, Kaplowitz K, Schuman JS, Loewen, NA. Outcomes of ab interno trabeculectomy with the trabectome by degree of angle opening. J Ophthalmol. 2015;99:914-919.
  9. Masahiro M, Mitsunori W, Kazuo I. Evaluation of Trabectome in Open-Angle Glaucoma. Article in Journal of glaucoma. 2013;22(3):205-8. https://doi.org/10.1097/IJG.0b013e3182311b92
  10. Jens FJ, Thomas W, Christian VO, Alexandra A, Thomas R, Daniel B, Matthias N. Trabectome surgery for primary and secondary open angle glaucomas. Graefes Arch Clin Exp Ophthalmol. 2013;251(12):2753-2760. https://doi.org/10.1007/s00417-013-2500-7
  11. Jessica LMT, Karim FD, Michael CS. Ab interno trabeculectomy: Outcomes in exfoliation versus primary open-angle glaucoma. JCRS. 2012;38(2):315-323.
  12. Kaplowitz K, Bussel II, Honkanen R, Schuman JS, Loewen NA. Review and meta-analysis of ab-interno trabeculectomy outcomes. Br J Ophthalmol. 2016;100(5):594-600. https://doi.org/10.1136/bjophthalmol-2015-307131
  13. Lee YJ, Yoon CH, Choi SJ, Kang YJ, Kim JK, Kwon BS, Lee YK, Nam KC. Perspective Diversity of Domestic Stakeholders on Medical Device Adverse Event Reporting. JBER. 2019;40:171-178.
  14. Mitchell DF, Amy JP, Jeffrey AT. Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment. J Gen Intern Med. 2007;23:57-63. https://doi.org/10.1007/s11606-007-0275-4
  15. James DC, Katherine EM, Peter JN. Medicare Covers The Majority Of FDA-Approved Devices And Part B Drugs, But Restrictions And Discrepancies Remain. HEALTH AFFAIRS. 2013;32(6):1109-1115. https://doi.org/10.1377/hlthaff.2012.1073
  16. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K061258. Accessed on 5 June 2017.
  17. KIM BG, Yang SJ. A Study on Improvement of Medical Deivce Management System in Clinical Perspective. Hannam journal of Law & Technology. 2019;25(4):3-36.