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논문 기본 정보

자료유형
학술저널
저자정보
권범선 (동국대학교)
저널정보
대한의용생체공학회 의공학회지 의공학회지 제42권 제3호
발행연도
2021.1
수록면
86 - 93 (8page)

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The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital’ in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.
#Medical device #Oriental medicine #Safety #Adverse event #Monitoring

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참고문헌 (12)

참고문헌 신청
2019 / MEDICAL DEVICES ACT. Article 2 (Definitions) [Enforcement Date 24. Oct, 2019.] [Act No.16402, 23. Apr, 2019., Partial Amendment] google schola http://www.akomnews.com/bbs/board.php?bo_table=news&wr_id =39942 google schola Fitch Solutions, Worldwide Medical Devices Market Factbook, 2019.12,; EvaluateMedTech, World Preview 2018, Outlook to 2024, 2018.9 google schola http://www.monews.co.kr/news/articleView.html?idxno=214176 google schola Ministry of Food and Drug Safety / 2019 / Regulations on management of medical device safety informations including side effect google schola

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