2023 Fiscal Year Final Research Report

Development of infrastructure for the use of donated cadavers in medical device development

Research Project

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Project/Area Number	21K12746
Research Category	Grant-in-Aid for Scientific Research (C)
Allocation Type	Multi-year Fund
Section	一般
Review Section	Basic Section 90140:Medical technology assessment-related
Research Institution	Hokkaido University
Principal Investigator	Toshiaki Shichinohe 北海道大学, 医学研究院, 准教授 (70374353)
Co-Investigator(Kenkyū-buntansha)	平野聡北海道大学, 医学研究院, 教授 (50322813) 渡辺雅彦北海道大学, 医学研究院, 特任教授 (70210945) 佐藤典宏北海道大学, 大学病院, 教授 (50360912) 渡邊祐介北海道大学, 大学病院, 特任講師 (90789405) 岡本吉弘国立医薬品食品衛生研究所, 医療機器部, 室長 (40776027)
Project Period (FY)	2021-04-01 – 2024-03-31
Keywords	cadaver study / 医療機器開発 / 献体
Outline of Final Research Achievements	In 2012, Guidelines for cadaver dissection in education and research of clinical medicine was published, which allowed the use of cadavers for research purposes, but there was no practical platform in Japan. The purpose of this study was to examine appropriate implementation methods in accordance with laws, regulations, and guidelines, and to present a draft guidance. The Center for Medical Device Development in Hokkaido University Hospital conducted 10 cadaver trials during the period and summarized the issues. In addition, the preparation of draft guidance, which is one of the objectives of this research, will be handed over to the 2023-4 AMED project "Development of Guidance for the Use of Cadavers in Medical Device Development" (Representative: Toshiaki Shichinohe), and will be made public from there.
Free Research Field	医療機器開発
Academic Significance and Societal Importance of the Research Achievements	本研究の実施により、これまで我が国に実施基盤がなかった献体を使用した医療機器開発の重要性が認識され、複数の大学で実施されるようになった。また、マスメディアの取材を受けることで、献体登録者と社会からの理解が得られるようになった。今後は広く社会と献体登録者の協力を得て、高度な医療の普及や、国内の産業振興に資する研究開発が推進することに期待したい。