Japanese guidance for ventricular assist devices/total artificial hearts

Takashi Yamane*, Shunei Kyo, Hikaru Matsuda, Yusuke Abe, Kou Imachi, Toru Masuzawa, Takeshi Nakatani, Kazuhiro Sase, Koichi Tabayashi, Setsuo Takatani, Eisuke Tatsumi, Mitsuo Umezu, Toshie Tsuchiya

*Corresponding author for this work

Research output: Contribution to journalShort surveypeer-review

12 Citations (Scopus)

Abstract

To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology.

Original languageEnglish
Pages (from-to)699-702
Number of pages4
JournalArtificial Organs
Volume34
Issue number9
DOIs
Publication statusPublished - 2010 Sep
Externally publishedYes

Keywords

  • Evaluation criteria
  • Guidance
  • Total artificial heart
  • Ventricular assist device

ASJC Scopus subject areas

  • Bioengineering
  • Medicine (miscellaneous)
  • Biomaterials
  • Biomedical Engineering

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