Proposal of International Standards and Medical Approval for Cuffless Sphygmomanometer

2023 Fiscal Year Final Research Report

• Project/Area Number: 21K12760
• 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: Waseda University
• Principal Investigator: Tamura Toshiyo 早稲田大学, 次世代ロボット研究機構, その他(招聘研究員) (10142259)
• Project Period (FY): 2021-04-01 – 2024-03-31
• Keywords: レギュラトリサイエンス / 国際標準規格 / 医療機器承認 / カフレス血圧計 / ISO / IEEE

Outline of Final Research Achievements

Cuffless sphygmomanometers may be useful alternative blood pressure monitors for screening and home healthcare. The main requirements for these devices are accuracy in the resting state, accuracy during dynamic blood pressure changes, and long-term stability. Intermittent measurements can ensure that the accuracy of active measurements mirrors that of measurements in the resting and dynamic states. In this study, a new protocol is proposed to evaluate long-term stability based on a comparison with a medically approved cuff-based automated sphygmomanometer rather than an auscultatory sphygmomanometer. Dynamic changes in blood pressure are not usually assessed based on intermittent measurement. The validation testing focused on the accuracy of the over-the-counter cuffless sphygmomanometer in the resting state as well as the long-term stability of the device and these values　showed similar to those of the cuff-based sphygmomanometer.

Free Research Field

生体医工学

Academic Significance and Societal Importance of the Research Achievements

カフレス血圧計の国際標準化を目指し新しい提案を国内外に発表するとともに国際委員会に提案することにより、わが国のカフレス血圧計開発を推進することを考えた。提案した新しい規格は、健康管理機器としての血圧計の精度検証に役立つものと考える。血圧計のメーカーが使用するための、質の高いエビデンスに基づく基準を策定するためには、さらなる研究と議論を期待する。