Development, evaluation, standard and regulation of cuffless blood pressure

2021 Fiscal Year Final Research Report

• Project/Area Number: 17K01440
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical engineering assessment
• 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): 2017-04-01 – 2022-03-31
• Keywords: レギュラトリーサイエンス / カフレス血圧計 / 標準規格 / 医療機器承認

Outline of Final Research Achievements

Aims of this research are 1) To develop a cuffless sphygmomanometer and evaluate the device with static accuracy and long-term stability. 2) To propose a new standard of cuffless sphygmomanometer and 3) To discuss a suitable protocol to evaluate the cuffless sphygmomanometer. The results of this research show 1) developed cuffless sphygmomanometer had a good accuracy within 5±8 mmHg which is enough accuracy of cuff-based sphygmomanometer. 2) We proposed a standard of cuffless sphygmomanometer to ISO.TC121/S3/JWG7, but the proposal was rejected. 3) to discuss the regulatory authority of PMDA, the protocol of cuffless sphygmomanometer was good and the obtained accuracy, is acceptable, but the that of long-term stability continuously needed to improved.
In conclusion, the cuffless sphygmomanometer may use as an alternative blood pressure monitor and the accuracy, stability and reliability tests are required to approve as medical device.

Free Research Field

生体計測

Academic Significance and Societal Importance of the Research Achievements

カフレス血圧計は廉価で取扱いが容易で、精度、安定性が保証されれば、日常生活における在宅での健康管理や健診時のスクリーニングに最適である。今回の研究では、精度については満足できる結果を得ることはできた。今後医療機器としての承認に向けて安定性の検証を行い、医療機器として承認されれば、健康管理面での学問的、社会的意義は大きい。