Validation of the FM-800 Ambulatory Blood Pressure Monitor According to the Association for the Advancement of Medical Instrumentation Criteria and the International Protocol

Abstract

To validate the FM-800 device (Fukuda Denshi Co., Ltd., Tokyo, Japan) for ambulatory blood pressure monitoring (ABPM), this validation study was performed based on the European Society of Hypertension (ESH) protocol and the Association for the Advancement of Medical Instrumentation (AAMI) criteria. Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2) in the ESH protocol. The device was tested on 85 participants according to the AAMI criteria, which require a mean device-observers discrepancy within 5 ± 8 mmHg. The tested device passed all the criteria for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), and for the Korotkoff and oscillometric methods according to the ESH protocol. The test device also fulfilled the AAMI accuracy criteria for the 85 participants; the mean ± SD of the SBP//DBP differences between the tested device and the mean of the observer readings were –1.1 ± 4.2//–0.8 ± 4.2 mmHg for the Korotkoff method and 2.3 ± 3.9//–2.3 ± 3.9 mmHg for the oscillometric method. The FM-800 device for ABPM passed all the validation criteria of the ESH and AAMI and can, therefore, be recommended for clinical use in an adult population.

• ambulatory blood pressure monitoring (ABPM)
• validation
• accuracy

ACKNOWLEDGMENTS

This work was funded by a grant from Fukuda Denshi Co., Ltd., Tokyo, Japan. The authors gratefully acknowledge the technical assistance of Koji Imai, Shinichi Kawamura (Fukuda Denshi Co., Ltd., Tokyo, Japan). This study was also supported in part by Grants for Scientific Research (15790293, 16590433, 17790381, 18390192, 18590587, 19590929, and 19790423) from the Ministry of Education, Culture, Sports, Science, and Technology, Japan; Grant-in-Aid (H17-Kenkou-007, H18‐‐Junkankitou [Seishuu]-Ippan-012, and H20-Junkankitou [Seishuu]-Ippan-009, 013) from the Ministry of Health, Labor and Welfare, Health and Labor Sciences Research Grants, Japan; Grant-in-Aid for Japan Society for the Promotion of Science (JSPS) fellows (16.54041, 18.54042, 19.7152, 20.7198, 20.7477, and 20.54043); Health Science Research Grants and Medical Technology Evaluation Research Grants from the Ministry of Health, Labor and Welfare, Japan; Japan Atherosclerosis Prevention Fund; Uehara Memorial Foundation; Takeda Medical Research Foundation; National Cardiovascular Research Grants: and Biomedical Innovation Grants.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.