Validating the accuracy of the Omron HBP-M4500 blood pressure measuring device according to the ISO81060-2:2018 + Amd 1:2020 protocol

Abstract

BACKGROUND:

Blood pressure (BP) naturally undergoes fluctuations and variations, particularly during anesthesia administration during surgery, hemodialysis, upper and lower gastrointestinal endoscopy, exercise testing, arterial and venous catheterization, and rehabilitation. These changes in BP may lead to life-threatening events.

OBJECTIVES:

The performance of the Omron HBP-M4500 device in monitoring blood pressure (BP) in the upper arm was validated according to the International Organization for Standardization (ISO) 81060-2:2018 $+$ amendment (Amd) 1:2020 protocol.

METHODS:

The device was used to assess 113 participants in the inflation mode, and 107 participants in the deflation mode. All the patients fulfilled the inclusion criteria, including the arm circumference range and systolic and diastolic BP levels, outlined in the protocol. Data validation and analysis were performed according to the manufacturer’s instructions.

RESULTS:

In criterion 1, the mean $\pm$ standard deviation (SD) values of the differences between the test device and reference BP were $-$ 0.6 $\pm$ 5.80/2.8 $\pm$ 6.78 mmHg (systolic/diastolic) and $-$ 1.0 $\pm$ 5.35/3.2 $\pm$ 6.52 mmHg for the inflation and deflation modes, respectively. These data fulfilled the ISO81060-2:2018 $+$ Amd1:2020 requirements of $\leqslant$ 5 $\pm\leqslant$ 8 mmHg. In criterion 2, the differences were $-$ 0.6 $\pm$ 4.44/2.8 $\pm$ 6.26 and $-$ 1.0 $\pm$ 3.84/3.2 $\pm$ 6.09 mmHg for the inflation and deflation modes, respectively, fulfilling criterion 2 with SD values of $\leqslant$ 6.91 and $\leqslant$ 6.87 for systolic BP and $\leqslant$ 6.34 and $\leqslant$ 6.14 for diastolic BP in the inflation and deflation modes, respectively. These two criteria were fulfilled in both studies.

CONCLUSION:

The Omron HBP-M4500 device, either in inflation or deflation mode, fulfilled the criteria outlined in the ISO protocol. Therefore, this device is valuable for BP measurement in clinical and hospital settings.

Keywords

Blood pressure monitoring device validation study international protocol

Get full access to this article

View all access options for this article.

References

Parati

Stergiou

Dolan

Bilo

. Blood pressure variability: Clinical relevance and application. J Clin Hypertens (Greenwich). 2018; 20(7): 1133-1137.

Di Iorio

Di Micco

Torraca

Sirico

Guastaferro

Chiuchiolo

, et al. Variability of blood pressure in dialysis patients: A new marker of cardiovascular risk. J Nephrol. 2013; 26(1): 173-182.

Williams

Mancia

Spiering

Agabiti Rosei

Azizi

Burnier

, et al. Authors/Task Force Members. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018; 36(10): 1953-2041.

Umemura

Arima

Asayama

Dohi

Hirooka

, et al. The japanese society of hypertension guidelines for the management of hypertension (JSH 2019). Hypertens Res. 2019; 42(9): 1235-1481.

The International Organization for Standardization (ISO). INTERNATIONAL STANDARD. Non – Invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. ISO 81060-3rd ed. 2018.11. Reference number ISO81060-2:2018(E). https://iso.org/standard/73339.html, accessed on Feb. 21, 2020.

The International Organization for Standardization (ISO). INTERNATIONAL STANDARD. Non – Invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. ISO 81060-Amendment 1 2020.01. Reference number ISO81060-2:2018/Amd. 1.2020(E). https://iso.org/standard/75432.html, accessed on Feb. 21, 2020.

Badnjević

Pokvić

Deumić

Bećirović

. Post-market surveillance of medical devices: A review. Technol Health Care. 2022; 30(6): 1315-1329.

Badnjević

. Evidence-based maintenance of medical devices: Current shortage and pathway towards solution. Technol Health Care. 2023; 31(1): 293-305.

Saito

Hishiki

Takahashi

. Validation of the Omron HBP-9031C professional office blood pressure monitor in the general population according to the ANSI/AAMI/ISO 81060-2:2013 protocol. J Hum Hypertens. 2020; 34(10): 735-738.

10.

Takahashi

Saito

Hishiki

. Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias. Blood Press Monit. 2021; 26(2): 156-159.

11.

Pan

Chen

Zhao

Sun

, et al. Evaluation of cuff deflation and inflation rates on a deep learning-based automatic blood pressure measurement method: A pilot evaluation study. Blood Press Monit. 2021; 26(2): 129-134.

12.

Glenning

Lam

Clarke

Bourne

Smolich

Cheung

MMH

, et al. Assessment of diastolic blood pressure with the auscultatory method in children and adolescents under exercise conditions. Hypertens Res. 2021; 44(8): 1009-1016.

13.

Stabouli

Chainoglou

Evripidou

Simão

Antza

Petrou

, et al. Comparison of validation protocols for blood pressure measuring devices in children and adolescents. Front Cardiovasc Med. 2022; 9: 1001878.

14.

Frick

Herberigs

Matsumura

Sarkis

Verberk

Wojcik

. Industry perspectives on the global use of validated blood pressure measuring devices. J Hum Hypertens. 2023; 37(2): 130-133.

15.

Stergiou

O’Brien

Myers

Palatini

Parati

Kollias

, et al. STRIDE BP Scientific Advisory Board. STRIDE BP international initiative for accurate blood pressure measurement: Systematic review of published validation studies of blood pressure measuring devices. J Clin Hypertens (Greenwich). 2019; 21(11): 1616-1622.