To develop scientific consensus recommendations for the optimal design and functions of different types of blood pressure (BP) measuring devices used in clinical practice for the detection, management, and long-term follow-up of hypertension.
A scientific consensus meeting was performed by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability and STRIDE BP (Science and Technology for Regional Innovation and Development in Europe) during the 2022 Scientific Meeting of the ESH in Athens, Greece. Manufacturers were also invited to provide their feedback on BP device design and development. Thirty-one international experts in clinical hypertension and BP monitoring contributed to the development of consensus recommendations on the optimal design of BP devices.
International consensus was reached on the requirements for the design and features of five types of BP monitors, including office (or clinic) BP monitors, ambulatory BP monitors, home BP monitors, home BP telemonitors, and kiosk BP monitors for public spaces. For each device type \"essential\" requirements (must have), and \"optional\" ones (may have) are presented, as well as additional comments on the optimal device design and features.
These consensus recommendations aim at providing manufacturers of BP devices with the requirements that are considered mandatory, or optional, by clinical experts involved in the detection and management of hypertension. They are also directed to administrative healthcare personnel involved in the provision and purchase of BP devices so that they can recommend the most appropriate ones.

In China, automated blood pressure monitors have been readily available for home use. Home blood pressure monitoring has been indispensable in the management of hypertension. There is therefore a need to establish guidelines for home blood pressure monitoring on the basis of the 2012 consensus document. In this guidelines document, the committee put forward recommendations on the selection and calibration of blood pressure measuring devices, the frequency (times) and duration (days) of blood pressure measurement, and the diagnostic threshold of home blood pressure.

Unlike other international guidelines but in accord with the earlier Japanese Society of Hypertension (JSH) guidelines, the 2019 JSH guidelines (\"JSH 2019\") continue to emphasize the importance of out-of-office blood pressure (BP) measurements obtained with a home BP device. Another unique characteristic of JSH 2019 is that it sets clinical questions about the management of hypertension that are based on systematic reviews of updated evidence. JSH 2019 states that individuals with office BP < 140/90 mm Hg do not have normal BP. The final decisions regarding the diagnosis and treatment of hypertension should be performed based on out-of-office BP values together with office BP measurements. For hypertensive adults with comorbidities, the office BP goal is usually <130/80 mm Hg and the home BP goal is <125/75 mm Hg. Recommendations of JSH 2019 would be valuable for not only Japanese hypertensive patients but also Asian hypertensive patients, who share the same features including higher incidence of stroke compared with that of myocardial infarction and a steeper blood pressure-vascular event relationship.

OBJECTIVE: We evaluated the performance of the Omron HEM-9700T, an automatic upper-arm-type device for the self-measurement of blood pressure (BP), in the sitting and supine positions according to the ANSI/AAMI/ISO81060-2:2013 guidelines.
METHODS: We screened 106 participants for the validation study in both positions. After excluding 21 participants, a total of 85 participants [38 (44.7%) men; 47 (55.3%) women] with mean±SD age of 54.5±12.2 years (range: 21-78 years) were included. Their arm circumference was 27.5±1.4cm (range: 17.9-40.8cm). The arm circumference distribution met the ANSI/AAMI/ISO81060-2:2013 requirement. The participants\' BP measurements alternated between the use of a conventional mercury sphygmomanometer and the automatic device according to the ANSI/AAMI/ISO81060-2:2013 guidelines to measure their BP.
RESULTS: The mean differences between reference BPs and HEM-9700T readings in the sitting and supine positions were -0.6±6.4/1.3±5.5 and -1.0±6.2/1.9±5.4mmHg for systolic BP/diastolic BP, respectively.
CONCLUSIONS: The Omron HEM-9700T fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines for both the sitting and supine positions.

BACKGROUND: Allowing patients to measure their blood pressure (BP) at home will be the standard for evaluating the disease state as the process of clinical diagnosis, and it is recognized as having great clinical utility. To measure BP as accurately as possible, innovative techniques have been incorporated into home BP measurement devices.
OBJECTIVE: The present study aimed to evaluate the performance of the Omron BP765 (HEM-7311-ZSA) and the Omron BP760N (HEM-7320-Z), which are equipped with functions to detect irregular pulses and arm movement that lead to inaccurate BP readings.
METHODS: A team of three trained medical doctors validated the performance of these devices by comparing the data alternatively obtained from both devices with those from a standard mercury sphygmomanometer.
RESULTS: The magnitude of the difference in BP readings between the tested device and the standard mercury sphygmomanometer in the Omron BP765 and BP760N was within the range of ±3 mmHg (mean) allowed by the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2009 guidelines.
CONCLUSIONS: The Omron BP765 and BP760N were found useful for the self-measurement of BP at home, and their performance fulfilled the requirement of the ANSI/AAMI/ISO 81060-2:2009 guidelines.

The current ISO Standard is accepted as the National Standard in almost every industrialized nation. An overview of the most recently adopted standards is provided. Standards writing groups including the Advancement of Medical Instrumentation Sphygmomanometer Committee and ISO JWG7 are working to expand standardized evaluation methods to include the evaluation of devices intended for use in environments where motion artifact is common. An Association for the Advancement of Medical Instrumentation task group on noninvasive blood pressure measurement in the presence of motion artifact has published a technical information report containing research and standardized methods for the evaluation of blood pressure device performance in the presence of motion artifact.

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