Related Experiment Video
Updated: Aug 13, 2025
Measuring the Carotid to Femoral Pulse Wave Velocity Cf-PWV to Evaluate Arterial Stiffness
Published on: May 3, 2018
Validations of Blood Pressure Measuring Devices Using Recognized Protocols
Victoria Mazoteras-Pardo1, Sagrario Gómez-Cantarino1, Miguel Ramírez-Jiménez2
1Research Group "ENDOCU", Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing of Toledo, University of Castilla-La Mancha, 45071 Toledo, Spain.
Insights
Accurate blood pressure monitoring is crucial. While most devices lack validation, the study found few validated by the demanding 2018 universal standard, highlighting a need for more rigorous testing, especially for new technologies.
Area of Science:
- Cardiovascular Health
- Medical Device Technology
- Hypertension Management
Background:
- Self-measurement of blood pressure is essential for managing hypertension, a global health priority.
- Accurate readings require devices validated by recognized protocols, yet most available devices are not.
- Current validation protocols include the 2010 European Society of Hypertension (ESH) revision and the 2018 AAMI/ESH/ISO universal standard.
Purpose of the Study:
- To identify blood pressure monitoring devices validated according to established protocols.
- To assess the extent of device validation using the 2010 ESH and 2018 AAMI/ESH/ISO standards.
Main Methods:
- A narrative review of blood pressure device validation studies was performed.
- Literature search conducted on the PubMed database.
- 37 studies were included from an initial 52 records.
Main Results:
- Most validations followed the older 2010 ESH protocol; only six studies adhered to the more stringent 2018 universal standard.
- Validated devices were predominantly automated oscillometric sphygmomanometers for the general population.
- Validation extended to wrist devices, new technologies, and specific populations (obese, pregnant, children).
Conclusions:
- The 2018 AAMI/ESH/ISO universal standard is considered the benchmark for blood pressure device validation.
- There is a critical need for increased device validations adhering to the 2018 standard.
- Further validation of emerging technologies is essential to ensure accuracy in the evolving market.
Abstract:
Preventing, diagnosing, and controlling high blood pressure is a global health priority. The self-measurement of blood pressure is therefore fundamental and should be done with devices validated by recognized protocols, although most are not. The most widely used and current protocols are the 2010 European Society of Hypertension (ESH) revision and the 2018 Association for the Advancement of Medical Instrumentation (AAMI)/ ESH/ the International Organization for Standardization (ISO) universal standard, respectively. The aim of this study was to find out which blood pressure measuring devices have been adequately validated by the above protocols. A narrative review of blood pressure device validations was conducted by searching the PubMed database. From 52 records identified, 37 studies were included. Most validations follow the 2010 revision and only six follow the 2018 protocol, which is more demanding. Almost all validated sphygmomanometers are automated oscillometric sphygmomanometers in the general population. Wrist devices and devices combining new technologies are also validated, as well as in specific populations, such as the obese, pregnant women, or children. There is sufficient evidence to confirm that the universal AAMI/ ESH/ISO standard is considered the protocol of the century. However, it is necessary to increase the number of validations following it and, above all, validations of the new technologies that are invading the current market.
More Related Videos
Related Concept Videos
01:30Equipments Used To Measure Blood Pressure
This invasive approach involves cannulating a peripheral artery. During each cardiac contraction, pressure generates mechanical motion within the catheter, transmitted through rigid, fluid-filled tubing to a transducer. This transducer converts mechanical motion into electrical signals displayed as waveforms on a monitor. An automatic flushing system prevents blood backflow. Due to the potential risk of unexpected arterial blood loss, this method is primarily used in intensive...
01:25Errors occurring during blood pressure monitoring
Several factors...
01:17Measurement of Blood Pressure
01:21Sites for measruring blood pressure
The Brachial Artery: Primary Site for Blood Pressure Measurement
01:28Special considerations while measuring blood pressure
Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.
01:10Pre-Procedural Guidelines for Assessing Blood Pressure