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Improved accuracy for blood pressure monitors
Treatment for hypertension relies on early detection, and that depends on accurate blood pressure measurements using sphygmomanometers (blood pressure monitors). European directives require clinical trials prior to market entry for these instruments, involving costly tests on human subjects and allowing average errors of no more than ±5 mm Hg. However, most of the blood pressure devices on the market, known as automated oscillometric sphygmomanometers, undergo only limited accuracy checks and calibrations. Currently these checks are only performed at static pressure and just check the accuracy of the pressure sensor. The algorithm used for the determination of the systolic and diastolic pressure is ignored and consequently the accuracy of the measurands themselves is never examined.
EMPIR project Developing an infrastructure for improved and harmonised metrological checks of blood-pressure measurements in Europe (18RPT02, adOSSIG) has successfully built and tested an advanced oscillometric signal generator (aOSG). This instrument can accurately reproduce real-life oscillometric blood pressure signals and thus perform in-depth tests of a sphygmomanometer’s accuracy. These tests meet the requirements of the newly published standard ISO/TS 81060-5, and were performed using a recording unit also built within this EMPIR project.
Following successful initial tests, the devices were sent to project partners for further studies. Using the newly developed aOSG, the consortium is developing innovative guidelines for the evaluation of automated sphygmomanometers. To ensure a world-wide dissemination of these, the work of the consortium will contribute to new OIML Guidelines. In addition, the work of this EMPIR project will contribute to a new OIML Recommendation covering the requirements for the evaluation of non-invasive blood pressure (commercial and non-commercial) simulators used for the testing of automated non-invasive sphygmomanometers. The development of both the Guideline and the Recommendation will start in January 2022.
Project Coordinator Václav Sedlák from CMI said
‘Metrology for blood pressure measurements is usually taken as a mere supplement to classical pressure metrology and as a result, there are many undeveloped national metrology laboratories in this field. Our project focuses on improving the whole traceability chain with the aOSG as the main technical objective. This will allow easier and more affordable in-depth performance checks of automated sphygmomanometers. Furthermore, the aOSG has a potential to be used in development process of sphygmomanometers for new and small manufacturers, offering them a chance to access the market at lower costs and thus encouraging innovation. Parallel to the technical work, our project focuses also on the capacity building and cooperation through a smart specialisation concept by establishing joint research capacity with competence centre and working group on blood pressure metrology. This enables metrology for advanced blood pressure measurements to be accessible to a broader range of countries. Problems with traceability of current and future devices will be solved not by individual laboratories, but by sharing knowledge and thus overcoming the problem of equally undeveloped NMIs.This work of this project will help the clinical trials by replacing particular hard-to-find subjects (such as patients with very high blood pressure) required by the relevant standards with the aOSG developed by this project, enabling lower development costs and empowering monitoring bodies to ensure market quality.’
This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.
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