Perspectives of Global Standards on Validation of Blood Pressure Measuring Devices

Blood pressure (BP) measuring devices are essential tools across all areas of medicine, where BP is used as a vital sign for assessing cardiovascular status, guiding clinical decisions in acute medicine, critical care, and routine monitoring of hospitalized patients. International standards for BP measuring devices establish safety and accuracy criteria to ensure the reliability and usability of these instruments. The standardization of BP device validation protocols is vital to guarantee the accuracy and consistency of readings, which are crucial for effective medical decision-making. However, with the rapid advancements in the field of novel cuffless continuous or intermittent blood pressure monitoring devices, traditional validation standards for cuff-based devices are not applicable to cuffless systems. To address this, various organizations have established specific standards tailored for cuffless continuous blood pressure monitoring devices. Nevertheless, only 67 out of over 3,800 studies on the cuffless continuous BP devices (<2%) adopted the appropriate validation criteria, thereby compromising the accuracy and reliability of their reported results. This work presents a comparative analysis of validation protocols for BP measuring devices and provides guidance on the appropriate standards for different types of BP monitors, aims to highlight areas where standards might be strengthened or harmonized. The findings of this research are intended to contribute to the ongoing efforts to establish globally recognized, scientifically rigorous guidelines for the validation of BP measuring devices, fostering innovation and technological advances in this field over time.