Why the study?
Clinical investigation of automatic sphygmomanometers is costly and time-consuming, requiring a way to ascertain the accuracy of blood pressure simulators as an alternative.
A newly developed statistical procedure based on ISO 13528:2015 is suitable for determining the accuracy of blood pressure simulators, offering a potential alternative to costly clinical investigations for automatic sphygmomanometers.
Supports further evaluation of simulation-based accuracy checks for sphygmomanometers; does not yet justify replacing clinical validation studies.
To be used in the diagnosis and monitoring of hypertension, automatic sphygmomanometers must undergo clinical investigation. This is a time-consuming and costly process, which is why it is not conducted for every manufactured sphygmomanometer. In this context, blood pressure simulators can serve as an alternative, provided there is a way to ascertain their accuracy and this article addresses that situation. Utilizing statistical concepts associated with proficiency tests (ISO 13528:2015), a procedure was developed to determine the accuracy of simulators based on the oscillometric method. The procedure was evaluated through a simulation involving 100,000 iterations. The results indicate that the procedure is suitable, enabling its use for evaluating the measurement error of automatic sphygmomanometers.
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Farias et al. (2024) studied this question.
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