A model for early failure prediction of blood pressure measurement devices in a stepped validation approach.

ABSTRACT: Blood pressure monitoring (BPM) devices have to be validated according to strict international validation protocols. Each protocol requests a specific number of participants to be included. All protocols use vast amounts of resources, as three people have to be present for every measurement, making trials costly, especially when the manufacturer has no intention to execute a validation study, reflected in the low share of validated in the commercially available BPM devices. The aim of our study was to develop criteria, which could detect low accuracy devices that could not pass a validation protocol early in the course of the validation process. The 2010 European Society of Hypertension International Protocol (ESH-IP) and the Universal Standard for Validation of BPM devices (AAMI/ESH/ISO)

SUBMITTER: Vischer AS 

PROVIDER: S-EPMC9106088 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature