Key result
A majority of automated non-invasive blood pressure device models available on the European Union market were not validated by clinical trial to one of the recognized protocols.
Cross-Sectional (n=116)
A majority of automated non-invasive blood pressure devices available on the EU market lack clinical validation according to recognized protocols.
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Clinicians should verify validation status before device selection; leaves open the real-world accuracy of unvalidated models.
Sims et al. (2005) conducted a cross-sectional in Automated non-invasive blood pressure devices (n=116). Automated non-invasive blood pressure devices was evaluated on Clinical validation and CE marking of automated non-invasive blood pressure devices. A majority of automated non-invasive blood pressure device models available on the European Union market were not validated by clinical trial to one of the recognized protocols.
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