A systematic review of blood pressure monitor validation studies

Rosina Cross1, Ian Porter1, Sinead McDonagh1

  • 1University of Exeter, Exeter, UK.

Insights

Accurate blood pressure (BP) monitoring is crucial for hypertension care. Many published BP monitor validations, even those using universal protocols, fail to meet essential criteria, impacting reliable hypertension management.

Area of Science:

  • Cardiology
  • Medical Devices
  • Health Informatics

Background:

  • Accurate blood pressure (BP) measurement is essential for effective hypertension management.
  • Validated BP monitors ensure reliable readings, guiding clinical decisions and public health initiatives.
  • The British and Irish Hypertension Society provides an independent list of validated BP monitors.

Purpose of the Study:

  • To review current BP monitor validation protocols and their adherence to the 2018 universal standard.
  • To assess the proportion of recent BP monitor validation studies that meet established protocol criteria.

Main Methods:

  • Systematic review of Medline and Embase databases for BP monitor validation studies published from 2018 to September 2025.
  • Independent screening of citations and full texts by two authors.
  • Independent data extraction and review against protocol criteria checklists.

Main Results:

  • Of 197 device validation studies reviewed, 104 (63%) utilized universal protocols.
  • While 93% of validations were reported as successful by authors, only 74% met all protocol criteria upon review.
  • A significant 26% of published successful validations were deemed inadequate due to unmet criteria or protocol violations.

Conclusions:

  • Current journal peer-review processes for BP monitor validation studies show inadequacies.
  • Impartial guidance is necessary for healthcare professionals, purchasers, and the public regarding BP monitor accuracy.
  • Ensuring adherence to validation protocols is critical for reliable hypertension care.
Abstract

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