JOINT INITIATIVE WITH

Validated devices listing – Principles and procedure

The STRIDE BP Validated Devices Lists include only blood pressure measuring devices adequately validated and approved by the STRIDE BP Advisory Board and therefore recommended for clinical use.

The STRIDE BP Validated Devices Lists are developed using data from:

  1. validation studies published as full papers in peer-review PubMed journals,
  2. declarations by manufacturers providing data on new devices showing ‘Equivalent measurement function’ or demonstrating that are ‘Identical’ with devices approved by the STRIDE BP. *

    *Manufacturers can submit data for ‘Equivalent’ or ‘Identical’ devices using an online application system.

At the present time STRIDE BP does not consider cuffless blood pressure measuring devices. The 2021 European Society of Hypertension Practice Guidelines for Blood Pressure Measurement recommend that cuffless devices should not be used for diagnostic or treatment decisions, as the established validation protocols are inadequate for such devices and their accuracy remains uncertain.

VALIDATION PROTOCOLS

Validation studies of blood pressure monitors performed using the following protocols* are considered (https://www.ncbi.nlm.nih.gov/pubmed/30003697):

*Validations reported after December 2019 should use the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

INTERNAL AND EXTERNAL REVIEW OF VALIDATION STUDIES

STRIDE BP CRITERIA FOR VALIDATION STUDY APPROVAL/ REJECTION

Criteria for validation study rejection

  1. Validation pass criteria not fulfilled or not reported.
  2. Smaller sample size.
  3. Violation in the procedure or sequence of test and reference device blood pressure measurements, or the number of observers.
  4. Validation in pregnancy without data in women with hypertension and with preeclampsia.

Protocol violations which are accepted

  1. Minor violation in age and/or gender criteria.
  2. Minor blood pressure distribution criteria violation.
  3. Blood pressure level criteria not reported but grossly visible in scatterplot.
  4. Minor cuff distribution criteria (if applicable).

 

STRIDE BP ‘VALIDATED’ AND ‘PREFERRED’ DEVICES

OFFICE MONITORS

1. Upper-arm cuff device.
2. At least one STRIDE BP approved validation study, which was published within the last 10 years and used a recent protocol (AAMI/ESH/ISO 2018; ANSI/AAMI/ISO 2013 or 2009; ESH-IP 2010).
 

HOME MONITORS

1. Upper-arm cuff device.
2. At least one STRIDE BP approved validation study, which was published within the last 10 years and used a recent protocol (AAMI/ESH/ISO 2018; ANSI/AAMI/ISO 2013 or 2009; ESH-IP 2010).
3. Automated storage of multiple readings, or mobile phone, PC or internet link connectivity enabling data transfer and objective reporting.

AMBULATORY MONITORS

1. Upper-arm cuff device.
2. At least one STRIDE BP approved validation study, which was published within the last 10 years and used a recent protocol (AAMI/ESH/ISO 2018; ANSI/AAMI/ISO 2013 or 2009; ESH-IP 2010).
 

CRITERIA FOR EQUIVALENT BLOOD PRESSURE MEASUREMENT FUNCTION OF NEW DEVICES COMPARED TO PREVIOUSLY VALIDATED ONES

CRITERIA FOR IDENTICAL DEVICES TO PREVIOUSLY VALIDATED ONES

STRIDE BP VALIDATED DEVICES LISTING PROCEDURE

Device data to be considered
  • Published validation studies;
  • Data on devices showing ‘equivalent measurement function’ with STRIDE BP approved devices.
  • Data on devices showing that they are ‘Identical’ with STRIDE BP approved devices.
Validation Protocols
  • AAMI (Association for the Advancement of Medical Instrumentation)
  • BHS (British Hypertension Society)
  • ESH-IP (European Society of Hypertension International Protocol)
  • ISO (International Organization for Standardization)
  • AAMI/ISO
  • AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Validated blood pressure measuring devices that fulfil the requirements below are listed as ‘Preferred’ devices.

  1. Upper-arm cuff devices.
  2. At least one STRIDE BP approved validation study, which was published within the last 10 years and used a recent protocol (AAMI/ESH/ISO 2018; ANSI/AAMI/ISO 2013 or 2009; ESH-IP 2010).
  3. Automated storage of multiple readings, or mobile phone or PC link connectivity enabling data transfer and objective reporting (only for home monitors).
Validation Studies Review Management System
Administrator

New device/study data entry, or Equivalent/Identical device data entry.

Internal Review

Independent review and checklist by 2 Reviewers

Administrator

Final Internal Review - Submission to Advisory Board

External Review

Independent review and approval by 2 Advisory Board members

Administrator

Final External Review - Publish on the STRIDE BP website

References

1. Stergiou GS, O'Brien E, Myers M, Palatini P, Parati G; STRIDE BP Scientific Advisory Board. STRIDE BP: an international initiative for accurate blood pressure measurement. J Hypertens. 2019 Oct 30. Epub ahead of print.

https://www.ncbi.nlm.nih.gov/pubmed/31688462

2. Stergiou GS, O'Brien E, Myers M, Palatini P, Parati G, Kollias A, Birmpas D, Kyriakoulis K, Bountzona I, Stambolliu E, Anagnostopoulos I, Karpettas N, Menti A; STRIDE BP Scientific Advisory Board. STRIDE BP international initiative for accurate blood pressure measurement: Systematic review of published validation studies of blood pressure measuring devices. J Clin Hypertens 2019;21:1616-22.

https://www.ncbi.nlm.nih.gov/pubmed/31654494.