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Validated devices listing – Principles and procedure

The STRIDE BP Validated Devices Lists include only 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. newly performed independent validation studies (complete reports signed by the principal investigator),
  3. data on new devices provided by manufacturers showing ‘equivalence’ with previously validated devices.

VALIDATION PROTOCOLS

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

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 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 1 successful validation study published within 10 years before the current year.
 

HOME MONITORS

1. Upper-arm cuff device.
2. At least 1 successful validation study published within 10 years before the current year.
3. Automated storage of multiple readings, or mobile phone, PC or internet link connectivity enabling data transfer.

AMBULATORY MONITORS

1. Upper-arm cuff device.
2. At least 1 successful validation study published within 10 years before the current year.
 

EQUIVALENCE CRITERIA FOR NEW DEVICES COMPARED TO PREVIOUSLY VALIDATED ONES

STRIDE BP VALIDATED DEVICES LISTING PROCEDURE

Device data to be considered
  • Published validation studies;
  • Data of newly performed validation studies;
  • Data on devices showing ‘equivalence’ with validated 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 fulfill the requirements below are listed as ‘Preferred’ devices.

  1. Upper-arm cuff devices.
  2. At least one STRIDE BP approved successful validation study published within 10 years before the current year.
  3. Automated storage of multiple readings, or mobile phone or PC link connectivity enabling data transfer (only for home monitors).
Validation Studies Review Management System
Administrator

New device/study data entry or New equivalence device data entry devices.

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