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:
- validation studies published as full papers in peer-review PubMed journals (monthly literature search),
-
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):
- 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)*
*New validation studies should use the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1, 2020-01.
INTERNAL AND EXTERNAL REVIEW OF VALIDATION STUDIES
- For each validation study a ‘STRIDE BP Validation Study Checklist Report’ is developed, which is specific to the validation protocol (and version) and the study population, and verifies key methodological aspects and results (device type, population, sample size, selection criteria, pass/fail criteria, conclusion, etc).
- Two members of the STRIDE BP team independently prepare a ‘Validation Study Checklist Report’ for each study. Any disagreement between them is resolved by the STRIDE BP Executive Management Board and a final report is generated (see figure end of page).
- Each validation study paper and the accompanying ‘STRIDE BP Validation Study Checklist Report’ are reviewed independently by two members of the STRIDE BP Scientific Advisory Board. Any disagreement between them is resolved by the STRIDE BP Executive Management Board. Devices approved are posted to the STRIDE BP website (see figure end of page).
STRIDE BP CRITERIA FOR VALIDATION STUDY APPROVAL/ REJECTION
Criteria for validation study rejection
- Validation pass criteria not fulfilled or not reported.
- Smaller sample size.
- Violation in the procedure or sequence of test and reference device blood pressure measurements, or the number of observers.
- Validation in pregnancy without data in women with hypertension and with preeclampsia.
Protocol violations which are accepted
- Minor violation in age and/or gender criteria.
- Minor blood pressure distribution criteria violation.
- Blood pressure level criteria not reported but grossly visible in scatterplot.
- Minor cuff distribution criteria (if applicable).
STRIDE BP ‘VALIDATED’ AND ‘PREFERRED’ DEVICES
- Devices that successfully pass the above described procedure will be listed on the STRIDE BP website as ‘VALIDATED’ devices.
- Validated devices that fulfil the following requirements will be listed on the STRIDE BP website as ‘PREFERRED’ devices, suggesting that these are the most appropriate ones to use.
OFFICE MONITORS
HOME MONITORS
AMBULATORY MONITORS
CRITERIA FOR EQUIVALENT BLOOD PRESSURE MEASUREMENT FUNCTION OF NEW DEVICES COMPARED TO PREVIOUSLY VALIDATED ONES
- A new device can be included in the STRIDE BP Validated Devices Lists without requiring a new validation study when there is documentation that it has ‘Equivalent Blood Pressure Measurement Function’ to another ‘Reference’ device which has a validation study approved by the STRIDE BP.
- For the Equivalence procedure the device manufacturer submits an online ‘STRIDE BP Checklist for Equivalent Measurement Function Device or Identical Device’ including information on the ‘Equivalent’ and the ‘Reference’ device and their differences, signed by the manufacturer CEO.
- Devices with differences in (i) signal sensor (transducer) and processing, (ii) blood pressure estimation algorithm, (iii) inflation or deflation system, or (iv) cuff characteristics, typically are not regarded as Equivalent, unless any such differences can be fully justified in the application.
- The ‘STRIDE BP Checklists’ are subjected to Internal (2 Reviewers) and External Review (2 Advisory Board members), as described above for original validation studies (see figure end of page). Devices approved by the Advisory Board as ‘equivalent’ are posted to the STRIDE BP website.
- Manufacturers submit to STRIDE BP data on their ‘Equivalent’ devices online at https://stridebp.org/login-form after obtaining a company username and password from the STRIDE BP administrator (email: manufacturer@stridebp.org).
CRITERIA FOR IDENTICAL DEVICES TO PREVIOUSLY VALIDATED ONES
- A device may be marketed with different model names in different countries. This ‘Identical’ device can be included in the STRIDE BP Validated Devices Lists if documentation is provided that it has no differences from a device already approved by the STRIDE BP.
- For the ‘Identical device’ procedure the device manufacturer needs to submit an online ‘STRIDE BP Checklist for Equivalent Measurement Function Device or Identical Device’ form signed by the company CEO, providing information on the ‘Identical’ and the ‘Reference’ device and a statement that there are no differences between them.
- The ‘STRIDE BP Checklists’ are subjected to Internal (2 Reviewers) and External Review (2 Advisory Board members), as described above for original validation studies (see figure end of page). Devices approved by the Advisory Board as ‘Identical’ are posted to the STRIDE BP website.
- Manufacturers submit to STRIDE BP data on their ‘Identical’ devices online at https://stridebp.org/login-form after obtaining a company username and password from the STRIDE BP administrator (email: manufacturer@stridebp.org).
STRIDE BP VALIDATED DEVICES LISTING PROCEDURE
- 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.
- 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.
- Upper-arm cuff devices.
- 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).
- Automated storage of multiple readings, or mobile phone or PC link connectivity enabling data transfer and objective reporting (only for home monitors).
New device/study data entry, or Equivalent/Identical device data entry.
Independent review and checklist by 2 Reviewers
Final Internal Review - Submission to Advisory Board
Independent review and approval by 2 Advisory Board members
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.