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 Scientific 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 (monthly literature search).
2. new unpublished validation studies with research data submitted directly to STRIDE BP by the study principal investigator.
3. declarations by manufacturers providing data on new devices showing ‘Equivalent measurement function’ or demonstrating that are ‘Identical’ with devices approved by the STRIDE BP.

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):

*Starting from Jan 2024, new validation studies must use the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1, 2020-01.

NEW UNPUBLISHED VALIDATION DATA SUBMITTED ON STRIDE BP

• Research data of new unpublished validation studies can be submitted directly to STRIDE BP using a standard application form.
• The Principal Investigator of the Validation Study must submit to STRIDE BP detailed information for the validation study including (i) methodology, (ii) results and plots, (iii) device photos, (iii) cuffs’ photos.
• A fee is required for the STRIDE BP review and presentation of the data.
• For information on the submission and review process, please contact the STRIDE BP administrator at manufacturer@stridebp.org.

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, cuffs, 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 internal 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 at least three 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).
• The entire STRIDE BP review process is performed through the STRIDE BP Online Review Platform which stores the database of all the validation studies and the results of the internal and external reviews and automatically transfers new information to the STRIDE BP website.

STRIDE BP CRITERIA FOR VALIDATION STUDY APPROVAL/ REJECTION

STRIDE BP ‘VALIDATED’ AND ‘PREFERRED’ DEVICES

• Devices that successfully pass the STRIDE BP review procedure as described above are listed on the STRIDE BP website as ‘VALIDATED’ devices.
• Validated devices that fulfil the following requirements are listed on the STRIDE BP website as ‘PREFERRED’ devices, suggesting that these are the most appropriate ones to use.

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 been approved by STRIDE BP.
• For an ‘Equivalent’ device to be considered by STRIDE BP, the device manufacturer must submit to STRIDE BP detailed information for the ‘Equivalent’ and the ‘Reference’ device, including (i) technical information, (ii) device photos, (iii) cuffs’ photos, (iv) user manual, and (v) link to manufacturer website with device information.
• Devices with differences in (i) signal sensor (transducer) and processing, (ii) blood pressure estimation algorithm, (iii) inflation or deflation system, (iv) cuff size, shape, rigid vs. soft cuff, or (v) tubeless device or with tubes, typically are not regarded as ‘Equivalent’, unless any such differences can be fully justified in the application.
• Manufacturers can submit to the STRIDE BP Online Review Platform data on an ‘Equivalent’ device for review, after obtaining a password by the STRIDE BP administrator at manufacturer@stridebp.org. A fee must be paid to STRIDE BP for reviewing a new ‘Equivalent’ device submission, irrespective of whether the device will be eventually approved or rejected by STRIDE BP.
• The ‘Equivalent’ device submissions are subjected to Internal Review (by 3 independent Reviewers) and External Review (by at least 3 members of the STRIDE BP Scientific Advisory Board) through the STRIDE BP Online Review Platform, as described above for original validation studies (see figure end of page). Devices approved by the STRIDE BP Scientific Advisory Board as ‘Equivalent’ are posted to the STRIDE BP website.

CRITERIA FOR ‘IDENTICAL’ DEVICES TO PREVIOUSLY VALIDATED ONES

• A device may be marketed with different model names in different countries. Thus, an ‘Identical’ device can be listed at the STRIDE BP website if there is documentation by the manufacturer that there are no differences from a device already approved by the STRIDE BP (‘Reference’ device).
• For an ‘Identical’ device to be considered by STRIDE BP, the device manufacturer must submit to STRIDE BP detailed information for the ‘Identical’ and the ‘Reference’ device, including (i) technical information, (ii) device photos, (iii) cuffs’ photos, (iv) user manual, and (v) link to manufacturer website with device information.
• Devices with any differences apart from model name typically are not regarded as ‘Identical’, unless any such differences can be fully justified in the application.
• Manufacturers can submit to the STRIDE BP Online Review Platform data on an ‘Identical’ device for review, after obtaining a password by the STRIDE BP administrator at manufacturer@stridebp.org. A fee must be paid to STRIDE BP for reviewing a new ‘Identical’ device submission, irrespective of whether the device will be eventually approved or rejected by STRIDE BP.
• The ‘Identical’ device submissions are subjected to Internal Review (by 3 independent Reviewers) and External Review (by at least 3 members of the STRIDE BP Scientific Advisory Board) through the STRIDE BP Online Review Platform, as described above for original validation studies (see figure end of page). Devices approved by the STRIDE BP Scientific Advisory Board as ‘Identical’ are posted to the STRIDE BP website.

STRIDE BP VALIDATED DEVICES LISTING PROCEDURE

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. 2020;38:395-399.

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.

3. Stergiou GS, Parati G, Kollias A, Schutte AE, Asayama K, Asmar R, Bilo G, de la Sierra A, Dolan E, Filipovsky J, Head G, Kario K, Kyriakoulis KG, Mancia G, Manios E, Menti A, McManus RJ, Mihailidou AS, Muntner P, Niiranen T, Ohkubo T, Omboni S, Protogerou A, Saladini F, Sharman J, Shennan A, Shimbo D, Topouchian J, Wang J, O’Brien E, Palatini P. Requirements for design and function of blood pressure measuring devices used for the management of hypertension: Consensus Statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability and STRIDE BP. J Hypertens. 2023 Dec 1;41(12):2088-2094.

https://pubmed.ncbi.nlm.nih.gov/37303225/