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):

• 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)

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

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 fulfill the following requirements will be listed on the STRIDE BP website as ‘PREFERRED’ devices, suggesting that these are the most appropriate ones to use.

EQUIVALENCE CRITERIA FOR 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 this is ‘Equivalent’ to another ‘Reference’ device which has a validation study approved by the STRIDE BP.
• For the Equivalence procedure the device manufacturer submits a ‘STRIDE BP Device Equivalence Checklist’ 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.
• The ‘STRIDE BP Device Equivalence 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.

STRIDE BP VALIDATED DEVICES LISTING PROCEDURE