A group of experts from reputable blood pressure measuring device (BPMD) manufacturers was invited to provide industry perspectives on the global use of validated BPMD. The authors support the recommendations of (1) using the consolidated universal ISO 81060-2:2018 in all future validation studies to ensure consistent and trustworthy quality standards; (2) validation studies to be led by investigators independent from the manufacturer; (3) validation study results to be published in peer-reviewed journals with an independent investigator as the corresponding author; and (4) validated BPMDs to be listed on validated device registries such as STRIDE BP, Validated Device Listing (VDL), and others that are backed by acknowledged scientific associations. The authors call for public awareness of the existence of legally marketed consumer BPMDs that lack sufficient evidence of clinical accuracy. Other important issues and future considerations were discussed, including the need: for awareness building and promoting the use of validated BPMDs among practitioners; to identify a non-mercury sphygmomanometer based reference device to validate BPMDs; to include all cuffs available for use with each BPMD in the validation study; for the promotion of validation studies for special patient populations; for validated wrist BPMDs as an alternative for some patients; for technical innovations to help reduce limitations related to the human aspect of validation studies; for validation of cuffless BPMDs; for validation through equivalency to validated base models; and to use validated BPMD in remote patient monitoring programs. A future collaborative to find solutions to support the use of validated BPMD is envisaged.
|Number of pages||4|
|Journal||Journal of Human Hypertension|
|Early online date||27 Jun 2022|
|Publication status||Published - 2023|
- MEDICAL INSTRUMENTATION/EUROPEAN SOCIETY
- HYPERTENSION/INTERNATIONAL ORGANIZATION
- UNIVERSAL STANDARD