Industry perspectives on the global use of validated blood pressure measuring devices.

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.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation.

Techniques for self-measurement of blood pressure: limitations and needs for future research.

Self blood pressure measurement (SBPM) improves the overall management of hypertension provided it is implemented with methodologic care. This concerns especially the accuracy and technical requirements of blood pressure (BP) measuring devices that should be validated according to internationally accepted protocols. The use of memory-equipped automatic home monitors is strongly recommended because they reduce observer bias, avoid patients' misreporting, and allow fully automatic analysis by software.