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. 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.

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 past 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 the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

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. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

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. For current use, simple software should be worked out that allow for analysis of readings in an objective manner. Miscuffing is also a frequent source of measurement error in obese arms when oscillometric devices are used. Modern automatic devices can overcome this problem because of special software algorithms that can provide accurate measurements over a wide range of arm circumferences when coupled with a single cuff of standard dimensions. Tronco-conical-shaped cuffs are a key component of this instrumentation because they better fit on large conical arms frequently present in obese individuals. Semi-rigid cuffs should be increasingly used because they ensure that the proper amount of tension is applied without the intervention of the user. Continuous technology improvement of instrumentation for SBPM can be achieved through close cooperation between manufacturers and validation centers.