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Guideline
. 2018 Mar;36(3):472-478.
doi: 10.1097/HJH.0000000000001634.

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

George S Stergiou  1 , Bruce Alpert  2 , Stephan Mieke  3 , Roland Asmar  4 , Neil Atkins  5 , Siegfried Eckert  6 , Gerhard Frick  7 , Bruce Friedman  8 , Thomas Graßl  9 , Tsutomu Ichikawa  10 , John P Ioannidis  11 , Peter Lacy  12 , Richard McManus  13 , Alan Murray  14 , Martin Myers  15 , Paolo Palatini  16 , Gianfranco Parati  17 , David Quinn  18 , Josh Sarkis  19 , Andrew Shennan  20 , Takashi Usuda  21 , Jiguang Wang  22 , Colin O Wu  23 , Eoin O'Brien  24
Affiliations
Guideline

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

George S Stergiou et al. J Hypertens. 2018 Mar.

Abstract

: 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.

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Conflict of interest statement

Conflict of interest: GS, BA, RA, PP, GP: conducted validation studies for various manufacturers; advised manufacturers on device and software development. NA: Conducted validation studies for various manufacturers; advised manufacturers on device and software development; Medaval employee. GF: Microlife employee. BF: GE Healthcare employee. TG: Dräger employee. TI: Omron employee. RM: Received blood pressure monitoring equipment for research purposes from Omron and Lloyds Pharmacies; Chair of British Hypertension Society Blood Pressure Monitoring Working Party which oversees validation studies for various manufacturers. AM: Patent holder for manual blood pressure device; research grant holder for blood pressure measurement techniques. DQ: Welch Allyn employee, USA. JS: PharmaSmart International employee, USA. AS: Conducted validation studies for various manufacturers; developed the CRADLE VSA. TU: Nihon Kohden employee. JW: Conducted validation studies for various manufacturers. SE, JI, PL, MM, SM, CW: none.

Figures

Figure 1
Figure 1
Standardized Bland-Altman scatterplots as shown below will be presented in the AAMI/ESH/ISO validation study report (with permission from ref. [8] modified).
See this image and copyright information in PMC

References

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    1. Association for the Advancement of Medical Instrumentation. Electronic or automated sphygmomanometers. Arlington, VA: AAMI; 1993. American national standard.
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