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Review
. 2020 Dec;22(12):2167-2174.
doi: 10.1111/jch.14065. Epub 2020 Oct 5.

How to check whether a blood pressure monitor has been properly validated for accuracy

Dean S Picone  1 , Raj Padwal  2 , Norm R C Campbell  3 , Pierre Boutouyrie  4 , Tammy M Brady  5 , Michael Hecht Olsen  6   7 , Christian Delles  8 , Cintia Lombardi  9 , Azra Mahmud  10   11   12 , Yaxing Meng  1 , Gontse G Mokwatsi  13   14 , Pedro Ordunez  9 , Hoang T Phan  1   15 , Giacomo Pucci  16 , Aletta E Schutte  13   14   17 , Ki-Chul Sung  18 , Xin-Hua Zhang  19 , James E Sharman  1 ; Accuracy in Measurement of Blood Pressure (AIM-BP) Collaborative
Affiliations
Review

How to check whether a blood pressure monitor has been properly validated for accuracy

Dean S Picone et al. J Clin Hypertens (Greenwich). 2020 Dec.

Abstract

Hypertension guidelines recommend that blood pressure (BP) should be measured using a monitor that has passed validation testing for accuracy. BP monitors that have not undergone rigorous validation testing can still be cleared by regulatory authorities for marketing and sale. This is the situation for most BP monitors worldwide. Thus, consumers (patients, health professionals, procurement officers, and general public) may unwittingly purchase BP monitors that are non-validated and more likely to be inaccurate. Without prior knowledge of these issues, it is extremely difficult for consumers to distinguish validated from non-validated BP monitors. For the above reasons, the aim of this paper is to provide consumers guidance on how to check whether a BP monitor has been properly validated for accuracy. The process involves making an online search of listings of BP monitors that have been assessed for validation status. Only those monitors that have been properly validated are recommended for BP measurement. There are numerous different online listings of BP monitors, several are country-specific and two are general (international) listings. Because monitors can be marketed using alternative model names in different countries, if a monitor is not found on one listing, it may be worthwhile cross-checking with a different listing. This information is widely relevant to anyone seeking to purchase a home, clinic, or ambulatory BP monitor, including individual consumers for use personally or policy makers and those procuring monitors for use in healthcare systems, and retailers looking to stock only validated BP monitors.

Keywords: ambulatory blood pressure/home blood pressure monitor; blood pressure determination; device; validation.

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Conflict of interest statement

Aletta E Schutte: Her University has received equipment and funding from manufacturers of BP devices including IEM and Omron. Azra Mahmud has received equipment and research funding from manufacturers of BP devices including AtCor Medical and IEM but has no personal commercial interests in these or any other BP companies. Raj Padwal: Canadian representative to the ISO Sphygmomanometer committee and sits on the AAMI Sphygmomanometer committee. Co‐Founder and CEO of a digital health company (mmHg Inc), based at the University of Alberta. James E Sharman: His university has received equipment and research funding from manufacturers of BP devices including AtCor Medical, IEM and Pulsecor (Uscom). He has no personal commercial interests related to BP companies. Cintia Lombardi and Pedro Ordunez are staff members of the Pan American Health Organization. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent the decisions or policies of the Pan American Health Organization. Tammy Brady: is Co‐Chair of the Association for the Advancement of Medical Instrumentation (AAMI) Sphygmomanometer Committee and is a nominated expert on the IEC (International Electrotechnical Commission)/ISO (International Organization for Standardization) joint working group on non‐invasive blood pressure monitoring devices. The remaining authors have no disclosures.

Figures

Figure 1
Figure 1
How to check whether a blood pressure (BP) device has been validated for accuracy. An overview of regional and general registries of validated BP devices is included. This figure with live links can be downloaded at https://www.menzies.utas.edu.au/documents/pdfs/Blood‐pressure‐devices.pdf
Figure 2
Figure 2
How to check whether a blood pressure (BP) device has been validated for accuracy using the STRIDE BP registry. This figure with live links can be downloaded at https://www.menzies.utas.edu.au/documents/pdfs/Blood‐pressure‐devices.pdf
Figure 3
Figure 3
How to check whether a blood pressure (BP) device has been validated for accuracy using the Medaval registry. This figure with live links can be downloaded at https://www.menzies.utas.edu.au/documents/pdfs/Blood‐pressure‐devices.pdf
See this image and copyright information in PMC

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