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

Journal of Human Hypertension volume 37, pages 130–133 (2023)Cite this article

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Abstract

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.

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Acknowledgements

The authors would like to thank James Sharman, PhD, for his facilitation during the entire course of the development of this paper—he attended the meetings, answered questions, and provided writing direction from an editorial perspective, without influencing the content.

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Authors and Affiliations

  1. Omron Healthcare Co., Ltd., Kyoto, Japan

    Jim Li & Karel Herberigs

  2. Microlife AG, Widnau, Switzerland

    Gerhard Frick & Willem J. Verberk

  3. SunTech Medical, Morrisville, NC, USA

    Paul Matsumura

  4. PharmaSmart, Rochester, NY, USA

    Josh Sarkis

  5. Department of Biomedical Engineering, CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, The Netherlands

    Willem J. Verberk

  6. A&D Company, Limited, Tokyo, Japan

    Caryl Wojcik

Authors
  1. Jim Li
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  2. Gerhard Frick
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  4. Paul Matsumura
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  5. Josh Sarkis
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  6. Willem J. Verberk
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  7. Caryl Wojcik
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Contributions

The first draft of the manuscript was compiled by JL; all authors provided feedback and intellectual contribution to the manuscript.

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Correspondence to Jim Li.

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Competing interests

All authors are employees of the manufacturers of blood pressure measuring devices as listed in the affiliations. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent those of all manufacturers of blood pressure measurement devices. JL, GF, PM, JS, and WJV are ISO committee members.

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Li, J., Frick, G., Herberigs, K. et al. Industry perspectives on the global use of validated blood pressure measuring devices. J Hum Hypertens 37, 130–133 (2023). https://doi.org/10.1038/s41371-022-00717-6

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