Global proliferation and clinical consequences of non-validated automated BP devices.
Journal
Journal of human hypertension
ISSN: 1476-5527
Titre abrégé: J Hum Hypertens
Pays: England
ID NLM: 8811625
Informations de publication
Date de publication:
02 2023
02 2023
Historique:
received:
07
11
2021
accepted:
23
02
2022
revised:
06
02
2022
pubmed:
14
3
2022
medline:
3
3
2023
entrez:
13
3
2022
Statut:
ppublish
Résumé
Professional societies, guideline writing committees, and other interested parties emphasize the importance of accurate measurement of blood pressure for clinical and public health decisions related to prevention, treatment, and follow-up of high blood pressure. Use of a clinically validated instrument to measure blood pressure is a central component of measurement accuracy and precision. Despite this, most regulatory authorities do not specify validation requirements that manufacturers must meet to sell their blood pressure measurement devices. Likewise, device validity is not a major area of focus for most consumers and healthcare providers, perhaps because they assume it is a pre-requisite for market approval. This has led to a global proliferation of non-validated blood pressure measurement devices, with only a small minority of blood pressure measurement devices having passed internationally accepted validation protocols. The clinical consequences are likely to be significant because non-validated devices are more likely to provide inaccurate estimates of blood pressure compared with validated devices. Even small inaccuracies in blood pressure measurement can result in substantial misdiagnosis and mistreatment of hypertension. There is an urgent need for clinical validation of blood pressure measurement devices prior to marketing them to consumers. There is also need for simplification of the process for consumers and healthcare providers to determine whether a blood pressure measurement device has successfully met an internationally accepted test of validity.
Identifiants
pubmed: 35279699
doi: 10.1038/s41371-022-00667-z
pii: 10.1038/s41371-022-00667-z
doi:
Types de publication
Journal Article
Review
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
115-119Subventions
Organisme : NCRR NIH HHS
ID : M01 RR005096
Pays : United States
Organisme : NIGMS NIH HHS
ID : P20 GM109036
Pays : United States
Organisme : NIGMS NIH HHS
ID : P20GM109036
Pays : United States
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.
Références
Whelton SP, McEvoy JW, Shaw L, Psaty BM, Lima JAC, Budoff M, et al. Association of normal systolic blood pressure level with cardiovascular disease in the absence of risk factors. JAMA Cardiol. 2020;5:1011–8.
doi: 10.1001/jamacardio.2020.1731
pubmed: 32936272
pmcid: 7287937
Lewington S, Clarke R, Qizilbash N, Peto R, Collins R, Prospective Studies C. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903–13.
doi: 10.1016/S0140-6736(02)11911-8
pubmed: 12493255
Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, et al. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014;383:1899–911.
doi: 10.1016/S0140-6736(14)60685-1
pubmed: 24881994
pmcid: 4042017
Fuchs FD, Whelton PK. High blood pressure and cardiovascular disease. Hypertension. 2020;75:285–92.
doi: 10.1161/HYPERTENSIONAHA.119.14240
pubmed: 31865786
Whelton PK. Evolution of blood pressure clinical practice guidelines: a personal perspective. Can J Cardiol. 2019;35:570–81.
doi: 10.1016/j.cjca.2019.02.019
pubmed: 31030860
Armitage P, Rose GA. The variability of measurements of casual blood pressure. I. A laboratory study. Clin Sci. 1966;30:325–35.
pubmed: 5943215
Armitage P, Fox W, Rose GA, Tinker CM. The variability of measurements of casual blood pressure. II. Survey experience. Clin Sci. 1966;30:337–44.
pubmed: 5943216
Rakotz MK, Townsend RR, Yang J, Alpert BS, Heneghan KA, Wynia M, et al. Medical students and measuring blood pressure: results from the American Medical Association Blood Pressure Check Challenge. J Clin Hypertens. 2017;19:614–9.
doi: 10.1111/jch.13018
Campbell NRC, Padwal R, Picone DS, Su H, Sharman JE. The impact of small to moderate inaccuracies in assessing blood pressure on hypertension prevalence and control rates. J Clin Hypertens. 2020;22:939–42.
doi: 10.1111/jch.13915
Roerecke M, Kaczorowski J, Myers MG. Comparing automated office blood pressure readings with other methods of blood pressure measurement for identifying patients with possible hypertension: a systematic review and meta-analysis. JAMA Intern Med. 2019;179:351–62.
doi: 10.1001/jamainternmed.2018.6551
pubmed: 30715088
pmcid: 6439707
Drawz PE, Agarwal A, Dwyer JP, Horwitz E, Lash J, Lenoir K, et al. Concordance between blood pressure in the systolic blood pressure intervention trial and in routine clinical practice. JAMA Intern Med. 2020;180:1655–63.
doi: 10.1001/jamainternmed.2020.5028
pubmed: 33044494
pmcid: 7551238
Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13–e115.
pubmed: 29133356
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021–104.
doi: 10.1093/eurheartj/ehy339
pubmed: 30165516
Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, et al. Measurement of blood pressure in humans: a scientific statement from the American Heart Association. Hypertension. 2019;73:e35–e66.
doi: 10.1161/HYP.0000000000000087
pubmed: 30827125
International Standards Organization. ISO 81060-2:2018. Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type. 2020. https://www.iso.org/standard/73339.html .
International Standards Organization. ISO 81060-2:2018/AMD 1:2020Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type—Amendment 1 2020. https://www.iso.org/standard/75432.html .
Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. 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. Hypertension. 2018;71:368–74.
doi: 10.1161/HYPERTENSIONAHA.117.10237
pubmed: 29386350
Akpolat T, Dilek M, Aydogdu T, Adibelli Z, Erdem DG, Erdem E. Home sphygmomanometers: validation versus accuracy. Blood Press Monit. 2009;14:26–31.
doi: 10.1097/MBP.0b013e3283262f31
pubmed: 19190492
Jung MH, Kim GH, Kim JH, Moon KW, Yoo KD, Rho TH, et al. Reliability of home blood pressure monitoring: in the context of validation and accuracy. Blood Press Monit. 2015;20:215–20.
doi: 10.1097/MBP.0000000000000121
pubmed: 25856420
Sharman JE, Padwal R, Campbell NRC. Global marketing and sale of accurate cuff blood pressure measurement devices. Circulation. 2020;142:321–3.
doi: 10.1161/CIRCULATIONAHA.120.046205
pubmed: 32718253
Alpert BS. Can ‘FDA-cleared’ blood pressure devices be trusted? A call to action. Blood Press Monit. 2017;22:179–81.
doi: 10.1097/MBP.0000000000000279
pubmed: 28678035
Picone DS, Deshpande RA, Schultz MG, Fonseca R, Campbell NRC, Delles C, et al. Nonvalidated home blood pressure devices dominate the online marketplace in Australia: major implications for cardiovascular risk management. Hypertension. 2020;75:1593–9.
doi: 10.1161/HYPERTENSIONAHA.120.14719
pubmed: 32275193
John O, Campbell NRC, Brady TM, Farrell M, Varghese C, Velazquez Berumen A, et al. The 2020 “WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff”. Hypertension. 2021;77:806–12.
doi: 10.1161/HYPERTENSIONAHA.120.16625
pubmed: 33517681
Shimbo D, Artinian NT, Basile JN, Krakoff LR, Margolis KL, Rakotz MK, et al. Self-measured blood pressure monitoring at home: a joint policy statement from the American Heart Association and American Medical Association. Circulation. 2020;142:e42–e63.
doi: 10.1161/CIR.0000000000000803
pubmed: 32567342
Fan WG, Xie F, Wan YR, Campbell NRC, Su H. The impact of changes in population blood pressure on hypertension prevalence and control in China. J Clin Hypertens. 2020;22:150–6.
doi: 10.1111/jch.13820
Sakhuja S, Jaeger BC, Akinyelure OP, Bress AP, Shimbo D, Schwartz JE, et al. Potential impact of systematic and random errors in blood pressure measurement on the prevalence of high office blood pressure in the United States. J Clin Hypertens (Greenwich). 2022. https://doi.org/10.1111/jch.14418 . Online ahead of print.
Picone DS, Padwal R, Campbell NRC, Boutouyrie P, Brady TM, Olsen MH, et al. How to check whether a blood pressure monitor has been properly validated for accuracy. J Clin Hypertens. 2020;22:2167–74.
doi: 10.1111/jch.14065
Graves JW. A survey of validated automated home blood pressure monitors available for the Internet shopper. Blood Press Monit. 2005;10:103–7.
doi: 10.1097/00126097-200504000-00009
pubmed: 15812259
Pan American Health Organization. HEARTS in the America’s regulatory pathway to the exclusive use of validated blood pressure measuring devices. PAHO IRIS General Publications [Internet]. 2021. https://iris.paho.org/handle/10665.2/55382 .