Can ‘FDA-cleared’ blood pressure devices be trusted? A call to action
Abstract
Department of Pediatrics, University of Tennessee Health Science Center (Retired), Memphis, Tennessee, USA Correspondence to Bruce S. Alpert, MD, 1350 Poplar Ridge Dr., Memphis, TN 38120, USA Tel: +1 901 229 3719; fax: +1 901 757 8181; e-mail: [email protected] Received March 13, 2017 Accepted June 21, 2017
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Many of the more than 3500 automated BPMD models are without evidence of having passed validation testing.
“hundreds of companies manufacturing more than 3500 different models of automated BPMDs, many of which are without evidence of having passed validation testing [25–29].”
From Automated 'oscillometric' blood pressure measuring devices: how they work and what they measure (2022) · cites this paper as [27]
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Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research
Muntner, P., Einhorn, P. T., Cushman, W. C., Whelton, P. K., Bello, N. A., Drawz, P. E., Green, B. B., Jones, D. W., Juraschek, S. P., Margolis, K. L., et al. (2019) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.10.069 · Cited by 199 · see citing works
Sharman, J. E., O’Brien, E., Alpert, B., Schutte, A. E., Delles, C., Hecht Olsen, M., Asmar, R., Atkins, N., Barbosa, E., Calhoun, D., et al. (2020) · Journal of Hypertension · doi:10.1097/hjh.0000000000002246 · Cited by 139 · see citing works
Self-citationAutomated 'oscillometric' blood pressure measuring devices: how they work and what they measure
Sharman, J. E., Tan, I., Stergiou, G. S., Lombardi, C., Saladini, F., Butlin, M., Padwal, R., Asayama, K., Avolio, A., Brady, T. M., et al. (2022) · Journal of Human Hypertension · doi:10.1038/s41371-022-00693-x · Cited by 84 · see citing works
Sharman, J. E., Ordunez, P., Brady, T., Parati, G., Stergiou, G., Whelton, P. K., Padwal, R., Olsen, M. H., Delles, C., Schutte, A. E., et al. (2022) · Journal of Human Hypertension · doi:10.1038/s41371-022-00747-0 · Cited by 31 · see citing works
Measurements of arterial pressure and flow in vivo
Sharman, J. E., Segers, P., & Chirinos, J. A. (2022) · Textbook of Arterial Stiffness and Pulsatile Hemodynamics in Health and Disease · doi:10.1016/b978-0-323-91391-1.00002-9 · Cited by 3 · see citing works
- Authors
- Alpert, B. S.
- Affiliations
- University of Tennessee Health Science Center (US)
- Corresponding author
- Alpert, Bruce S.
- ORCID
- Alpert, Bruce S.
- Venue
- Blood Pressure Monitoring
- Published
- 2017-08
- Volume
- 22
- Issue
- 4
- Pages
- 179-181
- ISSN
- 1359-5237 (ISSN-L)
- OpenAlex
- W2732348779
- Cited by
- 31
- References
- 0
- Citations by year
- 2025: 3 · 2024: 4 · 2023: 1 · 2022: 7 · 2021: 3 · 2020: 6 · 2019: 3 · 2018: 2 · 2017: 1
- FWCI
- 2.57
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Blood Pressure Monitoring (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Keywords
- blood pressure monitoring devices, FDA clearance, device regulation, blood pressure measurement accuracy, consumer health devices
- MeSH terms
- Blood Pressure, Blood Pressure Determination, Humans, Hypertension, Sensitivity and Specificity, United States, United States Food and Drug Administration, Drug Approval, Device Approval
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