Feasibility of commercially marketed health devices for potential clinical application

Kevin D. Uchimura, Teagan L. Adamson, Kara M. Karaniuk, Mark L. Spano, Jeffrey LaBelle

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Concerns have been raised regarding the lack of validation on consumer-marketed health-monitoring de-vices. An investigation to characterize current health monitoring devices was carried out in the laboratory using widely accepted clinical and industry criteria. In total, 16 unique devices were examined. These devices were assessed according to their sensing modalities: step count, blood pressure, body temperature, electrocardiogram, blood oxygen saturation, and respiratory rate. Devices were tested at rest and immediately following exercise. Our results revealed that only four devices meet target requirements for accuracy. The AliveCor, a portable ECG monitor, accurately detected the heart rate for 87% of all recordings. To meet the target criterion for accuracy, the heart rate must be within ± 5 beats/minute or 10% of the standard measurement, whichever is lower. The Withings Pulse Ox, the Tinké, and the Santamedical SM-110 measured blood oxygen saturation with 2.1, 2.6, and 1.4 root-mean-square (rms) error, respectively. For blood oxygen saturation, the device should demonstrate rms error of < 3%. However, the Withings Pulse Ox and the Tinké failed to meet the accuracy criteria for their alternative biosensing capabilities: step count and respiratory rate, respectively. We conclude that the use of consumer-marketed health-monitoring devices for clinical or medical purposes should be under-taken with caution, especially in the absence of FDA or comparable clearance.

Original languageEnglish (US)
Pages (from-to)159-167
Number of pages9
JournalCritical Reviews in Biomedical Engineering
Volume47
Issue number2
DOIs
StatePublished - Jan 1 2019

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Blood
Health
Electrocardiography
Mean square error
Oxygen
Monitoring
Blood pressure
Industry
Temperature

Keywords

  • Fitness devices
  • MHealth
  • Quantified self
  • Readmission
  • Wearable sensors

ASJC Scopus subject areas

  • Biomedical Engineering

Cite this

Feasibility of commercially marketed health devices for potential clinical application. / Uchimura, Kevin D.; Adamson, Teagan L.; Karaniuk, Kara M.; Spano, Mark L.; LaBelle, Jeffrey.

In: Critical Reviews in Biomedical Engineering, Vol. 47, No. 2, 01.01.2019, p. 159-167.

Research output: Contribution to journalArticle

Uchimura, Kevin D. ; Adamson, Teagan L. ; Karaniuk, Kara M. ; Spano, Mark L. ; LaBelle, Jeffrey. / Feasibility of commercially marketed health devices for potential clinical application. In: Critical Reviews in Biomedical Engineering. 2019 ; Vol. 47, No. 2. pp. 159-167.
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