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Smartphone-Integrated Consumer Pulse Oximetry Baby Monitors May Not Be Accurate

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This has nothing to do with anesthesia however most of our readers have either kids or grand kids so I wanted to share it.

Bonafide CP et al. JAMA 2018 Aug 21

Compared with an FDA-approved monitor, two non–FDA-approved monitors had inaccurate and inconsistent readings.

As smartphone-integrated health apps become more ubiquitous, the accuracy of those that are not FDA approved is of concern. Researchers compared oximetry and pulse rate readings between two commercially available but not FDA approved home monitor devices (A: Owlet Smart Sock 2 and B: Baby Vida) and an FDA-approved oximetry device (Masimo Radical-7) in 30 hospitalized noncritically ill patients aged 0–6 months (median age, 50 days).

Each patient had the FDA-approved monitor attached to one foot and the other two monitors attached to the other foot alternately in random order. Exclusion criteria included prematurity (<34 weeks’ gestation), anemia, fever, hypothermia, and hypotension.

A total of 2266 simultaneous SpO2 and 1801 simultaneous pulse rate readings at stable points were obtained. Hypoxemia (SpO2 <91%) observed in 12 patients with the reference monitor was not consistently observed in 5 patients with monitor A. Monitor B detected none of 14 patients with hypoxemia observed with the reference monitor. There were no instances of false bradycardia with monitor A, whereas 14 patients had false bradycardia readings with monitor B. Sensitivity and specificity for hypoxemia were 89% and 86% for monitor A and 0% and 100% for monitor B. Sensitivity for bradycardia was 0% for both monitors; specificity was 100% for monitor A and 82% for monitor B.

COMMENT

These findings raise concerns about the accuracy of current non–FDA-approved pulse oximetry monitoring devices. Not only are these devices potentially inaccurate, the study found significant inconsistencies and difficulty observing stable values. Unclear criteria for monitoring as well as the unproven value of home monitoring in general should discourage recommending non–FDA-approved wearable baby monitors to parents (NEJM JW Pediatr Adolesc Med Feb 2015 and BMJ2014; 349:g6639).

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