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Researchers ‘concerned’ about effectiveness of baby monitors measuring vital signs

Researchers found that two baby monitors using pulse oximetry had inconsistent performance in detecting hypoxemia and pulse rates.

The two devices — the Owlet Smart Sock 2 and the Baby Vida — are the only two marketed smartphone-integrated baby monitors that use pulse oximetry to measure vital signs, and neither are regulated by the FDA, according to the report in JAMA.

Christopher P. Bonafide, MD, MSCE, of the division of general pediatrics at Children’s Hospital of Philadelphia, and colleagues tested the two devices on 30 infants younger than 6 months. Infants were not included if they were anemic, born before 34 weeks’ gestation, had compromised perfusion or were critically ill, febrile, hypothermic or, based on their age, hypotensive. Researchers recorded 1,801 stable pulse rate points and 2,466 stable SpO₂ points.

Researchers found Owlet Smart Sock 2 had 88.8% sensitivity and 85.7% specificity for hypoxemia and 0% sensitivity and 100% specificity for bradycardia, while Baby Vida had 0% sensitivity and 100% specificity for hypoxemia and 0% sensitivity and 82.3% specificity for bradycardia.

The accuracy testing “revealed concerning findings,” Bonafide and colleagues wrote.

“Other concerns about consumer monitor use include the lack of medical indications for monitoring infants at home, the absence of FDA oversight, and the potential for unintended consequences.”

“As more neonate and infant vital sign monitors emerge in this largely unregulated market, physicians and parents should exercise caution incorporating data from these monitors into medical decisions,” they added. – by Janel Miller

Disclosure: Bonafide reports no relevant financial disclosures. Please see the study for the full list of other authors’ relevant financial disclosures.