How Effective Are Smartphone-Integrated Baby Monitors?
Jessica Tomaszewski, MD
Primary Care Pediatrics, Nemours Children’s Health System, Wilmington, Delaware
Tomaszewski J. How effective are smartphone-integrated baby monitors? [published online October 10, 2018]. Consultant360.
Bonafide CP, Localio AR, Ferro DF, et al. Accuracy of pulse oximetry-based home baby monitors. JAMA. 2018;320(7):717-719. doi:10.1001/jama.2018.9018.
Smartphone-integrated consumer baby monitors that measure vital signs are marketed to parents to create peace of mind, but they are not regulated by the US Food and Drug Administration (FDA). These devices are smartphone applications (apps) integrated with sensors that are built into everything from socks to diaper clips and that measure infant’s respirations, pulse rate, and blood oxygen saturation. They also sound alarms for apnea, tachycardia, bradycardia, and desaturations. The popularity of these devices is growing despite the lack of publicly available evidence of their efficacy.
Bonafide and colleagues conducted a small but fascinating study to measure the accuracy of pulse oximetry–based consumer baby monitors using an FDA-cleared oximeter as a reference. Using the 2 current systems that measure pulse oximetry—the Owlet (monitor A) and the Baby Vida (monitor B)—paired reference monitor–consumer monitor points were obtained from infants aged 0 to 6 months who were hospitalized in the general pediatric and cardiology wards at Children’s Hospital of Philadelphia. To minimize ascertainment bias, 10 stable points were obtained per patient. Scatterplots were generated, and sensitivity and specificity for hypoxemia and bradycardia were calculated.
Data points were gathered from 30 infants with a median age of 50 days. Common diagnoses included bronchiolitis, brief resolved unexplained events, hypoplastic left heart syndrome, and double outlet right ventricle. Almost 2500 peripheral capillary oxygen saturation points and 1801 pulse rate points were recorded.
The results of analysis of these data points were somewhat troubling. While monitor A did appear to pick up some of the hypoxemia noted on the reference monitor, it missed several points. Monitor B appeared to miss all of these hypoxemia readings found on the corresponding reference monitor. Monitor A did not display falsely bradycardic pulse rates, but monitor B did display bradycardic pulse rates when the reference rate was normal. For monitor A, the sensitivity and specificity for hypoxemia were 88.8% and 85.7%, respectively, and for bradycardia were 0% and 100%, respectively. For monitor B, the sensitivity and specificity for hypoxemia were 0% and 100%, respectively, and for bradycardia were 0% and 82.3%, respectively.
While larger studies are surely needed, the accuracy testing completed here showed serious flaws in these devices, revealing inconsistent detection of hypoxia and falsely low pulse rates. Because these are over-the-counter devices, there is a lack of both medical and FDA oversight. An American Academy of Pediatrics policy statement states that no data exist to support that commercial devices that measure vital signs reduce the risk of sudden infant death syndrome.1 Besides the inherent anxiety involved, there is also the real fear of false alarms and overdiagnosis in these young infants, leading to potentially unnecessary interventions.2 Clinicians and parents should be aware of these concerns and exercise caution in the interpretation of data from these devices.
- Task Force on Sudden Infant Death Syndrome. SIDS and other sleep-related infant deaths: updated 2016 recommendations for a safe infant sleeping environment. Pediatrics. 2016;138(5):e20162938. doi:10.1542/peds.2016-2938.
- Bonafide CP, Jamison DT, Foglia EE. The emerging market of smartphone-integrated infant physiologic monitors. JAMA. 2017;317(4):353-354. doi:10.1001/jama.2016.19137.