Company Clarifies Findings and Provides Data by Third Party Labs
Today, an article from The Children's Hospital of Philadelphia (CHOP) was published in The Journal of the American Medical Association regarding a study testing consumer pulse oximeter baby monitors' accuracy, namely the Owlet Smart Sock and the Baby Vida. Owlet would like to clarify the findings of this study and provide data from accuracy testing that has been conducted by accredited third party labs verifying the Owlet Smart Sock meets industry and regulatory accuracy standards.
Kurt Workman, co-founder and CEO of Owlet says, "The accuracy and performance of the Owlet Smart Sock is something we take very seriously. It is important to note that our product is designed for in-home use, with healthy babies while they sleep, to provide parents with information about their child's wellbeing." He goes on to say, "As the CHOP study states, one of the limitations of their methodology was not using arterial blood gas measurements. Owlet's sensor accuracy was tested against arterial blood gas measurements in December 2017 and the sensor performed well within industry and regulatory standards for pulse oximetry, which require devices to perform within 3% Accuracy Root Mean Square (ARMS). In January 2018, Owlet also tested its sensor accuracy in babies between 0 and 17 months against the Masimo Radical-7, a hospital-grade device, with both sensors on one foot and reached desired industry accuracy standards, comparing favorably to Masimo Radical-7."
The Owlet accuracy study on ClinicalTrials.gov can be found here.
The company would also like to make mention of additional inaccuracies within the study, including:
- The study included high-risk, primarily late premature babies (median gestational age 39 weeks). Owlet's intended use is on healthy babies in the home.
- For all 12 patients where the control device detected low oxygen, the Owlet Smart Sock notified of at least one O2 occurrence. Clinicians often use saturation data as an indicator of an acute problem, or an exacerbation of a chronic problem. In the majority of those cases it is the trend of saturation, not a single point that will direct a course of action. To that end, there is nothing in this study that undermines the benefits of Owlet.
- There was no mention of whether babies were moving or not as this can significantly alter results, especially in this population. Owlet is intended to be used while babies are sleeping.
- The reference device (Masimo) and test device (Owlet) were on opposite feet which is against industry standards for such comparisons.
Others in the medical field have also found the study to be questionable, including Gary Freed, Professor of Pediatrics at the Philadelphia College of Osteopathic Medicine. He says, "I question the methodology and accuracy of this study. The population studied was atypical. Overall, the Owlet Smart Sock performed well, despite the fact that this is not approved usage for the product. All pulse oximetry technology has false positives and false negatives, even the Masimo. Without obtaining blood gases, there's no way to say that the Masimo was correct and Owlet was incorrect. Owlet has conducted accuracy testing using arterial blood gas measurements and that study showed the Smart Sock performed according to the FDA and industry standards for pulse oximetry."
"This study compares a consumer product for use in healthy babies with a hospital-based product being used in ill infants," said Larry Consenstein, MD, Clinical Professor, Dept Pediatrics, SUNY Upstate. "Even in the hospital we don't react to a single abnormal oximetry alarm, rather than to a trend or critically low values. As I read this study, both trending and critical hypoxia are preserved, especially device A [the Owlet]. Before we use the data in this study to discard a device that may make collection of population-based infant oximetry data possible, we need to be clear about the purpose for which the device is intended."
Owlet makes pulse oximetry simple and appropriate for everyday consumers. It is designed to be used to track sleep trends, view averages of heart rate and oxygen levels and provide parents data on the overall wellbeing of their child. For more information about Owlet, please visit https://blog.owletcare.com/is-the-owlet-smart-sock-accurate/.
About Owlet Baby Care
Owlet Baby Care (http://www.owletcare.com) is a health technology company founded by a team of parents in 2013. The company's flagship product is the Smart Sock baby monitor, which uses pulse oximetry technology to track a baby's heart rate and oxygen levels during sleep. Owlet's mission is to empower parents with the right information at the right time.