Recent innovations in physiological baby monitor technology (with the ability to monitor breathing, pulse and other vital signs) have led to the introduction of some very popular product lines, such as Owlet and Baby Vida, that are marketed with the ability to tell whether your baby stops breathing or heart rate drops significantly.
This lines have been extremely popular, with one recent line selling upwards of 40,000 units. No one can blame a nervous new parent for wanting to know as much as they can about the health of their child, and so the popularity makes a lot of sense. However the Journal of the American Medical Association (JAMA) has recently come out against them, citing their safety, accuracy and effectiveness has not been established.
Units Avoiding Regulation as Medical Devices
For at least one company, the units were originally meant to treat a medical condition (such as avoiding Sudden Infant Death Syndrome (SIDS) and other conditions), however the cost and time associated with achieving FDA approval proved too much for the companies to endure. Instead they branded the products as “heart rate monitors” and were able to go to market without needing FDA approval.
Despite this legal technicality, parents are still utilizing the units, and perhaps relying upon them, for medical concerns. This is the main issue that the JAMA article has with it, namely: “The fundamental question that must be answered for consumer infant health monitors centers on their safety accuracy and effectiveness. To date medical apps have a disappointing track record.” (http://jamanetwork.com/journals/jama/article-abstract/2598780)
With accuracy not monitored by a regulatory body like the FDA, it seems apparent that parents should not rely on the monitors for measurements in any significant way.
What do you think about this topic? Let us know in the comments!