Amid the boom of wearables came the birth of devices for babies. Fretful, gadget-loving parents can now choose from a range of mini monitors that hide in tiny socks, strap to chubby little legs, snap onto diapers, or pin to onesies. The pastel gizmos promise peace of mind by effortlessly tracking an infant's vital signs, movements, and sleep while parents take a breather.

Several companies dance around the idea that the monitors could even help prevent SIDS, sudden infant death syndrome. Of course, the reason for the footwork is because they have no basis to make such a claim; none of these consumer devices has been adequately tested and approved as medical devices by the Food and Drug Administration.

In fact, despite the makers’ assurances, the devices have no proven value and may actually cause harm in the way of false alarms and over-diagnoses, experts argue in an opinion piece published Tuesday in JAMA.

The piece concludes:

Until these monitors have been thoroughly evaluated and guidelines for use have been established, the recommendations physicians should give to parents who ask about these products is simple. There is no evidence that consumer infant physiologic monitors are life-saving, and there is potential for harm if parents choose to use them.

The piece was written by pediatrician and safety expert Christopher Bonafide, of Children's Hospital of Philadelphia, neonatologist Elizabeth Foglia of the University of Pennsylvania, and David Jamison, executive director of Health Devices at ECRI Institute, a respected nonprofit research organization that studies patient safety.

In their opinion piece, the trio reviewed five monitors, including the Owlet, a $250 sock monitor that tracks a baby’s heart rate and oxygen levels. The authors made note that in a video online, Owlet’s CEO said, “We can’t promise to prevent Sudden Infant Death Syndrome (SIDS) right now… but... we believe notifying parents when something’s wrong maybe can help.”

But the authors note that the American Academy of Pediatrics specifically says not to use such home monitors as a strategy to try to reduce the risk of SIDS. “The use of cardiorespiratory monitors has not been documented to decrease the incidence of SIDS,” the AAP said in its latest recommendation (#13). And the academy noted that “there are no data that other commercial devices that are designed to monitor infant vital signs reduce the risk of SIDS.”

Instead, the authors of the opinion piece argue, the devices come with the risk of raising false alarms, triggering unnecessary trips to the emergency room that could lead to lab tests, scans, and over-diagnoses. In fact, the authors note that healthy infants actually can have temporary drops in blood oxygen levels, and 80 percent of those are harmless—little baby glitches.

In a statement on its website, Owlet responded, saying:

As a company with more than 80,000 families using the product, we are confident in the positive results these families are experiencing. As evidenced by the continued success, the Owlet Smart Sock is filling a void and responding to the demand from parents for this information. A number of our current customers are physicians and healthcare providers, who have expressed support for the product and the information it provides through its continued use with their own children. Due to innovations developed by Owlet to lessen false alarms, many users will use the Owlet Sock for several months without ever getting a false alarm, greatly reducing the risk of over diagnosis…

The company said it had submitted third-party accuracy studies to the FDA and is awaiting review.

JAMA, 2017. DOI: 10.1001/jama.2016.19137 (About DOIs).

Photo Credit: Bonafide, Jamison, Foglia, JAMA