While most wearable baby monitors are designed with the intention to give parents peace of mind, some experts warn they may do just the opposite.

In a recent JAMA article, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices have no evidence of medical benefits.

“These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child’s cardiorespiratory health, but there is no evidence that these consumer infant physiological monitors are life-saving or even accurate, and these products may cause unnecessary fear, uncertainty or self-doubt in parents,” Dr. Christopher Bonafide, pediatrician, safety expert and lead author of the article said in a statement.

Bonafide and his colleagues looked at five models of infant physiological monitors that have been introduced over the past two years: MonBaby, Baby Vida, Owlet, Sproutling and Snuza Pico, which take the form of smart, sensor-enabled socks, onesies, leg bands or diaper clips. The researchers noted that, despite the lack of publicly available evidence supporting the safety, accuracy and effectiveness of the devices, sales have been “brisk and the market is expanding,” with most products ranging from $150 to $300.

The researchers took issue with the fact that even though these companies are steering clear of the FDA by avoiding direct statements claiming that their products diagnose, treat or prevent disease, they often advertise their role as serving as an alert to parents when something is wrong with their infant’s health.

For example, the website for smart sock company Owlet features a statement from the company’s CEO saying they can’t promise to prevent Sudden Infant Death Syndrome, but believes notifying parents when something is wrong is helpful. Baby Vida, another sock-based pulse oximeter, recommends the use of its product every time the baby goes to sleep to alert parents if the baby stops breathing.

“There is no publicly available evidence that these baby monitors are accurate in measuring a baby’s vital signs,” David T. Jamison, executive director of Health Devices at the nonprofit research organization ECRI Institute and fellow author of the paper, said in a statement. “And since these baby monitors are not regulated by the FDA, we have to question what testing has been done to assure the safety and quality of these designs.”

Another issue was whether such monitoring is even necessary. Considering even healthy infants have occasional oxygen desaturations of less than 80 percent without consequences, the researchers worry the monitors could increase the risk of overdiagnosis.

“A single abnormal test – such as a self-resolving desaturation – can trigger a cascade of events,” the researchers write. “For example, a low pulse oximetry alarm from a consumer monitor could prompt an emergency department visit with laboratory tests, imaging studies, and hospital admission. Rather than reassuring parents, these experiences may generate anxiety and a false assumption that their infant is at risk of dying.”
 
In the short history of these devices, establishing their safety, accuracy and effectiveness hasn’t exactly been clear cut, the authors cede, but the FDA’s 2015 draft guidance on mobile medical apps should provide infant wearable companies some potential guidance. Additionally, the authors would like to see the FDA step in and take on their evolving role in digital health.

“Striking a balance between fostering innovation while providing appropriate and efficient regulation in the rapidly expanding mobile medical app market is challenging,” they write in the article. “In their 2015 guidance document on mobile medical apps, the FDA provides examples of apps that are the focus of their regulatory oversight and include ‘apps that transform a mobile platform into a regulated medical device,’ with breathing frequency monitors, apnea monitors, and oximeters among the device types listed. Based on these regulations consumer infant physiologic monitors would likely be categorized as FDA class II and subject to the 510(k) pathway that requires that the makers demonstrate ‘substantial equivalence’ to a legally marketed device.”

The authors also suggest that the clinical research community work either independently or in partnerships with these infant wearable companies to evaluate and publish the findings from scientific investigations. Until that happens, the researchers say, physicians should advise parents that the products can’t be considered helpful and are thus far potentially harmful.

“The current market of smartphone apps integrated with sensors that monitor infants’ vital signs are innovative and have the potential to improve care. However, their performance characteristics are unknown to the public and there are no medical indications for their use,” the researchers conclude. “Child and family advocates should make it clear to the FDA and policy makers that regulatory guidance and research evaluating the safety, accuracy and effectiveness of these products are needed.”