Why Infant Biometric Devices are a Bad Idea

Having a newborn is a joyful time. But understandably, it can also be fraught with anxiety. New “smart” device companies use careful wording to suggest that monitoring your baby’s vital signs with their products can help ease worry.

Smart baby biometric monitoring devices, such as Owlet and Nanit, have come on the market in recent years. Depending on the device, they offer a range of features: monitoring your baby’s breathing, oxygen levels, sleep cycles, and more. The aim of these devices is to give you “peace of mind” about your infants’ health so you can rest easy at bedtime too. After all, your sleep quality and quantity are just as crucial as your infant’s. You can’t care for your family if you aren’t sleeping.

However, researchers and physicians alike are concerned that parents will trust these devices too much, which could put their children at risk. Currently no evidence shows that these devices can save lives. Plus, accuracy is a concern. Could you be receiving false assurances? The additional anxiety parents may experience while constantly watching vital signs on an app is a real issue as well.

A grim statistic: About 3,400 babies die unexpectedly each year in the United States, according to the Centers for Disease Control and Prevention. Sudden unexpected infant death (SUID) happens to about 90 out of 100,000 infants annually, according to the American Academy of Pediatrics. SUID encompasses sudden infant death syndrome (SIDS), accidental suffocation while sleeping, and loss of life for an unknown reason. SIDS alone accounted for 37% of SUIDS in 2019.

Ultimately, researchers don’t yet know the underlying cause or causes of SIDS, so we don’t have devices that can prevent it. Safe sleep guidelines, however, help remove environmental risk factors, which experts note can “tip the balance in favor of the infant’s survival,” according to the U.S. Department of Health and Human Services.

The loss of a child is an unimaginable horror for parents, and understandably, parents are looking for ways to keep their children safe. But we don’t have evidence yet that a smart device can prevent infants from suddenly dying. In 2022, the American Academy of Pediatrics updated its recommendations for a safe sleeping environment to reduce the risk of sleep-related infant deaths.

Furthermore, the organization expresses worry about overreliance on smart devices and does not recommend their use. “There is also concern that use of these monitors will lead to parent complacency and decreased adherence to safe sleep guidelines,” the authors add. Instead the, American Academy of Pediatrics says these monitors should not be considered a substitute for following its safety recommendations.

Another concern is that terminology like “FDA cleared” can give parents a false sense of security. However, when a device is “cleared” by the Food and Drug Administration, that designation doesn’t mean the FDA has approved or even extensively reviewed the device. The same is true for general wellness products.

FDA cleared devices are considered Class II medical devices. These are not required to undergo clinical trials. The main requirements to achieve FDA cleared status is that the item is low risk or similar to existing devices. The FDA places these under what’s called “510(k) review” to determine if the device is “substantially equivalent” to an existing device. A device is cleared if it fulfills this requirement. But the FDA does not review it for safety or effectiveness.

Some of Owlet’s offerings fall under the FDA cleared category. However, Owlet began marketing one of its products without FDA clearance. It then received an FDA warning letter in 2021 that it was in violation and needed to undergo 510(k) clearance.

Other smart monitors and apps fall under the general wellness products category. The FDA defines these as “intended for maintaining or encouraging a healthy lifestyle” and “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.” Nanit falls under this general wellness category.

If biometric baby monitor companies did make claims that their devices were crucial to health or that they sustained life, then they would be considered Class III medical devices and would be required to undergo FDA approval to be classified as “FDA approved” rather than “FDA cleared.”

Often these companies abstain from making such claims and instead provide disclaimers. For example, Owlet’s says, “Disclaimer: Dream Sock is not intended to diagnose, treat or cure any disease or other condition, including but not limited to, Sudden Infant Death Syndrome (SIDS) and/or Respiratory Syncytial Virus (RSV). Medical decisions should never be made using Dream Sock data. Dream Sock should not substitute for the care and oversight of an adult or consultation with medical professionals.” At the same time, as of February 2024, Owlet continues to market to consumers as offering “ultimate peace of mind.”

Wearable devices that pair sensors with apps aren’t without accuracy concerns. And while wearing a sensor generally won’t cause direct harm, the inaccuracy of the device could.

Let’s consider the Apple Watch, for example. Wearing the watch itself and tracking metrics won’t cause injury or death. But even the Apple Watch comes with a disclaimer and recommendation. Apple Watches now have the functionality to take an electrocardiogram (ECG) for checking if you’re experiencing atrial fibrillation (A-fib).

However, Apple says, “Regardless of the result, if you aren’t feeling well or are experiencing any symptoms, you should talk to your doctor.” That’s because, although the watch proves highly accurate when tested in clinical settings, Apple can’t guarantee 100% accuracy of the functioning, and it can’t account for user error. The watch can be a useful tool that may alert you to potential concerns if you’re unaware and need to see a doctor, but it shouldn’t be used to reassure you that you’re not experiencing an arrhythmia. 

As another example, a small 2016 study of a blood pressure app found that it had a low sensitivity of about 20%. This means that nearly 80% of the 85 participants were told their blood pressure was fine when it was not.

Many biometric smart devices are marketed toward adults and adolescents, people generally old enough and able to note when they aren’t feeling well. So even if they get the all-clear from a device, they know when something feels off and can either see a doctor themselves or voice their concerns to a guardian. Infants cannot. So let’s consider the accuracy rates of some baby biometric monitors.

One independent, peer-reviewed 2018 study published in JAMA, the journal of the American Medical Association, looked at the Owlet Smart Sock 2, which is marketed to parents to monitor their baby for hypoxemia, a low blood oxygen level. The Owlet’s sensitivity was 88.8%. This means that roughly 11% of the time, the monitor would indicate an infant is fine when they are not. The same study looked at the Baby Vida, another monitor. The sensitivity was 0%, meaning that 100% of the time the monitor failed to detect hypoxemia.

The study authors called the findings “concerning.” They wrote, “[Owlet] detected hypoxemia but performed inconsistently. [Baby Vida] never detected hypoxemia and also displayed falsely low pulse rates. Beyond their accuracy, other concerns about consumer monitor use include the lack of medical indications for monitoring infants at home, the absence of FDA oversight, and the potential for unintended consequences.”

The American Academy of Pediatrics recognizes that technology is changing rapidly. In the future, we may have better biometric baby monitoring devices that could prevent sudden infant deaths. But for now, following sleep guidelines remains the best way to keep your baby safe.

Following the guidelines helps reduce the risk of SIDS, the recommendations include information on the following (which are abbreviated).

• Sleep position
  “It is recommended that infants be placed for sleep in the supine (back) position for every sleep by every caregiver until the child reaches 1 year of age. Side sleeping is not safe and is not advised.”
• Sleep surfaces
  “Use a firm, flat, non-inclined sleep surface (eg, tightly fitting mattress in a safety-approved crib) covered by a fitted sheet with no other bedding or soft objects to reduce the risk of suffocation or wedging or entrapment.”
• Room ventilation and sleep clothing
  “Avoid overheating and head covering in infants.”
• Bedding
  “Keep soft objects, such as pillows, pillow-like toys, quilts, comforters, mattress toppers, fur-like materials, and loose bedding, such as blankets and nonfitted sheets, away from the infant’s sleep area to reduce the risk of SIDS, suffocation, entrapment or wedging, and strangulation."
• Pacifier use
  “Offering a pacifier at nap time and bedtime is recommended to reduce the risk of SIDS.”
• Pre- and postnatal exposure to substances
  “It is recommended [to] obtain regular prenatal care… Avoid smoke and nicotine exposure during pregnancy and after birth… Avoid alcohol, marijuana, opioids, and illicit drug use during pregnancy and after birth.”
• Infant immunizations
  “It is recommended that infants be immunized in accordance with guidelines from the American Academy of Pediatrics and CDC.”
• Tummy time
  “Supervised, awake tummy time is recommended to facilitate infant development and to minimize development of positional plagiocephaly. Parents are encouraged to place the infant in tummy time while awake and supervised for short periods beginning soon after hospital discharge, increasing incrementally to at least 15 to 30 minutes total daily by 7 weeks of age.”
• Swaddling
  “There is no evidence to recommend swaddling as a strategy to reduce the risk of SIDS. There is a high risk for death if a swaddled infant is placed in or rolls to the prone position. If infants are swaddled, always place them on the back. When an infant exhibits signs of attempting to roll, swaddling should no longer be used.”
• Hearing screening
  “Current data do not support the use of newborn hearing screens as screening tests for SIDS.”
• The use of commercial devices
  “Avoid the use of commercial devices that are inconsistent with safe sleep recommendations.”
• The use of home monitors
  “Do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS.”

Understandably, parents want to seek every assurance and piece of information they can. However, as promising as baby biometric devices may seem, data does not support their use. Over reliance on these unreliable devices is a real concern, including the chance for false negatives. The American Academy of Pediatrics continues to advise against these devices. Despite marketing “ultimate peace of mind,” device makers must warn parents that their products are not “intended to diagnose, treat or cure any disease or other condition, including but not limited to, Sudden Infant Death Syndrome (SIDS) and/or Respiratory Syncytial Virus (RSV).” 

If, down the road, science proves that at-home baby biometric devices do save lives, that will be welcoming news for parents and kids everywhere. Until then, parents should follow safe sleep guidelines and consult with medical professionals if they have health concerns about their children.