Parents often rely on home monitoring products to protect babies from sudden infant death syndrome (SIDS), an unexplained death that can happen to seemingly healthy babies, often during sleep. But they shouldn't, argues a new editorial report in the journal The BMJ.
David King, author of the piece and clinical lecturer in pediatrics at the University of Sheffield, wrote that smart baby monitors and infant wearables provide a false sense of security to parents who use the products to keep their babies safe.
Take Owlet, King says, a U.S. company that raised $1.85 million in April 2014 for a smart sock that could measure babies' vital signs. Other companies like Rest Devices and Sproutling have advertised similarly smart clothing for monitoring babies' vitals. The problem, King argues, is that while the companies don't outright claim that their products reduce the risk of SIDS, parents' fears of the disorder are responsible for spurring the industry's growth.
In August, Sproutling co-founder and CEO Chris Bruce told TIME the product was developed out of his own need to incessantly check on his baby to make sure she was still breathing. "I’d get nervous," he said. "I tried to listen at the door and I didn’t want to wake her up…So I sneak in, I try and listen if she’s breathing, and I end up putting my hand on her and waking her up."
King writes that devices can be helpful in some circumstances. "Home monitoring may be justified in some situations, such as for preterm infants or infants who need oxygen," he says. "But in these cases parents and other caregivers should be trained in observation techniques, operation of the monitor, and infant cardiopulmonary resuscitation." These monitoring products do not require premarket approval by the US Food and Drug Administration (FDA), and King argues that despite the fact that the companies disclose that they are not medical devices, there's not enough information ensuring parents really know that. He argues that the advertising for these products is confusing.
In the report, King writes:
Owlet states on its website that the device “alerts you if something appears wrong with your baby’s heart rate or the amount of oxygen in his/her body.” Rest Devices claims that its product allows parents to see their “baby’s breathing patterns, in real-time.” Sproutling says that it will let you know “if your baby is sleeping soundly or if something is wrong.” No published data support any of these claims, and because the devices are being sold as consumer rather than medical devices such data are not required. Ideally, manufacturers would be required to undertake observational studies or randomized trials to support any claims they make concerning the utility and efficacy of wearable devices in infants—even if they are categorized as consumer devices.
The American Academy of Pediatrics has already said that home cardiorespiratory monitors shouldn't be used to reduce SIDS risk.
In response to King's report, the founder of Owlet Kurt Workman says in a statement sent to TIME: "I have hundreds of comments from Owlet testers and none of them focus on SIDS. They just want to know if something is wrong. That’s what pulse oximetry does in hospitals and in homes worldwide. Parents simply want something that can monitor their child pro-actively (something that video and sound can’t do). As parents we’re tired of monitors that only serve a purpose when we’re awake. We want something that can let us rest easier. That’s the purpose of Owlet and for many parents it is worth the expense."
Rest Devices, the company behind the Mimo Smart Baby Monitor, also responded to TIME:
Mimo was never designed to be a medical device. It's worth noting that our founding team did clinically validate our sensors when doing early-stage development of adult respiratory diagnostic devices, and we continued to use that knowledge base once we transitioned to baby and family products. We do communicate to our customers in several different forms that our product is a baby monitor, not a medical device. It's on our website, it's on our packaging, it's in our support tools—including the setup booklet that helps a parent get up and running.
Owlet says nearly 3,000 people have pre-ordered their product and that their technology is more advanced than the research King mentions in his piece. "The bigger point is that technology has progressed and we can now fit a pulse oximeter, accelerometer and even temperature sensors comfortably on a baby’s foot without any cords," says Workman, adding that the company is creating a product that they will submit to the FDA as a medical device to take home from the neonatal intensive care unit.
"Some professionals have the notion that the less parents know the better, we feel the opposite," he says. "We also feel that they have the right to know more about their child."
King says medical professionals should not recommended the products to ease parents' fears, but should instead recommend methods long known to work, like positioning a child on its back to sleep. But in our new age of tracking ourselves, why not keep tabs on the vitals of our dependent kin? Smart monitoring devices won't hurt as an extra way for parents to track their children—as long as they're well aware that doing so won't alert them to SIDS in their babies.
Sproutling did not respond to requests for comment at publication.