Experts are worried about an emerging market of smart devices that pledge to monitor babies’ vital signs during sleep. In an editorial published this week in the Journal of the American Medical Association, two doctors and a medical researcher warn that relying on these smart baby monitors could actually put infants at risk. The authors call on the Food and Drug Administration to step up its regulation of these devices.
Smart diaper clips, smart onesies, smart socks, and smart leg monitors are sold to parents by manufacturers claiming the devices can help prevent infants from dying in their sleep. Sleep-related deaths, including sudden infant death syndrome, or SIDS, kill about 3,500 babies a year in the US. They’re also hard to detect — short of checking whether a baby’s chest is rising and falling, parents have very few options.
But these smartphone-connected devices aren’t cheap. The ones mentioned in the editorial cost anywhere from $ 150 to $ 300. Owlet Baby Care’s smart sock monitor, for example, is supposed to track a baby’s heart rate and blood oxygen levels. It has reportedly sold 40,000 smart socks for $ 250 a sock.
These monitors capitalize on parents’ fears and may not actually keep babies safer, the authors say. For one thing, there’s no evidence that monitoring the vital signs of healthy babies actually reduces their risk for SIDS, according to the American Academy of Pediatrics.
For another, many of these devices aren’t actually evaluated for safety, accuracy, or efficacy, the authors write. If they have been tested in clinical trials, that data isn’t publicly available. That’s a problem, because medical apps have a record of being dangerously inconsistent. A blood-pressure app, for example, was found to incorrectly tell 80 percent of people with high blood pressure that their blood pressure was fine. Likewise, a faulty smart baby monitor could falsely reassure parents that an ailing baby is healthy, or alarm parents that a healthy baby is sick.
These smart baby monitors should be regulated by the FDA like class II medical devices — the same category as pregnancy tests — the authors write. In fact, the FDA already has power to regulate mobile apps that are used in combination with medical sensors. But these baby monitors escape that oversight because the companies that market them avoid making health claims. “Yet their advertised role is to alert parents when something is wrong with their infants,” the editorial reads. The authors call for the agency to step up its oversight.
Ken Ward, medical director of Owlet Baby Care, wrote in statement emailed to The Verge that a medical version of the company’s smart sock is under review by the FDA. The story will be updated when we hear back on how it differs from the one currently sold to parents. “While many of the statements in the JAMA opinion paper about the present lack of evidence behind certain products has merit, Owlet is actively addressing and resolving these concerns,” Ward said.
More research, preferably published in peer-reviewed journals, is a good idea. Because these smart baby monitors could be powerful tools for parents — if we knew for sure that they actually worked.
