Wearable devices for infants offer to give parents peace of mind, but are they being lulled into a false sense of security, asks an article in The BMJ?
David King, clinical lecturer in paediatrics at the University of Sheffield, says medical professionals and consumers need to be aware that such devices “have no proved use in safeguarding infants or detecting health problems, and they certainly have no role in preventing [sudden infant death syndrome] SIDS.”
Wearable devices for infants are a growing industry worldwide. Devices that attach to a newborn baby to monitor its vital signs are marketed by several US companies at a cost of around $200 to $300 to give parents “peace of mind” about their baby’s health.
One company’s website says the device “alerts you if something appears wrong with your baby’s heart rate or the amount of oxygen in his/her body.” Another claims that its product allows parents to see their “baby’s breathing patterns, in real-time.”
None of these products requires Food and Drug Administration (FDA) approval, says King. They are not yet available in Europe, and it is unclear whether regulatory approval will be needed here, he adds.
Furthermore, 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.
He recalls that in the 1980s and 1990s a plethora of similar products was developed and sold with the intention of reducing SIDS, but studies showed that such devices had no effect on the incidence of SIDS in healthy infants.
Although none of the makers of these new devices claim that they reduce the risk of SIDS, King argues that “parental fears about SIDS have driven the development of their products – and the themes in their marketing.”
He acknowledges that some situations, such as preterm infants or infants who need oxygen, may justify home monitoring. But he says parents and other caregivers in these cases need to be trained in observation techniques, operation of the monitor, and infant cardiopulmonary resuscitation.
Ideally, manufacturers would be required to undertake observational studies or randomised trials to support any claims they make concerning the effectiveness of wearable devices in infants – even if they are categorised as consumer devices, suggests King.
Until this time, he says healthcare professionals “should not recommend these products to reduce parents’ fears of SIDS but should instead focus on interventions that have been proved to work, such as encouraging parents to put infants on their back to sleep.”
He also believes manufacturers “should place prominent disclaimers at the point of sale to emphasise that they are not medical devices and that no evidence shows that they reduce the risk of SIDS or have any other health benefits.”
Are the manufacturers of these wearable devices for infants being completely transparent with their future customers, asks King? “If they are not, the risk is that the substantial amounts of money that parents pay for such devices might lull them into a false sense of security.”
Marketing wearable home baby monitors: real peace of mind?, The BMJ, doi: 10.1136/bmj.g6639, published 18 November 2014.