Smart baby trackers monitor a baby’s heart rate and oxygen level with the intention to alleviate parental anxiety over the risk of SIDS (Sudden Infant Death Syndrome), or more commonly known as crib death. This is good news for parents whose babies are diagnosed with cardiovascular diseases but the products prove to be unnecessary and even controversial for healthy infants. Doctors spoke out against the monitoring devices due to the increasing number of false alarms showing up in hospital Emergency Departments. For hospitals and medical staff, these visits waste time and resources; and for parents who believe their baby is at serious risk, this experience is extremely frightening and stressful. Doctors are concerned, saying that these devices could be causing more harm than good and that they should require FDA approval.
Dr. Foglia, Dr. Christopher Bonafide and Dr. David Jamison, authors of the opinion piece published by the American Medical Association journal Jamanet, wrote “Healthy infants have occasional oxygen de-saturations to less than 80% without consequence, and these monitors could increase the risk of over-diagnosis and potential harm if these innocuous events generate alarms.”
Dr. Elizabeth Foglia is a neonatologist, and says that “For most healthy babies there is not a role for home monitoring at all,” and that “There are few classes of babies for whom it would be appropriate to go home with a medical monitor – and a physician would prescribe that monitor.”
Despite Doctor cautioning, smart baby trackers are growing in popularity.
Ben Wood, analyst at CCS Insight said “It is unsurprising that new parents are seduced into buying new gadgets for their babies and as technology evolves there is a growing array of monitoring products.”
“New parents are low-hanging fruit for gadget-makers because they want to give their babies the best start in life.”
“The problem is that in the age of the ‘worried well’ such products can end up leading to false alarms that can alarm parents and place even more pressure on already stretched health services.”
David King, a lecturer in pediatrics at the University of Sheffield, argues in his editorial report that “Home monitoring may be justified in some situations, such as for preterm infants or infants who need oxygen but in these cases parents and other caregivers should be trained in observation techniques, operation of the monitor, and infant cardiopulmonary resuscitation.” Like many doctors, King too is concerned about the product being publicly available without FDA approval. Despite the fact that companies selling the products state that they have not received FDA approval, he doesn’t think that the message is clear enough for parents. King thinks the product advertising is confusing – and possibly misleading.
Owlet, a brand which sells their smart baby-tracker for $250 (USD), states on their website that they have submitted a medical version to the FDA for approval. Until they receive FDA approval, these devices are not considered medical devices, but rather just a monitoring product.