A new report suggests that baby monitors have little proven benefit for healthy infants and can potentially cause more harm than good.
A new article, published in the journal JAMA, investigates the pros and cons of using a smartphone-integrated physiological baby monitor.
In the article, pediatrician and safety expert Dr. Christopher P. Bonafide, of the Children's Hospital of Philadelphia (CHOP), and his colleagues comment on the health benefits of the new class of infant physiological monitors that have become widely available over the past two years.
These monitors come in the form of apps that are connected to sensors built into the babies' clothes and diapers, which can measure the baby's heart rate, respiration, and blood oxygen saturation.
The apps can generate alarms for tachycardia, sleep apnea (a condition in which the infant's breathing stops during sleep), a slow heart rate (also known as bradycardia), and oxygen desaturation, which is a reduction of oxygen levels in the blood below 80 percent.
As Dr. Bonafide and colleagues point out, these apps have been marketed "aggressively" at parents of newly born infants, leading to an unprecedented expansion of the consumer-use baby monitor market.
Evaluating the benefits of baby monitors
So what are the real benefits of these medical gadgets? Dr. Bonafide - together with CHOP neonatologist Dr. Elizabeth E. Foglia and David T. Jamison, executive director of Health Devices at ECRI Institute, a nonprofit that assesses medical devices - evaluated five baby monitor models across three parameters: their advertised role, medical indications, and existing state regulations.
The five models are Baby Vida, MonBaby, Owlet, Snuza Pico, and Sproutling, with prices ranging from $150 to $300.
These consumer baby monitors, the authors note, do not straightforwardly say that their products treat or even diagnose disease. However, they promise to alert parents when something is wrong with their child's cardiorespiratory health.
Regarding something as serious as sudden infant death syndrome (SIDS), Owlet manufacturers, for instance, insist that their product can notify parents if something goes wrong, despite acknowledging that SIDS is an "unknown issue" which they "cannot yet claim to help prevent."
Physiological baby monitors bypass regulations, raising safety concerns
Furthermore, Dr. Bonafide and colleagues point out the absence of official medical guidelines for the home monitoring of healthy newborns. The American Academy of Pediatrics clearly state "do not use home cardiorespiratory monitors as a strategy to reduce the risk of SIDS," emphasizing the lack of evidence suggesting that medical devices such as baby monitors can lower the risk of SIDS.
As for state regulations, Bonafide and colleagues suggest that smartphone-integrated physiological baby monitors have bypassed United States Food and Drug Administration (FDA) regulations by not stating that their products would prevent SIDS. This makes the authors question the effectiveness, reliability, and safety of these products.
"There is no publicly available evidence that these baby monitors are accurate in measuring a baby's vital signs," says Jamison. "And since these baby monitors are not regulated by the FDA, we have to question what testing has been done to assure the safety and quality of these designs."
Dr. Bonafide and colleagues report that in one study, for example, a blood pressure app was revealed to falsely display normal blood pressure levels in 80 percent of the hypertensive study participants.
Baby monitors may trigger overdiagnosis
Even if these monitors do eventually turn out to be highly accurate, Bonafide says that, "there is a serious question whether [they] are appropriate in monitoring healthy infants. A single abnormal reading may cause overdiagnosis - an accurate detection that does not benefit a patient."
The authors write that research shows healthy infants occasionally have oxygen desaturations that go below 80 percent, with no clinical consequence whatsoever. With physiological baby monitors, however, one incidental low saturation reading - that would otherwise go away on its own - may alert the parents and bring them to the emergency department. This, in turn, could trigger unnecessary tests and checkups.
"These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child's cardiorespiratory health. But there is no evidence that these consumer infant physiological monitors are life-saving or even accurate, and these products may cause unnecessary fear, uncertainty, and self-doubt in parents."
Dr. Christopher P. Bonafide