Doctors Warn Against Using Baby Health Monitors

A pair of doctors and medical device researchers writing for the Journal of the American Medical Association caution parents against the consumer-use electronic devices that monitor babies' vital signs for healthy children.

They argue that these devices can cause undue stress to parents, have not been shown to have medical benefits and may lead to unnecessary treatment.

"These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child's cardiorespiratory health," said Dr. Christopher Bonafide, a pediatrician at the Children's Hospital of Philadelphia and one of the authors of the article. "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."

The article, published Tuesday, was also authored by Dr. Elizabeth Foglia, also at CHOP, and David Jamison, the executive director of Health Devices at ECRI Institute, which researches medical devices and procedures.

The devices in question attach to a baby's clothing or body and can monitor breathing, movement, oxygen blood level and heart rate. Brands that sell these devices include MonBaby, Owlet and Baby Vida. The costs range from $100 to $300.

Since they do not claim to treat, diagnose or prevent a disease, they do not have to be regulated under the same strict guidelines as medical devices.

However, the authors point out that the makers of Owlet produced a video in which the company's CEO says, "We can’t promise to prevent Sudden Infant Death Syndrome right now, it’s an unknown issue but…we believe notifying parents when something’s wrong maybe can help.”

Other ads suggest that monitors should be worn whenever the baby is sleeping.

"These direct-to-parent advertising strategies may stimulate unnecessary fear, uncertainty, and self-doubt in parents about their abilities to keep their infants safe," the authors write.

"There is no publicly available evidence that these baby monitors are accurate in measuring a baby's vital signs," said 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."

"There is a serious question whether these are appropriate in monitoring healthy infants," said Bonafide. "A single abnormal reading may cause overdiagnosis--an accurate detection that does not benefit a patient."

He points out that erroneous diagnoses could lead to unnecessary tests, X-rays and possibly hospital admissions. While any number of these steps is reasonable in a true emergency, they can carry small risks that are not worth taking without good reason.

A representative for MonBaby told Patch, "JAMA article misses a few key points." They note that one of their devices sells for around $100, while the press release for the article said they range from $150 to $300.

She also noted that MonBaby does not claim it can prevent SIDS, though the authors of the article never said otherwise.

She continued: "Our monitor notifies parents that their baby rolled over during the sleep so that they can act fast. It also proactively notifies parents about changes in sleep position, breathing movement, excessive activity, and falls."

MonBaby offered no evidence that the device provides medical benefits and did not respond to the authors' concern that they can cause unnecessary parental stress and may lead to overdiagnosis. Its statement concluded: "While we are not on the same page with the article, we welcome any collaboration with medical institutions."

Dr. Ken Ward, the medical director for Owlet, recognized that the article in JAMA made important points.

"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," he said. "I recently joined the Owlet team because I believe that the data being collected have the potential to answer critical questions about infant health. Having delivered over 8,000 babies, most of whom were high-risk infants, I’m passionate about the possibility of helping new parents and their babies through novel technologies."

A broader statement from the company argues that Owlet in particular has worked to reduce the risk of overdiagnosis: "Due to innovations developed by Owlet to lessen false alarms, many users will use the Owlet Sock for several months without ever getting a false alarm, greatly reducing the risk over diagnosis."

Foglia, a neonatologist and one of the authors of the article, was optimistic that the technology had promise, despite present failings.

"In the future, some physiological monitors may offer real benefits to vulnerable infants at home, but we have no evidence now that these devices are safe, accurate or effective," she said.

Photo credit: Sabian Maggy