TUESDAY, August 21, 2018 (HealthDay News) – The wearable oxygen monitor you bought for your child may provide you with bad information, the researchers report.
The tests of two infant oxygen monitors sold directly to consumers have raised serious concerns about the accuracy of these devices, which are designed to keep the baby's heart rate and oxygen levels in check.
But one of the monitors, Baby Vida, failed to detect low levels of oxygen and continued to show numbers that appeared normal, the researchers found. He also generated false low heart rate warnings even though the baby was fine.
The other monitor, the popular Owlet Smart Sock 2, has inconsistently detected low levels of oxygen in children, said lead researcher Dr. Chris Bonafide. She is a pediatrician and safety expert at the Children's Hospital of Philadelphia (CHOP).
"These products are sold as consumer products, but are compared to hospital grade monitors," Bonafide said. "I think we've shown here that it's not a fair request to make, of course they're not working at the hospital grade level."
The American Academy of Pediatrics (AAP) recommends against parents who use oxygen for newborns to monitor, since research has shown that even the best hospital grade devices can not protect from sudden infant death syndrome ( SIDS).
Monitor manufacturers propose devices as a way to help new parents recover their sleep while keeping their eyes open on their child.
Instead, the devices could provide a false sense of security, said Dr. Rachel Moon, who chairs the task force of the AAP on SIDS.
"My main concern is that people feel complacent, the child has monitored that it is OK for them not to practice safe sleep," said Moon, head of pediatrics for the Faculty of Medicine at the University of Virginia. "Using a monitor is much easier than practicing safe sleep and then, if the monitors do not work, you're in a horrible situation, then."
Baby Vida seems to no longer be on the market. His website displays an error message and the monitor is no longer available on Amazon or Walmart.
Owlet responded by stating that Smart Sock "is not a medical device and is intended for healthy children. It heals or prevents any disease, including SIDS."
According to the statement, "Owlet recommends the same AAP guidelines to sleep peacefully and encourages the use of the device as the parents' peace of mind ".
Bonafide and her colleagues tested devices on 30 children 6 years of age or younger in CHOP cardiology and general pediatrics units during the last half of 201
Each child wore a monitor of hospital grade approved by Food and Drug Administration in the United States on one foot and a consumer monitor on the other foot.
None of the 14 children who experienced low oxygen levels according to the hospital grade monitor had simultaneous low oxygen readings on Baby Vida.
At the same time, Baby Vida also falsely displayed the slow heart rate in 14 children who had a normal pulse, the results showed.
"He had problems with false negative values and false positive values in the same monitor," Bonafide said.
The Owlet device detected low levels of oxygen in all 12 patients who had a lower blood oxygen drop than normal,
But Owlet incorrectly indicated that five of the 12 children had normal oxygen levels at least once during these prolonged periods of reduced oxygen, the researchers found.
"Sometimes when these children had low oxygen saturation, Owlet inconsistently showed normal oxygen saturation," Bonafide said.
Overall, Owlet detected low levels of oxygen with accuracy almost 89 percent of the time. "If something goes wrong with a sick child, you would like to know that 100% of the time," Bonafide said.
The results were published as a research letter in the August 21 issue of the Journal of the American Medical Association .
Owlet argues that this consumer test was not fair, because he compared their Smart Sock with another device used in hospitals. A real assessment would involve extracting blood from the children, testing their blood gas levels in a laboratory and comparing it to the Owlet readings.
"The accuracy and performance of Owlet Smart Sock is something we take very seriously" Kurt Workman, co-founder and CEO of Owlet, stated in a statement.
Bonafide said he is worried that these devices could unnecessarily scare the parents by sounding an alarm when there is nothing wrong. He is also worried about false reassurance.
"A child could really be very sick and perhaps the parents' instinct is to say, I should really bring this baby, but maybe they check the number and the number can therefore falsely reassure, if they have to do with a monitor that is not completely accurate, "said Bonafide
Parents who choose to use these monitors should discuss it with their pediatrician, he suggested.
"They should know what they are going to do if this monitor goes off in the middle of the night," Bonafide said. "Make that conversation with the pediatrician before that happens, so you can really have a plan in place."
The American Academy of Pediatrics has more information on the guidelines on safe sleep.
SOURCES: Chris Bonafide, MD, pediatrician and security expert, Children's Hospital of Philadelphia; Rachel Moon, MD, Head of Pediatrics, University of Virginia School of Medicine, Charlottesville; August 20, 2018, Owlet, statements; August 21, 2018 Journal of the American Medical Association