Consumer Pulse Oximetry Home Baby Monitors May Be Inaccurate: What Parents and Physicians Need to Know
Dr. Brian Carter, Bioethics, Neonatal/Perinatal Medicine
Parents of infants and children with respiratory or cardiovascular conditions that use smartphone-integrated consumer pulse oximetry baby monitors need to know these over-the-counter devices may not be accurate.
A pulse oximetry measures the oxygen saturation level of the blood and how well that oxygen is being sent from the heart to other parts of the body. Many parents are drawn to this technology to reassure their child is sleeping safely during the nighttime hours, but new research regarding the accuracy was recently published in The Journal of the American Medical Association. Our colleagues at the Children’s Hospital of Philadelphia studied two different models accessible to parents and found the devices have inconsistent readings compared to FDA-approved monitors.
The Danger of Inaccurate Information
In several instances, the consumer devices indicated the child may be in distress when in fact the child was fine. The consequence of inaccurate information can lead to increased parental anxiety, unnecessary visits to the Emergency Department (ED) and unnecessary testing of the baby.
On the other hand, misinformation that reassures the parent can be detrimental for babies. False-negative findings suggest the baby has “normal blood oxygen saturation” when the child does not. This is dangerous, especially if the child truly has poor blood oxygenation as a result of congenital heart disease, chronic lung disease, or even an acute episode of viral or bacterial bronchiolitis or pneumonia.
Why Parents Use Home Monitoring Devices
Most often parents use a home pulse-oximeter for one of three reasons. The first, is if there is a history of a critically-ill baby in the home that required home monitoring or maybe an older sibling is still home-monitored for congenital heart disease or a chronic respiratory problem. The parents, who are already on high-alert, are looking for reassurance even though the current newborn has no health concerns.
The second reason may be the parent has lost a child, whether due to Sudden Unexpected Infant Death, heart disease, lung disease or central nervous system disease. Again, parental anxiety is already heightened and monitoring may provide some peace of mind. In either situation, a discussion needs to be had with a pediatrician or other health care professional about whether or not the child qualifies for, or would benefit from, home monitoring. If recommendations are met, the child would be prescribed an FDA approved device as opposed to over-the-counter smart phone technology.
The third reason many parents use an over-the-counter device is because parents are becoming increasing tech savvy. Parents have used baby monitors and cameras to monitor a child’s movement and sound for years. This is just one more technology available on the market.
Why FDA Approval is Important
The FDA regulates medical devices used for improved health or treatment of health conditions. For instance, if a child needs oxygen at home, an oxygen tank which can regulate the flow of the oxygen, and a monitoring device such as a pulse-oximeter or an apnea and bradycardia alarm is required. An FDA-approved device has been tested for accuracy, precision and appropriate use in the home, and the agency has determined the benefits of the product outweigh the known risks for the intended use.
If the device is not FDA approved, such as the over-the-counter home pulse oximeters, it means the consumer isn’t protected when using the device.
Takeaway for Parents and Pediatricians
Both consumers and clinicians need to be informed about pulse oximetry-based home baby monitors and make well-informed decisions about the appropriate use of the device.
Pediatricians caring for at-risk NICU graduates should be aware tech-savvy parents might be inclined to use these devices, and should let parents know the machine is not as precise as desired and doesn’t meet FDA standards.
There may be a day when over-the-counter physiologic monitoring technology using a smartphone app will be FDA approved. Until then, parents should do their own research and know what they’re buying. They should also have open discussions with their pediatric health care professional to determine whether it's appropriate to continue using the device.
If a parent uses a consumer home monitor they need to look at the condition of the baby (color, activity, breathing) and not just pay attention to the pulse-oximeter saturation or heart-rate value. If a child is cyanotic (blue), lethargic or has respiratory problems, the child needs to be taken to the ED for a thorough evaluation. Bottom line, don’t simply trust a home evaluation with a smart-phone app.
Read the entire study via The Journal of the American Medical Association.