Evaluation Background: Consumer-Marketed Baby Vital Signs Monitors
October 24, 2018 | Evaluations & Guidance
Here's background for our Evaluations of consumer-marketed baby vital signs monitors, outlining the key considerations for making wise purchasing decisions. Learn our product ratings, how the technology is used, which specs are important, and what factors we test for.
Consumer baby vital signs monitors are marketed to parents for monitoring of their sleeping infants, with the intent of alerting them to changes in the child's general cardiorespiratory status that might be predictive of a harmful or even life-threatening change in their health. To be considered in this category, the baby monitors must monitor and display pulse rate and blood oxygen saturation, which differentiates them from the more common motion, audio, or video baby monitors marketed to consumers.
According to their manufacturers, the monitors are intended to provide parents with peace of mind, allowing them to sleep while their child is sleeping. Because they are intended for consumer home use and are not considered medical devices, they do not offer features commonly found on pulse oximeters marketed for healthcare use (e.g., pulse waveform, fully adjustable alarm functions). These devices fall into a gray area, in that manufacturers caution that they are not medical devices and are not intended for use in preventing or diagnosing medical conditions, yet consumers clearly adopt them for the purpose of identifying situations that may require medical attention. This is a new consumer technology that has been increasingly adopted by concerned parents, with or without the knowledge of their pediatricians. We believe pediatricians need to be aware that parents are buying these devices and may seek guidance on their use.
The devices employ pulse oximetry technology to acquire pulse rate and oxygen saturation information and relay it wirelessly to mobile devices (i.e., smartphones or tablets). The mobile device software applications (apps) used to monitor the information have preestablished limits for pulse rate and blood oxygen saturation levels and will alert parents when these limits are exceeded. The alarm limits should not necessarily be aligned with those on medical pulse oximeters used in healthcare facilities, because medical devices are designed to be used on infants who are hospitalized or receiving medical care. It is expected that the consumer baby vital signs monitors would have less sensitive alarm thresholds because these devices are intended for use in the home on healthy infants that are unlikely to become seriously ill. However, precisely where the alarm limits should be set for blood oxygen saturation and pulse rate in a home setting is not clear, and we reviewed medical literature and consulted with clinical experts in pediatric monitoring for guidance.
These products do not currently have or require FDA premarket review, although at least one vendor is seeking FDA 510(k) clearance for a medical version of its monitor.
Consumer baby vital signs monitors...