FDA Warns Against Using Unauthorized Infant Monitors

The US FDA is warning consumers, caregivers, and healthcare providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature).

According to the FDA, many infant monitors currently sold over-the-counter (OTC) for vital sign monitoring do not have FDA marketing authorization, meaning the FDA has not evaluated the safety and effectiveness of those devices.

The FDA became aware of unauthorized products being marketed to consumers through routine monitoring of the medical device market and is alerting customers of the risks associated with the use of these unauthorized devices. The agency also warns that no devices, including infant monitors, have been authorized to prevent SIDS or SUID.  

Infant monitors are devices that are claimed to monitor vital signs such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. These devices alert caregivers to check on infants or prompt intervention. Interventions are actions such as seeking medical or emergency care or changing medications. These monitors may be worn by the infant, such as on the foot or belly, or are contactless, such as a sensor placed under a mattress or a wall-mounted camera.

These devices are required to receive FDA marketing authorization to be lawfully marketed in the United States. These devices do not fall within the FDA’s policy for general wellness products because they are not intended solely for a general wellness use and are not low risk.

Risks of Using Unauthorized Devices

Infant monitors are intended to alert caregivers of values outside of set thresholds, prompting intervention such as calling their doctors or seeking emergency care. Inaccurate measurements from unauthorized devices can lead to unnecessary medical care. These devices may also fail to detect changes in condition, which could delay treatment for serious symptoms or cause the user to miss the detection of a medical condition.

Risks of using an infant monitor that has not been authorized by the FDA include:

• Failure to detect changes in heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. 
• Delays in seeking treatment for serious symptoms due to an over-reliance on alerts to prompt action.
• Adverse tissue reactions such as burns or rashes.
• Inaccurate alerts leading to unnecessary medical interventions.

Devices that monitor vital signs for infants are manufactured by dozens of companies and sold under multiple brand names. To see if an infant monitoring device has been evaluated and authorized by the FDA, search the FDA’s De Novo database and 510(k) database using the device name. Devices that have been evaluated and authorized will have the product code QYU. No devices, including infant monitors, have been authorized to prevent SIDS or SUID.

Recommendations for Consumers and Caregivers

• Do not use unauthorized infant monitors that claim to measure vital signs including heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. These devices may be sold through online marketplaces or directly from the seller.
  • Be aware that the safety and effectiveness of these devices have not been reviewed by the FDA, and the use of these devices could result in inaccurate measurements.
  • To see if an infant monitoring device has been evaluated and authorized by the FDA, search the FDA’s De Novo database and 510(k) database using the device name. Devices that have been evaluated and authorized by the FDA will have the product code QYU.
• If medical care depends on accurate monitoring, talk to your health care provider about an appropriate FDA-authorized device for your child’s needs.
• Do not use baby products with claims to prevent or reduce the chance of SIDS/SUID.
• Refer to the FDA’s recommendations for parents and caregivers about the use of baby products.

Recommendations for Healthcare Providers

• Read and follow the recommendations above for consumers and caregivers.
• Talk to your patients’ caregivers about the risks of using unauthorized infant monitors.
• Help your patients’ caregivers select an appropriate, FDA-authorized monitoring device, if needed.

The FDA will keep the public informed if significant new information becomes available.