Per the notice below, the United States Food and Drug Administration (FDA) is alerting people not to use unauthorized devices that monitor vital signs in infants.

Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care 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).  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 recommends looking for an FDA-authorized device appropriate for your child’s needs.

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This safety communication provides:

• Recommendations for consumers, caregivers, and health care providers.
• Background on the safety concerns and the FDA’s actions in this area.
• Instructions for reporting problems with infant monitoring devices to the FDA.

Questions?

If you have questions, contact the Division of Industry and Consumer Education.