The Food and Drug Administration (FDA) recently issued a safety communication about baby monitors being sold over the counter without agency approval. The warning is intended not only for primary caregivers but for healthcare providers as well.
The alert was the result of routine market checks that found unauthorized devices being sold online and through direct-to-consumer retailers. The agency also repeated warnings about infant sleep positioners, which have been tied to suffocation deaths.
The devices in question claim to measure heart rate, oxygen levels, breathing, and temperature, but the FDA says their readings can be unreliable and could lead to unnecessary medical treatment or, in some cases, dangerous delays in emergency care.
The federal agency emphasized that no infant monitor has been cleared to prevent sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID), even though some of these products are marketed that way.
What could go wrong
Risks of depending on these over-the-counter infant monitors include failure to detect serious changes, repeated false alarms, and burns or rashes from some of them. The products are sold as wearables, mattress sensors, or wall cameras, but all need FDA authorization to be legally marketed in the U.S.
The agency recommends that parents check its device databases for approved monitors and speak with health care providers before relying on one. Doctors were also advised to discuss the risks with families and suggest cleared products when monitoring is medically necessary.
Guidance for families and medical staff
Parents who suspect their baby monitor provided inaccurate readings or caused any adverse reactions are encouraged to file reports with the FDA’s MedWatch system. Healthcare facilities should follow their standard reporting protocols for device-related incidents. These reports allow the agency to track safety issues and gain a better understanding of potential risks associated with medical devices.
Sources: FDA, Contemporary Pediatrics