FDA safety warning for infant monitors
The Food and Drug Administration (FDA) is warning consumers not to purchase unauthorized infant monitors that claim to measure vitals signs (heart rate, oxygen levels or breathing rate). The safety and effectiveness of these devices have not been evaluated by the FDA.
Inaccurate readings or interpretation can cause unnecessary alarm or fail to detect real issues. Further, reliance on these devices could delay proper medical care. The FDA advises against using any baby products claiming to prevent Sudden Infant Death Syndrome (SIDS) or Sudden Unexplained Infant Death (SUID).
No monitor is a substitute for adult supervision or safe sleep practices. If medical monitoring is needed, talk with your healthcare provider for safe and effective monitoring.
— Rebecca Caperton RN, BSN