Thursday, July 30, 2015

No such thing as an FDA approved SIDS Prevention Baby Product

Baby Safe Sleep
According to the FDA website, Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.

A common medical claim being made is the prevention of Sudden Infant Death Syndrome (SIDS). The National Institute of Child Health and Human Development defines SIDS as "the sudden death of an infant under one year of age, which remains unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history."

The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.
Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include:
  • baby monitors,
  • mattresses,
  • crib tents,
  • pillows,
  • crib bedding, including bumpers and blankets, and
  • infant positioners.
Current research shows that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby: alone, in their own sleeping space with no other people in the crib or bassinet; on their backs on a firm sleep surface; and in a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.

Michigan Safe Sleep offers these tips:
  1. Baby should sleep alone in a crib, portable crib or bassinet.
  2. Always put baby on back to sleep even when he/she can roll over.
  3. No pillows, blankets, comforters, stuffed animals or other soft things should be in the sleep area.  
  4. Keep baby's face uncovered during sleep for easy breathing. Use a sleeper instead of a blanket.
  5. Don't allow anyone to smoke around the baby.
  6. Don't overheat the baby. Dress the baby in as much or as little clothing as you are wearing.
  7. Use a firm mattress with a tightly fitted sheet.
  8. Place baby in the same sleep position every time.
And Michigan Safe Sleep offers these warnings:
  • Babies are not safe sleeping on a couch, pillow or anything soft. 
  • Babies are not safe sleeping with other children, adults or pets. 
  • Babies are not safe sleeping in adult beds. If you feed your baby in bed, put your baby back into his/her crib to sleep.

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