Medical Devices

Recommendations for Parents / Caregivers About the Use of Baby Products

The FDA cautions parents and caregivers against purchasing baby products with claims to prevent or reduce the chance of Sudden Infant Death Syndrome (SIDS). These baby products can pose a risk of serious injury to a baby, including the risk of suffocation.

Common baby products with these claims include:

  • Infant sleep positioners - using this type of product to hold an infant on his or her side or back is dangerous and unnecessary,
  • baby monitors,
  • mattresses,
  • crib tents,
  • pillows,
  • crib bedding, including bumpers and blankets

What Should Parents/Caregivers Know?

  • Do not use any infant positioners --- they could harm your baby. The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping Using a device to hold an infant in a particular position poses a serious suffocation risk and is unnecessary.
  • The FDA is aware of infant deaths from these products over the years. Infants may suffocate after rolling from a side to stomach position or after being placed on their sides in the positioning product. Even if placed properly on their backs, infants may scoot up or downward on the positioning device, and may become entrapped in the product or between the positioning device and the crib, play yard, sleep mat or bassinet.
  • Infant positioning products pose a risk of suffocation, whether or not they make medical claims.
  • The FDA is not aware of any clinical or scientific evidence that shows that currently available baby products prevent or reduce the chance of SIDS.
  • Be aware that any product that claims to prevent or reduce the chance of SIDS has never been cleared or approved for that use by the FDA.
  • The FDA discourages consumers from purchasing any product claiming to reduce a baby’s SIDS risk. These products are not proven to prevent SIDS.
  • Always check with your health care professional before using any new medical product for your baby.

Tips for Reducing the Chances of SIDS

The National Institute of Child Health and Human Development recommends that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby. You can create a safe environment by following the ABC’s of safe sleep listed below:

A: Alone in their own sleeping space, with no other people in the crib or bassinet;

B: on their Backs on a firm sleep surface;

C: and in a Crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.

Report a Problem

If you experience an injury or malfunction when using an infant sleep positioner, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Please include the following information in your reports:

  • Device Name (Brand Name)
  • Manufacturer’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)

Baby Safe Sleep Resources


Consumer Update

 

Page Last Updated: 08/22/2018
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