FDA: Sleep Positioners are Hazardous

Within the past 13 years, 12 infants between the ages of 1 to 4 months have suffocated to death while sleeping in products marketed as 'infant sleep positioners', or became trapped between a sleep positioner and the side of a crib or bassinet leading to death by suffocation. 

Based on reports  to the CPSC and FDA regarding the 12 infant deaths, the CPSC issued an immediate press release warning consumers to stop using infant sleep positioners.

While most of the infants suffocated after rolling from a side to stomach position, the CPSC also has received dozens of reports of infants who after being placed on their backs or sides in sleep positioners, were found later in hazardous and potentially deadly positions within or next to the sleep positioners.

“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.”

The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.

The American Academy of Pediatrics does not support the use of any sleep positioner to prevent Sudden Infant Death Syndrome.

The infant sleep positioners have never been cleared by the FDA as effective in the reduction of SIDS risk.  The CPSA and the FDA also note there are no scientific studies demonstrating that infant sleep positioners prevent SIDS, or any other life-threatening hazard, that they are aware of.

Both types of sleep positioners are marketed claiming to ensure infants remain on their backs during sleep reducing the risk of SIDS.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. “We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.”

Manufacturers of the sleep positioners profess that in addition to lowering the risk of SIDS, the use of sleep positioners also aids in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD) and prevent flat head syndrome (plagiocephaly), neither of which have been proven scientifically.  The FDA emphatically states, "any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation."

CPSC and the FDA are warning parents and child care providers to:

    * STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
    * NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
    * ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.

FDA warns, "Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data."

FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.

According to the American SIDS Institute (ASI), "SIDS is 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."

ASI suggestions for Parents-to-Be:
    1.  Get medical care within the first 3 months of pregnancy and regularly throughout the pregnancy in addition to a nutritious diet decreasing the risk of premature birth which is a major risk factor for SIDS.
    2.  Do not smoke, use cocaine or heroin, as they increase SIDS risk.
    3.  Teen pregnancy is a high risk factor for SIDS; the SIDS risk decreases for babies born to older mothers and is highest in teenage mothers.  The more babies a teen mother has the greater the risk for SIDS.
    4.  Wait at least a year between the birth of a child and the next pregnancy; the shorter the interval between pregnancies, the higher the SIDS risk.

ASI suggestions for Parents:
    1.  Place infants to sleep on their backs.
    2.  Infants should sleep in a baby bed with a firm mattress without covers, pillows, bumper pads, positioning devices or toys.
    3.  Keep baby's crib in the parents' room until 6 months of age.
    4.  Adult beds are not safe for babies.
    5.  Overheating an infant may increase SIDS risk; use just enough clothes to keep the baby warm without using blankets.
    6.  Avoid exposing infant to tobacco smoke.
    7.  Breastfeed babies whenever possible; breast mild decreases respiratory and gastrointestinal infections contributing to a lower SIDS rate than formula fed babies.
    8.  Avoid crowds and people with respiratory infections; insist on hand washing prior to handling the infant.
    9.  Some studies report a decrease rate of SIDS among babies who use pacifiers.
    10. If your baby has periods of not breathing, going limp or turning, tell your pediatrician immediately.
    11. If your baby stops breathing or gags excessively after spitting up, discuss with your pediatrician immediately.
    12. Discuss thoroughly each of the above points with all caregivers.

For more information regarding sleep positioner warnings:

CPSC: Consumer Blog http://www.cpsc.gov/onsafety/2010/09/sleep-positioners-a-suffocation-risk/

FDA: Infant Sleep Positioners Pose Suffocation Risk (Consumer article) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm