fda approved infant sleep positioner

“The US Food and Drug Administration is reminding parents and caregivers not to put babies in sleep positioners. The only things in the crib should be the baby and a tightly fitting crib sheet. Some sleep positioner companies claim that their products prevent SIDS. Some sleep positioner companies claim that their products prevent SIDS. The FDA regulates baby products that claim to cure, treat, prevent or reduce a disease or condition. The FDA and the U.S. Consumer Product Safety Commission are aware of 12 infant deaths in the past 13 years associated with the use of infant sleep positioners. The FDA is warning against this very type of sleep positioner.

More recently, in September 2010, the FDA and the Consumer Product Safety Commission issued a joint warning against using infant sleep positioners because of the suffocation risk these devices pose. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.

The device may entrap infants … The FDA regulates baby products that claim to cure, treat, prevent or reduce a disease or condition. This surface should not contain soft objects, toys, pillows, or loose bedding.

WEDNESDAY, Oct. 4, 2017 (HealthDay News) -- Infants should be put to sleep on their backs on a firm, empty surface and never placed on a sleep positioner, the U.S. Food and Drug Administration (FDA) says..

The FDA has approved 18 infant sleep positioners since the early 1980s because of some evidence that the devices ease the symptoms of gastroesophageal reflux disease (GERD) and … The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS.

CPSC and the U.S. Food and Drug Administration (FDA) are warning parents and caregivers to stop using sleep positioners.Over the past 13 years CPSC and FDA have received 12 reports of infants between the ages of 1 month and 4 months who have died when they suffocated in these positioners or when they became trapped between a sleep positioner and the side of a crib or … Parents and caregivers purchase the positioners to keep infants … The only way for a baby to sleep safely is on his or her back in a crib. No sleep positioners, bumpers, blankets, stuffed animals, etc. The agency warned parents and caregivers that these products, also known as "nests" or "anti-roll" supports, can prevent babies from breathing.. The FDA warned parents on Tuesday that sleep positioners can cause potentially lethal suffocation of babies. How Should Babies Sleep? Instead, infants should be put to sleep on their backs, positioned on a firm, empty surface.

But the FDA has never approved any infant sleep positioner to reduce the risk of SIDS. The FDA warns that parents and caregivers should NEVER use infant sleep positioners.

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