Parents should stop using infant sleep positioners, warn the FDA (Food and Drug Administration) and the Consumer Product Safety Commission. Sleep positioners are devices with cushions aimed at stopping the baby from rolling over. The FDA informs that there have been 12 reports of infants aged between 1 and 4 months who died of suffocation after becoming trapped between a sleep positioner and the side of their bassinet/crib.
In the majority of cases, the babies died when they turned over from their side onto their stomach. Several parents have reported placing their babies on their backs, and later on finding them in precarious positions either in or next to the sleep positioners.
CPSC Chairman Inez Tenenbaum, said:
The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC. 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 FDA says it refers to two types of infant sleep positioners:
- Flat mats with side bolsters
- Inclined wedge mats with side bolster
Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician, said:
To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS. We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.
The FDA adds that the sleep positioners makers also claim their products:
- Help food digestion, which eases colic and the symptoms of GERD (gastroesophageal reflux disease)
- Prevent plagiocephaly (flat head syndrome)
The FDA and CPSC warns parents/cargivers not to use these infant sleep positioners, there is no need for them, and they are dangerous. Pillows, comforters, quilts or infant sleep positioners should not be used under a baby or in a crib. When placing the baby down to sleep, position him/her on his/her back.
The FDA informs that the AAP (American Academy of Pediatrics) does not support the use of sleep positioners to prevent SIDS.
Infant sleep positioner makers should submit their products for review by the FDA before making any medical claims, the FDA stresses.
In a communiqué, the FDA writes:
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.
Please visit https://www.cpsc.gov/cgibin/incident.aspx to file an incident or injury report related to these products.
Written by Christian Nordqvist