Sudden infant deaths are seen in many cases without any explainable cause called sudden infant death syndrome (SIDS) which may be due to deaths from suffocation. Sometimes also baby is smothered by the pressure of deeply asleep mother.
Some over the counter sell products like infant sleep positioners may cause suffocation of baby. The Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) are aware of at least 12 deaths over 13 years associated with sleep positioners.
Here are some examples of medical claims that would cause an infant sleep positioner to be considered a medical device:
- "Minimize the risk of flat head syndrome"
- "Slight incline reduces acid reflux…"
- "…designed to address the dual risk of SIDS and sleep-related skull flattening (deformational plagiocephaly)";
FDA clears its stand saying that;
"The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. Also, the FDA is unaware of any scientific study that shows infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.
In the past, the FDA has cleared infant sleep positioners for the prevention of flat head syndrome and the treatment of GERD; however, in light of new safety data there is no evidence that any benefits of these devices outweigh the risk of suffocation."Further FDA recommends, I quote;
"The FDA and CPSC warn parents, caregivers and health care professionals:
- Stop using infant sleep positioners. Using a device to hold an infant in a particular position is dangerous and unnecessary.
- Never put pillows, infant sleep positioners, comforters, or quilts under the baby or in the crib.
- Always place an infant to sleep on his/her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics (AAP) recommends placing infants to sleep on their backs and not their sides.
Child health care providers and professionals who educate parents about infant safety should advise the parents and caregivers of their infant patients to not use or stop using infant sleep positioners."