Do not use sleep positioners for your baby - ever. That's the clear warning from the US Food and Drug Administration, issued to parents last week.
"These products - sometimes also called "nests" or "anti-roll" products - can cause suffocation that can lead to death," the FDA notes in a statement.
Sleep positioners typically come in two different types and feature raised supports or pillows called "bolsters". Bolsters are attached to each side of a mat, or to raise a baby's head. Their aim is to keep babies in a specific position while they sleep - and they're marketed for bubs under six months old.
"The federal government has received reports about babies who have died from suffocation associated with their sleep positioners," the FDA notes, adding that in most cases, the baby suffocated after rolling from their side onto their stomach.
"The FDA has never cleared an infant sleep positioner that claims to prevent or reduce the risk of SIDS," they add. "And, there is no scientifically sound evidence to support medical claims about sleep positioners ... The FDA can continue to take action against manufacturers who make unproven medical claims about their products. You can do your part to keep your baby safe by not using sleep positioners."
It is the second time the FDA has issued such a warning. The first came in 2010, in conjunction with the US Consumer Product Safety Commission and the American Academy of Paediatrics, after a review of 12 infant deaths associated with the products over the preceding 13 years.
"Sleep positioners do not prevent SIDS and in fact can increase the risk of babies suffocating," the AAP said at the time. "These deaths are tragic and avoidable."
Closer to home, in 2015, the Australian Government's Therapeutic Goods Association conducted a post-market review of infant sleep positioners and pillows due to concerns that they conflicted with current safe sleeping guidelines, placing infants at risk.
"Infant sleep positioners and pillows are sometimes promoted for preventing or resolving plagiocephaly, or flat-head syndrome," the TGA noted. "This is a serious medical condition and the risk from a delay to diagnosis/ seeking medical advice might have grave consequences."
Following their review, several pillows and sleep positioners were voluntarily withdrawn from the Australian Register of Therapeutic Goods. The remaining three products were tested for safety, and to ensure the products' medical claims could be substantiated. Products were also reviewed for compliance with evidence standards of the Australian Regulatory Guidelines for Medical Devices. All three were subsequently removed from the ARTG due to non-compliance.
Red Nose in Australia takes a similarly firm stance regarding the use of baby sleep positioners.
"Red Nose does not recommend positional products such as anti-roll devices and items that fasten a baby into a sleeping position," their website notes. "Products that restrict the movement of a baby or a baby's head should not be used." Red Nose reiterates that there are no Australian Standards for these products - and "case studies" have demonstrated that they can be unsafe.
"There is strong scientific evidence to show that the best way to reduce the risk of SIDS and sleep accidents is to sleep babies on their back with face and head uncovered, to avoid exposing babies to tobacco smoke and to provide a safe sleeping environment," they note.
Specifically, Red Nose recommends the following evidence-based tips:
1) Sleep baby on the back from birth, not on the tummy or side
2) Sleep baby with head and face uncovered
3) Keep baby smoke free before birth and after
4) Provide a Safe Sleeping Environment night and day (Safe cot, Safe mattress, Safe bedding)
5) Sleep baby in their own safe sleeping place in the same room as an adult caregiver for the first six to twelve months
6) Breastfeed baby
Additionally, there should be no soft surfaces or bulky bedding in cots, including no pillows, cot bumpers, lambs wool, soft toys or doonas.