Baby positioners that are meant to
hold infants snugly while they sleep are being withdrawn from store shelves
after US officials warned that they were “dangerous and unnecessary”.
The Consumer Product Safety
Commission and the Food and Drug Administration in the United States issued a
warning that the positioners should not be used, although there is no official
recall of the products.
Over the past 13 years, the
Consumer Product Safety Commission and the Food and Drug Administration have
received 12 reports of infants between the ages of one month and four months
who died when they suffocated in sleep positioners or became trapped and
suffocated between a sleep positioner and the side of a crib or bassinet.
“The deaths and dangerous
situations resulting from the use of infant sleep positioners are a serious
concern to CPSC,” said the commission’s 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.”
Most of the infants suffocated
after rolling from a side to stomach position. In addition to the reported
deaths, the commission has also received dozens of reports of infants who were
placed on their backs or sides in sleep positioners, only to be found later in
potentially hazardous positions within or next to the sleep positioners.
The sponge positioners are designed
to limit a baby’s movement and make the child sleep in one position. They had
been thought to ensure babies slept on their backs and prevent Sudden Infant
The two main types of infant sleep
positioners are flat mats with side bolsters or wedge mats with side bolsters.
Some stores in Cayman that stock
baby positioners have removed them from shelves following Wednesday’s advisory,
although others are waiting for more information or for an official recall to
Susan Clarke, manager of Noah’s Ark
in Cayman said all baby sleep positioners had been removed from her store.
“We’ve seen the advisory and taken the product off the floor,” she said.
Cody Bain of The Baby Shoppe said
he had also removed the positioners from sale after seeing the alert.
Owner of Little Darlings, Donna
Daije, said she would continue to sell the positioners until a recall of the
products is made. “I’m not taking sleep positioners off the shelves for now,
there hasn’t been a recall of them. It was a suggestion that they not be used,”
she said, adding that she may post a notice of the US advisory about the potential
danger of the products in the store.
According to the Food and Drug
Administration, it had not cleared infant sleep positioner to prevent or reduce
the risk of SIDS, and was not aware of any scientific studies demonstrating
that infant positioners prevent SIDS or are proven to prevent suffocation or
other life-threatening harm.
“To date, there is no scientifically
sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua
Sharfstein, FDA Principal Deputy Commissioner and a paediatrician. “We want to
make sure parents, health care professionals, and childcare providers
understand the potential risk of suffocation and stop using infant sleep
Sleep positioners also typically
claim to aid in food digestion to ease colic or the symptoms of
gastro-oesophageal reflux disease and prevent flat head syndrome
In light of the new safety data,
the Food and Drug Administration stated that it believed any benefit from using
these devices to ease GERD or prevent plagiocephaly is outweighed by the risk
The FDA warned parents and child
care providers that “using a positioner to hold an infant on his or her back or
side for sleep is dangerous and unnecessary”. It is also warning against the
use of pillows, positioners, comforters, or quilts under a baby or in a crib.
The organisations are also urging
parents to place infants on their backs at night and during nap time.
The American Academy of Pediatrics
recommends placing infants to sleep on their backs and not their sides.
The FDA has advised manufacturers
of infant sleep positioners with medical claims that have not been reviewed by
the administration to stop marketing those products until they submit, and the
FDA clears their submissions.