The CPSC and the FDA came together yesterday to issue a warning to parents and caregivers to stop using infant sleep positioners immediately as two recent deaths underscore concerns about suffocation.
You may remember the recent recall of the Nap Nanny. Well, now the CPSC is issuing a general warning with regard to sleep positioners after reviewing reports of 12 known infant deaths associated with the products which have occurred over the past 13 years. Most of the infants suffocated after rolling from a side to a stomach position. In addition to the 12 reported deaths, the CPSC has 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 most common types of sleep positioners are:
- sleeping bolsters, usually a flat or inclined mat with round or triangular cushions on each side of a baby (see Figure 1) and
- wedge-style positioners, which elevate a baby’s head higher than its body, sometimes by placing the infant in an attached, diaper-like sling (see Figure 2).
With bolster-style positioners, if a baby is placed on its stomach or if a baby rolls from its side to its stomach, his or her mouth and nose can become pressed against a bolster or other parts of the device. Even if placed on its back, a baby may move upward or downward in the positioner, entrapping its face against a bolster or becoming trapped between the positioner and the crib side or bassinet.
A baby placed on a wedge-style positioner can scoot upward so that its head falls off and hangs over the high edge of the positioner, or the baby may scoot or roll down the wedge so that its mouth and nose are pressed into the positioner. The baby’s movement may also cause the positioner to flip on top of the baby, trapping the baby underneath the positioner or between the positioner and the side of the crib.
Many of these devices have been marketed with medical claims that they reduce the risk of SIDS by keeping a child on their back, help with food digestion and reflux (GERD), ease colic, and/or prevent flat head syndrome. However, the FDA and the CPSC have stated that there is currently no scientific evidence supporting these claims and they believe that any benefit from using these devices is outweighed by the risk of suffocation.
The FDA, which has jurisdiction over products making medical claims, is now contacting all manufacturers of infant sleep positioners, including those it had previously cleared with medical claims, and requesting that they stop marketing them until they submit scientific data showing that the benefits of their products outweigh the risk of suffocation or other serious harm. The FDA has also indicated it will be contacting retailers to ask them to stop selling the devices.
The FDA and CPSC warn parents, caregivers, and healthcare professionals to take this warning seriously and follow these recommendations:
(1) STOP using infant sleep positioners. Using a device to hold an infant in a particular position is dangerous and unnecessary.
(2) NEVER put pillows, infant sleep positioners, comforters, or quilts under the baby or in the crib.
(3) ALWAYS place an infant to sleep on his/her back, and not their sides, at night and during nap time.
FDA pediatric expert Susan Cummins, M.D., M.P.H., says, “The safest crib is a bare crib,” and summarizes the above recommendations with the “ABCs of safe sleep—Alone on the Back in a Bare Crib.”
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Other recent recalls:
Similac Baby Formula Recalled
Nap Nanny® Recall: What you Should Know
CPSC Vote to Issue Safety Standards that will Eliminate Drop-Side Cribs
Massive Crib Recall Announced: What You Should Know
Double Check your Children’s Medicine
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