Tag Archives: Sleep Positioners

Infant Sleep Positioners Dangerous

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Update on Infant Sleep Positioners from the FDA.  Get them out of the cribs NOW!! ~ Nurse Mommy

FDA and the Consumer Product Safety Commission (CPSC) are warning people not to use sleep positioners for their babies, because there is a chance they could suffocate. In the last 13 years, at least 12 babies between the ages of one and four months have died when they suffocated in positioners, or when they became trapped between a sleep positioner and the side of their crib or bassinet.

People have been using positioners to keep their babies in certain positions when they sleep. Some positioners are flat pads with side bolsters. Others are inclined like a wedge, or have some other design. These products may be promoted to reduce acid reflux, minimize “flat head” syndrome, or even to prevent sudden infant death syndrome (SIDS). But there is no scientific evidence to support any of these claims.

Many parents and other people who care for babies know that babies should be placed on their backs to sleep. This reduces the chance of SIDS by nearly half. They may worry about how to make sure their babies stay on their backs. But once babies are able to roll over onto their tummies, it is okay to leave them there, because babies who can flip over can also turn their heads, which reduces their chance of suffocation. However, if babies flip over or scoot around while in a sleep positioner, they can have a hard time freeing their faces from the device or they can become trapped between the positioner and the side of their crib or bassinet.

So do not use infant sleep positioners. They are not necessary, and they can be dangerous. Put your baby to sleep on his or her back, and keep the crib free of pillows, comforters, quilts and toys. That way, your baby has room to safely move or turn while sleeping. Here is an easy way to remember – follow the ABCs of safe sleep – Alone on the Back in a bare Crib.

And if you have any questions, contact your child’s healthcare provider.

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Infant Sleep Positioners Pose Suffocation Risk per FDA

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This was just posted yesterday by the FDA.  Wanted to make sure it made it my readers ASAP!!~Nurse Mommy

Food and Drug Administration (FDA) Notice

Posted: September 29, 2010

Two government agencies are warning parents and other caregivers not to put babies in sleep positioning products as two recent deaths underscore concerns about suffocation.

The Food and Drug Administration (FDA) and the Consumer Product Safety Commission issued the warning after reviewing reports of 12 known infant deaths associated with the products.

The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding.

Advice for Consumers

STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.

NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.

ALWAYS place a baby on his or her back at night and during nap time.

REPORT an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission by visiting www.cpsc.gov/cgibin/incident.aspx5 or calling 800-638-2772, or to FDA’s MedWatch program6.

Suffocation and Other Dangers

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.

In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

“We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep,” says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.

FDA pediatric expert Susan Cummins, M.D., M.P.H, says parents and caregivers can create a safe sleep environment for babies if they leave the crib free of pillows, comforters, quilts, toys, and other items.

“The safest crib is a bare crib,” she says. “Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC’s of safe sleep—Alone on the Back in a bare Crib.”

Medical Claims

Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD)—in which stomach acids back up into the esophagus—or flat head syndrome, a deformation caused by pressure on one part of the skull.

Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new information suggests the positioners pose a risk of suffocation.

As a result, FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products’ benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data.

Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately, agency experts say, adding there’s no evidence the devices have benefits that outweigh the risk of suffocation.

“At this time, there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners,” says Cummins.

This article appears on FDA’s Consumer Updates page7, which features the latest on all FDA-regulated products.

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