Implantable medical devices help improve the health of millions of people. Usually placed in patients' bodies through surgery, these devices treat a wide range of medical conditions, including cardiac and nervous system disorders.
The Food and Drug Administration (FDA) regulates all medical devices through its Center for Devices and Radiological Health (CDRH).
Many of the implantable devices FDA regulates have been approved for pediatric use, meaning they can be used by people who are under the...
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.
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.