FDA has never approved
infant sleep positioners to reduce or prevent the risk of SIDS in babies.
In this latest report, researchers from the CDC, FDA, and CPSC reviewed data on deaths related to
infant sleep positioners from January 1997 to March 2011.
There are two main types of
infant sleep positioners.
A few
infant sleep positioners have been cleared by the FDA to treat specific medical conditions, such as gastroesophageal reflux.
Many types of
infant sleep positioners are banned due to characteristics mentioned in the legal code.
According to a joint statement issued by the Consumer Product Safety Commission (CPSC) Chairman Inez Tenenbaum and the U.S. Food and Drug Administration (FDA), deaths and dangerous situations arising from use of
infant sleep positioners is a serious concern.
Suffocation deaths associated with use of
infant sleep positioners — United States 1997 - 2011.
FDA: Letter to Manufacturers Concerning Medical Claims About
Infant Sleep Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227302.htm
«We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using
infant sleep positioners.»
«To date, there is no scientifically sound evidence that
infant sleep positioners prevent SIDS,» said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician.
Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with
infant sleep positioners.
The two main types of
infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.
CPSC and FDA Warn against using
infant sleep positioners because of suffocation risk: Initial communication.
After the federal safety warnings, most major manufacturers stopped making
infant sleep positioners, and they became hard to find in stores.
The bottom line is that
infant sleep positioners are not necessary.
Unfortunately, we know now that some types of
infant sleep positioners can be dangerous to babies.
In 2010, CPSC and FDA released a safety warning about
infant sleep positioners.
«The deaths and dangerous situations resulting from the use of
infant sleep positioners are a serious concern to CPSC,» said CPSC Chairman Inez Tenenbaum.
An infant sleep positioner is one of those products.
An infant sleep positioner is essentially a flat or wedged mat that is meant to keep a baby on her back while she's sleeping.
If you have had a problem with
an infant sleep positioner, the agencies encourage you to file a report through FDA's MedWatch program, at https://www.accessdata.fda.gov/scripts/medwatch/
The FDA has never cleared
an infant sleep positioner to prevent or reduce the risk of SIDS.
A few years ago, every mother wanted
an infant sleep positioner.
Not exact matches
There are even claims (that are impossible to prove) that the material of some
sleep positioners is breathable and safe should an
infant's mouth / nose be pressed against it for some time.
July 1 2003 If you believe some of the claims on packaging of
sleep positioners and wedges, you might think these products help prevent Sudden
Infant Death Syndrome (SIDS) by keeping the baby positioned on its back or side.
Avoid using home cardiorespiratory monitors and commercial devices — wedges,
positioners, and special mattresses — to help decrease the risk for SIDS and
sleep - related
infant deaths.
With our third child coming in 2 months, I was thrilled to test Summer
Infant's Supreme Inclined
Sleep Positioner with Heartbeat ($ 32 - 39).
In fact, Consumer Reports points out that putting anything soft in the crib, including a
sleep positioner, may increase rebreathing, which may increase the likelihood of Sudden
Infant Death Syndrome.
Baby
sleep positioners, a popular product for safety - conscious parents, were suppose to save lives by keeping
infants from rolling onto their stomachs.