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This article is from the WebMD News Archive

Baby sleep position devices alert

Tesco and Mothercare withdraw sleep positioners from sale after safety warnings issued in the US
WebMD UK Health News
Medically Reviewed by Dr Farah Ahmed
crying baby

1st October 2010 - Two US government agencies have issued a joint warning against the use of sleep-positioning devices designed for babies. The Food and Drug Administration and Consumer Product Safety Commission say the devices have caused 12 infant deaths over the past 13 years in the US.

In the UK, Tesco and Mothercare have withdrawn baby sleep position devices from sale. Tesco tells us the products have been withdrawn while it investigates with its suppliers. In an emailed statement a Mothercare spokesperson says: “Due to concerns raised in the US over the safety of infant sleep positioners, we have decided to remove from sale ... infant sleep positioners sold at Mothercare while we review the situation.”

US alert

“Our goal is to make sure parents and caregivers are aware of the risks and to warn them to immediately stop using these devices,” says FDA principal deputy commissioner, Joshua Sharfstein, in a statement to reporters.

The devices, which have been on the market since the 1980s, have risers on their sides to hold a baby in place during sleep. Some also include wedges to raise the baby’s head. Several of the devices were cleared in the US as a means of alleviating symptoms caused by gastroesophageal reflux disease ( GORD) and for preventing flat-head syndrome, a deformity caused by pressure on one side of a baby’s head.

However, the FDA, which has jurisdiction over the products because of the medical claims made by the manufacturers, has now determined that the risk of death far outweighs any potential benefits provided by the sleep positioners.

In the UK, consumer safety is the responsibility of the Department for Business Innovation & Skills. A BIS spokesperson tells us by email: “There have been no cases reported to us in relation to the safety of baby positioners - however we will of course keep these products under review following the joint CPSC/FDA warning in the USA”.

Sleep positioners and SIDS (cot death)

Perhaps most disturbing to US parents is that while these devices have been marketed as aids in the prevention of sudden infant death syndrome (SIDS) -- a claim never approved by the US regulators -- there is no evidence to support the claim. Instead, there is now significant evidence that these devices actually cause death.

“I can understand why parents choose to use them,” says Dr Rachel Moon, who chairs the American Academy of Paediatrics Sudden Infant Death Syndrome Task Force. “They believe these devices keep babies safe. But these devices do not keep babies safe.”

The majority of the deaths occurred after the baby rolled from side to stomach and became wedged against the side of the device or between the device and the side of the crib, causing the baby to suffocate.

Moon says many of the positioners come with a warning to stop using them when a baby begins to roll during sleep. This, she says, usually happens at four months. However, it can happen as early as age two months, and it is dangerous for parents to try and predict when their baby will begin to roll.

“A baby can roll at any time,” she says.

Baby sleep advice

The NHS advises that babies should always be laid to sleep on their back, with their feet touching the foot of the cot.

Sheets or thin blankets should go no higher than your baby's shoulders, to prevent them wriggling under the covers. Covers should be are securely tucked in so they don’t slip over a baby's head.

Reviewed on September 30, 2010

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