The U.S. Food and Drug Administration (FDA) has green-lighted the production of a "smart sleeper" for babies that keeps them safely positioned on their back.
The so-called Happiest Baby SNOO Smart Sleeper is being touted as a “significant advance in infant safety,” with babies that are positioned on their back known to be at a lower risk of SIDS (Sudden Infant Death Syndrome) and SUID (Sudden Unexpected Infant Death).
According to Cision PR Newswire, currently about 3,500 babies die each year in their sleep from suffocation and unexplained causes, including SIDS. With those deaths collectively known as SUID, authorities say that SUID ranks as the leading cause of death of healthy, full-term infants during the first year of life, with 90% of all such tragedies reported to occur over the first six months. Over the last two decades, the number of these deaths has remained steady. This is the first time the FDA has given De Novo Approval to such a product.
Doctors discovered more than three decades ago that sleeping on the back dramatically reduces the incidence of SUID. Today several medical organizations have joined the Centers for Disease Control and Prevention (CDC) in agreeing that back sleeping greatly reduces the chance of SIDS, with the National Institutes of Health (NIH) touting back sleeping as “the single most effective action that parents and caregivers can take to lower a baby’s risk of SIDS.”
SNOO is designed to be used with infants under 6 months of age, or until they have consistently demonstrated the ability to roll from stomach to back during sleep. The "SNOO Sack" safely swaddles babies and attaches to the bed, facilitating back (supine) sleeping. A study conducted on 1,012 infants showed that SNOO reduced unsafe stomach sleeping by 91.5%. However, it should be noted that SNOO has not directly proven to reduce the incidence of SIDS or SUID.
"As a pediatrician for over 40 years, I've witnessed far too many times the unbearable pain of parents who placed their baby in bed at night, only to find them lifeless in the morning," Dr. Harvey Karp, cofounder and CEO of Happiest Baby, Inc., told Cision PR Newswire. "Stomach sleeping leads to the tragic death of thousands of healthy infants every year. Yet we routinely put babies in bed totally unsecured for 12 to 14 hours every day. Just as infant seats dramatically improve car safety, we hope to dramatically improve sleep safety by keeping babies on the back and reducing risky rolling."
The De Novo Approval creates a new category for the approved device, with the FDA identifying the generic type of this device as an "infant supine sleep system," which is "a device intended to facilitate supine position during sleep for use in infants that are not yet able to roll over consistently."
