Federal Rule Approved To Address Safety of Infant Sleep Products

Following a series of recalls that impacted millions of dangerous infant sleeper products, which have been blamed for more than 50 child deaths, federal safety officials have approved a new rule that will eliminate inclined sleeper designs from the market, and require all infant beds to meet more stringent safety standards.

The U.S. Consumer Product Safety Commission (CPSC) voted 3 to 1 this week to approve a new infant sleep product rule, which will require all products marketed for infant sleep to meet new mandatory safety standards intended to prevent suffocation and entrapment hazards.

The federal rule was proposed in response to problems with inclined sleepers, which featured designs that elevate the baby’s head and torso to prevent acid-reflux or congestion. Despite the claimed benefits of the design, inclined sleepers have proven to be potentially deadly after babies are old enough to rollover on their own, which may allow them to become trapped against the fabric without the ability to lift their head, creating a suffocation risk.

The CPSC outlined new requirements this week that are intended to reduce new, and existing sleeper products from being elevated above certain heights, to avoid entrapment hazards that increase the risk of suffocation.

According to the final rule, infant sleep products must not exceed a 10 degree elevated sleep surface, and the products must comply with the CPSC’s Safety Standard for Bassinet and Cradles. The agency announced these standards will be regularly updated based on the most recent voluntary standard developed by ASTM International.

The new standard will also require that inclined sleepers, travel and compact bassinets, and in-bed sleepers that do not already meet the requirements of an existing CPSC sleep standard to be tested, and if not compliant, removed from the market.

“What we’ve done today fulfills the most sacred of our obligations as Commissioners—to take steps to protect vulnerable consumers, including babies,” said CPSC Acting Chairman Robert Adler in the press release.

Safety concerns with inclined sleepers were first disclosed to the public in April 2019, when the CPSC issued a Fisher-Price Rock’n Play warning, instructing consumers to stop placing their infants in the sleepers by three months old, or before they begin to show signs that they can roll over independently.

Shortly after the initial CPSC warning was released, the American Academy of Pediatrics (AAP) called on the commission to issue an immediate recall for the Rock’n Play Sleepers, indicating parents will not know the exact moment a child gains the ability to roll over, which may be too late and result in another infant death.

By the end of April, CSPC officials recalled 4.7 million Rock’n Play Sleepers and Kids II recalled all 694,000 of its inclined rocking sleepers. Fischer- Price subsequently issued another recall impacting 71,000 of its Price Ultra-Lite Day & Night Play Yards.

By June 2019, CPSC officials had become aware of at least 32 infant deaths, with at least 18 additional deaths identified after the initial warnings, bringing the total number of deaths to approximately 50. The agency announced that between January 2019 and December 2020, a total of 254 incidents related to inclined sleep products were reported.

Since the recalls, Fischer-Price has been riddled with a number of inclined sleeper individual wrongful death lawsuits and also a class action lawsuit alleging the manufacturer knew or should have known about the risk of problems, yet delayed announcing a recall or warning, and knowingly allowed parents to continue purchasing life threatening sleeper devices.

According to the FDA, about 4,000 infants annually die unexpectedly during sleep from accidental suffocation, SIDS, or unknown causes. Many of the reported fatalities are a result of suffocation from rolling on their sides or stomach.

To reduce suffocation and accidental deaths, the American Academy of Pediatrics recommends that infants sleep on their backs positioned on a firm, empty surface, not containing any soft objects toys, pillows or loose bedding. The recommendation for new parents is to always follow the ABCs of safe sleep: Alone on the Back in a bare Crib.