All Infant Inclined Sleep Products Should Be Recalled, Consumer Reports Says
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Update: On October 31, 2019, the Consumer Product Safety Commission issued a warning that cautioned consumers to stop using infant inclined sleep products, which have been linked to at least 73 infant deaths. The announcement followed a unanimous vote by CPSC commissioners on October 25, 2019, to move forward with a proposal that, if finalized, would prohibit the sale of all infant sleepers with an incline greater than 10 degrees and ensure that all baby sleep products meet strong mandatory safety requirements.
On November 4, 2019, Consumer Reports CEO Marta Tellado wrote to manufacturers to urge the immediate recall of any infant inclined sleepers that remain on the market.
This article was originally published on October 23, 2019.
When Sara Thompson’s 15-week-old son Alex died in the Fisher-Price Rock ’n Play Sleeper on Sept. 23, 2011, she had no idea what caused his death. After leaving him alone for no more than 15 minutes, as she helped her other child set up a Mr. Potato Head toy, she returned to find him unresponsive, with his head slumped at a strange angle.
“I yanked him out of the sleeper and tried to remember CPR,” says Thompson, who lives in Nazareth, Pa. But despite her efforts and those of the paramedics and hospital staff, Alex could not be revived.
Neither the doctors nor the autopsy report offered any explanation. “No illnesses, no signs of aspiration, no fibers in his mouth or throat,” she says. “They just ruled it sudden unexplained infant death.”
Without a clear cause, Thompson spent the next eight years wondering whether she could have done anything to prevent her son’s death. “What if I hadn’t set him down? What if I had taken him with me to play Mr. Potato Head?” she says. “I was searching for answers when there weren’t any.”
But last April, she finally got one, when Consumer Reports tied the Fisher-Price Rock ’n Play Sleeper to dozens of infant deaths, prompting the recall of all 4.7 million of the sleepers. “If it weren’t for that, I would still be questioning myself about what went wrong, why my baby died,” Thompson says.
And last week Thompson got even more confirmation: An independent study commissioned by the Consumer Product Safety Commission concluded that “none of the inclined sleep products that were tested and evaluated as part of this study are safe for infant sleep.” Based in part on that study, the CPSC’s staff proposed last week that infant inclined sleepers be eliminated from the market by recommending that no infant sleeper exceed a back angle of 10 degrees.
The research and the new CPSC staff proposal reinforce what CR has reported for months and what the American Academy of Pediatrics (AAP) has stated: There is no such thing as a safe infant inclined sleeper, a product that typically positions an infant at an incline of up to 30 degrees and usually has design elements such as a rounded sleep surface and plush side padding. The AAP recommends that infants sleep on their backs, alone, unrestrained, on a firm, flat surface, free of padding, bumpers, and other soft bedding.
“The study makes it clearer than ever that inclined sleepers place infants at a substantial risk of injury or death,” says William Wallace, CR’s manager of home and safety policy. “And while we welcome the CPSC staff proposal to essentially prohibit inclined sleepers, it could take many months before it’s approved and final, and countless babies using these products would remain at risk. That’s why all inclined sleepers still on the market should be recalled immediately.”
To date, at least 73 infant deaths have been tied to inclined sleepers, as recently as May 2, 2019, several weeks after Fisher-Price issued its recall. In fact, between January and May of this year, as both the agency and industry allowed inclined sleepers to remain on the market, at least six babies died in the products, according to incidents cited in the study and lawsuits that have been filed.
Inclined Sleeper Study Is Long Overdue
The study—led by Erin Mannen, Ph.D., a biomechanics researcher and assistant professor of orthopedic surgery at the University of Arkansas for Medical Sciences—was presented Monday at a meeting on infant inclined sleep products convened by ASTM International, an organization that facilitates the development of voluntary safety standards for consumer products. CR is a member of the ASTM committee and attended the meeting, along with other consumer safety groups, representatives from the juvenile product industry, experts from the AAP, and other stakeholders.
The CPSC says it commissioned the study about a year ago because it had documented a growing number of injuries and deaths connected to infant inclined sleep products over the past several years, but had no specific research to explain why they had occurred. To evaluate the product’s potential risks, the researchers conducted a study that involved carefully monitoring the movements and oxygen levels of 10 infants, ages 2 to 6 months old, while they were in inclined sleepers. The researchers compared that with the movements and oxygen levels of the babies when they were placed on a flat mattress and also on an inclined mattress of varying degrees.
The study found that the design of inclined sleepers allows babies to move very differently from when they are on a firm, flat surface. “Babies were able to roll over more easily from their backs to their tummies in inclined sleep products,” Mannen said.
And when babies did roll onto their stomachs in the inclined sleepers, they exerted nearly 250 percent more abdominal muscle activity and their oxygen levels dropped twice as much, compared with their activity and oxygen levels when on their stomachs on a flat crib mattress. This suggests that when babies end up on their stomachs in an inclined sleeper, they can exhaust themselves, and ultimately suffocate, while trying to reposition their heads and bodies so that they can breathe, researchers said.
Mannen said that the finding is backed up by the incident reports from many parents, who said that their babies had never rolled over before the day they suffocated in the inclined sleeper, where they were discovered dead and on their stomach.
The analysis concluded that even a “20-degree incline puts infants at risk for muscle fatigue” and suffocation, and the CPSC staff ultimately determined that “a flat surface that does not exceed 10 degrees offers the safest sleep environment for infants.”
A limitation of the study was that it did not specifically focus on the fatalities that occurred when infants remained on their backs in the inclined sleeper and were found unresponsive with their heads slumped down, with their chin resting on their chest, shoulder, or up against the product’s padding, blocking their airway and leading to suffocation. “I didn’t understand why that was not a focus,” says Thompson, whose son died this way.
Mannen agreed that more research into that question is needed, as well as more research looking into the breathability of the fabrics that line infant sleepers.
The researchers noted that several of the babies who died while on their backs in inclined sleepers were sick with a virus, had a chronic health problem, or were born prematurely, all of which may have made them more vulnerable to suffocation, even if they did not roll over. “A safe sleeping product may be even more important for infants who have previous risk factors for infant mortality,” the study said.
That finding is notable because Fisher-Price has said it developed the Rock ’n Play Sleeper particularly for babies with reflux. And it’s especially painful for Thompson, who says she had chosen the product precisely because her son Alex was born prematurely and had reflux.
Thompson is not alone in her frustrations. Pediatricians such as Roy Benaroch, M.D., an associate adjunct professor of pediatrics at Emory University in Atlanta, who sounded the alarm on the hazards of the Rock ’n Play Sleeper early on, says that the study is long overdue: “This is the kind of basic safety research that should have been done 10 years ago, before these inclined sleepers were brought to market.”
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