Suffocation Deaths Associated with Use of Infant Sleep Positioners — United States, 1997–2011

Weekly
November 23, 2012 / 61(46);933-937

Unintentional suffocation is the leading cause of injury death among children aged <1 1984="1984" 1="1" accidental="accidental" accounting="accounting" an="an" and="and" annually.="annually." bed="bed" been="been" deaths="deaths" environments="environments" estimated="estimated" for="for" fourfold="fourfold" has="has" in="in" increase="increase" infant="infant" linked="linked" many="many" nearly="nearly" observed="observed" of="of" since="since" sleep="sleep" states="states" strangulation="strangulation" suffocation="suffocation" the="the" these="these" to="to" united="united" unsafe="unsafe" with="with" year="year">1,2
). Infant sleep positioners (ISPs) are devices intended to keep an infant in a specific position while sleeping, yet ISPs have been reported to have been present in the sleep environment in some cases of unintentional infant suffocation (3,4) (Figure). Some specific ISPs have been cleared by the Food and Drug Administration (FDA) for the management of gastroesophageal reflux or plagiocephaly (asymmetry of the skull) (5). However, many unapproved ISPs have been marketed to the general public with claims of preventing sudden infant death syndrome (SIDS), improving health, and enhancing sleep comfort (5). To characterize infant deaths associated with ISPs, FDA, the U.S. Consumer Product Safety Commission (CPSC), and CDC examined information reported to CPSC about 13 infant deaths in the past 13 years associated with the use of ISPs. In this case series, all infants but one were aged ≤3 months, and most were placed on their sides to sleep. Many were found prone (i.e., lying on their abdomens). Accompanying medical issues included prematurity and intercurrent respiratory illnesses. When providing guidance for parents of newborns, health-care providers need to emphasize the importance of placing infants to sleep on their backs in a safe sleep environment. This includes reminders about the American Academy of Pediatrics (AAP) recommendations against side sleep position, ISPs and pillows, comforters, and other soft bedding. A case was defined as an infant death reported to CPSC during January 1997–March 2011 that occurred in the presence of an ISP in the sleep environment. Thirteen cases were identified. Information was abstracted from a CPSC In-Depth Investigation file,* which included medical examiner and police reports made available to CPSC. This report describes the circumstances of one case and summarizes all 13 cases of infant death.
Case Description
The male victim, aged 7 weeks, was one of twin infants born at 36 weeks' gestation but otherwise was physically and developmentally normal. Five days before his death, he had a well-baby visit that revealed no health concerns. He slept in an ISP in a crib separate from his twin brother. The morning of his death, the victim was fed, uneventfully, at approximately 1:00 a.m. and was placed to sleep on his side in the ISP. At about 4:00 a.m., a care provider prepared the infants for their next feeding and discovered the victim in the ISP, unresponsive, with his face close to one of the ISP's foam pads, which were used in conjunction with swaddling to keep a pacifier in the infant's mouth. The autopsy report listed the cause of death as asphyxia by obstruction of the nose and mouth by a "foam positioning device."
The ISP was a flat mat with side bolsters, which the mother purchased to prevent SIDS. The device was advertised as helping "position your baby while sleeping or resting" and instructions stated, "This product is to be used if your pediatrician has recommended side sleeping for your baby."
Summary of 13 Cases
Among the 13 cases of infant death reported to CPSC in association with ISP use, the victims ranged in age from 21 days to 4 months (mean: 9.5 weeks, median: 3 months) (Table). Eight were male. Four victims had been born prematurely, and three of them were one of a pair of twins. One deceased twin had been diagnosed with bronchopulmonary dysplasia and gastroesophageal reflux. Of the 13 infants, four had recent respiratory symptoms and/or diagnoses of respiratory illness, including respiratory syncytial virus infection and colds.
Infants were most commonly placed on their sides to sleep (nine infants). One infant was placed prone. The position placement was not known for two cases; a discrepancy was noted between parental report and medical examiner assessment for the remaining case. Three families reported using the device in an effort to prevent SIDS. Other reported uses included preventing reflux (two cases), elevating the head (one case), preventing rolling over (three cases), and preventing plagiocephaly (one case). Instructions for use of involved ISPs were available for review for five cases; three indicated that side positioning an infant in the device was an acceptable use of the product. At least three cases involved ISPs with cautionary labeling "once your baby begins to move around during sleep, the sleep positioner should no longer be used."

Reported by

Brenda Lawrence, MD, Gail Gantt, MGA, Joy Samuels-Reid, MD, Victoria Wagman, MA, Center for Devices and Radiological Health, Susan Cummins, MD, Center for Drug Evaluation and Research, Food and Drug Administration. Suad Wanna-Nakamura, PhD, Div of Health Sciences, Consumer Product Safety Commission. Julie Gilchrist, MD, Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Corresponding contributor: Joy Samuels-Reid, joy.samuels-reid@fda.hhs.gov, 301-796-6266.

Editorial Note

This case series summarizes characteristics of the 13 infant suffocation deaths related to ISP use reported to CPSC during January 1997–March 2011. In these cases, ISPs often were used to position infants on their sides. At least nine of the infants were placed on their sides (and one prone), raising the concern that the "back-to-sleep" message to position infants on their backs is either not being heard or not being followed. CDC data from the Pregnancy Risk Assessment Monitoring System CPONDER web-based query system provides an indicator of whether infants most often are positioned on their backs for sleep. Data from reporting states in 2008 suggest that approximately 25% of infants are not being placed supine for sleep (6).
Some infants are at increased risk for SIDS; risk factors include premature birth, twin birth, and male gender (7). This case series raises concerns about ISPs contributing to the risk for suffocation, in the absence of any evidence that ISPs are effective in reducing the risk for SIDS.
Although ISPs have been available since the 1980s, only a few ISP manufacturers have been cleared by the FDA to provide products, by prescription, to manage particular medical conditions (e.g., gastroesophageal reflux). Despite other manufacturers' claims regarding SIDS prevention or other health benefits, FDA has never cleared or approved an ISP for preventing or reducing the risk for SIDS. Cleared ISPs should only be used by prescription for treatment of specific medical conditions.
After reports of infant suffocation related to ISP use in 2010, CPSC and the FDA launched a joint effort; on September 29, 2010, FDA and CPSC released statements concerning the danger associated with the use of ISPs (5,8). The agencies urged families to discontinue use of unapproved ISPs, through media messages indicating that "back-to-sleep" is best and ISPs are not necessary to keep infants on their backs (5,8). In addition, they advised health-care providers to continue counseling families on safe sleep practices in accordance with AAP's recommendations (7). FDA has contacted all manufacturers requesting that all sales be halted until companies submit safety and effectiveness data that not only support the medical claims of their devices but also demonstrate that benefits from use of the product outweigh the risks for suffocation (3).
An additional concern is the "hand-me-down" availability of ISPs. Many products for children, some of which might have been recalled, are passed along by family and friends or purchased from second-hand stores. Public health education and health-care provider counseling are important ways to reduce the inappropriate use of ISPs.
In 2005, AAP definitively recommended against side positioning (9). In 2011, AAP released a comprehensive policy statement on safe sleep environments for infants to reduce the risk for SIDS and suffocation (7). FDA and CPSC also have issued recommendations consistent with the current AAP statements concerning ISPs. First, parents and caregivers should stop using ISPs unless specifically prescribed by their pediatricians. Supine sleeping is safest; use of a device is not necessary in this position and is potentially hazardous. Second, they should never put pillows, comforters, or unprescribed ISPs in an infant's sleep environment. Finally, they should place infants to sleep on their backs.
The findings in this report are subject to at least five limitations. First, as with many case series, the total number of cases is unknown because the data are from voluntary reporting. Second, because the number of ISPs in use is not known, the risk for suffocation when an ISP is present cannot be directly compared with the risk when no ISP is present. Third, only information on deaths was collected; nonfatal cases are not reported. Fourth, variability was observed in the type and detail of information in each report because no standardized system is implemented consistently. For example, one report used the more recently available Sudden Unexplained Infant Death Investigation reporting form.† Finally, this series includes cases reported during 1997–2011; products, instructions, and even recommendations have changed over this 13-year period, which might have influenced use of these devices and reporting of cases.
The need for a safe sleep environment for infants (i.e., in a crib, on their backs [not their sides], without soft objects, loose bedding, or an ISP) is still an important public health message. The original Back-to-Sleep campaign (launched in 1994 by the National Institute of Child Health and Human Development, the U.S. Department of Health and Human Services Child Care Bureau and Maternal and Child Health Bureau, and AAP) did not preclude side sleeping; consequently, manufacturers developed ISPs to keep babies in specific positions. However, ISPs are not necessary to keep a baby supine, and other positions increase the risk for SIDS and/or suffocation. Although some ISPs contained cautionary statements like "discontinue use once baby begins to move around," these statements are unclear, and caregivers cannot accurately predict when an infant will achieve milestones. Clear, consistent, and frequent reinforcement of the safe sleep messages by public health practitioners and health-care providers is needed to prevent further infant suffocations.
Additional information is available online from FDA at http://www.fda.gov/forconsumers/consumerupdates/ucm227575.htm

, from CPSC at http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html

, and from CDC at http://www.cdc.gov/sids.

Acknowledgments

Michelle Gillice, JD. John Topping, Div of Hazard Analysis, Directorate for Epidemiology, Jonathan Midgett, PhD, Div of Human Factors, Consumer Product Safety Commission.

References

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