Infant Sleep Positioners (ISPs) May Increase Risk
From the day they become pregnant, parents worry about how to keep their child as safe and healthy as possible. Sometimes this impulse leads parents to make very good decisions, such as ensuring their kids always wear helmets when engaging in potentially dangerous activities, feeding them a healthy diet including drinking water, or getting plenty of regular exercise. Other times, misinformation can lead the best intending parents into making decisions that actually put their children at much higher risk, such as not fully immunizing children, co-sleeping with infants, or offering juice or sports drinks. Some baby devices that initially seem or seemed like good ideas, e.g.,walkers, rotating activity stations, baby slings, Bumbos, crib bumpers, are now widely recognized to be dangerous either generally or for certain ages or situations. A new report from the Centers for Disease Control adds infant sleep positioners (ISPs) to that list.
The researchers reviewed the cases of 13 infants, 4 months of age and younger, who suffocated while in an infant sleep positioner, and concluded that the ISPs may have contributed to their deaths. Although a few ISPs (available since the 1980s) had been cleared by the FDA for prescription use for specific medical conditions (e.g., for gastro esophageal reflux), none have ever been approved for preventing or reducing the risk for SIDS. Despite this, “many unapproved ISPs have been marketed to the general public with claims of preventing [SIDS], improving health, and enhancing sleep comfort,” the authors write. The FDA has contacted all ISP 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. In the meantime, it is recommended that all parents and caregivers stop using ISPs unless specifically prescribed by their pediatrician.
The American Academy of Pediatrics Safe Sleep recommendations can be found at:
Don’t hesitate to contact your pediatrician if you have any further questions regarding the use of ISPs.
Update from Dr. Edwards as of 10/4/12:
My current understanding is that the FDA has contacted all Infant Sleep Positioner manufacturers requesting that 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. As for the prescription aspect, it wasn’t that the FDA positioners were only available BY prescription, the recommendation was that people only use them IF explicitly advised to by their pediatrician to address a specific medical condition, and only the FDA approved positioners be used. But as far as I know, at the moment, they’re all off the market until the companies can demonstrate both efficacy and safety.