The feds take a position on sleep positioners

A new warning came out yesterday about infant sleep positioners, following the suffocation deaths of 12 infants over the past 13 years. The Consumer Product Safety Commission and the Food and Drug Administration are telling parents not to use the mats with bolsters, which claim to keep infants on their backs and reduce the risk of SIDS. As well as the 12 deaths, there are dozens of cases of infants becoming wedged in a potentially dangerous position.

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Some manufacturers also claim the positioners help babies who have acid reflux or flat-head syndrome from pressure on one part of the head. The FDA has approved some sleep positioners for those two uses, but the agency is now questioning whether the risk of suffocation outweighs any possible benefits. It's putting the onus on the manufacturers, states the press release, and "requiring makers of FDA-cleared sleep positioners to submit data showing the products' benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data. Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately."

Perhaps in anticipation of questions that will be lobbed at them by supporters of the supporters, the CPSC's blog has a Q&A on the topic. We made special note of the explanation for why CPSC hasn't recalled positioners: "Because of the medical claims made with sleep positioners, they fall primarily under FDA's jurisdiction, rather than CPSC's." And why hasn't the FDA recalled them? Inez Tenenbaum, chair of the CPSC, explained today that "we have determined that a warning is the best approach. This warning is across all classes, all sleep positioners, not just one particular company. If we were to do a recall, we would have to go company by company, proving the defect. This is one way for us to communicate quickly and directly to consumers."