In January 2002, 8 week old Andy Sage died — not from SIDS as the medical examiner thought at first, but from suffocating on a sleep positioner. Andy turned his head down toward the cushion of the positioning device and suffocated. Since that day his parents, Judy and Mark Sage, have worked tirelessly to alert others to this danger. You can read Andy’s story in our Family Voices website.

Judy joined the board of Kids In Danger, joined ASTM International to talk to manufacturers and regulators directly, met with CPSC and repeated her heartbreaking story over and over to anyone who would listen.

And now, CPSC and FDA have confirmed what Judy and KID have said all along — these products are unnecessary and dangerous. In a rare joint press release, the agencies cited 12 deaths in 13 years and the unproven medical claims that the devices prevent SIDS.

“I’m confident that Andy would be with us today smiling if I did not use the sleep positioner,” stated Judy Sage. “My son and daughter would have their brother. While I’m happy that my voice is being heard to save other babies—it is heartbreaking that it took multiple deaths to effect change. I hope today’s action will keep another family from the grief our family has suffered.”

These products are sold to parents who are worried about SIDS — believing this product will keep their baby safe. But they are unnecessary and not supported by any SIDS organizations or medical professionals. FDA has now said they will require proof of these medical claims or demand manufacturers stop the sales of the products.

“While the safety warning falls short of a ban of the product that KID would like to see,” states Nancy Cowles, KID executive director. “We hope that it is enough to convince manufacturers to stop making this useless and dangerous product.”

KID urges retailers to stop selling the product; parents currently using the product to stop using it; and expectant parents to cross it off their registry — these products are unnecessary and dangerous.

Sleep positioners are sold to parents who are worried about SIDS — believing this product will keep their baby safe. But the product is unnecessary and not supported by any SIDS organizations or medical professionals for the prevention of SIDS.

There are many recommendations to lower the chance of SIDS or suffocation. First and foremost place the baby to sleep on a firm mattress with a tightly fitted sheet in a safe (read not recalled, fully functioning, no missing parts) crib — with nothing in the crib but a baby, placed on his or her back. You can get more safe sleep tips from Kids in Danger at www.KidsInDanger.org or from Sudden Infant Death Services (SIDS) of Illinois at www.sidsillinois.org.

Update: Here is a very helpful handout from FDA on the warning.