Saturday 5 February 2011

SIDS: Consumer Agency Tightens Scrutiny of Baby Sleep Products

Three years ago, Dr. Bradley Thach, a professor of pediatrics at Washington University in St. Louis, published findings that had the potential to upend nurseries across the nation, and perhaps save some lives too.
 Dilip Vishwanat for The New York Times
Dr. Bradley Thach’s findings about the dangers of crib bumpers are now getting a second look by the Consumer Products Safety Commission.

Minh Uong/The New York Times
In reviewing data from the Consumer Products Safety Commission, Dr. Thach concluded that crib bumpers — the padding wrapped around the inside of a crib that often matches the bedding—were killing babies. In a 10-year period beginning in 1995, he found 27 suffocation deaths involving bumper pads, and he theorized that many more might have occurred because of inconsistencies in the data.
“Because bumpers can cause death, we conclude that they should not be used,” he warned.
The Consumer Products Safety Commission initially ignored the findings. Last summer, it reached the same conclusion as a trade group representing product manufacturers, which asserted that other factors, like a crib crowded with pillows or babies sleeping on their stomachs, might have been a factor in those deaths, rather than the bumpers. As a result, most parents remained unaware of the debate over the safety of crib bumpers.
Now, prompted by consumer advocates and news reports highlighting potential dangers, the commission has reversed itself and decided to take a deeper look at crib bumpers as part of a broader regulatory crackdown on the hazards of an extensive line of baby sleep products that have been blamed for more injuries and deaths.
The sweeping overview is another sign of a heightened regulatory atmosphere among many agencies in the Obama administration.
For example, in September, the commission, along with the Food and Drug Administration, warned parents not to use sleep positioners intended to keep babies on their backs. Some sleep positioners were marketed to parents as reducing the risks of sudden infant death syndrome, but in fact, the agencies said, the products had caused the suffocation death of 12 babies over the last dozen years or so.
Then, in October, the commission warned parents about the dangers of baby monitor cords and urged them to keep the cords away from cribs, bassinets and play yards. Since 2004, the commission has received six reports of babies being strangled by the cords.
In December, the commission approved the first new mandatory standards for cribs in nearly two decades. The new rules banned existing designs for drop-side cribs, which have been blamed for entrapping and killing at least 32 babies since 2000, and required more rigorous testing on all cribs.
In addition, day care centers will be required to replace over the next two years any cribs that do not comply with the new regulations.
Nancy A. Cowles, executive director of Kids In Danger, a nonprofit organization that monitors the safety of children’s products, said the new crib standards were “a huge leap forward,” after years of relative inaction by the safety commission.
“It’s the safest in the world,” she said of the new standards.
The crackdown on baby sleep products was brought about by a confluence of factors. After an influx of contaminated products, including toys from China, Congress passed the Consumer Products Safety Improvement Act of 2008 which gave the commission — long criticized as toothless — more money and authority.
As part of the new law, Congress mandated that the commission issue mandatory standards for more than a dozen baby products, including strollers, bassinets, high chairs and cribs, replacing voluntary guidelines that had been the norm. News reports documenting baby deaths from unsafe products, particularly in The Chicago Tribune, put additional pressure on the commission.
Since 2007, more than 10 million cribs have been recalled, and Inez Tenenbaum, who was named chairwoman of the commission by President Obama in 2009, said she had made the safety of baby sleep products a top priority, or what she calls the “Safe Sleep” campaign.
In an interview, Ms. Tenenbaum said that when she became chairwoman she put together a team of experts to review 10 years of injury and fatality data on cribs. The result was 19 crib recalls and expedited regulations, actions which she says have “cleaned up the marketplace.”
She said the commission had also tried to educate parents about how to keep a sleeping baby safe, distributing a video to pediatricians’ offices and hospitals.
In the next year, Ms. Tenenbaum said her agency would be writing new regulations for bassinets and toddler beds. She declined to comment on why the commission had not taken more forceful action sooner.
Even with a renewed focus on the safety of baby sleep products, Ms. Tenenbaum and others acknowledge that obstacles remain.
Though the commission has ordered the recall of millions of cribs and other sleep products, many of them are still being used by parents. In addition, some parents and caregivers continue to put babies to sleep on their stomachs; experts recommend that babies be put to sleep on their backs to prevent against suffocation or sudden infant death syndrome, or SIDS.
And for all the attention on defective products, the majority of deaths of sleeping infants are caused by suffocation from pillows and other bedding that crowds a crib.
A commission report from July found that 531 deaths from 1992 to May 2008 were associated with pillows or cushions, an average of 35 deaths a year. In a vast majority of the cases, the babies were placed to sleep on their stomachs. In half the cases, the infants were put to sleep on top of a cushion or pillow.
There also remains some debate about what is safe for babies and what isn’t.
Several small manufacturers offer products that promise to reduce the incidence of sudden infant death syndrome, though medical experts and regulators remain dubious. Indeed, the F.D.A. says products that claim to prevent SIDS would be considered medical devices and therefore would require agency approval.
For instance, the Web site Eve’s Best claims that the BabeSafe mattress cover it sells has been “100 percent successful in preventing SIDS (crib death) for over 12 years.” The cover is promoted as preventing toxic gas from leaking out of the mattress, one controversial theory for the cause of SIDS.
“As a parent, I can tell you that the opinions of ‘government regulators’ as well as the A.A.P. mean absolutely nothing to me,” said Evie Maddox, who runs the Eve’s Best Web site, referring to the American Academy of Pediatrics. She said the cover was so safe that babies could sleep on their stomachs. “There are many well-educated parents out there who feel the same,” she said in an e-mail late last year.
Manufacturers of baby products, meanwhile, have challenged allegations that their products are unsafe. Michael Dwyer, executive director of the Juvenile Products Manufacturers Association, said critics frequently claimed that a product was unsafe based on emotion, whereas his members relied on science-based facts.
After federal authorities warned parents not to buy sleep positioners, the Juvenile Products Manufacturers Association suggested that parents could continue using them, as long as they used them properly.
And the association disputes the Dr. Thach’s findings on crib bumpers. Mr. Dwyer said the association commissioned its own study and found that it was often unclear what caused the babies’ death since there were other things crowded in the cribs, like pillows or soft toys. The association recommends that crib bumpers be firm, rather than pillowlike, and be removed from the crib when a baby is able to stand.
“Whereas bumpers may have been mentioned as being present in the crib, we really challenge whether the bumper was the cause,” he said.
For his part, Dr. Thach said he remained available to talk to regulators and industry officials about his findings. He noted that it was nearly impossible to buy bedding for a crib without bumpers.
“They are still selling them,” he said. “People see these in stores and assume they are safe.”
http://www.nytimes.com/2011/02/01/business/01safety.html?_r=1&src=busln&pagewanted=all

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