FDA Working on Draft Rule to Allow Medically Required Drop Side Cribs

The U.S. Consumer Product Safety Commission (CPSC) has banned the sale of drop side cribs, and as of the end of 2012, the design is no longer permitted in child care facilities, hotels or other public accommodations. However, the FDA indicates that it is working on a draft rule to allow the use of drop side cribs in certain settings, when medically necessary.

Drop-side cribs are designed to have one side that can be unlocked and lowered to allow easier access to the baby during care.

The crib design became popular over the past few decades, allowing shorter care givers and those with back problems to easily reach over the rails of a baby crib. However, design and manufacturing problems with a number of different drop-side cribs have been linked to serious injuries and deaths that occurred when an infant became entrapped in a gap that developed between the mattress and drop side of the crib.

The CPSC launched a crib safety campaign in 2010, as the result of millions of cribs which were recalled from the market due to structural failures and faulty hardware. Many of these cribs allow moving parts to become loose and create a gap that can trap or suffocate infants.

In December 2010, the U.S. Consumer Product Safety Commission (CPSC) voted to ban all drop-side crib designs from the marketing, including the sale, resale and manufacture of the cribs. The vote came after the drop-side design was linked to at least 32 infant and toddler deaths since 2000, and was suspected in another 14 fatalities.

The ban took effect for consumer crib manufacturers and retailers on June 28, 2011. In addition, as of December 28, the ban also took effect on child care centers, family child care homes and places of public accommodation, such as hotels.

In a statement posted by the FDA on January 2, the agency indicated that current regulations do allow the use of pediatric medical cribs with drop-side railings in hospitals, to offer critical medical care to sick children.

The FDA indicated that it recognizes that this accommodation may also be medically necessary in other settings outside of hospitals, such as child care facilities or in the home, when medically relevant.

With this in mind, the FDA is formulating a draft rule for drop-side cribs in these settings, which would make the crib design available with a physician prescription. Some child care facilities currently have pediatric medical drop-side cribs, these facilities are urged to contact local or state licensing agencies to find out how the CPSC’s final rule affects them.

The rule will also propose specific slat width and mattress flammability requirements to be consistent with the CPSC standards that have been previously established. In addition, the rule will propose separate safety requirements for pediatric medical cribs medical bassinets.

The FDA hopes the draft rule will reduce potential risk of entrapment or fire while aligning the safety requirements of pediatric medical cribs with those of consumer cribs. Officials anticipate the draft rule will require approximately one year to finalize, but will be issued sometime this year. The public will be offered an opportunity to comment on the draft rule prior to its finalization.