Medical Drop-Side Cribs To Be Allowed In Homes Under New FDA Rule
Federal safety officials have proposed new regulations that would allow previously banned drop-side cribs to be used outside of healthcare settings, when prescribed by a physician for use in private homes when medically necessary.
Drop-side cribs were previously a popular design for consumer cribs, featuring one side that can be unlocked and lowered to allow easier access to the baby. The cribs became increasingly popular among shorter parents or those with back problems that caused difficulty reaching over the rails of a standard crib. However, problems with the design were found to pose a serious risk for infants, where dangerous gaps may develop between the mattress and drop side of the crib, causing a number of babies to become entrapped and suffocate.
Since 2012, drop side cribs have been banned by the U.S. Consumer Product Safety Commission (CPSC), preventing the sale of the design or use of the cribs outside of healthcare facilities.
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This week, The FDA released a proposed rule that aims to establish special safety requirements that would allow the use of cribs with the drop-side rail design to be used outside of health care settings when prescribed by a physician. The rule was published in the Federal Register today.
Drop Side Crib Safety Concerns
Amid concerns about the risk of entrapment and suffocation from drop-side rail cribs, millions of different consumer models have been recalled in recent years, ultimately leading the U.S. CPSC to universally ban the design all together.
The ban came after at least 32 infant and toddler deaths were associated with drop side cribs and a another 14 were suspected to be linked to the design, but unconfirmed.
The drop-side cribs have moving parts that could become loose or fall out, causing the sides to drop unexpectedly. The cribs were linked to multiple deaths when infants became trapped or suffocated.
Many reports have indicated the cribs are not built sturdily and their retractable pegs, metal locking pins, and slats all wear out over time, allowing pieces to break and fall off.
The CPSC’s ban made the use of drop-side rail cribs only allowable in health care settings that were supervised, inspected, and approved by the safety officials. Currently, the only permitted use of the design is for pediatric medical cribs used in health care centers because it is critical for providing appropriate medical care to sick children.
However, the FDA and the CPSC have recognized that in certain situations the use of pediatric drop-side medical cribs may be necessary in homes and other non-health care settings. The new rule would allow physicians to prescribe the use of pediatric medical cribs and pediatric medical bassinets to those in a home, child care center, or other facility when deemed medically necessary.
The rule also proposes that separate safety requirements be implemented to reduce and mitigate the potential risks for entrapment and suffocation hazards and specifically provide manufacturers with specific designs requirements. The FDA plans to finalize the proposed rule after the agency has had time to review the public’s comments and concerns.
The FDA is accepting public comments on the proposed rule through December 7.
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