The Food and Drug Administration (FDA) published a final rule on Dec. 19, 2016, that provides
guidance on using pediatric medical cribs and medical
bassinets outside the health care setting and addresses
risks associated with these devices.
The new rule allows pediatric medical cribs with
drop-side or latched rails and medical bassinets to be
used in a home, child care center or other facility if
prescribed by a health care provider for a particular
patient. The FDA requirements will provide reasonable assurance that pediatric medical cribs and medical
bassinets are safe and effective.
In 2011, the Consumer Product Safety Commission
(CPSC) banned cribs with drop-side rails for use in
homes due to infants falling out of the cribs and getting
limbs caught between slats. The ban was extended to
cribs used in child care centers and facilities such as
hotels in 2012.
FDA regulation has allowed pediatric medical cribs
used in health care settings to have drop-side rails to
make it easier to provide medical care to sick children.
The new rule expands the settings in
which medical cribs with side rails may
The final rule will:
• provide, when it is medically nec-
essary, continued access by prescrip-
tion to pediatric medical cribs with
drop-side rails in a home, child care
or other facility;
• further reduce potential risks associated with pediatric medical cribs
and medical bassinets, such as entrapment or fire;
• require warning labels for both pedi-
atric medical cribs and medical bas-
sinets to reduce risks of injuries; and
• convey the FDA’s safety expectations
and requirements by providing man-
ufacturers with more specific design
requirements for pediatric medical cribs and med-
The rule specifies that manufacturers conduct de-
sign and performance testing to reduce risks associated
with pediatric medical cribs, such as entrapment and
strangulation due to slat width and spacing, falls due
to unsecure latches and other locking mechanisms, and
injuries caused by compromised surface material.
The requirements address risks associated with medical bassinets, such as tipping of the device and cracks in
the plastic material, which may result in injuries (e.g.,
bruises, burns and cuts).
The rule specifies that mattresses intended for use
with pediatric medical cribs are required to meet CPSC
mattress flammability standards.
FDA issues new rule on pediatric medical cribs, medical bassinets
from the Food and Drug Administration Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, and Center for Devices and Radiological Health
For more information on the use of pediatric medical
cribs and bassinets, visit http://bit.ly/2kxn3kz.