Bedside Devices a 'Death Trap,' Says Advocacy Group
Public Citizen also wants the FDA to investigate the association between the design and use of all bedhandle or rail devices made by any manufacturer.
The device is installed by sliding horizontal bars of the bed handles between the mattress and box spring of the bed, according to the package insert. "The bed handles can slip out of place, creating a gap between the edge of the patient's mattress and the vertical bars. The patient can then slip into this gap, becoming entrapped," Wolfe and Carome wrote.
The group's petition asks the FDA to consider the Consumer Product Safety Commission's 11 recalls in the last six years of "seven million drop-side baby cribs that posed a risk of death by strangulation or suffocation to infants and toddlers" in response to the deaths of 32 infants and toddlers between 2000 and 2010.
"It is important that federal agencies responsible for protecting the public health act consistently by safeguarding the health and safety of both young and old individuals alike," they wrote.
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