“Many death and injury reports related to entrapment and falls for adult portable bed rail products and hospital bed rails have been reported to the FDA and the CPSC [U.S. Consumer Product Safety Commission],” the FDA said in a new webpage.
Use bed rails with care, especially with older adults and people with altered mental status, physical limitations and certain medical conditions, the FDA advised.
The FDA regulates bedrails that are sold for medical purposes. These might be used to help someone who is disabled, injured or recovering from surgery to transfer in and out of bed, and reduce the risk of falling or fracture.
Those not marketed for medical purposes are instead considered consumer products and are under the jurisdiction of the CPSC.
Sometimes these types of equipment are called side rails, bed side rails, half rails, safety rails, bed handles, bed canes, assist bars, grab bars, and adult portable bed rails.
The FDA’s new webpage explains some of the risks associated with bed rails and offers some safety advice.
Bed rails typically are divided into three distinct types, according to the FDA. There are portable bed rails for adults, portable bed rails used for children, and hospital bed rails that are attached to a hospital or medical bed.
Adult portable bed rails are not designed as part of the bed by the manufacturer but are instead attachable and removable. They may be used at home, in long-term care facilities, assisted living facilities and nursing homes.
“These rails are intended to provide assistance to the bed occupant in moving on the bed surface, or in entering or exiting the bed, to minimize the possibility of falling out of bed or for other similar purposes,” the agency explained.
While some rails run along the full length of the bed, others are shorter.
Hospital bed rails are meant to be either part of or an accessory to a hospital bed or other FDA-regulated bed.
Portable bed rails for children are meant typically for ages 2 to 5 who can get in and out of an adult-size bed without help. They are considered consumer products.
The Federal Register has more on bed rail safety standards.
SOURCE: U.S. Food and Drug Administration, news release, Feb. 27, 2023
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