Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
The U.S. Food and Drug Administration (FDA) is reminding consumers and health care providers about bed rail safety. Adult portable bed rails intended for medical purposes are medical devices, including those intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed or repositioning, or intended to reduce risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions.
Adult portable bed rails are used by many people to help create a supportive and assistive sleeping environment in homes, assisted living facilities and residential care facilities. This type of equipment has many commonly used names, including side rails, bed side rails, half rails, safety rails, bed handles, bed canes, assist bars, grab bars, and adult portable bed rails.
Patients using adult portable bed rail devices and bed rail consumer products may be at risk of entrapment and falls. All bed rails should be used with caution, especially with older adults and people with altered mental status, physical limitations, and certain medical conditions.
Many adult portable bed rails can be purchased by consumers on websites and in stores without a prescription and without the recommendation of a health care provider. Adult portable bed rails marketed for medical purposes such as those intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed or repositioning, intended to reduce risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions are considered medical devices regulated by the U.S. Food and Drug Administration (FDA). See 21 CFR 890.5050 Daily activity assist device, product code, QTC Adult Portable Bed Rails for Medical Purposes. Other adult portable bed rails that are not intended for medical purposes are considered consumer products and under the jurisdiction of the U.S. Consumer Product Safety Commission (CPSC). 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. All bed rails should be used with caution, especially with older adults and people with altered mental status, physical limitations, and certain medical conditions (for example, patients who are disabled, injured, or those post-surgery or hospitalized).
This webpage contains information about the risks of adult portable bed rails, recommendations for their safe use, alternatives to bed rails, and how to report a problem with medical devices to the FDA or consumer products to CPSC.
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