Adult Portable Bed Rail Safety-New updates from the FDA.

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.

The FDA website 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.