Prompt reporting of problems with bed rails can help the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) identify and better understand the risks associated with these products. If you have had a problem with bed rails, we encourage you to file a report for medical devices at the FDA's MedWatch, or for consumer products call CPSC's Hotline at (800) 638-2772.
How do I know if a bed rail is a medical device or a consumer product so I can report the incident to the correct agency?
Whether the FDA or the CPSC oversee a particular bed rail depends on its intended use. The FDA oversees medical devices and the CPSC oversees consumer products. Medical devices are intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. If intended for medical purposes, these products are generally regulated as medical devices by the FDA.
Adult portable bed rails 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 regulated as medical devices.
Guardrails or side rails intended for use on FDA-regulated hospital beds are also medical devices but are not portable bed rails. Portable bed rails used for pediatrics and adult portable bed rails that are not intended for medical purposes are regulated as consumer products by CPSC.
Check the intended use on the product label, accompanying labeling, promotional material, advertising or other relevant source to help determine if it is a consumer product or a medical device.