Portable Bed Rail Safety Risks Highlighted by FDA

In response to safety concerns associated with portable bed rails, which may have resulted in more than 150 deaths in recent years, the FDA has updated warnings for consumers and caregivers to raise awareness about the potential risks associated with the products.   

In a Consumer Update posted by the FDA on December 19, the agency urges caution with the use of portable bed rails, indicating that users may become trapped by the rails or fall from the bed itself.

Portable bed rails are a separate piece that can be attached to a standard bed. They are attached by sliding a piece of rail under the mattress and use the floor for support.

Bed rails are used to create a supportive and assistive sleeping environment in homes, assisted living centers and residential care facilities. The devices are intended to reduce risk of falling, assist the user in repositioning the bed and assist the consumer in transitioning into or out of bed.

A recent report from the Consumer Product Safety Commission (CPSC) highlighted the safety risks of bed rails, indicating that at least 155 deaths and five injuries have been linked to adult use of portable bed rails between January 2003 and September 2012.

The report revealed nearly 130 of the deaths included adults older than 60 years of age, with 94 of the deaths occurring at home. More than half of the victims also suffered from a medical condition, including cardiovascular disease, Alzheimer’s disease and dementia or other mental illnesses.

CPSC noted more than 90% of the deaths were caused by entrapment by the rails. Users can become trapped anywhere in or around the rail, between rail bars, between the rail and the mattress or between the rail and the headboard.

There are three types of portable bed rails; the portable bed rail for adults, the portable rail for kids and bed rails with attach to hospital or medical beds. Bed rails used in hospitals or used as a medical device in other settings are regulated by the FDA. However, there are currently no regulatory standards for the design or manufacturing of adult portable bed rails that are not medical devices.

In June 2013 the FDA, CPSC and ASTM International formed a working committee and invited manufacturers and organizations to participate in the development of voluntary standards for adult portable bed rails.

The FDA safety website warns caretakers against using portable bed rails as a substitute for proper monitoring of patients. The FDA also reminds them to check rails regularly to make sure they remain firmly installed.

Users should also remember not all bed rails, bed frames and mattresses are interchangeable and that it is important to check with the manufacturer to ensure compatibility and to follow manufacturers’ instructions for proper fit, checking for gaps between the rails and mattress, the FDA advises. Gaps are often created by an individual’s movements or shift in position.