Portable bed rails can make the person using them vulnerable to becoming trapped in the rails or falling. Unlike hospital beds that are generally designed as a unified system of bed, mattress, rails, and head- and foot-boards, portable bed rails are separate pieces that are attached to a normal bed, often by sliding a piece of the rail under the mattress or by using the floor for support. A senior nurse-consultant at the FDA noted that people can get trapped anywhere in or around the rail, such as between the bed rail bars, between the rail and the mattress, or between the rail and the headboard.
To increase awareness by consumers, patients and caregivers, the FDA has released a new web page on bed rail safety to provide information about the potential hazards and offer tips to promote safe use. Adult portable bed rails are sometimes known as bed handles, grab bars and assist bars. They can be used in a number of different settings, including the home, long-term care facilities, assisted living facilities and nursing homes. They come in a wide variety of styles, shapes and sizes; some run the full length of the bed, while others run a half, quarter or even shorter lengths of the bed.
"Bed rails may provide greater support and mobility when the person using them changes position or gets in and out of bed," said Joan Todd, the FDA senior nurse-consultant. But the rails also need to be monitored and maintained so they do not loosen over time and create unsafe openings in which a person could become trapped. "Portable bed rails must not be installed and forgotten," Todd noted.
While all hospital beds are regulated by the FDA as medical devices, portable rails can either be regulated by the FDA as medical devices or by the U.S. Consumer Product Safety Commission (CPSC) as consumer products, depending upon their intended use. At this time, there are no regulatory standards for the design or manufacturing of adult portable bed rails that are not medical devices. From January 2003 to September 2012, the CPSC received reports of 155 deaths and five injuries related to portable bed rails designed for adult use.
Robert Howell, the CPSC's deputy executive director of safety operations, said that more than 90 percent of the deaths associated with portable bed rails that were reported to CPSC were related to rail entrapment. Most involved people 60 and older. Of the 155 bed-rail-related deaths reported to CPSC:
- 129 occurred in people who were 60 years and older;
- 94 occurred at home; and
- About half indicated that the victim had a medical condition, including cardiovascular disease, Alzheimer's disease, and dementia or other mental limitations.
"Consumers need to realize that even when bed rails are well designed and used correctly, they can present a hazard to certain individuals, particularly to people with physical limitations or who have an altered mental status, such as dementia or confusion," said Joan Todd.
In June 2013, the FDA and CPSC in conjunction with ASTM International, a standards development organization, formed a working committee and invited related manufacturers and organizations to participate in the development of voluntary standards for adult portable bed rails.
"While portable bed rails can be effective, caretakers should not use them as a substitute for the proper monitoring of patients," Joan Todd said. "You need to check bed rails regularly to make sure they remain firmly installed, that the patient is using them for the intended purposes and to watch for areas of possible entrapment."
Here are some things to keep in mind if you are using adult portable bed rails.
- Make sure the individual is a good candidate for using bed rails. Alternatives include roll guards, foam bumpers, lowering the bed and using concave mattresses which can help reduce rolling off the bed
- Remember that not all bed rails, mattresses and bed frames are interchangeable. Check with the manufacturer to make sure the different pieces you're using are compatible.
- Follow the manufacturer's instructions to ensure a proper fit (no gaps should exist between the rail and the mattress). Be aware that gaps can be created by an individual's movements, or a shifting of the bed's position.
See the FDA Announcement
Also see the FDA’s New Bed Rail Safety Web Page