The U.S. Food and Drug Administration (FDA) released Consumer Guidance regarding portable bed rails safety and tips for caretakers on December 19, 2013. The recommendations were released because of the continuing injuries and deaths related to entrapment and falls associated with bed rail products. Overall, there is no standard definition for bed rails but they are typically divided into three distinct types: adult portable bed rails, child portable bed rails, and hospital bed rails. Adult portable bed rails are different from hospital beds, which feature a unified system of mattress, frame, and rails.
Adult 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 as support. Because many portable bed rail products can be purchased by consumers without prescription or recommendation from a health care provider, FDA is actively working with governmental agencies, non-governmental organizations, consumer groups, and health care providers to alert consumers to the dangers of using portable bed rails.
Currently, FDA and the U.S. Consumer Product Safety Commission (CPSC) separately regulate adult portable bed rails. FDA oversees and regulates bed rails used on hospital beds as part of hospital bed systems and certain transfer bars or assistive devices as medical devices. This oversight applies to all bed rails used on hospital beds, even when hospital beds are used in a person’s home or other non-clinical settings (e.g., an assisted living facility). CPSC regulates bed rails that are not designed as part of the bed by the manufacturer, and installed on or used along the side of a bed as consumer products. Overall, as the FDA’s consumer guidance notes, at this time there are no regulatory standards for the design or manufacturing of adult portable bed rails that are not medical devices.
FDA is also working with the CPSC, ASTM International (a standards-setting organization), manufacturers, consumer representatives, and health care providers to develop voluntary consensus standards for adult portable bed rails, regardless of whether they are regulated by FDA or CPSC. The goal of the voluntary standards is to eliminate the gaps in federal oversight of the safety of these products.
In an ongoing effort to raise consumer awareness regarding the potential dangers associated with adult portable bed rails, and in conjunction with the development of voluntary standards, FDA provided the following tips for caretakers:
* Make sure the individual who will use the bed rail 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 can be used compatibly; and
* 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.