U.S. Regulators Issue New Safety Standards for Adult Portable Bed Rails

Federal safety officials hope that new bed rail safety standards will help protect seniors and other vulnerable patients from a surprising number of injuries and deaths linked to the products, after determining the industry has failed to comply with its own voluntary standards.

The U.S. Consumer Product Safety Commission (CPSC) announced new federal mandatory safety standards for adult portable bed rails (APBRs) in a press release issued on July 6, after approving the updated safety guidelines in a unanimous commission vote.

The agency will establish mandatory performance criteria and testing procedures to reduce incidents of falls, entrapment, and other potentially fatal hazards linked to the devices, which will override the current voluntary guidelines followed by the medical device industry.

Bed Rail Entrapment Risks

Adult bed rails are marketed to keep seniors and other vulnerable consumers from accidentally rolling out of bed and injuring themselves, and are frequently used in nursing homes to keep elderly residents safe. However, manufacturers have issued several massive portable bed rail recalls in recent years, due to design problems linked to entrapment, which can result in suffocation deaths and injuries.

CPSC data indicates 284 entrapment deaths involving adult portable bed rails occurred between January 2003 and December 2021. Some of those sparked massive recalls. A 2021 adult bed rail recall warned consumers to stop using three popular models after reports linked the devices to at least three suffocation deaths. More recently, in March a Vaunn Medical Adult Bed Rails recall warned that vulnerable consumers could become wedged between the mattress and bed rail, possibly leading to fatal suffocation.

Adult portable bed rails also pose fall risks to seniors, including in nursing homes that frequently use the devices. Improperly designed bed rails can allow seniors to accidentally roll out of bed, causing a potential fatal nursing home fall injury. According to the CPSC, these kinds of fall accidents are one of the top three severe injury risks for U.S. adults over 65.

CPSC Issues New Mandatory Bed Rail Standards

The new CPSC standards follow agency device testing conducted in 2018-2019, and 2021. Those results indicated manufacturers failed to comply with voluntary American Society for Testing and Materials (ASTM) standards. The CPSC has issued five public warnings regarding safety defects with adult portable bed rail models not in compliance with those voluntary standards.

To address those safety deficits, the CPSC commission voted 4 to 0 to change the voluntary ASTM standards into new mandatory guidelines. Those guidelines are expected to go into effect sometime in August 2023. All adult portable bed rail devices manufactured after the effective date must comply with the updated performance and testing requirements.

The modified, mandatory adult portable bed rail safety standards include the following updates:

• New definitions to ensure consistency throughout the rule.
• Improved requirements for manufacturers to inform the consumer of the range of mattress thicknesses to ensure safe product use.
• Providing testers with guidance for selecting correct mattress thickness during test development.
• Updating the entrapment testing requirements to ensure consistency with known hazards.