An 87-year-old woman living at a residential care facility in South Carolina died after becoming stuck between the bed rail and mattress. Another 76-year-old woman in a senior nursing facility in Iowa died similarly in July 2019, the CPSC and Medline said in the recall announcement.
Bed rails are used to prevent people from falling out of bed and to assist them in adjusting positions. But the device, while promising safety for people with medical needs, has injured thousands of users and been linked to hundreds of deaths, according to federal estimates. People’s heads and other body parts can get stuck in the rail or in a gap between the rail and mattress.
“This is one of the more frightening, tragic, catastrophic injuries that we’ve encountered in representing nursing home residents and their families,” said Steven M. Levin, founder of the Chicago-based law firm Levin & Perconti, which handles nursing home cases and periodically sees bed rail-related cases.
The Medline recall is the seventh recall of bed rails since 2021, according to the CPSC.
The problem has been under scrutiny for years. Last year, after finding that manufacturers weren’t adequately complying with a voluntary safety standard, the CPSC issued a new mandatory standard for the devices.
The commission “determined that there is an unreasonable risk of injury and death associated with entrapment and other hazards from adult portable bed rails,” it wrote in the final rule, which established mandatory testing and performance requirements.
The commission found that at least 284 people had been killed in incidents related to adult bed rails between 2003 and 2021. Separately, the Food and Drug Administration has estimated that 480 people died after being caught or strangled in bed rails between 1985 and 2008.
In addition, bed rails were associated with an estimated 36,900 injuries from 2003 to 2011. About 60 percent of the 155 deaths that were recorded between 2003 and 2012 occurred in private homes and 28 percent in nursing home, assisted living or hospice facilities, a 2012 CPSC report found.
“The cases that we have handled are enormously frightening,” Levin said. “You have to imagine your loved one is literally being suffocated in their own bed. Trapped between the mattress and the bed frame, they just can’t breathe and they die.”
People at higher risk for injury include those with cognitive impairment or lack of muscle control, including people with dementia, Parkinson’s disease, multiple sclerosis and other conditions, according to the FDA.
The FDA recommends alternatives including roll guards and foam bumpers for people at a higher risk. Bed rails must be installed correctly and fit the mattress properly, without gaps between the mattress and rails.
Medline spokeswoman Kristi Krasovetz said the bed rails were not securely attached to the bed in the two reported deaths.
“Medline has worked closely with the CPSC throughout this process and Medline fully supports the agency’s commitment to consumer safety. It is important for all our impacted customers to participate in this product recall,” Krasovetz said in a statement.
Levin recommended that family members with loved ones in nursing homes who have concerns about the recall contact the facility, mention the recall and ask about their relative’s mattress and bed rail.
“All family members need to be vigilant advocates for their loved ones in a nursing home,” Levin said.
The recall covers two models of Medline Bed Assist Bar adult portable bed rails, which were sold with the model numbers MDS6800BA and MDS6800BAH. The products were on sale from July 2009 through March of this year and were sold online by retailers including Amazon, Walmart and CVS.
Consumers should stop using the recalled Medline bed rails immediately, the CPSC said, and contact Medline at 1-866-359-1704 for a refund. The commission also asked consumers to report any incidents related to use of the bed rails at SaferProducts.gov.
