Bed rails, which can injure and kill the elderly, remain on the market
As US regulators and lawmakers move on to a potential ban Deadly baby sleep products, Bed rails and bed handles that have killed hundreds of mostly elderly Americans remain in the market.
Often bought for the sick or frail elderly, the side rails or metal bars are used on hospital beds and in home care to help patients pull up or to keep them from falling out of bed. But these products – marketed as safety devices and sold by retailers like Amazon and Walmart, as well as medical supply stores – have proven far from safe for the thousands of elderly and disabled patients who have been injured by them.
“The person who bought it felt a lot of guilt,” said Gloria Black, whose 81-year-old mother Clara Marshall died after her neck was trapped in side rails in 2007.
Concerned Marshall would slip off her mattress to the floor, Black’s father bought the bed rails on the advice of nurses at the Vancouver, Washington, assisted living facility, Black told CBS MoneyWatch. A month after her mother’s funeral, the state health department contacted Black to see if she was aware of the product’s role in her mother’s death.
“It’s very common in these cases. People don’t necessarily know it’s a bed rail, ”Black said. “When I found out, the agreement with my father was that we had to do something.
While researching what had happened to her mother, Black learned that others had also died of suffocation after their necks got caught in bed rails. “There was no evidence that these products could make people safer.”
Trending news
Decades of accidents
Black also learned that government agencies had been aware of the danger for years.
Between 1985 and 2013, the Food and Drug Administration received reports of 901 incidents of patients trapped, pinched, entangled, or strangled by hospital bed rails. They included 531 deaths, 151 non-fatal injuries and 220 cases in which staff had to intervene to prevent injuries.
“Most of the patients were frail, elderly or disoriented,” said the agency, which regulates hospital beds with side rails as medical devices.
US Food and Drug Administration Drug
In addition, seven deaths related to portable bed rails were reported to the FDA from 2005 to 2013, the agency said.
For more recent examples of bed rail incidents, see the FDA website. Although the details are inconclusive, a 2016 case reported to the FDA described a patient who died and who was found with “her head in the bed frame and the rest of her body on the floor.”
According to the Consumer Product Safety Commission, an estimated 69,000 adults were treated in emergency rooms in U.S. hospitals for splint injuries from 2003 to 2019. Among those incidents, 260 cases involved portable adult bed rails, including 247 deaths, according to a July 2020 CPSC briefing paper.
“The question of whether the products currently on the market essentially meet the voluntary standard in 2020 has yet to be clarified,” added the agency in the report, which estimates that between 90,000 and 425,000 portable bed rails for adults are sold annually .
“They are all unsure,” says one doctor
Wearable splints can be regulated either by the FDA as a medical device or by the CPSC as a consumer product, depending on their intended use.
The agencies “have received many reports of deaths and injuries related to both adult portable bed rail products and hospital bed rails,” the FDA states on its website. Most involve entrapment and falls, with the potential for death and serious injury even if products are properly designed, compatible with the bed and mattress, and used properly, the agency said.
The problem is likely to be underestimated as bed rails are not necessarily listed as a cause of death by nursing homes and coroners, or a cause of injury by emergency doctors.
“They are all unsure: whether a bed rail attached to the side of the bed to protect an adult or a child from falling out of bed, or to help them position themselves to make it easier to get in and out, they are too dangerous, “said Dr. Michael Carome, director of health research at Public Citizen.” There is no way to design them to be safe as inclusions can occur.
The FDA and CPSC did not respond to requests for comment.
US Consumer Product Safety Commission
The CPSC recently announced new security standards to effectively eliminate slanted sleepers in babies under five months of age. Inclined sleepers and bumper pads for cribs, which have been linked to numerous infant deaths from suffocation, would also be banned under the Safe Sleep for Babies Act passed by the House last month, and a bipartisan version was introduced in the Senate.
But a decade-long effort to prevent similar dangers to elderly and disabled Americans has largely failed. In a 2013 petition called by Public Citizen and other supporters, including Black, to ban bed rails, federal agencies overseeing the products have instead focused on recalls and creating voluntary standards to improve their safety.
The FDA warned against bed rails in 1995 and passed voluntary guidelines for manufacturers in 2006. The CPSC standard, which is also voluntary, came into force in 2017. Literature requirements to minimize the risk of entrapment and strangulation, “said CPSC.
The Product Safety Board also monitored several product recalls in April Warn consumers before use three models of portable bed rails sold online by Walmart and other retailers due to the risk of entrapment and strangulation.
Consumer Product Safety Commission
In connection with the strangulation of four elderly or disabled people, including Black’s mother, around 113,000 adult portable bed handles were recalled in 2014 so they could be fitted with seat belts to counter the hazard.
“CPSC has examined the bed rails and found that they could allow a person to become trapped between the bed rail and the mattress or in the parts of the bed rail itself, causing suffocation,” CPSC said in its warning.
Tougher measures required
Some experts consider government warnings and voluntary industry standards to be inadequate.
“The problem with the portable splints is that they really can’t be safely adjusted to keep the gap between the splint and the mattress from opening,” said Steven Miles, a retired MD and professor emeritus at the Center for Bioethics the University of Minnesota, which first warned federal regulators about the rails in 1995.
“Also, the FDA believes that if all rails are fundamentally the same, one splint will be different,” added Miles, dismissing the notion that standards or warnings limit the inherent hazards.
With bed rail deaths and injuries particularly affecting the elderly, Miles believes the danger is being overlooked.
“These are people who are old and who are expected to die anyway,” he said. “Is there another population we can hide 500 dead in?”