The Food and Drug Administration recently issued guidelines to try to end a little-known, but not uncommon, cause of death to people in nursing homes and hospitals: entrapment in the bedrails on hospital beds.
Bedrails are simple, metal devices that are supposed to be helpful. Patients use the rails to pull themselves up, and they can prevent patients from rolling out of bed. But sometimes patients -- particularly frail, older ones with dementia or Alzheimer's -- can get trapped between a bedrail and the bed mattress, which can lead to serious injury or even death.
About 350 bedrail-related deaths have been reported to the FDA since 1995. Thirty-five deaths were reported in the last year and a half. But federal officials say they believe these are just a fraction of the actual number of injuries and deaths. Larry Kessler, director of the FDA’s Office of Science and Engineering Laboratories, says many nursing homes and hospitals don't know that they're expected to report such injuries. Others may not be reporting the incidents because they're afraid of legal liability or don't want the bad publicity that results when these deaths occur.
"People shouldn't die this way," says Kessler, who has reviewed the reports of these deaths. "They're very serious and we believe they're largely preventable."
The FDA guidelines, issued in March, tell hospitals and nursing homes how to make complex calculations to check that beds are properly assembled.
"Sometimes the problem is caused by people who put together hospital beds from disparate parts," says Kessler, who led the group of federal officials, industry representatives, consumer-group officials and others who came up with the new instructions.
If bed parts -- such as the mattress, rails and frame -- come from different companies, it can lead to dangerous gaps in the assembly, Kessler says.
“A frail person may slip his or her head or arm into one of the gaps and may not be able to extricate it," he says, "and that's where injury or death occurs."
Kessler says that when the beds are put together correctly, there's almost never a problem.
"We don't believe hospital beds are killer beds," he says. "We don't believe that it's an unsafe environment, on average. It's just that because a million or more people are in a hospital bed every day in this country, it only takes a few of them that are frail and disoriented and a bed that's slightly dangerous to cause a problem. It's a rare event but it's worth worrying about."
Guidelines 'Too Little, Too Late'?
But Steven Miles says the new FDA guidelines don't go far enough. Miles, a professor at the Center for Bioethics at the University of Minnesota, was one of the first to notice that people were dying after getting caught in bedrails.
He says the FDA did too little, too late to respond.
"I think right now, it's patient and family beware," Miles says. Even with the new guidelines, he says patients can't rely on hospitals and nursing homes to catch dangerous beds.
What Patients and Families Can Do
If you have a loved one in a hospital or a nursing-home bed that has a bedrail, check for a gap between the mattress, the bed frame and the bedrail, Miles says.
"Personally look at the bed and see if by pushing the mattress to the far side of the bed they can make a gap that is big enough to put four fingers between that and the rail," he advises. "If they can, that gap is too big."
Many hospitals and nursing homes have stopped using bedrails. Originally, they were used to restrain patients, to stop them from getting out of bed. But Miles says many hospitals found they don't do a good job of safely restraining patients. Administrators also found that confused patients sometimes try to climb over the rails, which is even more dangerous.
As nursing homes and hospitals cut back on bedrails, more of those devices are ending up in people's homes. Miles says that the older beds -- the ones most likely to be unsafe -- are winding up in the home-care and hospice market.
"Rent a bed for your disabled loved one who is coming home, and typically what happens is they'll pull some rails off a rack; they'll pull a mattress off the rack; and they'll throw it on a bed, and they'll assemble it," Miles says. "And they don't do the testing for the size of these gaps. Then they ship it off to the end user without any labeling as regard to these hazards."
And again, that means it's up to family members to check that the mattress is tight against a bed frame and the bedrail.
An Accidental Death
The new FDA rules came out too late for Bud Flynn. His mother, Frances Flynn, died in a bedrail accident in May 2004.
Flynn received a phone call from his mother's nursing home in Sacramento, Calif., telling him that she had died during the night.
"That's the way that it was explained to me: That my mom had passed away during the night," Flynn recalls. "So I thought that she had passed normally."
A second call came a few days later.
"The funeral director had called my wife and said that the coroner's office needed to transfer my mom to do an autopsy because her death wasn't a normal death -- meaning an accident had occurred," Flynn says.
That's when Flynn found out his mother's death had been anything but peaceful. According to the coroner in Sacramento County, the official cause was death by sudden cardiac arrest. When Frances Flynn got her body stuck between her bedrail and the bed mattress, she panicked and died.
Flynn has filed a lawsuit against his mother's nursing home, saying the death should have been prevented.
"And the image of my mom trapped in this bed mattress is just an awful thing to think about," he says. "And it's not a nice way to leave the world."