Thomas Patterson for The New York Times
Gloria Black’s mother died in her bed at a care facility.
In November 2006, when Clara Marshall began suffering from the effects of dementia, her family moved her into the Waterford at Fairway Village, an assisted living home in Vancouver, Wash. The facility offered round-the-clock care for Ms. Marshall, who had wandered away from home several times. Her husband Dan, 80 years old at the time, felt he could no longer care for her alone.
Thomas Patterson for The New York Times
Gloria Black, visiting her mother’s grave in Portland, Ore. She has documented hundreds of deaths associated with bed rails and said families should be informed of their possible risks.
But just five months into her stay, Ms. Marshall, 81, was found dead in her room apparently strangled after getting her neck caught in side rails used to prevent her from rolling out of bed.
After Ms. Marshall’s death, her daughter Gloria Black, who lives in Portland, Ore., began writing to the Consumer Product Safety Commission and the Food and Drug Administration. What she discovered was that both agencies had known for more than a decade about deaths from bed rails but had done little to crack down on the companies that make them. Ms. Black conducted her own research and exchanged letters with local and state officials. Finally, a letter she wrote in 2010 to the federal consumer safety commission helped prompt a review of bed rail deaths.
Ms. Black applauds the decision to study the issue. “But I wish it was done years ago,” she said. “Maybe my mother would still be alive.” Now the government is studying a problem it has known about for years.
Data compiled by the consumer agency from death certificates and hospital emergency room visits from 2003 through May 2012 shows that 150 mostly older adults died after they became trapped in bed rails. Over nearly the same time period, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed rail injuries. Officials at the F.D.A. and the commission said the data probably understated the problem since bed rails are not always listed as a cause of death by nursing homes and coroners, or as a cause of injury by emergency room doctors.
Experts who have studied the deaths say they are avoidable. While the F.D.A. issued safety warnings about the devices in 1995, it shied away from requiring manufacturers to put safety labels on them because of industry resistance and because the mood in Congress then was for less regulation. Instead only “voluntary guidelines” were adopted in 2006.
More warnings are needed, experts say, but there is a technical question over which regulator is responsible for some bed rails. Are they medical devices under the purview of the F.D.A., or are they consumer products regulated by the commission?
“This is an entirely preventable problem,” said Dr. Steven Miles, a professor at the Center for Bioethics at the University of Minnesota, who first alerted federal regulators to deaths involving bed rails in 1995. The government at the time declined to recall any bed rails and opted instead for a safety alert to nursing homes and home health care agencies.
Forcing the industry to improve designs and replace older models could have potentially cost bed rail makers and health care facilities hundreds of million of dollars, said Larry Kessler, a former F.D.A. official who headed its medical device office. “Quite frankly, none of the bed rails in use at that time would have passed the suggested design standards in the guidelines if we had made them mandatory,” he said. No analysis has been done to determine how much it would cost the manufacturers to reduce the hazards.
Bed rails are metal bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They can also prevent people from rolling out of bed. But sometimes patients — particularly those suffering from Alzheimer’s — can get confused and trapped between a bed rail and a mattress, which can lead to serious injury or even death.
While the use of the devices by hospitals and nursing homes has declined as professional caregivers have grown aware of the dangers, experts say dozens of older adults continue to die each year as more rails are used in home care and many health care facilities continue to use older rail models.
Since those first warnings in 1995, about 550 bed rail-related deaths have occurred, a review by The New York Times of F.D.A. data, lawsuits, state nursing home inspection reports and interviews, found. Last year alone, the F.D.A. data shows, 27 people died.
As deaths continued after the F.D.A. warning, a working group put together in 1999 and made up of medical device makers, researchers, patient advocates and F.D.A. officials considered requiring bed rail makers to add warning labels.
But the F.D.A. decided against it after manufacturers resisted, citing legal issues. The agency said added cost to small manufacturers and difficulties of getting regulations through layers of government approval, were factors against tougher standards, according to a meeting log of the group in 2000 and interviews.
