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.
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.
Lara L. Mahoney, a spokeswoman for Invacare, a manufacturer of medical beds and rails in Elyria, Ohio, said newer hospital beds with side rails and stand-alone bed rails are better designed today and come with features like safety straps to prevent patients from sliding between parallel bars.
“The guidance has certainly had an impact on the industry,” she said.
In an interview, Mr. Kessler, the former F.D.A. medical device official who is now a professor at the University of Washington School of Public Health, acknowledged that the manufacturers’ resistance was a factor in not pursuing mandatory rules for bed rails.
But Mr. Kessler said a bigger factor in the F.D.A.’s decision was Congress.
“You have to remember that a few years before we began working on this issue, they had passed legislation telling us to ease the regulatory burden on companies,” Mr. Kessler said. “It would have been impossible to get a set of regulations through in that environment.”
One issue is that hundreds of stand-alone bed rail devices and beds for home use offered at medical supply stores or discount retailers may or may not be considered medical devices, depending on whether the manufacturer makes specific claims, saying, for example, the device will keep a dementia or Alzheimer’s patient from falling out of bed. Without such claims, it may be viewed as a consumer product, the F.D.A. said.
The F.D.A. said consumer safety devices were regulated by the Consumer Product Safety Commission, but the commission has long maintained that bed rails are medical devices and outside its mandate.
But that may be changing. Recently, the agency said it had begun reviewing death and injuries attributed to bed rails and will consider what actions it should take after the study is complete possibly by the end of this month. The commission said it was also coordinating with the F.D.A. to find a way to close the regulatory gap between the two agencies.
“As the elderly population increases we’re going to see more and more people cared for in their homes and assisted living facilities,” said Robert S. Adler, a commissioner with the consumer safety agency, who has made elderly safety a priority at the agency. “Bed rails are widely used in both of these settings and it’s something we need to get a handle on.”
Industry officials say despite the deaths and injuries reported from the use of bed rails, the devices can be an effective way of keeping frail older patients safe. The problem, they say, is when the bed parts — such as the mattress, rails and frame — come from different manufactures.
“This is when you get dangerous gaps in the assembly of the bed which allows a person to slip out between the mattress and rails and get injured,” said Lance Lockwood, an industry consultant and former employee of Hill-Rom in Batesville, Ind., a medical device company that makes hospital beds and bed rails. “This is something that should be explained to nursing homes and family members before they go out and buy these devices.”
In court filings, Ms. Black, whose mother died in a bed rail accident, claimed the staff at the Waterford home suggested the family buy a bed rail to keep her mother from rolling out of bed after she had been injured in a fall, and that no one warned her father when he bought bed rails for her mother. Washington state nursing home regulators said the nursing facility also never told Ms. Black and her father about the dangers of bed rails. Waterford did not respond to requests for comment.
Mr. Adler, the commissioner at the safety agency, credits Ms. Black’s advocacy with prompting the study of bed rail deaths and injuries, a point she plays down.
“Families need to be told about the possible dangers of bed rails,” said Ms. Black, who has since documented hundreds of deaths associated with the devices. “Dangerous bed rails with poor design should not be allowed to stay on the market.”
(Source: nytimes.com)
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