Bed rails seem like such a good idea-metal bars installed on beds to help people pull themselves up or get out of bed, and to prevent them from rolling out of bed. But the clamor to make them safer is growing louder because some portable bed rails promoted as a safety device can pose a risk of injury and death.
Recent articles published in the journal Biomedical Safety & Standards(BS&S) and the New York Times describe a longstanding awareness of the problem, and illustrate it with sad tales of people losing their lives when their caregivers thought they were safe.
Two consumer watchdog organizations, Public Citizen and the National Consumer Voice for Quality Long-Term Care, have asked the Federal Trade Commission to stop one manufacturer from making false claims. Last year, a similar appeal was made to the FDA, and to recall certain bed rail models. Safety advocates want the feds to study the design and use of all similar devices that pose risks from entrapment and strangulation.
The groups said that more than 525 deaths had been reported to the FDA, and more than 155 to the Consumer Product Safety Commission (CPSC). The actual number of incidents, however, is probably much higher-home users and maybe even some health-care providers might not know that such events should be reported to these agencies. As BS&S reports, “Some facilities may seek to conceal a person’s cause of death for fear of liability or suggest that the patient bore some responsibility for the event.”
Bed Handles Inc. still claims that its Bedside Assistant “makes any bed a safer bed,” and “stable in all directions and can be firmly pulled, pushed, lifted, and leaned on,” Claims for other portable rails, BS&S says, are similarly inaccurate.
In 2008, the Consumer Product Safety Improvement Act set mandatory safety standards for many infant nursery products, including portable children’s bed rails in light of well-documented injuries and deaths in young children. After the standards were implemented, childhood crib and bed-related injuries declined significantly. In 2012, the CPSC enacted Safety Standard for Portable Bed Rails, but only for those affixed to beds for youngsters, not adults.
But elderly patients are particularly vulnerable to falls, which can be catastrophic. According to BS&S:
- The presence of bed rails does not deter adults or children from trying to get out of bed.
- There is no evidence that side rails prevent falls.
- Other evidence-based methods reduce the incidence of bed-related falls–lowering bed height and placing anti-slip matting at the bedside.
- Bed rails can be more dangerous to patients than falls.
- A fall with a bed rail in place is more dangerous than a fall without a rail.
According to CPSC Commissioner Robert Adler, older people comprise 13 of 100 Americans, but they suffer 60 in 100 deaths associated with consumer products. Injury-related emergency department visits by people 75 and older are double those of people 65 to 74.
As reported by The Times, from 2003 to 2012, 36,000 mostly older adults – about 4,000 a year – were treated in emergency rooms with bed-rail injuries.
Clara Marshall, whose story was told in The Times, was a member of that at-risk older demographic. In 2006 she was suffering from dementia, and her family moved her into an assisted living facility offering round-the-clock care. Five months later, she was found dead in her room from apparent strangulation. She caught her neck in bed rails that were supposed to keep her from rolling out of bed.
Her daughter, Gloria Black, contacted the CPSC and FDA, and learned that both agencies had known for more than a decade about deaths from bed rails. In 2010, after appeals by Black, the CPSC helped prompt a review of bed-rail deaths. “I wish it was done years ago,” Black told The Times. “Maybe my mother would still be alive.”
If safety experts call for more and stronger warnings, regulatory questions trump common sense: Who’s responsible for bed rails, the FDA, which monitors medical devices, or the Consumer Products Safety Commission, which monitors consumer products?
“This is an entirely preventable problem,” Dr. Steven Miles of the Center for Bioethics at the University of Minnesota, told The Times.
To review product recall information and file a report with the CPSC, link here. To review device recalls and alerts and file a report with the FDA, link here.
