In the wake of nursing home resident deaths, bed rails deserve more regulation

Most who have been to a hospital or a nursing home can picture a hospital bed in their mind. It is a lot like any other bed but it has certain safety features to help patients. One of those supposed safety features is bed rails.
The New York Times reports that there is controversy regarding the safety of bed rails. They aren’t necessarily the safety device they are cut out to be for all patients. In some cases, bed rails are blamed as the dangerous product tied to the death of a patient.Clara Marshall’s story was featured in The New York Times piece as an example of bed rails going wrong. She had put her mother into a nursing home when she needed constant care but lost her after only five months of her living in the home. She died when she got her head caught in her bed rails and was strangled.
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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 nursing 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 œvoluntary 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?
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.
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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.   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.      Instead, in 2006, the F.D.A. issued voluntary guidelines, instructing hospitals and nursing homes on the use of bed rails. They recommended size limits for the gaps and openings in the rails and identified body parts most at risk for getting stuck.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.
œYou 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. œIt 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.
œAs 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. œBed 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.
œThis 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. œThis is something that should be explained to nursing homes and family members before they go out and buy these devices.
While proper design, maintenance and warnings would all help improve the safety of bed rails, responsible caregiving is also crucial. Our law firm helps people who feel that nursing home neglect has caused an injury or the death of a loved one. If you think a loved one has been abused or neglected in a Florida nursing home, call one of our attorneys today or visit our Nursing Home Abuse/Neglect
page for more information about this sensitive legal matter.
Source: The New York Times, “After Dozens of Deaths, Inquiry Into Bed Rails,” Ron Nixon, Nov. 25, 2012 ()

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