Both the Consumer Product Safety Commission and the U.S. Food and Drug Administration issued a joint announcement recently that they would be establishing a joint committee that will update the voluntary safety standards for the adult portable bed rails frequently used in nursing homes and assisted living facilities.
Indian River County nursing home negligence attorneys know this has been a long time in coming, and remains to be seen whether it will be enough to curb the tens of thousands of elderly injuries and hundreds of deaths attributed to these devices.
Part of the problem previously was that the FDA and the CSPC battled over who had regulatory jurisdiction, as there was no clear guidance on whether bed rails were consumer products or medical devices.
With this effort, it may not matter either way. In their joint statement, both agencies said that all “reasonable and timely efforts should be undertaken to address this hazard and protect the safety of the public.”
It’s really something that should have been done some time ago, considering that since 1995, there have been an estimated 550 bed-rail related deaths – 155 of those from January 2003 through September 2012. Plus, there have been nearly 40,000 people treated in hospital emergency rooms between 2003 and 2004 for injuries related to adult bed rails.That amounts to about 4,000 each year.
The majority of those injured or killed were over the age of 60. Many suffered from dementia or Alzheimer’s disease.
The FDA was warned back in 1995 that adult bed rail deaths were a growing problem. Still, it wasn’t until four years later that the agency formed a working group comprised of patient advocates, researchers and medical device manufacturers. The agency was going to impose regulations that would have required manufacturers to add warning labels to the equipment. However, the industry staunchly opposed such action, and the FDA backed down, citing the cost to smaller bed rail companies and also the trouble in getting such regulation through layers of bureaucratic approval. Never mind, apparently, that some of our most vulnerable citizens would continue to be subjected to harm without warning.
If you aren’t familiar, bed rails are those metal bars used in nursing homes and hospitals that allow patients to help pull themselves up or out of bed. In some cases, they are intended to help people roll out of bed.
The problem is that in some cases, patients – particularly elderly ones – become confused and sometimes become trapped between the mattress and the railing. This ends up resulting in serious injury and death.
Nursing homes and hospitals don’t use them quite as often as they once did, but you can still find them in many facilities. What’s especially troubling is the fact that a lot of places still use the older models for many patients.
In 2006, the FDA finally issued voluntary guidelines that offered some instruction to nursing homes and hospitals regarding the use of adult bed rails. Those guidelines recommended gap and opening size limits in the rails and made a point to identify which parts of the body are most likely to become stuck.
The newer rails are supposed to be better-designed, but they certainly aren’t without issue.
With regard to the new guidelines, it’s expected that ASTM International, which publishes voluntary technical standards for a large number of products, will head the committee.
There are many who remain skeptical that these new standards will have much impact, given that previous voluntary guidelines failed to do much to stem the tide of injuries. One Massachusetts lawmaker called the government’s response to the issue “tepid.”
It remains to be seen whether these guidelines will produce different or better results.
Freeman, Mallard, Sharp & Gonzalez — 1-800-561-7777 for a free appointment to discuss your rights.
U.S. Agencies to Develop Standards for Bed Rails, June 14, 2013, By Ron Nixon, The New York Times
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