Public Citizen Calls for Recall of Bed Handles

By: Jessica Grogan, MDNews.com
Friday, May 20, 2011

Filed under: Critical Care | Emergency Medicine | Geriatrics

The nonprofit advocacy group Public Citizen says some hospital bed rails can be dangerous — even lethal — for patients.

In a petition to the U.S. Food and Drug Administration, Public Citizen claims that a variety of bed handles used to assist the elderly or otherwise weak patients in getting out of bed can trap or suffocate people.

The petition urges the FDA to recall Bedside Assistant bed handles made by Missouri-based Bed Handles, Inc., and to investigate similar bed rail devices made by other companies.

Due to a design flaw, the handles can shift out of place, causing a gap to form between the mattress and the bars of the device. A patient can become entrapped if they fall between this gap and can even die from the pressure on their tracheas or chest walls.

Public Citizen reviewed FDA records and found four deaths related to the Bedside Assistant bed handles since 1999. The advocacy group believes many incidents go unreported and that the number of casualties and life-threatening incidents is even higher.

To view the petition, visit the Public Citizen website.

MDNews.com would like to know what you think. Are the risks associated with bed rail devices as serious as Public Citizen claims? Leave a comment below to weigh in on this topic.

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1 comment for “Public Citizen Calls for Recall of Bed Handles”

Gloria Black

Posted Tuesday, September 27, 2011 at 4:24:04 AM

The statistics already gathered by the FDA and by the CPSC reporting on alleged deaths by bed rails of all different types (be it half rails, full length rails, bed handles, split rails, portable rails, fixed bed rails, hospital bed rails, etc.)tell a grim story. The FDA website,(the MAUDE reports), accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextSearch.cfm, reports on over 500 known deaths allegedly relating to bed rail use. The CPSC also has done investigative reporting into deaths allegedly involving bed rails, and it has knowledge of over 155 deaths, approx. 40 of which are children. Most of these deaths involve elderly people, of lighter weight; they are frequently women and in many cases the victims have dementia. If one reads the FDA reports in their entirety, one sees that in a number of instances resulting in death, it was the family physician who recommended use of a bed rail, in the mistaken belief the bed rail would make the user 'safer.' This - despite the fact that the AMA, according to the CPSC, is already well aware of the inherent risks that can be posed by use of bed rails. Nonetheless, many doctors are completely unaware of deaths or injuries caused by bed rail use, as patients become entrapped in the device or entangled or try to climb over the rail itself, thus experiencing a worse fall. Published research shows that bed rail use actually poses a higher risk of injury to a patient than risk of a fall, by approx. 5%. (See Myths and Facts about Side Rails, Talerico and Capezuti, AJN, July 2001, vol. 101, issue 7, 43-48; also 'Bed-rail entrapments still a serious problem,' William A. Hyman, July 24, 2008, McKnights.) Reporting of deaths by bed rails either to the CPSC or the FDA is voluntary. Thus, the true numbers of deaths caused by bed rails cannot presently be known. It is certainly higher than what is reported. (There are also multiple hundreds of reports of injury or near injury reported for bed rails, but I deal only with the death statistics here.) What is most disturbing is that the public itself is not necessarily aware of the risks involved in bed rail use - these items do not have warnings of risk of asphyxiation on them, even when the FDA has already received reports of death for a given item. In some instances, there are multiple reports on file and yet the item remains marketed with no warnings. In my opinion, neither the FDA nor the CPSC appears to have fulfilled their mandate of ensuring safety of the public, particularly when the lives of senior citizens are involved. It is important that doctors educate themselves on this issue, and make certain their patients are educated as well before making any decisions on bed rail purchase and use. Inexpensive alternatives exist - placing mattresses on floor, lowering bed, adding cushioning on floor to avoid a dangerous fall, etc. Even retailers themselves may be unaware of prior deaths or injuries associated with a bed rail product they are selling. I would urge any doctor or patient to refer to the above-mentioned FDA website to ascertain that a product/device about to be used has not already been reported to the FDA for a problem. You can click on 'Simple Search' and input the name of the manufacturer to read any reports filed with the FDA. Please keep in mind, absence of a report is, sadly, no guarantee that in fact there have been no adverse events which may have taken place with the device. Bottom line, if you still wish to recommend purchase of a bed rail, please, carefully, carefully do the research yourself on the history of that device. You can't count on the FDA to have done that for you.