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Portable Bed Rails Pose Life-Threatening Risk to Elderly, Frail Adults

Health Letter, March 2014

Family members of loved ones who are frail or physically impaired due either to advanced age or to physical or mental health disorders sometimes buy and install portable bed rails under the mistaken belief that these products will help their loved ones to be safer in bed. However, rather than making beds safer for such individuals, portable bed rails pose an unacceptable risk of serious injury and death due to entrapment and strangulation or suffocation.

On Christmas morning in 2004, a 75-year-old man was found with his neck entrapped between the mattress or frame of his bed and a bed rail. The New York Times blog in which this story was identified includes an important common, but flawed, perception of these products:

Like a lot of people, I supposed that bed rails were a safety device, analogous to a seat belt in a car, meant to keep, sick, drugged, confused or restless people from falling or climbing out of beds in hospitals and nursing homes.

This story is, unfortunately, not an isolated occurrence. Indeed, the Consumer Product Safety Commission (CPSC) found that of the 155 fatalities related to bed rail use in teenagers and adults between June 2003 and September 2012, 145 incidents were related to rail entrapment.

Since 2011, Public Citizen has fought to have adult portable bed rails removed from the U.S. market, petitioning both the Food and Drug Administration (FDA),[1],[2] and the CPSC[3] to ban them. Unfortunately, reckless foot-dragging and inaction by these federal agencies has allowed the hazardous products to remain on the market for far too long.

What are portable bed rails?

Adult portable bed rails are sold and marketed directly to the public and are intended to be used with a home bed rather than a hospital bed. They are made of rigid materials (usually metal), have horizontal and vertical components joined together at a right angle, and are installed by sliding the horizontal component of the bed handle between the mattress and box spring of a bed, with or without a supporting strap.

These products are marketed online; in department stores, medical supply stores and other retail outlets; and directly by manufacturers. No special requirement or prescription is currently needed for the sale or purchase of portable bed rails, even though a store selling them may advertise that it specializes in medical supplies.

Examples of adult portable bed rails include the following:

  • The Bedside Assistant and Travel Handles made by Bed Handles, Inc. (see photos at http://www.bedhandles.com/page2.htm#page3.htm and http://www.bedhandles.com/TravelHandlesPage.htm);
  • Freedom Grip Bed Rail, manufactured by ActiveForever (see photos at http://www.activeforever.com/freedom-grip-bed-rail); and
  • Home Bed Assist Handle, manufactured by Drive Medical Design and Manufacturing (see photos at https://www.drivemedical.com/osc/catalog/product_info.php?products_id=733#).

Public Citizen petitions the FDA

On May 4, 2011, Public Citizen petitioned the FDA to ban the marketing of Bedside Assistant bed handles manufactured by Bed Handles, Inc., and all similar medical device products made by other manufacturers and to order a recall of all such devices.[4] Public Citizen was prompted to take this action by an Oregon woman whose elderly mother was tragically killed after becoming entrapped and strangled by a Bedside Assistant made by Bed Handles, Inc., based in Blue Springs, Miss. The product had been purchased by a family member and installed on her mother’s bed at an assisted living facility upon the advice of a physician.

At the time Public Citizen petitioned the FDA, the Bedside Assistant bed rails and certain similar products appeared to be classified by the agency as a class I medical device in the category of “daily activity assist devices.”[5],[6],[7] A daily activity assist device is defined by the FDA as a modified adapter or utensil (e.g., dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function. As class I devices, these products can be marketed without the manufacturer seeking approval or clearance from the FDA.

Advertising for Bedside Assistant bed handles originally indicated that the product was intended for a medical purpose:

Makes any bed a safer bed . . . Especially for anyone who uses a cane or walker or who feels dizzy or unsteady as they get in and out of bed.

Designed by an engineer for his wife who has [multiple sclerosis], the Bedside Assistant was tested by people with weakness from Parkinson's, injury, medication, hypertension, chemotherapy and stroke.[8]

In its petition to the FDA, Public Citizen asserted that contrary to the manufacturer’s claim that the product “makes any bed a safer bed,” data previously provided to the FDA demonstrated that these devices turn a bed into a death trap for patients who are physically weak and have physical or mental impairments. In support of this assertion, Public Citizen cited its review of the FDA medical device adverse event records, which found that since 1999, the agency had received reports of four patient deaths secondary to entrapment by Bedside Assistant bed handles.[9],[10],[11],[12] In three of these cases, the description clearly was consistent with death having been caused by strangulation or suffocation. A fifth report described another life-threatening incident in which this device entrapped a hospital patient.

In a December 13, 2011, supplement to its original FDA petition, Public Citizen reported finding in FDA records another recent report of a patient who died from strangulation and suffocation after becoming entrapped by an adult portable bed rail. In this case, the product had been manufactured by Drive Medical Design and Manufacturing in Port Washington, N.Y.[13]

Public Citizen believes that the number of people killed or injured by bed handles was higher than the number of such events that had been reported to the FDA. These incidents generally weren’t reported to the FDA because people didn’t realize portable bed rails are medical devices overseen by that agency.

The mechanism by which adult portable bed rails, like the Bedside Assistant bed handles, can cause death is straightforward and well-known to the FDA.[14] Given its design and installation, the bed handles can slip out of place, creating a gap between the edge of the patient’s mattress and the vertical support bars. A frail or elderly person with physical or mental impairment can then slip into this gap, becoming entrapped. Even a small gap, particularly when such devices are used with soft or worn mattresses, can lead to patient entrapment. Death may ensue either through compression of the trachea (windpipe) against the horizontal support bars and subsequent strangulation, or through positional asphyxia (being unable to breathe adequately because of body position, leading to suffocation).[15]

Public Citizen’s petition to the FDA compared the need to recall the bed handles to the CPSC’s 11 recalls involving more than 7 million drop-side baby cribs that posed a similar risk of strangling or suffocating infants and toddlers to death.[16]

In 2012, Public Citizen learned from congressional sources who had expressed an interest in the risks posed by adult portable bed rails that the FDA was claiming that it had no oversight over bed rails that did not make a health or medical claim and that it was the agency’s position that portable bed rails are not medical devices.

Public Citizen petitions the CPSC

Faced with FDA inaction on its 2011 petition and armed with new data on the extent of harm caused by adult portable bed rails, on May 9, 2013, Public Citizen petitioned the CPSC to declare all currently marketed adult bed rails to be banned hazardous products and to order a recall of all such products.[17]

The most important new data supporting Public Citizen’s petition to the CPSC came from that agency’s own research on hazards presented by adult portable bed rails. In the summer of 2012, the CPSC conducted a study to examine the issue of bed rail injuries and deaths in adults. The resulting findings were reported in an October 11, 2012, CPSC memo entitled “Adult Portable Bed Rail-Related Deaths, Injuries, and Potential Injuries: January 2003 to September 2012.”[18] People age 13 years and older were included in the analysis.

The reported CPSC study results were stunning. The agency uncovered 155 fatalities in that approximately nine-year period.[19] Of these fatal incidents, 143 (93 percent) were related to rail entrapment, and 129 (83 percent) were in adults age 60 years and older.[20] The CPSC found that 94 of these fatalities (61 percent) took place at home, 25 (16 percent) in nursing homes, 15 (10 percent) in assisted living facilities and 3 (2 percent) in hospice care settings.[21]

The CPSC study identified five nonfatal adult portable bed rail-related incidents reported between January 2003 to September 2012, two of which involved entrapment.[22] No injuries were reported for these incidents.[23]

In this same study, the CPSC also estimated that 36,900 adults and children older than 13 years were treated for bed rail-related injuries in U.S. hospital emergency departments nationwide between January 2003 and December 2011.[24] (These estimates excluded injuries related to hospital beds.) The injuries were fairly evenly distributed among age groups and did not increase or decrease significantly from one year to the next. The most commonly injured body parts were the head (14%), lower leg (12%), and foot (12%). Most injuries involved laceration (30%), contusions/abrasions (30%), and fracture (14%).[25] There were no reported deaths among these patients, all of whom were treated in hospital emergency rooms.

In its petition to the CPSC, Public Citizen emphasized that in addition to posing an entrapment risk, individuals attempting to climb over bed rails placed on their beds also can become victims of injury due to falls. Bed rails raise the height from which patients can fall, potentially increasing the risk of serious injury. These risks are exacerbated among patients with limited cognitive function, who may fail to recognize the challenge of climbing over the rail or call for appropriate assistance. Full-length side rails installed on both sides of a bed can also be used as a form of restraint by impeding an individual’s ability to voluntarily get out of bed, creating a risk that patients will injure themselves attempting to navigate over the rail.[26]

Importantly, observational studies conducted in institutional settings have indicated that risk of serious falls can be reduced by programs to remove bed rails and other restraints while addressing fall risk through other measures.[27],[28],[29]

One approach commonly taken by the CPSC as an alternative to declaring a consumer product to be a banned hazardous product is to develop mandatory standards intended to ensure the safety of the product and to add warnings to the product labeling. In its petition to the CPSC, Public Citizen argued that for a variety of reasons, the development of mandatory standards for adult portable bed rails would not be sufficient to adequately protect against strangulation and suffocation from entrapment or fall hazards. Furthermore, Public Citizen argued that the addition of warning labels on bed rails also was not the solution to the dangers presented by these consumer products.

FDA responds to Public Citizen’s petition; CPSC action is pending

On December 19, 2013, the FDA denied Public Citizen’s petition to ban the marketing of Bedside Assistant bed handles manufactured by Bed Handles, Inc., asserting that the products were not medical devices and therefore not subject to the agency’s jurisdiction.[30] The FDA noted in its response that after the petition was submitted, the agency contacted the manufacturer regarding the claims made about the product on the company’s website. This prompted the company to revise its website so that the claims currently read as follows:[31]

Makes any bed a safer bed… Especially for anyone who simply needs something to hold on to as they get in and out of bed.

Designed by an engineer for his wife who was weak and unsteady, the Bedside Assistant has been used by many that need a little extra help to be more independent.

With this change, the FDA concluded that the Bedside Assistant bed handles are not intended for use in the mitigation of disease and are not medical devices within the agency’s regulatory jurisdiction. The FDA also stated that such bed rails are consumer products subject to the jurisdiction of the CPSC.

So now the regulatory ball is in the CPSC’s court. Although the CPSC has yet to respond to Public Citizen’s petition, the agency has initiated the process of drafting mandatory standards for adult portable bed rails. Unfortunately, if this is the regulatory pathway the CPSC chooses to take, many more consumers will be injured or killed by these inherently dangerous products over the next several years until appropriate definitive action is taken to remove them from the market.

In the meantime, Public Citizen urges readers of Health Letter to never use adult portable bed rails for themselves or their loved ones.

References

[1] Carome MA, Wolfe SM. Public Citizen’s petition to the FDA to ban the marketing of Bedside Assistant bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles and all similar medical device products. May 4, 2011. http://www.citizen.org/hrg1947. Accessed February 2, 2014.

[2] Carome MA, Wolfe SM. Supplement to Public Citizen’s petition to the FDA to ban the marketing of Bedside Assistant bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles and all similar medical device products. December 13, 2011. http://www.citizen.org/documents/supplement-to-May-4-2011-petition.pdf. Accessed February 2, 2014.

[3] Sorscher S, MA Carome. Public Citizen’s petition to the CPSC to ban all currently marketed adult portable bed rails. May 9, 2013. http://www.citizen.org/documents/2125.pdf. Accessed February 2, 2014.

[4] Carome MA, Wolfe SM. Public Citizen’s petition to the FDA to ban the marketing of Bedside Assistant bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles and all similar medical device products. May 4, 2011. http://www.citizen.org/hrg1947. Accessed February 2, 2014.

[5] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on March 9, 2007 associated with Bedside Assistant® bed handles. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1366563. Accessed February 3, 2014.

[6] Food and Drug Administration. Medical Devices Product Classification for Product Code IKX. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=4579. Accessed February 3, 2014.

[7] 21 C.F.R. 890.5050. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5050. Accessed February 3, 2014.

[8] Bed Handles, Inc., website. http://www.bedhandles.com/page4.htm#page4.htm. Accessed March 21, 2011.

[9] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on March 27, 1999 associated with Bedside Assistant® bed handles. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=218072. Accessed February 3, 2014.

[10] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on February 4, 2002 associated with Bedside Assistant® bed handles. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1366564. Accessed February 3, 2014.

[11] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on January 10, 2004 associated with Bedside Assistant® bed handles. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=507241. Accessed February 3, 2014.

[12] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on March 9, 2007 associated with Bedside Assistant® bed handles. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1366563. February 3, 2014.

[13] Food and Drug Administration. Manufacturer and User Facility Device Experience database: report of patient death on February 5, 2011 associated with Drive Medical Design and Manufacturing Bed Assist Rail. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=2281458. Accessed February 3, 2014.

[14] Food and Drug Administration. Guidance for industry and FDA staff: hospital bed system dimensional and assessment guidance to reduce entrapment. March 10, 2006. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072729.pdf. February 3, 2014.

[15] Hyman WA. Bed-rail entrapments still a serious problem. McKnight’s Long-Term Care News and Assisted Living. July 24, 2008. http://www.mcknights.com/bed-rail-entrapments-still-a-serious-problem/article/112809/. Accessed February 3, 2014.

[16] Carome MA, Wolfe SM. Public Citizen’s petition to the FDA to ban the marketing of Bedside Assistant bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles and all similar medical device products. May 4, 2011. http://www.citizen.org/hrg1947. Accessed February 2, 2014.

[17] Sorscher S, MA Carome. Public Citizen’s petition to the CPSC to ban all currently marketed adult portable bed rails. May 9, 2013. http://www.citizen.org/documents/2125.pdf. Accessed February 2, 2014.

[18] Memorandum to Richard McCallion, Adult Portable Bed Rails Project Manager: Adult portable bed rail-related deaths, injuries, and potential injuries: January 2003 to September 2012. October 11, 2012.

[19] Consumer Product Safety Commission. Memorandum from Angie Qin to Richard McCallion, Adult Portable Bed Rails Project Manager: Adult portable bed rail-related deaths, injuries, and potential injuries: January 2003 to September 2012. October 11, 2012. http://www.cpsc.gov/PageFiles/133466/adultbedrail.pdf. Accessed February 4, 2014.

[20] Ibid.

[21] Ibid.

[22] Ibid.

[23] Ibid.

[24] Ibid.

[25] Ibid.

[26] Capezuti E, Minimizing the use of restrictive devices in dementia patients at risk for falling. Nurs Clin N Am. 2004;39:625-647.

[27] Hanger HC, Ball MC, Wood LA. An analysis of falls in the hospital: can we do without bedrails? J Am Geriatr Soc. 1999 May;47(5):529-31.

[28] Hoffman S, Powell-Cope G, Rathvon L, Bero K. BedSAFE: Evaluating a program for bed safety alternatives for frail elders. Journal of Gerontological Nursing. 2003;29(11), 34-42.

[29] Capezuti E, Wagner LM, Brush LB, et al. Consequences of an intervention to reduce restrictive side rail use in nursing homes. J Am Geriatr Soc. 2007;55:334–341.

[30] Food and Drug Administration. Response to Public Citizen’s May 4, 2011 petition to ban the marketing of Bedside Assistant bed handles manufactured by Bed Handles, Inc. December 19, 2013. http://www.citizen.org/documents/131219_FDA%20final%20response%20to%20petition.pdf. Accessed February 4, 2014.

[31] Bed Handles, Inc. The Bedside Assistant detailed information. http://www.bedhandles.com/page4.htm#page4.htm. Accessed February 4, 2014.

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