The Consumer Product Safety Commission has recently addressed the subject of bedrail safety. In part, this investigation was initiated by the tireless efforts of one woman, after her mother tragically died after becoming entrapped within the bedrails of her bed in a nursing home facility. Until now, the actual number of deaths from bedrails have not elicited much response from policy makers. However, public pressure, a changing age demographic, and the number of reported injuries by the CPSC just may. Approximately 37,000 people were treated in hospitals between 2003-2011 for injuries sustained from bedrails. Additionally, between January 2003 and September 2012, 155 fatalities have been attributed to bedrails.
Upon case investigation, the CPSC identified potential bedrail hazards. Ranked as to frequency of occurrence, they are entrapment, falls, miscellaneous incidents, and structural integrity. Rail entrapment occurs in over 90 percent of these accidental deaths.
The majority of these injuries, 61 percent, actually occurred in home care settings according to the study, and over a quarter of the injuries happened in nursing home or assisted living facilities.
In response, published in a New York Times article, Representative Edward J. Markey, “called for the consumer and drug agencies, as well as the Federal Trade Commission, to form a task force to address the regulation of bedrails and bed systems, specifically rails that blur the line between being medical devices and consumer products.” He went on to say, “We need a national task force dedicated to addressing any regulatory gaps and protecting these vulnerable patients from preventable bedrail injuries.”
While this is certainly true, the FDA has been involved in bedrail safety for quite some time. A safety alert, regarding entrapment, was issued in 1995 to biomedical and clinical engineers, nursing, home healthcare agencies, hospices, hospital administrators, nursing homes and risk managers. In addition, “in response to continued reports of patient entrapment, the FDA, in partnership with the U.S. Department of Veterans Affairs, Health Canada’s Medical Devices Bureau and representatives from national health care organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers, formed a working group in 1999 known as the Hospital Bed Safety Workgroup (HBSW).
The HBSW also worked in cooperation with the Joint Commission on Accreditation of Healthcare Organizations, the U.S. Centers for Medicare and Medicaid Services, and the U.S. Consumer Product Safety Commission to improve patient safety associated with the use of hospital beds.” The committee conducted research and provided guidance for manufacturers and healthcare professionals concerning entrapments risks of bedrails and offered recommendations for dimensional considerations. However, due to industry resistance as well as a political hesitancy to regulate business, the FDA stopped short of regulating the devices and offered only recommendations, alerts, and voluntary guidelines at the time.
Now that the issue has resurfaced, there seems to be debate as to which group should regulate bedrail safety – the FDA under the auspices of medical devices, or the CPSC as consumer products. Perhaps they are both, depending upon product design and intent. Regardless, this debate is actually needed to propel the issue to the attention of legislators on a wave of public pressure to ensure needed change.
Patients and their families have a right to know that the products and materials used by healthcare providers, long-term care facilities, or for home care, are safe. Just as cribs, car seats, or seat belts are used as safety devices, so too are bedrails for the frail, ill, or restless. As patients, “or” consumers, we should not fear that the very bedrails intended for our care and wellbeing might actually increase the propensity for harm. We also know that no safety device ever prevents the need for appropriate supervision and monitoring.
The attorneys at Briggs & Wholey agree with safety advocates and believe that more comprehensive legislation, reporting methods and oversight of bedrails is needed to adequately protect our loved ones in healthcare and home environments. If you, or a loved one has suffered harm from bedrail devices intended to protect, contact the attorneys at Briggs & Wholey to discuss your legal rights. You should know that your action can help bring about positive change for the safety of others.
Photo Credit: Melodi2, Morguefile