Hospital beds are utilized in a variety of settings to create a supportive and assistive sleeping environment. Unfortunately, instances of bed rail entrapment and electrical fires have been responsible for patient injuries and death. Organizations working with patients utilizing hospital beds or beds equipped with portable bed rails may wish to carefully examine these devices to help reduce the instances of injury or death associated with their use.
Types of Bed Rails
There are two main types of bed rails: bed rails that are attached to a hospital or medical bed and portable bed rails.
Bed rails that are attached to a hospital or medical bed are considered medical devices and as such, are regulated by the U.S. Food and Drug Administration (FDA). These devices may be quite complex and to be familiar with their operation, it’s important that healthcare professionals be specifically trained.
Portable bed rails, as the name implies, are not designed as part of the bed by the bed manufacturer. The primary uses for this type of rail are to reduce the risk of a fall from bed, assist in transition into or out of the bed and/or assist in repositioning while in bed.
Proper Patient Selection
Many patients have conditions that can heighten the risk of falls from their bed. These can include dementia/memory problems, incontinence, pain or the inability to walk safely unaided. While these patients present a heightened fall risk, the FDA has indicated that most patients can be in bed safely without bed rails. However, in certain circumstances, bed rails can be beneficial. Such benefits include:
- Aiding in turning and repositioning within the bed.
- Providing a hand-hold for getting into or out of bed.
- Providing a feeling of comfort and security.
- Reducing the risk of patients falling out of bed when being transported.
- Providing easy access to bed controls and personal care items.
It is considered a best practice for organizations to develop specific policies for the selection of patients who may need bed rails. The policies may be developed by reviewing publications such as “A Guide to Bed Safety, Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts” (U.S. Food and Drug Administration, 2010) and in consultation with the organization’s medical director or the patient’s personal physician(s).
Bed Rail Entrapment
Between Jan. 1, 1985 and Jan. 1, 2013, the FDA received 901 incident reports of patients caught, trapped, entangled or strangled in hospital beds. Guidelines established in 2006 by the Hospital Bed Safety Workgroup identified recommendations for newly manufactured beds as well as providing information to review beds manufactured prior to the adoption of these guidelines.
The guidelines indicate the head, neck and chest are key body parts at risk of entrapment and identify seven potential “zones of entrapment” in beds that are fitted with bed rails. Use these areas of high susceptibility to determine if a patient is at risk for entrapment.
Zones of entrapment areas:
- Within the rail.
- Under the rail, between the rail supports or next to a single rail support.
- Between the rail and the mattress.
- Between the rail, at the ends of the rail.
- Between split bed rails.
- Between the end of the rail and the side edge of the head or foot board.
- Between the head or foot board and the mattress end.
As with any incident, if an entrapment occurs, complete an incident report and a post-incident analysis. The analysis can be used to evaluate the plan of care and to make revisions to address additional entrapment prevention strategies that may be needed. These incidents may need to be reported to a state or regulatory agency (including the FDA if the bed is a “medical device” or the Consumer Product Safety Commission).
Bed Safety Assessment
Individual beds may be tested to determine if they conform to The Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment guidelines. These guidelines were published by the U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health in 2006. The purpose is to provide guidance to healthcare administrators and providers to determine if there is an increased risk of accidental patient injury in the zones of entrapment. The guide is complete with testing instructions and provides specific forms to assist with documenting bed safety.
Hospital Bed Fire Safety
In addition to concerns related to the zones of entrapment, hospital beds equipped with electrical power have been involved in fires resulting in patient injury or death.
According to FDA reports, 75 percent of these fires were associated with the following causes:
- Failed motor starting capacitors.
- Overheated motors.
- Arcing from ill-fitting or damaged plugs.
- Missing ground pins.
- Fluid leaks that damaged the circuit boards.
- Missing components in the wiring.
- Poor maintenance.
- Failure to heed manufacturers' warnings.
The risk of electrical fire may be reduced by regular inspection of electrical parts. Regular inspection and documentation of electrical safety is encouraged. It is recommended that both clinical and maintenance staff work to reduce the incidence of hospital bed fires.
Clinical staff can ensure electrically powered beds are only plugged directly into wall outlets and power cords are not frayed, pinched, crushed or otherwise obstructed. Covering power cords with items such as rugs or carpets can impede air flow and lead to overheating. Keep the areas surrounding the power outlet and the motor free of dust and debris, which can lead to overheating of the motor and may cause fire.
Organizations can consult with the manufacturer’s guidelines in order to determine appropriate preventative maintenance timeframes. These guidelines can help organizations determine when preventative maintenance may be needed and be used as a guide to document maintenance.
Sale and Rental of Hospital Beds as Durable Medical Equipment
It is important to note some medical beds are regulated by the FDA as medical devices (beds most commonly designed with rails and electrical functions) but other beds with some hospital bed characteristics (raising or lowering height, position adjustment) are regulated by the Consumer Product Safety Commission (CPSC). Both the FDA and CPSC provide guidance on manufacturing standards associated with beds within their areas of oversight.
The sale, rental or loaning of new or used medical beds (whether a medical device or a consumer product) and bed rails is an undertaking to approach with caution. Give consideration to having the bed or rail evaluated and certified by a bio-medical technician or manufacturer’s authorized representative in order to certify the bed is in an acceptable condition for re-sale or between use by different patients (if equipment is rented or loaned).
Developing sound bed safety practices can help organizations reduce the risk of patient injury or death. Policies and procedures relating to hospital bed safety can be enhanced by developing checklists based on manufacturer’s guidelines for specific hospital bed models, resources available from the FDA and guidance from a bio-medical technician familiar with hospital beds. Checklists are also a good way to document proper hospital bed safety practices are in place. Educate both clinical and maintenance staff of hospital bed safety considerations and frequently review proper procedures to further enhance risk reduction strategies.
Braun, J. A., & Bruley, M. E. (2006, July 31). Bed Safety: Preventing Fires Caused by Hospital Beds. Retrieved January 22, 2014, from Long Term Living Magazine: http://www.ltlmagazine.com/article/bed-safety-preventing-fires-caused-hospital-beds
U.S. Food and Drug Administration. (2010, April). A Guide to Bed Safety Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts. Retrieved January 3, 2014, from U.S. Food and Drug Administration: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/ucm123676.htm
U.S. Food and Drug Administration. (2013, February). Practice Hospital Bed Safety. Retrieved January 10, 2014, from FDA.gov: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM164395.pdf