February 17, 2020
Bed rails are highly used assistive equipment that have applications in a variety of healthcare capacities, including hospitals and assisted living facilities. While bed rails help in creating a supportive environment across a variety of facilities, they also should be used cautiously, especially with elderly patients and those with altered mental status or physical limitations.
Bed rail entrapment is a continuing patient safety concern that occurs when a patient’s head, neck, chest or other body part is caught in the limited spaces around a bed rail. Between 1985 and 2013, there were 901 incidents of patients caught, trapped, entangled or strangled in beds with rails that were reported to the U.S. Food and Drug Administration (FDA)—resulting in 531 patient deaths, 151 nonfatal injuries and 220 cases where staff needed to intervene to prevent injuries.
If your healthcare facility is looking to implement stronger processes and technology for ensuring ongoing bed rail safety for patients, we can help. Take a look below to learn more about this prominent patient safety issue and how you can best address it.
The History of Entrapment Issues
In 1995, the FDA recognized a pattern of injuries and deaths in hospital beds that were deemed largely preventable. These large-scale problems led to a stakeholders meeting that included representatives of the hospital bed system industry, patient care advocacy groups, healthcare providers and healthcare organizations to further investigate the issues—and to determine the best preventative steps to take.
Because this was eventually deemed a multifaceted problem, the Hospital Bed Safety Workgroup (HBSW), a voluntary consortium of national bed system experts, was created in 1999 to help address these ongoing safety concerns.
This organization works in tandem with the FDA, as well as other national healthcare organizations, federal agencies and patient advocacy groups, helping implement change in safety standards. To provide concrete guidance around bed rail safety, the FDA and HBSW produced the “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” in 2006, which are guidance documents that assess and address entrapment issues associated with hospital bed systems.
It’s important to note, though, that while the Department of Health and other regulatory agencies may reference these documents, they are not official mandates. This often causes significant discrepancies in patient safety—and opens up a multitude of vulnerabilities across the spectrum of patient care.
Therefore, it’s important that your facility thoroughly familiarizes itself with this beneficial guidance and fully understands the necessity of bed rails within most patient care situations.
The Value of Prioritizing Bed Rails
Bed rails offer a number of benefits to healthcare facilities to assist with their overall patient-centered care. According to the FDA, these include:
Aiding in turning and repositioning within the bed
Providing a handhold for getting in or out of bed
Reducing the risk of patients falling out of bed when being transported
Providing a feeling of comfort and security
Offering easy access to bed controls and personal care items
With the benefits, however, there are risks associated with bed rails that healthcare facilities need to make sure they are familiar with. These include:
Bodily injury or death when a patient or part of his or her body becomes caught between the bed rails and/or the bed rails and mattress
Skin bruising, cuts and scrapes
More serious injuries from falls when patients attempt to climb over the rails
Plus, potential risks are exacerbated by:
Improper matching of the bed rail to bed frame
Improper installation and maintenance
Used with other devices or supports that remain when the bed rail is removed
The above causes of risks are all human-generated errors that can be prevented. Healthcare facilities can mitigate the risk of bed rail injuries and deaths by having a strong understanding of how to prevent issues—and by prioritizing enacting new policies that align with prevention.
This all starts with knowing the primary entrapment issues that need to be consistently monitored and addressed.
Critical Entrapment Areas to Test
Patients are most commonly injured by bed rails when they are trapped between the mattress and the bed rail itself. To help avoid this, the FDA and the HBSW identified four critical entrapment zones that healthcare providers should be aware of—and prioritize testing of:
Zone 1: Within the bed rail itself
Zone 2: Between the bottom of the rail and the top of the mattress and between the rail supports
Zone 3: Between the outside edge of the mattress and the inside of the side rail
Zone 4: Between the top of the compressed mattress and the bottom of the rail, at the end of the rail
In addition to the primary entrapment zones, there are three other entrapment zones:
Zone 5: Between split bed rails
Zone 6: Between the end of the rail and the side edge of the head or foot board
Zone 7: Between the head or foot board and the end of the mattress
While these three additional entrapment zones have been identified, no dimensional guidance or test methods have been developed for these specifically. If a facility is concerned about certain patients or a particular bed system in regards to these zones, it should follow the guidelines outlined in “A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment” and apply them to these unique entrapment zones.
Implementing Bed Rail Standards
To avoid some of the associated risk of bed rails, healthcare facilities instead have been removing them—but this practice has a variety of its own safety concerns. Instead of removal, healthcare facilities should focus on ensuring that bed rails are installed and maintained correctly, specifically focusing on the aforementioned critical areas for ongoing testing.
To help, the FDA and the United States Consumer Product Safety Commission (CPSC) jointly developed installation and maintenance recommendations for bed rail safety:
Confirm that your bed rail, mattress and bed frame are all compatible, as those are often purchased separately from each other
Select and place rails in a way that discourages climbing over to get in and out of bed
Ensure that the bed’s dimensions are the appropriate size and weight for the patient or resident
Install bed rails using the manufacturer’s instructions to ensure a correct fit
Routinely inspect the mattress and bed rails for potential entrapment areas, as well as shifts or loosening that can occur over time
Maintain awareness of all equipment alerts and recalls
You should also prioritize reassessment of your bed systems when:
There is reason to believe that some of the components are worn
Accessories are added or removed
Components of the bed system are changed or replaced
Facilities must also be aware that discrepancies can occur during testing, which can be caused by:
People handling the test tools differently
Errors or oversights
Certain testers being more inclined to pass or fail a bed when the results are on the border of passing or failing
A long period of time between tests, which can affect bed components
Working to standardize processes and implement a thorough bed safety program can help to limit or eliminate these discrepancies and streamline the testing process for lessened variability.
The most important takeaway is that your facility needs to take ownership of determining a concrete and ongoing process to help identify who should handle bed measurement testing—and establish the set criteria that must be adhered to. This will benefit the quality and safety of your patient care moving forward.
Integrating Safety Technology Solutions
Bionix® Patient Safety and Compliance is continually focused on helping healthcare providers offer the safest patient care. We understand the importance of bed rails for patient safety—and we also understand the priority of ensuring all patients feel safe when using bed rails.
That’s why we developed the B4000 Bed System Measurement Device, an intuitive device that tests the four critical entrapment zones of a hospital bed system.
This device offers easy-to-read pass/fail zones, and a two-person team can test the four critical zones in just 15 minutes. Once testing is complete, healthcare providers will have documentable results that comply with the Center for Medicaid Services (CMS) Guidance.
The B4000 is the only validated tool that tests to the FDA’s “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” document.
Looking to implement this innovative device into your patient safety protocols? Reach out to us today.
