DO YOUR BED RAILS MEASURE UP?

It was far from an ordinary night for Jane, a seasoned registered nurse with six years of experience in the unit she was working. As she entered room 203, she was met with a shocking and heartbreaking sight. One of her patients lay motionless across the bed, entrapped in the side rail that had been installed just days before. Jane's heart sank as she rushed to the patient's side; her hands trembled, and her heart pounded with urgency as she desperately tried to free them from the rail's tight grip. The weight of the situation bore down on her as she finally managed to release the resident, her mind racing with thoughts of what more she could have done to prevent this tragic accident. Despite her frantic efforts to free the individual, it was clear that significant injury had already occurred.

Jane's story is fictional, but unfortunately, incidents like this play out repeatedly across the country in nursing homes, assisted living communities, and other healthcare settings where unsuspecting individuals fall victim to the dangers of side rails and bed mobility assistive devices. While side rails can help promote autonomy and provide a sense of security and comfort, there are significant risks associated with their use. When misused, they can lead to accidental death. Knowing, understanding, and implementing policies and procedures to protect your residents from harm is imperative as a healthcare provider.

Regulatory Oversight: the FDA and CPSC

Side rails are typically  categorized as either medical devices, such as those installed on hospital beds, or adult portable bed rails, which are consumer-based products defined by the Consumer Product Safety Commission (CPSC) as "An adjacent type bed rail, grab bar, assistive bar, transfer aid, cane or rail intended by the manufacturer to be installed on, against, or adjacent to an adult bed to assist the bed occupant in moving on the bed surface, in entering or exiting the bed, to minimize the possibility of falling out of bed, or for other similar purposes." Most providers call these devices side rails, transfer bars, or grab bars.

Since hospital beds are considered medical devices, the Food and Drug Administration (FDA) regulates the use of side rails on these beds. Strict standards in the design and use of these products were enacted in 2017 based on standards established by the American Society for Testing and Materials (ASTM) to mitigate the risks associated with their use. Adult portable bed rails are regulated by the Consumer Product Safety Commission (CPSC), and their safety and design requirements also incorporate similar standards based on the ASTM requirements and apply to all bed rails manufactured after August 21, 2023.

Risks versus Benefits:

As we learned from Jane's story, the risks associated with the use of side rails and adult portable bed rails are significant and can lead to harm or death. The potential benefits must be carefully weighed against the risks based on an individual risk assessment for each person considering using such devices.

While many providers are familiar with the risks versus benefits of using bed rails, the FDA provides consumers with a convenient handout outlining them in detail. According to them, possible benefits of the use of side rails include aiding in turning and repositioning within the bed, providing a handhold 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, and providing easy access to be controls and personal care items. Risks include strangling, suffocating, bodily injury or death when patients or part of their body are caught between rails or between the bed rails and mattress, more severe injuries from falls when patients climb over rails, skin bruising, cuts, and scrapes, inducing agitated behavior when bed rails are used as a restraint, feeling isolated or unnecessarily restricted, preventing patients, who can get out of bed, from performing routine activities such as going to the bathroom or retrieving something from a closet.

Provider Responsibilities:

Healthcare providers have several key responsibilities to ensure the safe use of side rails in healthcare settings. These include assessing each patient's risks and abilities, providing education and training, ensuring the correct installation and maintenance according to the manufacturer's instructions, accurate care planning, and monitoring safety on an ongoing basis. When any of these criteria is overlooked, the opportunity for a tragedy to occur is substantial, and providers may be liable for any resulting injury or harm.  Additionally, providers are responsible for ensuring that the FDA or the CPSC has not recalled any device in their community. Recall notices can be found here: Medical Device Recalls | FDA or CPSC Recalls.

Assisted Living Providers:

It can be challenging in assisted living facilities, as residents or their families often purchase and install devices without the staff's knowledge. Still, the organization must educate all staff members to alert key personnel if new devices have been installed without the proper assessment, planning, or safety review. Having a rapid response plan to quickly identify and respond to issues regarding the use of bed rails is paramount to ensuring ongoing safe practices.  

As we can see, the responsibility of healthcare providers to ensure the safe and compliant use of bed rails is paramount in safeguarding patient well-being. By conducting thorough individual assessments, adhering to regulatory guidelines, and providing ongoing training, providers can mitigate the risks associated with bed rail use. It is essential to balance the benefits of bed rails, such as giving a sense of safety and comfort and aiding mobility, with the potential hazards, including entrapment and injury. Through diligent oversight and a commitment to patient-centered care, healthcare providers can create a safer environment that respects the dignity and safety of all patients.