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A Brochure Resource for You

 

Dear Colleagues,

I am always delighted to receive questions about fall prevention practices, resources, and even opinions. My commitment has been and will always be to help you as much as I can.

Of interest, every couple of months, I receive a question about use of side rails — bed safety rails related to fall-prevention in differing settings of care. I have a resource to help you.

In 2017, the US Food & Drug Administration (FDA) provided a national guidance brochure on bed rail use in hospitals, nursing homes, and home health care — yes, across the continuum of care. I share this brochure with you, in hopes that you will share this widely, because this brochure should inform all providers, administrators, and quality administrators about the balance of benefits versus risks when using bed rails. This balance needs to be understood. This guidance should help all organizations to evaluate policies and procedures specific to safe bedrail use. A Hospital Bed Safety Workgroup of 26 organizations participated in the development of this guidance. But first, let’s reflect on evidence that impacted bed rail use in healthcare settings.

 

Evidence of Harm

In April 1999, after the release of the bed entrapment sentinel alert, the FDA convened the first national Hospital Bed Safety Workgroup comprised of federal agencies, healthcare organizations, and patient advocacy groups. Members of my VISN 8 Patient Safety Center participated. Their goal was to provide guidance specific to improving the safety of hospital beds for patients in all healthcare settings who are most vulnerable for entrapment. They created the first Guide for Modifying Bed Systems, which expanded to full scale program evaluation systems, bed purchasing guidance, and quality monitoring programs released in 2006, updated in 2017. This guide is available here.

In 2002, research was published that exposed the dangers of hospital and nursing home bed rails that was cited by the then JCAHO — a sentinel alert about bed-rail entrapment. These dangers included patients being entrapped in the gap between side rails and bed mattresses, and injuries when patients fall with raised side rails.

As a result, side rail use was challenged, questioned, and stopped. CMS followed and developed new interpretive guidelines for surveyors of nursing homes. Dr. Capezuti, while confirming that bed rails were unsafe, did provide recommendations for hospital and nursing home staff to protect patients in two categories: equipment (i.e., low position beds, floor mats, hip protectors), and nursing interventions (i.e., teaching patients about safe bed exits, clear signage, individualized patient care). Some of you will remember this guidance, available here

Further research was conducted by the Department of Veteran Affairs VISN 8 Patient Safety Center’s Safe Bed Program to examine risk of serious injuries from bed, because floor mat use was being recommended without evidence. Researchers and clinicians set out to test the protective properties of changing bed height and floor mat use on reducing severity of injuries when patients fall from bed (Bowers, Lloyd, Lee, Powell-Cope & Baptiste, 2008). This research provided the evidence of increased severity of injuries when patients fall from bed at higher bed heights – i.e. patients fall climbing over bed rails.

While bed rails were essentially banned from post-acute care settings, they were still used for fall prevention in hospitals.

 

Recommendation for Individualized Care

In 2010, Oliver, et al., challenged the grouping of bed rails as restraints, and summarized the evidence of bed rails and falls and the weak methodological quality of many studies. Their recommendation was to individualize the use of bed rails, individually prescribed, and regularly re-evaluate use and need for bed rails. Thus, the creation of side rail assessment tools in rehabilitation and nursing homes, prescribed use of bed rails based on this assessment (half-rails, two or three rails). Hospitals were provided the autonomy to set policy.

This FDA brochure, presenting the facts that indeed apply across settings, bed rails were and still are being used as restraints. The FDA recommends that in all settings of care, patient needs are assessed and interventions are implemented providing safe care without restraints. The potential benefits of bed rail use should be considered, not just considering the risks. Interventions are listed to meet patient safety needs, acknowledging that most patients can be in bed safely without rail; and, if rails are used, suggestions to perform on-going assessment of the patient’s physical and mental status, as well as closely monitoring high-risk patients.

 

FDA Resource Brochure for You

Colleagues, I hope that this resource, available here for your easy access, is helpful to you to examine your policy and practices surrounding safe use of bed rails, patient engagement, and patient safety. Patient safety measures are paramount and do vary based on at-risk populations and level of vulnerability. Bed side rail use to assist with safe mobility, providing support for standing and transferring, are very different than use to prevent patients from getting out of bed. Let’s work together to create safe patient environments while meeting patients’ safety needs.

I hope this information and tool, along with references are helpful to you. If you would like more information, or have questions, please let me know. I would be happy to assist you.

You are welcome to contact me directly if you would like more information: pquigley1@tampabay.rr.com

Thank you for reading about this resource.

 

Pat Quigley

 

References:

Bowers, B., Lloyd, J., Lee, W., Powell-Cope, G., & Baptiste, A. (2008). Biomechanical evaluations of injury severity associated with patient falls from bed. Rehabilitation Nursing, 33(6). 253-259.

Oliver, D., Healey, F., & Haines, T. (2010). Preventing fall-related injuries in hospitals. Clinics in Geriatric Medicine, 26: 645-692.

U.S. Food & Drug Administration. (2017, Dec. 11). A guide to bed safety bed rails in hospitals, nursing homes, and home health care: The facts. Available: https://www.fda.gov/medical-devices/hospital-beds/guide-bed-safety-bed-rails-hospitals-nursing-homes-and-home-health-care-facts

U.S. Food & Drug Administration. (2017, Dec. 11). A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment. Available: https://www.fda.gov/medical-devices/hospital-beds/guide-modifying-bed-systems-and-using-accessories-reduce-risk-entrapment#preface

Dr. Patricia Quigley, PhD, MPH, APRN, CRRN, FAAN, FAANP, Nurse Consultant, is a retired Associate Director of the VISN 8 Patient Safety Research Center of Inquiry and is both a Clinical Nurse Specialist and a Nurse Practitioner in Rehabilitation.