By Healthcare Facilities Today

Last month, the Food and Drug Administration posted some new materials on bed rails and related products that offer a broad take on the bed rail problem by covering both bed rails and related products that are part of FDA regulated medical beds, or similar products that are not regulated by the FDA because they are “consumer products” rather than “medical devices." 

However, there is a gray area in long term care, according to a blog on the McKnight's website. Nursing home beds may not be subject to Food and Drug Administration regulation, and aftermarket products that might be used on a medical or hospital style bed are sold without FDA scrutiny. Even nominally regulated bed rails are subject to only voluntary FDA guidance, and may also see no FDA scrutiny if they are intended for use on a bed that is FDA Class I.

Bed rails do not have a separate FDA classification but are classified based on the class of bed for which they are an accessory, according to William A. Hyman is Professor Emeritus, Department of Biomedical Engineering, at Texas A&M University. 

The new FDA posting has multiple parts including a Bed Rail Safety overview page, Safety Concerns About Bed Rails, Recommendations for Consumers and Caregivers about Bed Rails, Recommendations for Health Care Providers about Bed Rails, Information for Manufacturers of Bed Rail Products, How to Report a Problem or Complaint, How to Report a Problem or Complaint, and Additional Resources, the blog said. 

The safety concerns include both entrapment and falls, the latter sometimes being associated with the bed user trying to climb over a rail. The FDA states here that bed rails are “intended to be assistive and should be used to facilitate mobility for those who need assistance getting in and out of bed or repositioning in bed."

"Unfortunately this ignores the major reason for bed rails, which is to prevent people from rolling or falling out of the bed. Bed rails are often suggested for people with dementia or other mental limitations, yet these are considered problems that can contribute to entrapment.The provider page focuses on individual patient assessment, careful evaluation of the rail (or similar product) and the fit to the bed and mattress, regular inspection, and a reminder that gaps can be created by movement or compression of the mattress, or by using a specialty mattress such as an air mattress, mattress pad or water bed," Hyman wrote.

Read the blog.