FDA updates bed rail entrapment guidelines
Last month, the FDA posted some new materials on bed rails and related products. This reiterated what should by now be the well-known hazards of entrapment and death when the bed user gets entangled within openings of the rail, or between the rail and the mattress or part of the bed frame.
The latest material offers 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 (including various “handles” and “positioning aids”) that are not regulated by the FDA because they are “consumer products” rather than “medical devices." Consumer products are under the jurisdiction of the Consumer Product Safety Commission rather than the FDA. These consumer products are typically intended for use on a regular home-style bed.
However, there is a gray area in long term care. Nursing home beds which may or not be subject to FDA regulation, as well as aftermarket products that might be used on a medical or hospital style bed but which 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.
In this regard, bed rails do not have a separate FDA classification but are classified based on the class of bed for which they are an accessory. The new 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 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.
Air mattresses have received attention in the past because of their propensity to “dump” the bed occupant off the edge and into the rail as a result of the relatively soft edges of the mattress. For all mattresses loss of close fit by movement of the product from its initial position, or movement of the mattress, is often a function of the means of attachment of the device or product to the bed, and the stability of that attachment over time. Such attachments range from mechanically securing the rail or handle to the frame of the bed to sliding a component under the mattress, with or without straps.
In general the latter systems have a greater propensity to move or become loose than do mechanically attached devices. The FDA/CPSC cooperation includes a current effort through ASTM to develop voluntary consensus standards that would “apply to all portable adult bed rails, whether they are regulated by the FDA or the CPSC, to assure there are no gaps in federal oversight of the safety of these products."
At least two things are unclear with respect to this effort. One is how long this will take. The second is why a standard that if effective would prevent deaths by entrapment should be voluntary. Death by entrapment is obviously an unacceptable outcome, especially from the use of a device/product whose intent is to increase safety. Absent mandatory testing and regulation, users remain largely on their own, whether the use occurs in professional facilities or at home. In either setting the disclaiming certain uses should not be allowed to be an excuse for designs that are fundamentally flawed, and warnings are not an acceptable way to “fix” such products.
William A. Hyman is Professor Emeritus, Department of Biomedical Engineering, at Texas A&M University.