The FDA and U.S. Consumer Product Safety Commission (CPSC) are currently investigating whether the use of bed rails constitute an entrapment and death risk for elderly and disabled patients, and the results of a soon-to-be completed study may shed more light on the risk of problems associated with bed rails.
The investigation came as a result of dozens of deaths believed to be caused by bedrail entrapment, and the New York Times reported this week that a study should be completed in the very near future, which is attempting to quantify the actual risk into something other than anecdotal information.
Preliminary data from the study indicates that there have been at least 150 people whose deaths in recent years that may have been caused by problems with bed rails. Most of them involved elderly individuals. There have also been about 35,000 injuries linked to the use of bed rails as well. The data is being compiled from emergency room visit information.
Some groups, like Public Citizen, have already indicated that there is enough information available to support a ban of some products, including Bedside Assistant portable bed rails made by Bed Handles, Inc. The consumer watchdog group has petitioned several agencies to enact a ban on the company’s products. So far those petitions have not been acted upon.
According to Public Citizen, there have been at least four reported deaths due to Bedside Assistant bed handles since 1999. However, the group estimates the actual number of bed handle deaths caused by the product is likely much higher, because most instances are never reported.
In a press release issued at the time the petition was filed, Public Citizen indicated that many people do not know that bedrails or bed handles are regulated by the FDA.
The Bedside Assistant bed handles are self-installed pieces of metal tubing that slip under the mattress and have a portion that curves up over the top of the mattress to act as an edge for the bed. While the instructions indicate that they should be slid all the way under the mattress, so that the handle end is snugly against the side of the mattress, the design can allow a dangerous gap to form between the handle and the mattress. This can allow someone in the bed to become entrapped (PDF), causing them to suffocate or be strangled.