Most people do not view bed rails, used to prevent patients from rolling out of bed, as a dangerous product. However, the issue is now being studied by the Consumer Product Safety Commission (CPSC). Surprisingly, the Food and Drug Administration (FDA) and the CPSC have been aware of the patient deaths from bed rails, but have done little to regulate manufacturers.
This review of deaths could affect Pittsburgh and other U.S. hospital and nursing home patients. However, it's troubling that these bastions of consumer protection have known for years that mostly older adults, including dementia patients, have died after getting trapped in bed rails.
Part of the problem involves how nursing homes and coroner's report injuries and deaths. Even emergency room doctors often do not report that bed rails were the cause of injury or death. However, experts, after studying these deaths, maintain that most cases are avoidable.
FDA did issue safety warnings about bed rails back in 1995. However, it didn't mandate that manufacturers include safety labels on bed rails, primarily because of industry resistance. Unfortunately, just "voluntary guidelines" were approved in 2006.
Further compounding the issue, there is a "technical question" surrounding which specific regulator should shoulder responsibility for bed rails. The question: Are they medical devices, applicable to FDA regulations? Or, are they consumer products, monitored and supervised by the CPSC?
Another issue, cost, influenced the lack of bed rail recalls and design changes that may have saved some lives. A former FDA official stated–on the record–that most bed rails in use during the review period would not have met "suggested design standards," if the FDA made the 2006 guidelines mandatory.
How do you feel about manufacturer resistance to make bed rails safer for older nursing home, hospital and home health care patients? Do you agree with the CPSC, which believes that bed rails are medical devices and, therefore, outside its regulation authority? Do you feel immediate action is necessary to reduce these avoidable deaths?
Source: The New York Times, "After Dozens of Deaths, Inquiry Into Bed Rails," Ron Nixon, Nov. 25, 2012