The Food and drug Administration should ban and order the recall of thousands of Bedside Assistant devices because they are blamed for the strangulation or asphyxiation deaths of four people and for entrapping a fifth patient in a hospital, says the health advocacy group Public Citizen.
"Data previously provided to the FDA demonstrates that these devices turn a bed into a death trap for patients who are physically weak and have physical or mental impairments," Sidney Wolfe, MD, and Michael Carome, MD, the group's director and deputy director wrote in a petition to U.S. Food and Drug Administration Commissioner Margaret Hamburg, MD.
The devices are bedside handles intended to help impaired patients get in and out of bed, sit up or turn over and as such are classified as medical devices requiring FDA approval.
What makes the issue of greater concern, Wolfe and Carome wrote, is that most healthcare providers and consumers may be unaware that the bedrails are classified as medical devices. As such, safety incidents related to the bedside handles should be reported to the FDA. The five incidents reflected in the FDA records go back to 1999.
"These devices are commonly used in the home setting without any involvement of a healthcare provider and family members of patients injured or killed by these devices likely are not aware of the procedures for reporting adverse events," they wrote.
The devices are more commonly used in nursing homes, assisted living facilities, and in private homes, and are sold by home healthcare medical supply stores.
Public Citizen's letter targets the devices by Bed Handles Inc. of Blue Springs, MO, but says similar devices made by other companies may be equally dangerous.
Bon Shaw, President of Bedside Handles, said in a telephone interview Wednesday that Public Citizen's claims are "incomplete, inaccurate, and misleading," because out of 200,000 bedside products sold, there have been only three incidents, not five.
He explained that the first incident, in 1999, was thought to be unique. But when the second one occurred in 2006, the company took steps to correct the problem.
"We added restraining straps with buckles to all our products across the board," Shaw says. Also, the company provided free straps and buckles to every customer using the products previously sold without them. "It is our belief that the problems occurred in instances where the products were being misused or the handles were improperly inserted."
"The attendant who put the person in bed pulled it out and then tried to jam it in after the person was on the mattress which is almost impossible to do correctly," he says.
Since the installation and distribution of the buckles and straps, there have been no adverse events caused by the products, he said.
Public Citizen also wants the FDA to investigate the association between the design and use of all bedhandle or rail devices made by any manufacturer.
The device is installed by sliding horizontal bars of the bed handles between the mattress and box spring of the bed, according to the package insert. "The bed handles can slip out of place, creating a gap between the edge of the patient's mattress and the vertical bars. The patient can then slip into this gap, becoming entrapped," Wolfe and Carome wrote.
The group's petition asks the FDA to consider the Consumer Product Safety Commission's 11 recalls in the last six years of "seven million drop-side baby cribs that posed a risk of death by strangulation or suffocation to infants and toddlers" in response to the deaths of 32 infants and toddlers between 2000 and 2010.
"It is important that federal agencies responsible for protecting the public health act consistently by safeguarding the health and safety of both young and old individuals alike," they wrote.