Bedside Assistant Bed Handles Should Be Recalled, Public Citizen Warns
The consumer watchdog group Public Citizen has filed a petition to ban a brand of bed rails that have been linked to the strangulation or suffocation of at least four people.
The petition was filed with the FDA on May 4, calling for a Bedside Assistant bed handles recall to be issued
Although they are designed to help elderly or infirmed patients get out of bed, the group claims that the bed handles could allow people to become trapped between the bedrail and the mattress.
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Public Citizen has specifically targeted the Bed Handles, Inc. Bedside Assistant line, but recommended that the FDA look into similar products that are made by a number of other companies.
According to Public Citizen, there have been 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.
“Contrary to the manufacturer’s claim that the Bedside Assistant bed handles make any bed a safer bed, data previously provided to the FDA demonstrate that these devices can turn a bed into a death trap for patients who are physically weak or have physical or mental impairments,” said Deputy Director Michael Carome, of Public Citizen’s Health Research Group.
Public Citizen’s petition states that three of the four deaths involving Bedside Assistant bed handles were clearly caused by asphyxiation or strangulation. A fifth, non-fatal case of a patient becoming entrapped has also been reported. The data was taken from the FDA’s own Manufacturer and User Facility Device Experience (MAUDE) database, which tracks medical device complaints.
The group said that the bed rails were as dangerous to the elderly as drop-side cribs are to infants. The U.S. Consumer Product Safety Commission recently banned all drop-side crib designs after numerous reports of infant deaths and tens of millions of cribs were recalled.
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