A variety of bedside handles intended to help elderly or ill patients get into and out of bed, sit up or roll over in bed pose a huge danger: They can trap and strangle or suffocate people, Public Citizen said in a petition to the U.S. Food and Drug Administration (FDA).
The consumer organization is urging the FDA to order Blue Springs, Mo.-based Bed Handles, Inc. to recall all Bedside Assistant bed handles, ban the marketing of these devices.
Public Citizen always wants the FDA to investigate the link between similar bed handles (also known as bed rail devices) made by other companies and the risk of life-threatening injury or death due to entrapment and subsequent strangulation or suffocation.
The bed handles are used in patients’ homes and in nursing homes; they are rarely used in hospital settings.
“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 Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.
On its website, the company claims the Bedside Assistant is safer than regular deb rails because it does not to be raised and lowered. To get out of bed, users swivel sideways and put their legs through the space between the handles, using the handles for support.
Because of the way the handles are designed and installed, they can slip out of place and create a gap between the edge of the patient’s mattress and the vertical bars of the device. The patient can slip into this gap, becoming entrapped.
Even a small gap, particularly when such devices are used with soft or worn mattresses, can trap people, who then can die when their tracheas or chest walls are compressed against the horizontal support bars.
Public Citizen’s review of FDA records found that since 1999, four patients have died after being trapped by Bedside Assistant bed handles. In three of these cases, it appears as though the patients were strangled or suffocated.
In a fifth life-threatening incident, the bed rails trapped a hospital patient. Public Citizen believes that the number of people killed or injured by bed handles is higher; these incidents generally aren’t reported because people don’t realize bed handles are medical devices overseen by the FDA.
Similar to cribs
The petition compared the need to recall the bed handles to the Consumer Product Safety Commission’s 11 recalls involving more than 7 million drop-side baby cribs that posed a similar risk of strangling or suffocating infants and toddlers to death. Hundreds of thousands of this variety of bed handles were sold between 1994 and 2009, the petition said.
“Although the patients jeopardized by the bed handles are primarily at the opposite end of the age spectrum than those exposed to dangerous drop-side cribs, it is important that federal agencies responsible for protecting the public health act consistently to protect the health and safety of both the young and old alike,” Carome said.