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.