Lawmaker queries FDA on regulations related to the manufacture, sale, and oversight of patient beds and bed accessories
WASHINGTON, D.C. – In the wake of a recent review conducted by The New York Times that revealed 550 people have died since 1995 as a result of entrapment in bed rails, including 27 people in 2011, Congressman Edward J. Markey (D-Mass.) today called on the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and Consumer Product Safety Commission (CPSC) to form a national task force dedicated to better addressing the regulation and oversight of bed systems and bed rails. Despite efforts undertaken in recent years by federal agencies and device manufacturers to improve the design and use of new bed systems, including voluntary measures released by the FDA, Rep. Markey remains concerned about the injury that bed rails can cause to elderly patients, particularly when the injury stems from beds that are already in use. Bed rails, while commonly used in hospitals, nursing homes, and assisted living facilities and marketed as products that assist patients or prevent patients from falling out of bed, but can entrap elderly and frail patients, leading to suffocation and death.
“While bed rail design has improved in recent years, older models that pose a risk to the elderly are still used in some hospitals and nursing homes across the country,” said Rep. Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over the FDA, FTC and CPSC. “Comprehensive oversight of these products, which sometimes blur the line between medical devices and consumer products, requires coordination among federal agencies. We need a national task force dedicated to addressing any regulatory gaps in order to protect these vulnerable patients from preventable bed rail injuries.”
A copy of Rep. Markey’s letter to the FDA can be found HERE.
Rep. Markey asks the FDA to respond to question that include: