TOLEDO, Ohio--U.S. Marshals have seized Vail Products' enclosed beds, which the Food and Drug Administration says have trapped and killed patients.
The FDA ordered the seizure of the Vail 500, 1000 and 2000 Enclosed Bed Systems on March 22, claiming the products pose a public health risk, are misbranded and lack adequate warnings and directions. FDA is aware of approximately 30 entrapments resulting from the use of the bed systems, of which at least seven resulted in death, according to an agency Preliminary Public Health Notification.
Vail refuted the claims on the company's Web site. "We strongly believe that the government is wrong in suggesting that any Vail Enclosed Bed System is unsafe or that parents and others who are using an enclosed bed should stop using it," CEO Joy Vail wrote. "For many vulnerable patients ... the alternative of falling out of bed or wandering off is a real and everyday risk."
The canopy-like padded beds--for institutional and home care use--are covered with nylon netting that is zipped into place to reduce falls or prevent patients from wandering. They are used for at-risk patients, both adults and children, with cognitive impairment, unpredictable behavior, spasms, seizures and other disorders.
According to the FDA, patients can become trapped between the side rails and mattress, between the mattress and canopy in places where the rails do not extend and areas between the end rails and mattress. Furthermore, the FDA said "the bed systems are misbranded because they lack adequate directions for use and warnings, thereby placing patients at an increased risk of entrapment and asphyxiation." The agency is advising hospitals, nursing homes and consumers to stop using the beds immediately.
If continued use of the beds is the only option, Vail has recommended further safety precautions. The company said it has voluntarily suspended shipment of the products since March 1.
For further details on the seizure, see FDA's Talk Paper on the FDA Web site, available by clicking here.
For additional product updates and information, check www.vailbed.com or call Vail Products' customer service department at (800) 235-8245.