Facility Operations
FDA Advisory To Stop Using Certain Vail Enclosed Beds Immediately
The Food and Drug Administration (FDA) and the U.S. Department of Justice have initiated a seizure of all Vail model 500, 1000 and 2000 enclosed bed systems made by Vail Products, Inc. of Toledo, Ohio. The beds are used for at risk patients, both adults and children, with cognitive impairment, unpredictable behavior, spasms, seizures and other disorders. According to the FDA announcement, the seizure is needed because patients can become entrapped and suffocate. The FDA states that it is aware of approximately 30 entrapments resulting from use of the Vail Enclosed Bed System, of which at least 8 resulted in death. More than half of the incidents involved children age 16 and under. FDA is advising hospitals, nursing homes and consumers who have a Vail 500, 1000 or 2000 enclosed bed system to stop using it immediately and move the patient to an alternate bed.
The FDA further advises facilities that have engineers available to check the beds for possible entrapment zones in all possible bed positions. The FDA release states that the agency believes the Vail products do not meet with the Quality System regulations of the Federal Food, Drug and Cosmetic Act and pose significant health risk for consumers.
Items 1 and 3 in the FDA announcement below contain the FDA's messages and details, links to additional information, the link to FDA's MedWatch program for voluntary reporting of adverse events, and Vail's recommendations if continued use of the bed is the only options for a patient.