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FDA today is revising its notification to consumers that Vail Products, Inc., of Toledo, Ohio, is initiating a nationwide recall* of approximately 5,000 enclosed or canopied bed systems--Models 500, 1000 and 2000. Use of these systems poses a public health risk because patients can become entrapped and suffocate.
FDA is advising hospitals, nursing homes, and other institutions to stop using these beds and to move patients to alternative bed systems, if possible. Consumers who are using Vail enclosed bed systems at home can consult with their physicians about other options.
"FDA has worked with Vail to make sure patients and healthcare providers are aware of this problem and are given the information needed to help minimize risk," said Dr. Daniel Schultz, Director of FDA's Center for Devices and Radiological Health.
Vail enclosed bed systems are canopy-like padded beds covered with nylon netting that is zipped into place to enclose the patient. They are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. The beds are an alternative to physical or drug restraint to reduce falls or other injury to patients.
Patients can become entrapped between the side-rail and mattress, or between the canopy and mattress. Due to the presence of the canopy, if a patient's head is entrapped, the patient may experience asphyxiation, which can result in permanent neurological injury or death. FDA is aware of approximately 30 entrapments associated with the use of Vail enclosed bed systems, of which at least eight resulted in death.
Under this recall, Vail is providing direct customers and distributors with new instruction manuals and warning labels. The company is not retrieving or replacing the bed systems and users will not be able to return the systems to Vail.
If continued use of the Vail bed is the only option, users are advised to follow the safety precautions contained in the company's new instruction manuals and warning labels in order to help minimize the risk of injury. The manuals and labels were mailed by the company to customers and distributors on June 23 and 24, 2005. They specify that the beds should not be used for patients who weigh less than 46 pounds or who are less than 45 inches in height. Users who have not received a copy of the new instruction manual may obtain a summary of the safety precautions from an FDA Public Health Notification (available at www.fda.gov/cdrh/safety/032505-vail.html). FDA's Notification has been updated to reflect the latest information on the problem.
As indicated above, users will not be able to return the bed systems to Vail Products. The company publicly stated on June 16, 2005, that it is permanently ceasing the manufacture, sale, and distribution of all its enclosed bed systems. Vail Products also will no longer provide accessories, replacement parts, or retrofit kits.
FDA encourages consumers, health care providers, and caregivers to report any adverse events related to Vail enclosed bed systems to MedWatch, the FDA's voluntary reporting program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.
* FDA has classified the recent corrective actions taken by Vail Products as a product "recall." Under FDA regulations, Vail's actions are considered a recall even though the bed systems cannot be returned to the company.
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