Contributed by Lisa Olen| 23 March, 2005 02:27 GMT
Neither the directions for use nor the warnings provided with the Vail 500, 1000, and 2000 Enclosed Bed Systems are adequate, the FDA charges, exposing patients to increased risk of entrapment and asphyxiation.
Certain hospital beds can be lethal, warns the US Food and Drug Administration (FDA). The agency has initiated seizures of the Vail 500, 1000, and 2000 Enclosed Bed Systems made by Vail Products, Inc., located in Toledo, Ohio, saying they pose a public health risk: Patients can become trapped in them, causing suffocation that could result in severe neurological damage or even death.
Consumers should stop using Vail 500, 1000 and 2000 Enclosed Bed Systems until they receive additional instructions from Vail Products, FDA advises.
Seven Deaths Reported
There have been at least 30 cases of entrapments resulting from use of the Vail Enclosed Bed Systems, with 7 resulting in death, FDA reports.
The U.S. Marshal’s Office also seized welded in-process components and all labeling and promotional materials for the Vail 500, 1000, and 2000 products.
The Vail products seized on Tuesday do not meet with the Quality System regulations of the Federal Food, Drug and Cosmetic Act and pose significant health risk for consumers, says FDA.
Inadequate Directions
The Enclosed Bed Systems are misbranded because they are dangerous to health when used in the manner prescribed, or with the frequency or duration recommended or suggested in the labeling, FDA explains.
Neither the directions for use nor the warnings provided are adequate, the agency charges, exposing patients to increased risk of entrapment and asphyxiation.
Additionally, Vail Products failed or refused to furnish material or information to the FDA as required by Medical Device Reporting regulation and the Reports of Corrections and Removals regulation says FDA.
FDA inspections of Vail Products, Inc., revealed that the firm has continually failed to follow the requirements of the Quality System regulation when manufacturing enclosed bed systems.
Warning Letters Ignored
Vail Products previously received two FDA Warning Letters outlining unacceptable practices. The firm was given an opportunity to correct the violations but failed to take appropriate actions, says FDA.
FDA says its responsibility for promoting and protecting the public health by enforcing the Federal Food, Drug, and Cosmetic Act necessitated this action.
FDA’s mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated products, including food, human and animal drugs, vaccines, blood products, medical devices, devices that emit radiation, and cosmetics, the agency notes. |
|
Home 
*Mental Illness 
