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FDA updates warning about bed system

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 17, 2007

On December 4, the FDA issued an updated public health notification warning hospitals to stop using Vail Enclosed Bed Systems and transfer patients to other beds. The beds are an alternative to restraints for patients with at-risk behavior such as spasms and seizures. The FDA notification describes the systems as padded beds with canopies and side netting.

Initial notifications about the chance of suffocation to patients who become trapped in the beds were first issued in March 2005 and updated in June 2005.

The FDA provided links to updated user manuals for the bed systems which are no longer available through the company. The company ceased to manufacture the systems and is no longer available to provide users with replacement parts or retrofit kits.

If switching to another bed system is not possible, the FDA summarized precautions the company has recommended users take, including:

• following weight and height restrictions for patients using the beds
• preventing use by patients with violent and other behavior issues
• only using recommended mattresses
• using side rails
• keeping bed flat when patient is unattended
• always zipping and locking canopy sides
• looking for potential for entrapment in various bed positions

The FDA notification also provides advice about retrofit kits and how to identify the affected beds. Finally, the FDA notification requires reporting of adverse events related to use of the beds.

Click here to read the FDA's notification.

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