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Tip of the week: The FDA reiterates warning about specific canopy bed

Hospital Safety Connection, December 5, 2007

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The Food and Drug Administration (FDA) issued a follow-up alert this week that outlines a series of recommendations if any hospitals continue to use Vail enclosed bed systems.

Vail models are canopy-like, padded beds covered with a nylon netting that you zip into place. They are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. The beds were intended as an alternative to a physical or drug restraint to reduce falls from a bed and prevent patients from wandering.

However, in June 2005, the FDA warned hospitals to stop using Vail equipment, saying the beds were a safety risk because patients could become entrapped in them and suffocate. Vail Products, Inc., in Toledo, OH, stopped manufacturing these bed systems at about the same time.

The FDA has reported 30 adverse events associated with Vail beds, including at least eight deaths resulting from entrapments, falls, and other incidents. More than half of the 30 adverse events involved children age 16 and under.

If a facility continues to use a Vail enclosed bed system, the FDA issued a list of precautions from Vail outlined in the full notice. The agency also posted revised instruction manuals for the beds, which Vail no longer publishes.

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