TOLEDO, OHIO--After the Food and Drug Administration issued a
nationwide recall warning consumers against the use of its enclosed
bed system, Vail Products announced it will be shutting its
doors.
Because the company has not been able to reach "satisfactory
accommodation" with government regulators, "Vail Products has
ceased operations and has begun the process of winding up its
business," President Joy Vail wrote in a statement on the company's
Web site. "We are truly sorry that it came to this, but the FDA's
positions made it impossible for Vail Products to continue or
survive."
Last month, the FDA issued a Class I recall of Vail's enclosed
bed systems, advising consumers to stop using the product.
According to the agency, Class I recalls are the most serious type
and "involve situations in which there is a reasonable probability
that use of the product will cause serious injury or death."
Vail's canopy-like beds, covered with nylon netting zipped in
place to enclose the patient, are designed for at-risk patients
with cognitive impairment, unpredictable behavior, spasms, seizures
and other disorders. The FDA said patients can become entrapped
between the side-rail and mattress, or between the canopy and
mattress. In a June 30 notice, the FDA said it is aware of
approximately 30 entrapments, of which at least eight resulted in
death.
"The FDA is making every effort to make sure that patients and
health care providers are aware of this problem, and are given
information needed to help minimize the risk," said Dr. Daniel
Schultz, director of the FDA's Center for Devices and Radiological
Health.
Vail sent new equipment manuals and warning labels informing
consumers of the FDA's advice to discontinue use of the product,
but wrote on its Web site that the FDA action "is not a recall" and
"the beds are safe and effective for continued use as long as the
instructions are carefully followed."
In March, the government ordered U.S. Marshals to seize the Vail
500, 1000 and 2000 enclosed bed systems, claiming the products pose
a public health risk, are misbranded and lack adequate warnings and
directions.
The FDA has updated its Public Health Notification, available by
clicking
here, to reflect the latest information on the matter.
