Devices & Diagnostics

FDA proposes ban on electrical stimulation devices that treat aggressive behavior

The regulatory agency said there are psychological and physical risks associated with use of such devices, including depression, anxiety and what appears to resemble PTSD. In addition to psychological effects, there have been reports of burns, tissue damage and shocks.

 

The U.S. Food and Drug Administration on Friday proposed a ban on electrical stimulation devices that have been used for treatment of aggressive or self-injurious behavior.

The regulatory agency said there are psychological and physical risks associated with use of such devices, including depression, anxiety and what appears to resemble post-traumatic stress disorder. In addition to psychological effects, there have been reports of burns, tissue damage and shocks.

According to a press release, the FDA only has information about one facility using these devices in the United States: the Judge Rotenberg Educational Center in Canton, Massachusetts. An estimated 45-50 people are currently being treated with such devices, the FDA said.

The proposed rule is available online at www.regulations.gov for public comment for the next 30 days.

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