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.
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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.