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April 22, 2016: FDA Proposes Electric Stimulation Devices Ban

Electric Stimulation Devices Ban

The US Food and Drug Administration (FDA) has resolved to ban electrical stimulation devices used to treat aggressive and self-injurious behaviors, according to an April 22 New Release.
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According to FDA, Electric Stimulation Devices are only used at a single US facility, the Judge Rotenberg Educational Center in Canton, MA. The Judge Rotenberg Educational Center is a special-needs school which uses Electric Stimulation Devices as a behavior modification method.

This proposed ban came to be because the FDA assertion that Electric Stimulation Devices pose a “substantial and unreasonable” risk to patients. Additionally, the FDA was unconvinced that the benefits of such treatment outweigh the risks.

FDA Finds Insufficient Evidence of Effectiveness, Seeks Electric Stimulation Devices Ban

Electric Stimulation Devices were originally classified as medical devices in as aversion conditioning devices “used to administer an electric shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.”

According to its advocates, the painful shock caused by the Electric Stimulation Devices creates a negative association with the behavior being treated, which would mainly be aggressive and self-injurious. However, FDA review found insufficient evidence supporting the validity of this use.

The FDA contends that Electric Stimulation Devices may cause significant physical and psychological harm to patients, such as burns, tissue damage, depression, panic and fear.

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