The U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) intended to treat self-injurious or aggressive behavior. According to a press release issued by the FDA, the devices present an “unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.”
ESDs apply electrical currents (shocks) through electrodes attached to a person’s skin to attempt to reduce or cease dangerous behavior. The main components of ESDs are an electrical stimulus generation module, electrodes, and a trigger switch. When individuals attempt a potentially harmful behavior (such as banging their heads against a wall), shocks can either be administered by a remote observer via a radio frequency signal or triggered automatically when a sensor detects the behavior.
After considering evidence and expert testimony, the FDA has concluded that ESDs pose a number of significant psychological and physical risks that cannot be eliminated through new or updated labeling.
According to the FDA, only one U.S. facility uses these devices, the Judge Rotenberg Educational Center in Canton, Massachusetts, where an estimated 45 to 50 people are currently being exposed to the ESDs. If the proposed rule is finalized, these devices would be completely removed from the marketplace, and the FDA would help facilitate a safe transition to alternate care, such as behavioral therapy and medications.
The proposed rule is available for public comment until May 25, 2016. Read the FDA’s announcement regarding the proposed ban on ESDs for self-injurious or aggressive behavior.