The U.S. Food and Drug Administration (FDA) has taken steps to end the use of certain electrical devices in treating patients manifesting aggressive or potentially self-injurious behaviors.
Under the terms of a Final Rule published in the Federal Register earlier this month, the FDA will ban the use of electrical stimulation devices (ESDs) in patient care and behavioral treatments. The ban takes effect in early April.
ESDs administer electrical shocks to patients through electrodes attached to their skin and are used to interrupt aggressive or potentially self-injurious behaviors. Although ESDs have been in use for more than 20 years, the FDA says that there is mounting evidence of the potentially harmful effects from the use of these devices, as well as advancements in medical science that are equally or more effective in treating patients without the harmful effects.
According to the FDA, the only facility in the U.S. currently using ESDs in the treatment of patients and residents is a facility in Canton, MA, where an estimated 45-50 individuals are subject to treatments using ESDs.