Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or aggressive behavior, a step rarely taken by the agency. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. This is the second time the FDA has proposed a ban of these particular devices.
ESDs deliver electrical shocks through electrodes attached to an individual’s skin to attempt to reduce or stop harmful behaviors. This proposed rule proposes to ban ESDs intended for self-injurious and aggressive behaviors. Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions. These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage…
