FDA Bans Electrical Stimulation Devices for Aggression and Self-Harm

The FDA has issued a final rule banning electrical stimulation devices (ESDs) used to reduce aggressive or self-harming behavior, saying that better treatment options are now available to treat those issues.

CDER’s director of the Office of Product Evaluation and Quality, William Maisel, said that scientific advancements have led to improved options for devices that reduce or stop self-injurious or aggressive behavior. Importantly, they don’t come with “the substantial risk ESDs present,” he said.

The devices deliver electrical shocks to patients through electrodes attached to the skin to immediately interrupt aggressive or self-harming behavior or condition them to stop such behavior.