Ban takes effect 30 days after publication in the Federal Register
WEDNESDAY, March 4, 2020 (HealthDay News) — Electrical shock devices (ESDs) used to reduce aggression and self-harm in patients with autism and other developmental disabilities will be banned, the U.S. Food and Drug Administration said Wednesday.
The devices deliver shocks through electrodes attached to the skin of patients, but there is evidence that they pose significant mental and physical risks to patients, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns, and tissue damage, the FDA said. It also noted that patients’ intellectual or developmental disabilities make it difficult for them to communicate their pain and that there is little evidence that ESDs are an effective treatment.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality at the FDA Center for Devices and Radiological Health, said in a statement. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present.”
The ban takes effect 30 days after publication in the Federal Register. The agency first announced its intention to ban the devices in 2016.
Copyright © 2020 HealthDay. All rights reserved.