FDA Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

https://www.fda.gov/news-events/press-announcements/fda-takes-rare-step-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior?utm_campaign=030420_PR_FDA%20Bans%20ESDs%20for%20Self-Injurious%20or%20Aggressive%20Behavior&utm_medium=email&utm_source=Eloqua

FDA Takes Rare Step to Ban Electrical Stimulation Devices forSelf-Injurious or Aggressive Behavior

Devices Found to Present Unreasonable and Substantial Risk of Illness or Injury

After careful consideration, the U.S. Food and Drug Administration today published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling. “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,” said William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “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.” ESDs administer electrical shocks through electrodes attached to the skin of individuals to immediately interrupt self-injurious or aggressive behavior or attempt to condition the individuals to stop engaging in such behavior. Evidence indicates a number of significant psychological and physical risks are associated with the...

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