Medical Device Safety and Recalls: Proposal to Ban Electrical Stimulating Devices (ESDs) for self-injurious or aggressive behavior

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Proposal to Ban Electrical Stimulating Devices (ESDs) for self-injurious or aggressive behavior

The U.S. Food and Drug Administration (FDA) has issued a Proposal to Ban Electrical Stimulation Devices (ESDs) Used for Self-injurious or Aggressive Behavior.

ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behaviors. A number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage. In addition, there is a risk of errant shocks from a device malfunction. Banning the product is necessary to protect the public because these risks cannot be corrected through new or updated labeling.

More information about medical device bans can be found on the FDA’s Medical Device Bans webpage.

Comments to the proposed rule can be submitted to the docket until May 25, 2016.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

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