The U.S. Food and Drug Administration on Wednesday banned electrical stimulation devices (ESDs) used in curbing self-injurious or aggressive behavior, citing substantial risks of illness or injury to patients.
The agency’s final decision comes after the devices were found to cause tissue damage and worsen underlying symptoms, leading to depression, anxiety and post-traumatic stress disorder.
“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,” the FDA’s William Maisel said in a statement.
ESDs administer electrical shocks through electrodes attached to the skin to deter self-injurious or aggressive behavior.
Many people exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent, the FDA said.
The ban does not apply to devices used for other purposes, such as those used for smoking cessation, or other approved devices or technologies such as cranial electrotherapy stimulators or transcranial magnetic stimulation.
The decision to ban a device is rare and the FDA has so far only banned two other medical devices.
(Reporting by Saumya Sibi Joseph in Bengaluru)
Topics Legislation
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