We may be witnessing electroconvulsive therapy’s final days. This week, a U.S. Food and Drug Administration (FDA) panel will review whether there’s enough evidence to downgrade electroconvulsive therapy (ECT) devices into the Class II medical device category — that is, a medical device that carries only “medium risk.” Like a syringe.
That’s right, a device that can send electricity directly into your brain is being considered to be placed in the same medical device category as a syringe. And guess who doesn’t mind that reclassification? Why, the American Psychiatric Association, of course — they are right on board with this re-classification (PDF).
Currently ECT devices are classified as Class III devices — high risk. Yet they have never undergone the very basic safety and efficacy the FDA requires for all Class III medical devices and medications. Why not?
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