Tuesday, January 25, 2011

FDA To Consider Fate of ECT

Dr. John Grohol of Psych Central has ascended the soapbox to speak out on the proposal 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." The American Psychiatric Association appears to endorse this change in writing.

"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?

"We’re told the devices were 'grandfathered' into the Class III category because they’ve been around so long...."

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