Thursday, February 4, 2016

APA Urges Members to Support Reclassification of ECT Devices

Five years after it last broached the matter, the Food and Drug Administration (FDA) is again proposing to reclassify electroconvulsive therapy (ECT) from a Class III (high risk) medical device to Class II (low risk). APA supports this change.

Opposition from anti-psychiatry groups was blamed for the FDA's maintaining the Class III status in 2011. Opponents to reclassification argued then that ECT causes memory problems, cognitive impairment, and other adverse effects. Supporters noted that current ECT practices, using anesthesia and muscle relaxants, significantly reduce those effects.

The FDA in a recent Federal Register notice acknowledged some side effects but concluded: “FDA believes that in the specified patient population, and with the application of general and special controls as described in this document, the probable benefit to health from use of the device outweighs the probable injury or illness from such use.”

APA urges psychiatrists to contribute their comments to the FDA in favor of the reclassification. A template form letter has been prepared that provides talking points. The FDA’s draft guidance on the proposed reclassification and a link to post comments can be accessed here. The FDA must receive comments by March 28.

“[I]t is so important for psychiatrists to take the lead in expressing their views in regard to the role that ECT plays in clinical practice and in the treatment of major depressive disorder,” wrote APA CEO and Medical Director Saul Levin, M.D., M.P.A., and APA President RenĂ©e Binder, M.D., in a blog post. “For appropriate patients, ECT has been a lifesaver. It has given them an opportunity for a normal, functional life.”

For more in Psychiatric News about the previous attempt to reclassify ECT, see “FDA Advisory Panel Favors ECT in High-Risk Category.”


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