Is high risk device classification pure shock value? FDA to weigh in on electroconvulsive therapy apparatus

On Thursday, the FDA will consider whether to downgrade the classification of the devices used to deliver electroshock therapy (or electroconvulsive therapy, ECT) to the “medium risk” category, thus waiving the need for new safety testing prior to entering the market. Despite its frightening portrayal in movies like One Flew Over The Cuckoo’s Nest and Requiem For A Dream, ECT has seen a resurgence in use as a treatment for the most severe form of depression — major depression — particularly in elderly patients who would experience dangerous drug interactions if an antidepressant is added to their drug regimen. Patients receiving ECT are given general anaesthesia and a mouth guard while a machine delivers an electric shock to the brain that induces a grand mal seizure lasting no more than a minute. The whole procedure lasts five to ten minutes and the patient can be sent home within two hours. How ECT works to alleviate severe depression is unknown.

National Institute of Mental Health psychiatrist Dr. Matthew V. Rudorfer told The New York Times that because the companies making the ECT apparatus are often relatively small, “the dilemma might be that undertaking [sic] new expensive clinical trials might be too expensive.”

ACSH's Dr. Elizabeth Whelan believes that the FDA’s ECT regulations are very outdated. “The literature showing that ECT can be highly effective and safe for the treatment of major depression has been accumulating over the past several decades. It’s time for the FDA to catch up.”

ACSH’s Jonathan Leaf points out that major depression can be “very devastating and may have a fluctuating course. A patient may go weeks or months without eating or sleeping properly and then suddenly snap out of it. While there have been cases of prolonged memory loss from ECT, some patients have reported that the therapy was life-saving.”