ECT EQUIPMENT LOW RISK OR HIGH RISH

The FDA recently proposed a rule change that would reclassify electroconvulsive therapy (ECT) devices used for treating major depressive disorder from class III (high risk) to class II (low risk). The change would significantly improve access to an effective and potentially lifesaving treatment.
In 1976, the FDA became responsible for regulating medical devices and the FDA placed ECT machines in the Class III category. This was partially due to testimony from former patients, who stated that they suffered permanent memory loss and brain damage.
A similar reclassification proposal by the FDA in 2010 met significant resistance from anti-psychiatry groups and did not pass. That is why it 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. For appropriate patients, ECT has been a lifesaver. It has given them an opportunity for a normal, functional life.
The FDA is currently requesting public comment on the safety and efficacy of this treatment. The American Psychiatric Association will be submitting a comment in support of this change in designation. The government does give importance to the number of letters or emails received, pro vs con, in its deliberations. With this in mind, APA has created a form letter that you can send to the FDA supporting the reclassification effort.

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