June 2016
2016 WPA NEWSLETTER 1st QUARTER

WPA ZONE 2 (UNITED STATES OF AMERICA)

The American Psychiatric Association recently reported that the U.S. Food and Drug Administration (FDA) 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. This revealed the importance of 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.

As the U.S. government gives importance to the amount of communications received in its deliberations, supporting or not supporting the reclassification, the FDA is requesting public comment on the safety and efficacy of this treatment. In addition to the American Psychiatric Association submitting comments to the FDA in support of this change in designation, it is also providing individual members who wish to support the reclassification effort with resources to respond directly to the FDA.

For more news and developments on this issue and other issues in the field of psychiatry that impact clinical care and professional practice, please visit psychiatry.org.

Edmond Hsin-tung Pi
WPA Zonal Representative for Zone 2 (United States of America)

  

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