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FDA May Ease Up on Electroshock Devices
Date:1/27/2011

THURSDAY, Jan. 27 (HealthDay News) -- Electroshock devices, currently classified by the U.S. Food and Drug Administration as high risk for the treatment of severe depression, could be downgraded to medium risk this year.

An FDA advisory panel is scheduled to meet Thursday to discuss reclassifying the devices, which would pave the way for wider use among people with depression and other mental illnesses.

A medium-risk classification would put the devices in the same category as syringes and allow them to be sold without new testing, The New York Times reported.

If the current classification continues, the FDA could require manufacturers to demonstrate that the devices are safe and effective, which it has not previously done. Some say the tests that such proof would require would be prohibitively expensive for the device makers.

The American Psychiatric Association supports the classification change, while opponents argue that electroshock therapy can cause long-term brain damage, including memory loss, the newspaper said.

"It's a treatment for the most severe form of depression," Dr. Charles Kellner, chief of geriatric psychiatry at Mount Sinai School of Medicine in New York City, told the Times. "It can really be lifesaving."

Dr. Edmi Y. Cortes, director of psychiatric services at the University of Miami Hospital, said that today's electroconvulsive therapy (ECT) devices are both safe and effective. "It's beneficial that some of the leading experts in psychiatry and ECT are getting together with the FDA to finalize a consensus," she said.

"The devices are effective when used appropriately," Cortes said. "For the most part, they are used to treat severe cases of depression, depression that has not been responsive to medication or depression that presents with symptoms like severe agitation or suicidal thoughts."

This type of depression is fairly uncommon, Cortes said. "For
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