An expert FDA panel has determined that electroconvulsive therapy (ECT) machines should undergo the same rigorous testing as new medical devices.
The Neurological Devices Advisory Committee held no formal vote, but a majority of members supported keeping ECT devices for most indications as Class III, MedPage Today reports. ECT devices are already considered Class III, but the FDA has never developed standards for approving new machines with the premarket approval process that is supposed to be used for high-risk products. Instead, the agency has cleared new models under the 510(k) process.
However, in 2009, the Government Accountability Office recommended that the 510(k) process not be available for Class III devices. These devices, according to the GAO, either need reclassification into the Class II category or else their manufacturers should have to go through the PMA process.
If the agency follows the panel's advice, the two companies whose machines are used in the U.S. will have to provide evidence of the therapy's safety and effectiveness either from existing research or new studies, as the Washington Post reports.
Roughly 100,000 U.S. patients undergo ECT annually, usually getting about a dozen treatments over several weeks. The treatment is most often used for depression, but also has been utilized for those with schizophrenia, catatonia, and more recently, to some violent children with autism.
During the meeting, some patients described their experiences with the devices. While some decried their use, others, including Kitty Dukakis, wife of 1988 Democratic presidential nominee Michael Dukakis, called it a lifesaver. "It is not an exaggeration to say that I don't think I would be alive without ECT. It has been a miracle in my life," she said, as quoted by the Post.
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