ECT Device Reclassification – The Mental Health Consumer/Survivor Network to FDA, 2009

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To: Food and Drug Administration,

      Dockets Management Branch (HFA-305),

      5630 Fishers Lane, Room 1061, Rockville, MD 20852

The Mental Health Consumer/Survivor Network of MN is a support and advocacy organization for people who have psychiatric diagnosis, including those who have received or may receive electroconvulsive therapy (ECT).

We are aware that the FDA has asked for public input on the safety and efficacy of the devices used to administer ECT. The devices are currently classified as Class III high risk devices.

Class III devices are required by law to undergo the same rigorous safety testing as new devices just coming onto the market; their manufacturers must prove them safe and effective.

Yet while other medical devices have had to undergo the rigorous safety investigation known as PreMarket Approval (PMA), the FDA has allowed shock machines to be used for over thirty years, not only without requiring clinical safety trials, but without any scientific evidence that the devices are either safe or effective.

Nor have patients been informed that they were submitting to an untested procedure.

When it classified the ECT device in Class III, the FDA named brain damage and memory loss as risks of the treatment.

Since then, dozens of volumes of evidence have accumulated in the FDA’s previous dockets on the device (#82P-02316 and #2003P-0555) documenting the risks of ECT, including firsthand accounts of permanent harm from former ECT patients.

The manufacturers of the devices, as well as the American Psychiatric Association and individual doctors who use shock, are lobbying to prevent the mandated scientific safety investigation from ever taking place.

They are asking you to reclassify the device to the low risk Class II (ruling that it is as safe as an X ray machine).

The manufacturers say they will not pay for clinical trials; the APA wants you to take their word that shock is safe.

But if the devices really are as safe as they claim, an investigation will prove that.

If the ECT device is reclassified, public and future patients will be denied the ability to make an informed choice about ECT based on valid scientific evidence.

We are strongly committed to informed consent and choice in the mental health system including whether to have ECT or not.

That choice can only be informed if patients have full and complete knowledge about its short and long term consequences.

FDA must place public and patient safety first, and that means not exempting the ECT device from the scrutiny required of other medical devices.

We strongly oppose the reclassification of the ECT device. In the absence of adequate scientific evidence of the safety of shock machines, the only responsible course of action is to keep the device in Class III and call for PMAs from the manufacturers.

That investigation will either show that ECT is safe or publicly reveal its lack of safety. Either way, patients have the right to know.

Sincerely,

Board of Directors

View on FDA Docket

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