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.
The International Center for the Study of Psychiatry and Psychology is calling upon the FDA to keep the Class III schedule until PMAs are performed on the devices. In truth, we would suggest an impartial review of the evidence requires the withdrawal of ECT machines from the market.
If the device is reclassified a scientific safety investigation of these devices will never take place, and patients will not have the information they need to make an informed choice about the treatment.
On more than one occasion this office has been asked to confirm a state hospital patient's consent to ECT only to determine that the patient did not understand the decision he or she was being asked to make or that other less intrusive treatments had not been tried.
These are reports from people who had ECT in recent years and experienced permanent deficits in memory ability and other cognitive abilities (known as anterograde amnesia).