Nebraska Advocacy Services, Inc., The Center for Disability Rights, Law, and Advocacy, supports the continued categorization of electroconvulsive therapy (ECT) machines as Class III devices.
Given the paucity of unbiased data on the safety and efficacy of these devices, coupled with the immediate and direct impact on an individual’s health that these devices deliver, requiring ETC machines to undergo a rigorous Pre-Market Approval process (PMA)—the same process required of new medical devices, including clinical safety trials—is highly appropriate.
In 1976, the Food and Drug Administration (FDA) began requiring that new medical devices undergo a rigorous PMA process in which manufacturers either had to prove they were safe and effective, or show that they weren’t high-risk and therefore did not need the stringent review required of Class III devices.
In this context, high-risk means that the device’s failure to function properly could lead to serious or life-threatening complications. But companies with high-risk products already on the market were allowed to keep selling them, with the understanding that eventually the agency would require them to submit the same type of data needed for newer products.
The time has come for ECT manufacturers to comply with standards and rules applicable to manufacturers of other high-risk devices.
ECT machines were grandfathered in through the 510(k) process, which automatically approves a device if it is “substantially equivalent” to an already approved product, called a predicate device.
However, since ECT machines were grandfathered in, no ECT machine went through the PMA process, thus there is no predicate device. Hence, manufacturers of ECT machines should be required to seek approval for an ECT machine as if it were new to the market.
ECT may have a place the realm of depression treatment, but it should, at a minimum, have the same kinds of research studies we now require of antidepressant drugs. Patients who consider undergoing ECT treatment should be fully informed of all of the risks associated with such treatment.
Given the inherent risk to an individual’s safety and health from ECT, it is only appropriate that ECT machine manufacturers submit to rigorous testing and data collection on the safety and efficacy of ECT machines.
The negative effect that ECT has on memory has been difficult for ECT practitioners to concede and is undisputable. As Dr. Harold Sackeim, the chief of biological psychiatry at the New York State Psychiatric Institute admitted:
“I tell all my patients that they are going to have memory loss. In the vast, vast majority of patients that will be limited to a few months surrounding the course of treatment. There will not be a blank slate. But there will be gaps in memory… But I also tell them that in very rare instances it can be more extensive, and that no one can tell for certain who is going to experience that and who is not.”
The certainty of memory loss due to ECT coupled with the ambiguity surrounding the extent to which long-term memory loss occurs, the FDA should command that ECT devices remain a Class III device and manufacturers be required to comply with stringent testing and data collection pursuant to the Class III designation.
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