FDA seeks to reclassify ECT from high risk to low risk
“The US Food and Drug Administration (FDA) is once again proposing to reclassify electroconvulsive therapy (ECT) from a high-risk to a low-risk intervention, and the American Psychiatric Association (APA) is encouraging its members to support this change … The FDA proposes to reclassify ECT devices from class III to class II for the treatment of severe major depressive episode associated with major depressive disorder or bipolar disorder in patients aged 18 years or older who are treatment resistant or who require a rapid response because of the severity of their psychiatric or medical condition,” according to a recent article in Medscape.
ECT then and now
Electroconvulsive therapy (ECT) was introduced in 1938 to treat psychiatric illnesses — in particular, severe medication-resistant depression. Use of this controversial treatment decreased in the 1960s because it was considered violent and inhumane. In the 1970s, ECT became more common and today is the most effective treatment for medication-resistant depression. Endorsed by the American Psychiatric Association, ECT treats approximately 100,000 patients in the U.S. each year.
Electrodes are strategically placed on the patient’s head and electricity is delivered to the brain until a patient undergoes a seizure. This electricity alters hormones and neurotransmitters in the brain, changing the brain’s chemistry and electricity. This once high-risk intervention is now deemed safe; therefore, many organizations are supporting the reclassification of this treatment as lower risk. Any type of treatment in the mental health field that is deemed high-risk will likely cause patients to avoid it and to shy away from seeking help altogether. Class III represents the highest risk-based classification for devices, class II is less risky, and class I is little or no risk. Currently ECT is class III and its proponents are trying to move it to class II.
Back in the early 1900s, ECT was administered without anesthesia or muscle relaxants, resulting in severe injury to the musculoskeletal system, such as joint dislocations and bone fractures. At that time, no regulations existed regarding dose parameters for electric stimulation, so the cognitive risks involved in ECT outweighed the benefits. Today, strict rules and regulations make this therapy much safer.
Reclassification may be limited
In 2011, the FDA Neurological Device Panel proposed that ECT should be lowered to class II classification instead of class III, but this proposal did not pass, as many patients and other governing bodies declared that ECT can result in memory deficits and cognitive impairments. ECT is not just used for depression but is considered the only treatment option for mania and catatonia. This current reclassification approach may be too limited, as it only includes re-classifying ECT for depression and not other mental illnesses, which could potentially create problems with insurance reimbursement and coverage if this classification does get passed through.
“I’m speaking partly as a clinician who has seen remarkable positive effects with it and who also has seen some patients who have suffered side effects, including the memory dysfunction … I believe we can moderate the known risks by using appropriate informed consent and check list procedures, so I am in favor of moving it to class II,” states Christopher Ross, M.D., professor of psychiatry at Johns Hopkins University.
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About the author
Kristen Fuller, M.D., is a senior staff writer at the Sovereign Health Group and enjoys writing about evidence-based topics in the cutting-edge world of medicine. She is a physician and author, who also teaches, practices medicine in the urgent care setting and contributes to medicine board education. She is also an outdoor and dog enthusiast. For more information and other inquiries about this article, contact the author at firstname.lastname@example.org.