The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
ESDs are devices that administer electrical shocks to a patient using electrodes that are placed on the skin. The electrical stimulus is intended to reduce self-injurious and aggressive behavior; it is applied to a patient when the target behavior occurs in an attempt to condition the patient to reduce or stop the behavior.
In a press statement, the FDA noted that following an extensive review of published literature and public comment on the 2016 proposed rule, banning ESDs was necessary as they “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.”
The final rule applies only to ESDs used for self-injurious or aggressive behaviors and does not apply to aversive conditioning devices used for other purposes such as smoking cessation. In addition, devices such as cranial electrotherapy stimulators or transcranial magnetic stimulators are excluded from the rule as the agency believes these devices used for their approved indications are reasonably safe and effective.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said William Maisel, MD, MPH, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present.” These include positive behavioral interventions, such as behavioral support or pharmacotherapy.
For more information visit fda.gov.