FDA Panel Recommends Ban on Electrical-Stimulation Devices

the Psychiatry Advisor take:

Aversive-therapy devices, which are sometimes used as a last option for psychiatric illnesses resistant to standard treatment, should not be used in patients with non-suicidal self-injury or aggressive behavior, an FDA advisory panel recommended.

In April, a majority of the Neurological Devices Panel of the Medical Devices Advisory Committee agreed that based on current information, the devices pose “an unreasonable and substantial risk of illness or injury” to patients. However, some members did say that treatment with the devices shows benefit in some cases where patients are nonresponsive to pharmacological and behavioral therapies.

The four class II electrical stimulation devices (ESDs) currently marketed in the United States were previously approved between 1976 and 1994. They use voltage ranging between 150 and 200 volts, and shock durations last between 0.5 and 12 seconds. ESDs are typically used in patients with severe autism or developmental disabilities.

The data [supporting the use of ESDs] is more than 50 to 55 years old,” said Steven Miles, MD, a professor of medicine and bioethics at the University of Minnesota Medical School, at the meeting, Psychiatric News reported. “I can’t think of any other comparable risk therapy that is allowed to persist on such old data.”

The FDA has not made a final decision on using ESDs for aversion therapy. However, the agency usually follows the recommendations of its advisory panels.

FDA Panel Recommends Ban on Electrical-Stimulation Devices
FDA Panel Recommends Ban on Electrical-Stimulation Devices

To ban, or not to ban, was the question at the spring meeting at which members of an advisory panel of the Food and Drug Administration (FDA) recommended that the agency should prohibit the use of class II electrical stimulation devices (ESDs) for aversive conditioning therapy in patients with nonsuicidal self-injuries or aggressive behaviors.

The decision was made after the majority of the members of the Neurological Devices Panel agreed that based on available data and information, the devices pose “an unreasonable and substantial risk of illness or injury” to patients. 

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