FDA Bans Electrical Stimulation Devices for Behavior Control

Megan Brooks

Disclosures

March 04, 2020

The US Food and Drug Administration (FDA) has banned electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior because they present an "unreasonable and substantial" risk for illness or injury that cannot be corrected or eliminated through new or updated device labeling.

"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," William Maisel, MD, MPH, director of the Office of Product Evaluation and Quality in the FDA's Center for Devices and Radiological Health, said in a statement.

"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," said Maisel.

Substantial Evidence of Harm

ESDs deliver electrical shocks via electrodes attached to the skin. They are used to condition patients to stop engaging in self-injurious or aggressive behavior, yet evidence of the devices' effectiveness is weak, the FDA says.

Evidence in the medical literature indicates a number of psychological and physical harms of ESDs, including depression, anxiety, posttraumatic stress disorder, fear, panic, pain, burns, and tissue damage, as well as worsening of underlying symptoms.

Many patients who undergo treatment with these devices have intellectual or developmental disabilities that limit their ability to communicate pain or give consent.

"As the risks presented by ESDs meet the agency's definition of unreasonable and substantial and cannot be corrected or eliminated through new or updated labeling, banning the product is necessary to protect public health," the agency said on March 4 in announcing its final decision to ban the devices.

As reported by Medscape Medical News, the FDA first proposed a ban on the use of ESDs for behavior control in 2016.

The FDA received more than 1500 comments on the proposed rule, with the overwhelming majority in support of the ban.

At this time, only one facility in the United States, the Judge Rotenberg Educational Center, in Canton, Massachusetts, uses ESDs, the FDA reports.

The FDA estimates that from 45 to 50 individuals are currently being exposed to an ESD at this time.

The FDA notes "state-of-the-art behavioral treatments, such as positive behavioral support, and medications can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients."

The ban only applies to ESDs used for self-injurious or aggressive behavior. It does not apply to aversive conditioning devices used for other purposes, such as smoking cessation, which are outside the scope of this rule.

The ban also does not apply to FDA-approved cranial electrotherapy stimulators or transcranial magnetic stimulation, both of which have been found to be reasonably safe and effective for different indications, the FDA said.

The final rule is available online.

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