FDA renews proposed ban on electrical stimulation devices

The US Food and Drug Administration is again proposing a ban on electrical stimulation devices used to reduce or stop self-injurious or aggressive behavior, the agency said in a statement Monday.

Electrical stimulation devices deliver electrical shocks through electrodes attached to a person’s skin to attempt to reduce or stop harmful behaviors. The only facility currently using these devices in the US is the Judge Rotenberg Education Center in Canton, Massachusetts, where an estimated 50 people have a treatment plan that includes the potential use of such a device, according to the statement.

The FDA says it has taken this rare step of banning a previously approved device because electrical stimulation devices “present an unreasonable and substantial risk of illness or injury.”

This is the second time the FDA has proposed a ban on these devices. In 2020, the agency issued a final rule that banned the devices from the marketplace, but that rule was annulled after a federal appeals court ruled that the FDA did not have the authority to ban the devices under the Federal Food, Drug, and Cosmetic Act.

Since that decision, changes to the act have made it clear that the FDA does have the authority to issue such a ban, according to Monday’s statement.

The FDA said the devices “present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

“Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions,” the agency said.

The Judge Rotenberg Educational Center said in a statement Tuesday that a 2018 Massachusetts court decision found no evidence of any psychological side effects to students receiving the treatment. The school has exceeded reporting requirements and opted to install 24-hour video monitoring to increase oversight, according to the statement.

“The responsible use of electrical stimulation devices as part of our Applied Behavior Analysis treatment plan is a matter of life or death for a small number of our clients,” the statement says. “The parents and guardians of clients at the Judge Rotenberg Educational Center will remain vigilant to ensure that this treatment remains available to those for whom all other treatment options have been tried and failed.”

The FDA said in a 2020 statement that other state-of-the-art behavioral treatments, such as positive behavioral support and medications, offer alternative approaches for self-injurious or aggressive behaviors.

“Those exposed to these devices may need time to gradually transition away from this device and adjust treatment plans. The FDA intends to consider the needs of these patients should we finalize the proposed ban,” it said.

The proposed ban would apply only to electrical stimulation devices intended to be used for self-injurious or aggressive behavior, not to aversive conditioning devices used for other purposes, such as smoking cessation, the agency said.

The new proposal will be open for comment until May 28, after which the FDA will review and consider comments before determining whether to issue a final rule.

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