FDA Proposes Ban on Controversial Devices Used for Aggressive Behavior

FDA Proposes Ban on Controversial Devices Used for Aggressive Behavior

The Massachusetts-based Judge Rotenberg Educational Center defends its use of the device despite evidence that the treatment leads to post traumatic stress disorder and other physiological issues

April 25, 2016

The U.S. Food and Drug Administration (FDA) has proposed a ban on controversial electrical stimulation devices (ESDs) that are sometimes used on people with special needs and behavioral disorders.

The agency is aware of one facility in the United States that uses the devices for behavioral modification in autistic adults who display aggressive behavior. The FDA estimates that between 45 and 50 people are exposed to ESDs at the Judge Rotenberg Educational Center in Canton, MA.

"Our primary concern is the safety and well-being of the individuals who are exposed to these devices," the FDA's William Maisel said in a written statement. "These devices are dangerous and a risk to public health--and we believe they should not be used."

ESDs use electrodes attached to the skin to administer electrical shocks when a person is behaving aggressively. The two-second shocks can be administered by a healthcare worker using a remote control.

According to reporting by the Sun Chronical, the facility says it only uses ESDs when other therapy options have been exhausted and only with the permission of parents and doctors. As a result of previous lawsuits against the center, Rotenberg must get court approval before using the device.

The FDA, however, says that there are a number of significant psychological and physical risks associated with ESDs, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction.

Rather than using shock treatments, the FDA says that other behavioral treatments, such as positive behavioral support, and medications can be a viable alternative.