FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

The U.S. Food and Drug Administration today announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, 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. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health.

“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “These devices are dangerous and a risk to public health--and we believe they should not be used.”

At this time, the FDA has information that indicates only one facility is using these devices in the United States, the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, and estimates between 45 and 50 individuals are currently being exposed to the device. The FDA believes that 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. A small subgroup of those exposed to these devices may need time to gradually transition away from this device to another treatment. The FDA stands ready to work with health care providers to help facilitate a safe transition to alternate care for all of those in need since the proposed rule, if finalized, would ultimately remove these devices from the marketplace completely.

In making the determination that these products present an unreasonable and substantial risk of illness or injury to the public, the FDA considered all available evidence, including clinical and scientific data, input from experts in the field and state agencies, comments from JRC, individuals and parents of individuals on whom ESDs have been used, and disability rights groups, as well as insights from an April 2014 FDA advisory panel.

The proposed rule is available online at www.regulations.gov for public comment for 30 days.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.