The U.S. Food and Drug Administration 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.
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.
