The FDA has 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.
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-injurious behaviors, worsening of symptoms of post-traumatic stress disorder, pain, burns, tissue damage, and errant shocks from a device malfunction, according to the FDA. 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, the agency says.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said William Maisel, MD, MPH, 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 that 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 ESDs may need time to gradually transition away from these devices to other treatments.
In making the determination that ESDs 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 meeting of an FDA advisory panel.
The proposed rule is available online at www.regulations.com for public comment for 30 days.
Source: FDA; April 22, 2016.