April 22 – A ban was proposed on Friday by the U.S. Food and Drug Administration on electrical stimulation devices (ESDs) which are used to curb individuals from engaging in self-injurious or aggressive behavior, because according to FDA these devices pose an “unreasonable and substantial” risk to public health.
ESDs administer electrical shocks through electrodes attached to the skin to attempt to condition to stop individuals from harming themselves or being aggressive. Where many people in whom the devices are used have intellectual or developmental disabilities which limit their ability to communicate their pain or give consent.
As evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, pain, burns, tissue damage and errant shocks from a device malfunction, the regulator noted. The FDA noted that subjective experience of the exposed individual can be difficult to predict and as a result, the intensity or pain of a particular set of shock parameters can be different big way between one patient and the other, also from shock to shock.
“As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health,” the agency said on Friday. Adding that few patients who are exposed to ESDs may need to “gradually transition away from this device to another treatment”.
The Judge Rotenberg Educational Center in Canton, Massachusetts is the only facility currently manufacturing and using these devices in the United States, the FDA said, adding that between 45 and 50 individuals are exposed to it.
State-of-the-art behavioral treatments, such as positive behavioral support and medication can be used rein in this type of behavior, the regulator said. If passed, the ban would not apply to ESDs used to create aversions to other conditions or habits, such as smoking, the FDA said.
In essence, the FDA made its decision after reviewing all available evidence, including clinical and scientific data, and 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.
Worth noting that public comments are sought by the FDA as they will be publishing the proposed rule on its website on April 25 and comments need to be submitted by May 25.