Story at a glance
- The FDA banned electronic stimulation devices (EDSs) on patients undergoing behavioral treatments.
- The ban specifically applies to usage of the devices on patients who are undergoing treatment for “self-injurious or aggressive behaviors.”
- The FDA believes more positive behavioral support treatments can be used as alternative methods.
The Food and Drug Administration (FDA) announced Wednesday that it will ban electric stimulation devices (ESDs) from being used to treat individuals with self-injurious or aggressive behavior. The decision ends a 20-year medical practice that had been found to have inherent risks of injury and illness.
“Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present,” William Maisel, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health, said in a statement.
Maisel further added that medical innovations point to the devices being more harmful rather than helpful.
ESDs work by administering an electric shock through electrodes attached to the skin of patients to discourage self-harming or hostile behavior as a form of negative reinforcement. Researchers at the FDA cite evidence that “a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage.”
Data also suggest that the majority of people who use these devices have an intellectual or other developmental disability, which can interfere with communicating how they feel with the ESD. Most importantly, there is little clinical or scientific evidence that supports the device is actually effective.
The FDA notes that banning a device is rare, but that the agency has the authority to do so when protecting the health of the public.
This ban will only apply to ESDs used to correct self-harming and aggressive behavior in patients, and will not apply to aversive conditioning devices used for other purposes, namely helping individuals quit smoking, or other FDA-approved devices that deliver electric shocks for as part of select medical treatments.