After clearing electrical stimulation devices (ESDs) for self-injurious or aggressive behavior over 20 years ago, the U.S. Food and Drug Administration (FDA) now wants to place a ban on them, citing that the devices pose an “unreasonable and substantial” risk to public health.
It rare for the FDA to ban a device for which it has already approved — although this time it makes a lot of sense for the ban. However, the government agency has concluded that ESD’s should not be used as a means to modify behavior.
According to an FDA statement:
“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.”
It is important not to confuse electrical stimulation devices with electroconvulsive therapy (ECT), which is a brain stimulation therapy that is used to treat major depression and other mood disorders. The induced seizures caused by ECT provide temporarily relief of symptoms, and is not meant to purposely hurt the patient.
It is understood that there is only one facility using ESDs in the United States, with approximately 45 to 50 individuals currently being exposed to shock treatments.
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, said in a statement:
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices.
“These devices are dangerous and a risk to public health — and we believe they should not be used.”
The FDA believes other behavioral treatments should be used, such as positive behavioral support and medication. However, the FDA understands that people who have been exposed to these devices may need time to progressively transition away from this device to another treatment.
The FDA is ready to work with healthcare providers to transition safely to alternate care, as if the proposed rule is finalized, it would remove these devices from the marketplace completely.