FDA Moves to Ban Controversial Therapy
Because the practice presents an "unreasonable and substantial risk to public health", the Food and Drug Administration (FDA) has announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior. ESDs are devices that apply a noxious electrical stimulus, one that is uncomfortable or painful, using electrodes that are placed on a patient's skin.
The electrical stimulus is intended to reduce self-injurious and aggressive behavior, it is applied to a patient when the target behavior occurs in an attempt to condition the patient to reduce or stop the behavior. At this time, the FDA states only one facility is currently using these devices in the U.S., the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, with approximately 50 individuals being exposed to the device.
“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.”
The FDA has determined that ESDs used to treat aggressive and self-injurious behaviors present a number of psychological and physical risks. The devices may cause patients to experience post-traumatic stress or acute stress disorders, shock stress reaction, and learned helplessness; these findings are based on literature for implantable cardioverter defibrillators. There have also been reports of patients experiencing depression, anxiety, fear, and pain.
Experts in the field of behavioral science and people who have been subjected to ESDs corroborate most of these findings. These behaviors also occur at disproportionately high rates in people with intellectual or developmental disabilities; many of these individuals are unable to adequately communicate the harms they experience to their healthcare providers.
Positive behavioral interventions, such as behavioral support or pharmacotherapy are safer alternatives for curbing self-injurious or aggressive behaviors in patients. It should be noted that some patients who have been exposed to these devices may need time to gradually transition away from the device to another treatment.
The proposed ban will include all ESD devices as it was determined that the substantial risk of illness or injury could not be corrected or eliminated with a labeling change. The proposed rule is available for public comment online for the next 30 days.
For more information visit FDA.gov.