FDA Considering Ban on Electrical Devices for Behavior Control
The U.S. Food and Drug administration is considering a ban on aversive conditioning electrical stimulation devices (ESDs) as a means to control aggressive and self-injury behavior (SIB).
About the ESD Meeting
According to Medscape, majority vote by the 20-member Neurological Devices Panel of the Medical Devices Advisory Committee made yesterday recommended a full ban on all current and future ESDs.
Panel members noted insufficient evidence of efficacy and a lack of research into the adverse events associated with the devices. Side effects noted by the FDA include: burns, tissue damage, stress disorder (PTSD), acute stress, anxiety, depression, and suicidal behavior.
While the FDA is authorized to ban any medical device that presents an “unreasonable and substantial risk of illness and injury”, the agency has not made a final decision. The latest meeting was convened to consider the use of non-self administered class III aversive conditioning devices.
Such devices are most often used as a preventive intervention to treat patients with severe developmental problems or autism who have displayed repeated aggressive behaviors or self-injury.
Many of the presentations made by professional society representatives during the meeting referred to electrical stimulation devices as a form of torture.
Once the proceedings had ended, panel members were asked several questions concerning the devices, including whether they believed ESDs were an effective form of treatment. The majority maintained that there is no real benefit offered by the devices, pointing to a lack of research to support their use.
Even among panel members who indicated that ESDs were effective (roughly 25 percent), most believed that current options should only be used with strict stipulations.