FDA Proposes Ban on Electrical Stimulation Devices
By Jonathan Springston, Associate Managing Editor, AHC Media
The FDA on April 22 proposed a ban on electrical stimulation devices (ESDs) that are used to control injurious or aggressive behavior, arguing such devices present “an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.”
ESDs administer electrical shocks to patients through electrodes attached to the skin. These shocks are designed to condition patients to cease engaging in negative behavior that leads to self-harm or injury to others. The FDA points to evidence that concludes such treatment leads to a variety of other physical and psychological maladies, including depression, anxiety, worsening behavior, and burns.
“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 played its hand in the wake of growing outrage against what is considered the only known facility left in the United States that uses this form of treatment – The Judge Rotenberg Educational Center, a group home and school in Canton, MA. Shortly after its announcement, the FDA released a 124-page document accusing the center of using flawed studies to defend its practices, misleading families, and underreporting adverse effects.
ProPublica, a non-profit watchdog, notes the FDA met in 2014 to discuss the center but took no action. Meanwhile, officials in Massachusetts and New York have made their own attempts to get the center to cease its practices in the face of mounting complaints.
The center’s website features a behavioral treatment section that contains no mention of using ESDs. In a subsection titled, “Effective treatment of aggressive violent behaviors,” the center says it, “is very successful in reducing or eliminating aggressive and other violent behaviors, and replacing them with more appropriate behaviors. JRC students are given behavioral contracts in which, if they can go for a defined period of time without showing aggressive behavior, they earn a powerful reward; if they break their contract by showing aggression, they lose important privileges.”
The website goes on to downplay the effectiveness of psychotropic drugs and “time outs.” And while it acknowledges the use of restraints to control bad behavior (another sticking point with critics), the center says it is able to “eliminate or minimize” such procedures thanks to “the effectiveness of [the center’s] treatment systems.”
Medical Ethics Advisor will take a closer look at this story in an upcoming issue.