FDA Moves To Ban Shock Devices Used On Those With Special Needs
The Food and Drug Administration is moving forward with plans to ban devices used to administer electric shocks to those with developmental disabilities in an effort to modify their behavior.
The agency said it will issue a proposed rule Monday barring the use of what are known as electrical stimulation devices, which use electrodes that attach to the skin to deliver electric shocks with an eye toward conditioning individuals not to engage in self-injurious or aggressive behaviors.
“FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling,” the federal agency said in its proposal, which comes two years after an advisory panel meeting on the issue signaled that the FDA might act on the devices.
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The use of electrical stimulation devices has long been controversial.
The Judge Rotenberg Educational Center in Canton, Mass. — which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems — is the only facility in the nation known to be using the devices.
Officials with the Rotenberg Center have insisted that the approach is a last resort for those with “life-threatening behavior disorders.” But disability advocates argue that the skin shocks are inhumane and the FDA now appears to agree.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said William Maisel, 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.”
Particularly troubling, the agency said, is that many of the people at risk of receiving electric shocks are not able to communicate or make their own treatment decisions because of their disabilities.
In a 2014 FDA report, investigators said they learned of burns, scars, muscle spasms, seizures and other effects from those who received the skin shocks. Former Rotenberg Center students told the agency that the experience left them “fearful” and “anxious.”
According to the FDA, between 45 and 50 individuals at the Rotenberg Center are currently believed to be exposed to the shocks. Some individuals may need time to be transitioned to a new treatment approach if the rule is finalized, the agency said.
The Rotenberg Center said in a statement Friday that it had not been notified by the FDA about the proposal.
“Aversive therapy, which may include continent skin shock treatments known as the GED (graduated electronic decelerator), are incorporated into treatment plans for students who struggle with violent, abusive or mutilating behaviors toward themselves or others, only after their families have exhausted other therapies, residential programs and psychiatric facilities,” the statement said. “We hope that the families directly involved will have a voice before any final decision is made on this matter.”
The proposed rule will be up for public comment for 30 days before it can be finalized.