FDA May Ban Shock Devices Used On Those With Special Needs
The Food and Drug Administration is considering banning devices used to administer electric shocks to children and adults with developmental disabilities in an effort to modify their behavior.
In a 126-page report issued this week, the federal agency said it is currently reviewing what are known as electrical stimulation devices and could move to bar their continued use.
“The FDA has grown concerned that serious risks of using these devices may outweigh the benefits for patients with limited intellectual ability or developmental disabilities, and that they may pose an unreasonable and substantial risk of illness or injury to patients,” FDA spokeswoman Jennifer Rodriguez said in an email to Disability Scoop.
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The Judge Rotenberg Educational Center in Massachusetts — which serves children and adults with developmental disabilities as well as those with behavioral and emotional problems — is believed to be the only entity in the nation currently using the devices.
Officials with the Rotenberg Center said that the approach is a last resort for individuals with “life-threatening behavior disorders” for whom other psychological and psychiatric treatments have been unsuccessful.
“Without the treatment program at JRC, these children and adults would be condemned to lives of pain by self-inflicted mutilation, psychotropic drugs, isolation, restraint and institutionalization — or even death,” the Rotenberg Center said in a statement.
The FDA report indicates that as of February 2013, as many as 86 students at the school were eligible to receive skin shocks for exhibiting undesired behaviors. The approach is only used with students whose parents have given consent and with authorization from the Massachusetts Probate Court, the Rotenberg Center indicated.
The school has long been under fire from disability advocates who say that it is inhumane to address behavior problems with electric shocks. In recent years, the Rotenberg Center has faced an inquiry from the U.S. Department of Justice and the United Nations Special Rapporteur on Torture determined that the rights of students at the center had been violated.
The FDA approved the electric shock devices used at the Rotenberg Center in the 1990s to treat individuals who “exhibit self-injurious behavior of sufficient intensity and frequency to cause serious damage to themselves.” But the agency warned the school in 2012 that its devices — which had been modified to deliver a current nearly three times as high — no longer had proper clearance.
In its report, the FDA said a former student told investigators that the shocks felt like “a thousand bees stinging you in the same place for a few seconds.” FDA investigators were told of burns, scars, muscle spasms, seizures and other effects resulting from the skin shocks and onetime students said the experience left them feeling “fearful” and “anxious.”
A federal advisory panel met Thursday to weigh the benefits of electric stimulation devices and could make a recommendation to the FDA, but it will be up to the agency to assess whether or not to ban the devices, Rodriguez said.