The Canton, Massachusetts-based Judge Rotenberg Center may soon be prohibited by federal law from practicing its long controversial “skin-shock therapy.”
On April 24, the Food and Drug Administration’s Medical Device Advisory Committee voted to ban all four devices that the Center uses to administer the practice. The vote, though influential, is nonbinding, meaning that FDA must still undergo a notice and comment process before any ban actually goes into effect.
The Center is the only facility in the country believed to use the devices.
“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,” agency spokeswoman Jennifer Rodriguez said prior to the panel’s vote, according to Healthday Reporter.
At the Judge Rotenberg Center, 250 youth are strapped with backpacks equipped with a Graduated Electronic Electric Decelerator (GED), a remote control device that allows school authorities to regularly shock the students’ skin on their legs, arms and stomach.
While the Center argues that the therapy is effective at deterring bad behavior, others, including the United Nations Special Rapporteur on Torture, characterize it as torture.
Since 1976, the FDA has approved four GED devices, which fit under the category of an “aversive condition device.” These devices are classified as Class II devices, meaning that they pose a moderate risk to consumers.
According to an extensive report produced prior to the vote, the device currently being used by the Judge Rotenberg Center has “an average output current” that is almost three times that of the devices approved by the FDA, in violation of federal law.
Under the Food, Drug, and Cosmetic Act, the FDA can ban medical devices that pose a “unreasonable and substantial risk of illness or injury.”
With the vote, the FDA panel is recommending banning the devices outright, as has long been advocated by many disability rights organizations.
“Students deserve better. There is a significant risk to health and safety through use of aversive conditioning devices that use a noxious electrical stimulus. In addition, the professional academic literature and practice among professional in the field and government and non-governmental organizations supports this conclusion,” said Curt Decker, executive director of the National Disability Rights Network, which provided comments to the panel, in a news release. “There are more humane and effective alternatives, such as positive behavioral interventions and supports. Therefore, such devices should be banned by the FDA.”
Disability Rights Washington, the publisher of DisAbility Rights Galaxy, is the protection and advocacy system for Washington State, and a member of the National Disability Rights Network.