The Food and Drug Administration issued new regulations April 22 that would ban the use of “electrical stimulation devices” as a tool to prevent people with disabilities from engaging in self-injurious and aggressive behaviors.
“Our primary concern is the safety and well-being of the individuals who are exposed to these devices,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a news release. “These devices are dangerous and a risk to public health–and we believe they should not be used.”
The Judge Rotenberg Center, located in Canton, Massachusetts, is the only facility in the country that continues to use these devices as a form of treatment. At the Center, about 250 people with autism spectrum disorders and related disabilities are strapped with remote control devices, known as a Graduated Electronic Decelerators, that allows school authorities to shock them in their legs, arms and stomach when they engage in prohibited behaviors.
Between 1976 and 1994, the FDA approved the use of four such devices, pursuant to its authority under the Food Drugs and Cosmetics Act.
Although the Advisory Committee’s votes are nonbinding, the new regulations reflect practically all of its findings, which cast doubt on all of the Center’s arguments as to the treatment’s beneficial impacts.
“The short-term effect of behavior interruption is outweighed by the numerous short- and long-term risks,” the proposed regulations state. “For many individuals who exhibit (self-injurious behaviors) or (aggressive behaviors), these risks are magnified by their inability to adequately communicate the harms they experience to their health care providers.
“Even if immediate cessation is achieved, without durable conditioning the target behavior will recur over time and necessitate ongoing shocks to cause immediate cessation, magnifying the risks. For some patients, the shocks are wholly ineffective and can lead to progressively stronger shocks with the same result.”
Moreover, the FDA determined that the Center had illegally modified the devices, making the shocks even more powerful than what the FDA authorized.
Accordingly, the FDA found that the devices pose an “unreasonable and unsubstantial risk of illness or injury” that cannot be cured by labeling or any alternative measures, and thus is seeking a complete ban.
The action represents only the third time the FDA has ever sought full prohibition of a medical device, Propublica reported.
The proposal, published in the Federal Register on April 25, is open to public comment until May 25.