Electrical shock devices meant to interrupt self-injurious or aggressive behavior have been banned by federal officials in a rare move.
The only facility known to use these devices in the US is the Judge Rotenberg Educational Center, according to the FDA. The school, based in Canton, Massachusetts, is for people age 5 to adults with behavior issues and intellectual disabilities. The FDA estimates 45 to 50 individuals are exposed to devices there.
The US Food and Drug Administration published a final rule Wednesday to ban the devices after years of pressure and complaints from advocacy groups and family members of people who’ve been treated with shock therapy. The electrical shocks were also an attempt to condition people to stop engaging in self-harming behavior.
“Many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain. Evidence of the device’s effectiveness is weak and evidence supporting the benefit-risk profiles of alternatives is strong,” the FDA said.
It’s rare to ban medical devices
The FDA’s final rule follows a rule proposed in 2016 to ban these electronic stimulation devices from the marketplace. It incorporates minor changes from the proposed rule, including clarification of which devices are banned and an explanation that this ban will not allow continued use of devices.
It’s rare to ban medical devices, the FDA said. It has banned two other devices since gaining the authority to do so in 1976.
Electrical stimulation devices, or ESDs, administer electrical shocks through electrodes attached to an individual’s skin. According to the FDA, the devices provide an “unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.” Risks include depression, anxiety, post-traumatic stress disorder, burns and tissue damage.
“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said Dr. William Maisel, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health.
“Through advancements in medical science, there are now more treatment options available.”
Compliance is required 180 days after publication of the final rule in the Federal Register.