The U.S. Food and Drug Administration has banned the use of shock therapy at a school for students with autism, emotional disturbances, and intellectual disabilities.
The ban specifically affects the Judge Rotenberg Center in Canton, Mass., which uses electrical stimulation devices to curb or stop aggressive and self-injurious behavior in students.
The FDA estimates that between 45 and 50 students are currently subjected to shock therapy, which involves administering electrical shocks through electrodes attached to the skin.
Risks tied to the use of the devices include: depression, anxiety, post-traumatic stress disorder, pain, burns, and tissue damage. The agency also cautioned that “many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain.”
The FDA rule will remove such devices from the market entirely, but the agency did indicate that the ban specifically affects the Rotenberg center.
“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, the 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 to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present.”
National Public Radio member station WGBH first reported news of the final rule on Wednesday.
With the ban, the Rotenberg Center, which serves children and young adults between the ages of 5 and 21, and any other individuals or organizations using the devices now have up to 180 days to comply, giving the school time to transition students to a different treatment plan. The FDA recommended that the school explore using positive behavioral support and medication as alternative approaches to curb unwanted behavior.
In a prepared statement shared with Education Week, the school said it plans to challenge the government ban in court. A parents’ group also defended the practice and said it too would fight the ban.
“The Judge Rotenberg Educational Center (JRC) will continue to advocate for and will litigate to preserve this court-approved, life-saving treatment. FDA made a decision based on politics, not facts, to deny this,” the statement from the center reads. “JRC has exceeded all reporting requirements, and the school opted many years ago to install a 24 hour-per-day video monitoring system offering unprecedented oversight of the students and staff. Those tapes are also available for viewing by family members; family are welcome to visit—without notice—anytime they wish.”
The final rule follows a 2016 FDA proposal to ban electrical stimulation devices in schools. The decision to ban devices is rare: The agency has only banned two other medical devices since 1983.
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