On June 4, more than 70 disability advocacy groups signed a letter to the Food and Drug Administration, calling on the agency to move forward on a proposal to ban a controversial skin shock therapy device.
In April 2014, the FDA’s Medical Device Advisory Committee voted to ban the devices, which are only used at the Judge Rotenburg Center in Canton, Massachusetts.
At the time, many disability advocates thought the vote, though nonbinding, was the first step toward the FDA banning the devices.
But in the year since, the FDA has not opened a notice and comment period, or taken any other steps toward adopting the committee’s recommendations.
“As many experts and disability rights advocates presented at last year’s hearing, contingent skin shock devices pose a substantial risk of skin burns and long-term trauma responses. This risk is unreasonable in light of the limited evidence supporting their efficacy for treating intensive behavioral support needs, their high potential for misuse and accidental activation, and the well-established body of evidence in favor of alternative options that do not rely on pain and fear.”
The devices, called Graduated Electronic Decelerators, are strapped to the backpacks of the 250 youth at the Judge Rotenburg Center. To deter students from participating in bad behavior, school officials remotely control the devices, which when activated, shock the student’s skin, often as many as 250 many times per day.
The Medical Advisory Committee found that the devices presented an “unreasonable and substantial risk of illness of injury,” meaning that under to the Food, Drug and Cosmetics Act, the FDA must ban them.
In addition, it found that the devices used at the Center are three times more powerful than the GED devices approved in 1976, the last time the FDA made any significant change to its regulation of such devices.
“The FDA has an excellent opportunity to demonstrate a firm commitment to safe, humane, and evidence-based treatments for people with disabilities by banning the types of devices used for this appalling and thoroughly unsupported practice,” the letter states.
“While there is only one institution using contingent electric shock at present, we are concerned that any decision short of a total ban might allow for the future expansion of contingent electric shock to other institutions and programs, thus subjecting additional people with disabilities to an unnecessarily painful and dangerous ‘therapy.’”