FDA Proposes Ban On Electrical Stimulation Devices Used On Children At Controversial Special Needs School
Federal regulators have called for a ban on electrical stimulation devices used during controversial treatment for children and teens at risk of engaging in aggressive or self-injurious behavior.
The proposal to ban electrical stimulation devices (ESDs) was announced by the FDA in a news release April 22.
Only one facility in the United States is known to be using these devices, the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, which is a residential facility that uses aversives, or unpleasant stimuli to punish behavior.
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Electrical stimulation devices administer electrical shocks through electrodes attached to the skin. The device is used to condition individuals to stop engaging in behavior that may cause them to injure themselves or someone else, but has drawn criticism from educators and consumer advocacy groups nationwide.
The FDA indicates that banning medical devices is taken very seriously, and after careful consideration, the agency believes a complete ban on the electrical stimulation devices is in the best interest of the public. Complete bans of this type are only done on “rare occasions” and proposed when there is an “unreasonable and substantial risk to public health” that cannot be corrected or eliminated through changes to the labeling.
“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. “These devices are dangerous and a risk to public health–and we believe they should not be used.”
About 45 to 50 individuals at the Judge Rotenberg Educational Center are currently exposed to ESDs.
Researchers warn that treatment with the devices may cause depression, anxiety, worsening of self-injury behaviors and symptoms of post-traumatic stress disorder. Individuals who undergo ESD may also experience pain, burns, tissue damage and errant shocks from a device malfunction.
The FDA also concluded there is a risk that many people who undergo the treatment cannot communicate their pain or offer consent, since many who are treated also have intellectual or developmental disabilities. These risks cannot be eliminated through new or updated labeling.
The proposed ban was announced in response to the recommendation of an FDA advisory panel in 2014. The panel recommended the FDA ban behavioral modification devises, ESDs, used to deliver shocks to the users. While the vote was not binding for the FDA, the agency often follows recommendations from advisory panels, as it did in this case.
Helping or hurting
Following the advisory panel’s recommendation, JRC said it stood by its use of the devices and has always used them with parental consent or approval of a probate judge. The facility described the shock as a sharp pinch that helps prevent the need for powerful psychotropic drugs, life-long institutionalization and other negative outcomes.
But during its own investigation, FDA reviewers found at least six instances of PTSD, two instances of depression and suicidal behavior, and at least one death associated with the devices, though the reviewers cautioned there was no direct causal link between ESDs and the death and suicide cases.
The FDA said those currently using the treatment may need time to gradually transition away from the device to another treatment and the agency is prepared to work with health care providers for a safe transition to alternate care.
If the proposed ban is finalized, it would remove the devices from the marketplace completely.
“The FDA believes that state-of-the-art behavioral treatments, such as positive behavioral support, and medications can enable health care providers to find alternative approaches for curbing self-injurious or aggressive behaviors in their patients,” the FDA news release states.
The FDA notice said the agency considered all available evidence, including clinical and scientific data, input from experts in the field and state agencies, comments from JRC, individuals and parents of individuals who ESDs have been used on, disability rights groups, and insights from the April 2014 FDA advisory panel.
The proposed ban will be available for public comment for 30 days.
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