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Regulatory News | 22 April 2016 | By Michael Mezher
The US Food and Drug Administration (FDA) says it intends to ban electrical stimulation devices (ESDs) used to treat aggressive and self-injurious behaviors after an advisory panel recommended banning the devices in 2014.
According to FDA, ESDs are only used to treat aggressive and self-injurious behaviors at a single US facility, the Judge Rotenberg Educational Center in Canton, MA.
FDA proposed the ban in a notice appearing in the Federal Register on Friday, saying ESDs used to treat aggressive and self-injurious behaviors pose a "substantial and unreasonable" risk to patients. The agency also found inconclusive evidence that the benefits of such treatment outweigh the risks, and determined that new labeling alone would not be enough to mitigate them.
Speaking on the ban, William Maisel, acting director of the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health, said, "Our primary concern is the safety and well-being of the individuals who are exposed to these devices."
The proposal comes one month after FDA proposed a ban on powdered medical gloves, and is only the third time the agency has proposed banning a medical device. In 1983, the agency banned the use of prosthetic hair fibers, citing risks to patient health and fraudulent claims of medical performance.
In 2010, the Judge Rotenberg Center was drawn into controversy after a report from the advocacy group Mental Disability Rights International said the center's use of ESD constituted torture.
In 2012, a graphic video of a patient at the center being treated with ESD was shown in court during a case filed against the center by the patient's mother.
Then, in 2013, a report by the United Nations Human Rights Council accused the Judge Rotenberg Center of violating the UN Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment.
After the UN report was released, FDA convened its Neurological Devices Panel to review ESD devices. While the panel was not asked to vote on such a ban, the majority of panelists called on the agency to do so.
ESDs were originally classified as medical devices in 1979 under 21 CFR Part 882.5235 as aversive conditioning devices "used to administer an electric shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics."
In theory, the painful shock caused by the ESD creates a negative association with the behavior being treated. However, in its review leading up to the proposed ban, FDA says it found insufficient evidence supporting any of the claimed benefits of such devices.
In addition to limited evidence supporting the benefit of ESDs, FDA says these devices can cause significant physical and psychological harm to patients, including burns, tissue damage, depression, panic and fear.
Furthermore, the agency says these devices no longer keep up with state-of-the-art therapies to treat aggressive and self-injurious behaviors, writing that the "Scientific advances … have yielded new insights into the organic causes and external (environmental or social) triggers of [self-injurious and aggressive behaviors]. As a result, multi-element positive interventions (e.g., paradigms such as positive behavior support or dialectical behavioral therapy) have become state-of-the-art- treatments [and] can achieve durable, long-term benefits."
FDA Press Release, Proposed Ban
Tags: Aversive, Banned, Center, devices, Educational, Electrical, ESDs, Judge, Rotenberg, stimulation, therapy, Torture