FDA Seeks to Ban Certain Electrical Stimulation Devices

Troy Brown, RN

Disclosures

April 22, 2016

The US Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior. The FDA says the devices "present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling."

ESDs give electrical shocks via electrodes attached to the skin of individuals for the purpose of conditioning them to stop self-injurious or aggressive behavior. "The medical literature shows that ESDs present risks of a number of psychological harms including depression, posttraumatic stress disorder, anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage," according to the FDA's proposed rule.

Many people in whom the devices are used have intellectual or developmental disabilities that limit their ability to communicate their pain or give consent. The FDA says that because these risks cannot be eliminated by changes to the labeling, it is necessary to ban the devices to protect public health.

"Our primary concern is the safety and well-being of the individuals who are exposed to these devices," William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in an agency news release. "These devices are dangerous and a risk to public health — and we believe they should not be used."

The subjective experience of the exposed individual can be difficult to predict. "[V]arious...factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain of a particular set of shock parameters can vary greatly from patient to patient and from shock to shock" the FDA explains.

"Possible adverse psychological reactions are even more loosely correlated with shock intensity in that the shock need not exceed certain physical thresholds. Rather, the shock need only be subjectively stressful enough to cause trauma or suffering. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock."

At this time, only one facility in the United States uses ESDs, according to the FDA: the Judge Rotenberg Educational Center in Canton, Massachusetts. The FDA estimates that between 45 and 50 individuals are being exposed to an ESD at this time.

The current state-of-the-art care is for healthcare providers to use treatments such as positive behavioral support and medications to limit self-injurious or aggressive behaviors in these patients.

The FDA says that a few patients who are exposed to ESDs may need to "gradually transition away from this device to another treatment."

If the proposed ban is finalized, ESDs will be removed from the marketplace entirely; therefore, the FDA will assist healthcare providers in safely transitioning patients to alternate care.

The FDA held a meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee on April 24, 2014, that included an open public forum to discuss issues related to FDA's consideration of a ban on these devices.

The FDA made its decision after reviewing all available evidence, "including clinical and scientific data, input from experts in the field and state agencies, comments from [Judge Rotenberg Educational Center], individuals and parents of individuals on whom ESDs have been used, and disability rights groups, as well as insights from an April 2014 FDA advisory panel."

The FDA will publish the proposed rule on its website on April 25 and is currently seeking comments from the public at https://www.regulations.gov/#!home. Comments need to be submitted by May 25.

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