FDA Considers Ban on 'Noxious' Electrical Devices for Behavior Control

Deborah Brauser

April 25, 2014

The US Food and Drug Administration (FDA) is considering a complete ban on aversive conditioning electrical stimulation devices (ESDs) to control aggressive and self-injurious behavior (SIB).

Yesterday, the majority of the 20-member Neurological Devices Panel of the Medical Devices Advisory Committee noted that there is insufficient evidence of efficacy and not enough research about the serious adverse events associated with such devices.

Potential side effects identified by the FDA and linked to ESDs, which administer a noxious electrical stimulus, include burns and other tissue damage, posttraumatic stress disorder (PTSD) and acute stress, anxiety, pain/discomfort, depression, and possible suicidal behavior.

The majority of the panel members recommended a full ban, including a ban on all current and future ESDs. This means that clinicians would need to help current users to transition to different options.

"The FDA appreciates the panel's discussion of this topic. The meeting provided valuable information and perspectives that will help inform FDA's deliberations," Carlos Peña, PhD, from the FDA's Division of General, Restorative, and Neurological Devices, concluded.

However, the FDA has not made any decisions.

"The FDA's primary concern as it considers the continued use of these devices is the safety and well-being of patients," said Dr. Peña.

The FDA is authorized to ban a medical device that presents "an unreasonable and substantial risk of illness and injury" after all available data have been examined, according to Section 516 of the Federal Food, Drug, and Cosmetic Act.

The meeting was convened to discuss only non-self-administered class III aversive conditioning devices, which are typically used as an intervention to prevent repeated aggressive behaviors and self-injury in individuals with severe developmental problems or autism.

Form of Torture?

Throughout the day-long meeting, presentations were made by representatives from professional societies, many of whom called the devices a form of torture, as well as from experts discussing clinical research, clinicians describing their experiences, and even patients who underwent treatment with ESDs and said they were happy with the outcomes.

At the end of the proceedings, panel members were asked several specific questions, which showcased differing opinions.

The majority of panel members answered "no" when asked whether approved options other than ESDs are effective for SIB and aggressive behavior. Of the 25% who answered "yes," most did so with stipulations.

Panel members were also asked whether ESDs are effective, and several said "yes," especially when other treatment options do not work. On the other hand, others maintained there is no real benefit from these devices and pointed out that there is little research to support their use.

Docket number FDA-2014-N-0238 has been opened for any individual to make public comments about a possible ban on ESDs until June 24. The FDA's 126-page Executive Summary, which was prepared before the meeting, is available for free download on its Web site.


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