FDA Proposes Ban on Controversial Electrical Stimulation Devices

FDA has proposed prohibiting electrical stimulation devices (ESD) used to treat aggressive or self-injurious behavior, a move that would make ESDs just the third type of device to be banned. The announcement comes just a month after the agency said it plans to ban powdered medical gloves.

In the proposed rule, which is open for public comment for 30 days, FDA defines ESD as "devices that apply a noxious electrical stimulus to a person's skin to reduce or cease aggressive or self-injurious behavior." FDA notes that these are made and used by only one entity, The Judge Rotenberg Educational Center, Inc. (JRC), a special-needs school in Canton, MA, and have never been marketed or distributed for sale. According to JRC's description, the devices deliver a two-second electrical stimulation via an electrode.

"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 CDRH's Office of Device Evaluation, said in a press release. "These devices are dangerous and a risk to public health--and we believe they should not be used."

Though FDA uses bans very rarely, with just one other device, prosthetic hair fibers, banned before last month's powdered glove proposal, the agency wrote that the ESD ban is needed because there are risks associated with the devices that labeling cannot prevent. One factor is that because ESDs are often used on people with intellectual or developmental disabilities, they can have trouble giving consent or reporting pain or adverse events. Use of ESDs is associated with major psychological and physical risks, FDA wrote, including PTSD symptoms, pain, burns, tissue damange, and unexpected shocks in the case of a malfunction.

A potential ban on ESDs was discussed during a 2014 meeting of the Neurological Devices Panel. According to a transcript of that meeting, representatives from the JRC argued that ESDs are only used in last resort cases and can have positive effects. Glenda Crookes, executive director of the JRC, said during that panel meeting that 60--none under the age of 18--of the school's 241 students use "an aversive conditioning device as one component of their behavior plan." In addition to calling the electrical stimulation "harmless," she described what she sees as the benefits of ESD use:

"The students that JRC treats with the aversive conditioning are those with extraordinary behavior disorders. They typically have been treated ineffectively with a wide range of therapeutic interventions over extremely long periods of time. They come to JRC typically after having been expelled or rejected from 12 to 15 prior placements . . . We have seen students that couldn't even feed themselves, dress themselves, they were not toiled trained, and to see the changes in their existence after the implementation of the treatment is miraculous."

There has been plenty of controversy around ESDs. JRC has faced investigations as well as strong criticism and negative media coverage as a result of its ESD use. According to the FDA press release, JRC estimates ESD are used on 45-50 students now. FDA wrote in the release, "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. A small subgroup of those exposed to these devices may need time to gradually transition away from this device to another treatment. The FDA stands ready to work with health care providers to help facilitate a safe transition to alternate care for all those in need . . ."

In a piece published last week on MD+DI, Nancy Stade, JD, a partner at Sidley Austin LLP who has extensive prior experience at FDA, wrote with seeming foresight about the agency's banning authority:

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