FDA bans electrical stimulation devices for self-injury, aggression
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The FDA today announced a ban on electrical stimulation devices for self-injurious or aggressive behavior — only the third medical device ban by the agency since it gained the authority to do so.
“Since [electrical stimulation devices] were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” William Maisel, MD, MPH, director of the Office of Product Evaluation and Quality at the FDA’s Center for Devices and Radiological Health, said in a press release. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk [these devices] present.”
According to the FDA, research has shown many physical and psychological risks associated with the use of these devices, including anxiety, depression, pain, burns, tissue damage, PTSD and worsening of underlying symptoms. Further, many individuals exposed to these devices have developmental or intellectual disabilities that hinder their ability to communicate pain. Research has also highlighted the devices’ lack of effectiveness and supports the benefit-risk profiles of alternatives, including positive behavioral support and medications. The FDA noted that the risks of electrical stimulation devices meet its definition of unreasonable and substantial. Thus, they cannot be corrected or eliminated through new or updated labeling, making a ban “necessary to protect public health,” according to the release.
The rule issued today follows a 2016 proposed rule to ban these devices from the marketplace and will take effect 30 days after publication in the Federal Register. For a subgroup of individuals currently exposed to these devices, the FDA will allow time for transition to another treatment by establishing two compliance dates. For those in use on specific individuals as of the date of publication and subject to a physician-directed transition plan, the compliance date is 180 days after publication of the final rule in the Federal Register. For all other devices, the compliance date is 30 days after publication of the final rule in the Federal Register.
Compared with the proposed rule, the final rule includes clarification of which devices are banned and an explanation that the ban is not a special control that allows continued use of the device. The rule does not apply to aversive conditioning devices used purposes, such as smoking cessation, or other FDA-cleared or approved devices or technologies, such as cranial electrotherapy stimulators or transcranial magnetic stimulation.
The Judge Rotenberg Educational Center in Canton, Massachusetts, is the only facility using the devices subject to the ban in the U.S., according to the FDA, which estimates between 45 and 50 individuals are being exposed to the devices.
To view the final rule, visit www.regulations.gov.
Disclosures: Maisel reports employment by the FDA.