In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors.
Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to ban these kinds of devices.
ESDs administer electrical shocks through skin-attached electrodes to help stop harmful behaviors. The FDA said it has determined that the devices pose an unreasonable and significant risk of illness or injury, particularly to individuals with intellectual or developmental disabilities who face difficulties in communication and decision-making regarding their treatment.
“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage,” Faris said.
If enacted, the ban will remove ESDs from the market, and the devices will not be considered “legally marketed.” Currently, only one facility in the U.S. uses these devices, and an estimated 50 individuals are under treatment plans involving the ESDs, according to the FDA. The agency said those receiving treatment may need time to gradually transition away from the device and adjust to alternative treatment plans.
The FDA’s first ban proposal for ESD devices in 2020 was challenged in court and annulled based on a court’s interpretation of the FDA’s authority to ban devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Changes in the FD&C Act make it clear that the FDA has the authority to issue a ban on certain devices and specific intended uses.
How the FDA decided to propose a ban
FDA’s proposed rule stems from updated data and insights on ESDs, including clinical evidence, expert opinions, feedback from stakeholders, patients and comments from disability rights groups and FDA advisory panels.
“This proposed rule analyzes the new information, available since the FDA engaged in the prior rulemaking, relating to the risks and effects of ESDs and treatment of self-injurious and aggressive behavior,” Faris said.
According to the FDA, the new information provided in the most recent ban proposal supported and did not change the agency’s previous determinations regarding the risks and benefits associated with the devices when ESDs are used for self-injurious or aggressive behavior. It also did not change the agency’s conclusion that the devices could cause “unreasonable and substantial risk” of injury or illness.
The proposed rule will only apply to ESDs intended for use for self-injurious or aggressive behavior. It will not apply to aversive conditioning devices for other purposes, such as smoking cessation. The FDA said those purposes are outside of the scope of the rule.
The FDA invites public comment on the Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior until May 28, 2024, before finalizing its decision.
What is a medical device ban?
A medical device ban completely prohibits a medical device’s sales, distribution, and manufacturing due to substantial deception or unreasonable risk of illness or injury. The FDA has used this authority sparingly, with only two prior bans on prosthetic hair fibers in 1983 and powdered gloves in 2017.
The process for banning a medical device involves rigorous analysis of risks and benefits, including adverse event assessment, literature review, expert consultations and consideration of alternative treatments. A ban can proceed if the device presents substantial deception or an unreasonable risk that cannot be corrected by labeling, according to the FDA.
In the case of ESDs, the FDA determined that numerous risks could not be eliminated through new or updated labeling, and a ban is necessary to protect public health.
