ESDs have been used to reduce or eliminate self-injurious or aggressive behavior by applying an electric shock to the skin. According to the proposal, FDA determined that ESDs “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.” The proposed rule also cited ethical concerns, as many people exhibiting aggressive or self-injurious behavior are among a vulnerable patient population due to intellectual or developmental disabilities. Such patients may have difficulty communicating pain or consent, and may be unable to make their own medical treatment decisions.
FDA’s “primary concern is the safety and well-being of the individuals who are exposed to these devices,” according to William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in an April 22 press announcement.
“These devices are dangerous and a risk to public health–and we believe they should not be used.”
FDA research indicates that only one facility is using ESDs to treat aggressive and self-injurious behavior in the United States, treating an estimated 45-50 people. Although medical practice has largely evolved toward positive behavioral treatments, sometimes combined with medication, the proposed rule “would ultimately remove these devices from the marketplace completely.”
FDA medical device bans are rare and typically used only when necessary to protect public health. However, the proposed ESD ban follows just one month after a March proposal to ban powdered gloves. The only medical device ban currently in effect was issued in 1983, covering implantable prosthetic hair fibers for concealing baldness.
The proposed rule is available online for public comment for 30 days.