The AP (3/4, Perrone) reports that on March 4, the FDA “banned electrical shock devices used to discourage aggressive, self-harming behavior in patients with mental disabilities.” The agency’s announcement “follows years of pressure from patient groups and mental health experts who have called the treatment outdated, ineffective and unethical.”
Reuters (3/4, Joseph) reports that in its “final decision,” the FDA cited “substantial risks of illness or injury to patients.” The FDA’s “decision comes after the devices were found to cause tissue damage and worsen underlying symptoms, leading to depression, anxiety and post-traumatic stress disorder.”
According to MedPage Today (3/4, Gever), just one clinic in the US “is believed to use this form of ‘aversive therapy,’ the Judge Rotenberg Educational Center (JRC) in Canton, Massachusetts, where the FDA said it believes some 45 to 50 people ‘are currently being exposed’ to the treatment.” The FDA’s ban, however, “does not apply to electrical stimulation devices used for other ‘aversive’ therapies, such as those approved for smoking cessation,” nor are “non-aversive electrical stimulators, such as for cranial electrotherapy,” affected by the ban.
Related Links:
— “FDA bans shock device used on mentally disabled patients, “Matthew Perrone, AP, March 4, 2020