FDA bans electrical shock devices used on people with develo
Released: Doctor's guide to managing the Coronavirus/COVID19 outbreakWatch VideoDownload SlidesReleased: Doctor's guide to managing the Coronavirus/COVID19 outbreakWatch VideoDownload Slides
U.S. Food and Drug Administration published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.

The only facility known to use these devices in the US is the Judge Rotenberg Educational Center, according to the FDA. The school, based in Canton, Massachusetts, is for people age 5 to adults with behavior issues and intellectual disabilities. The FDA estimates 45 to 50 individuals are exposed to devices there.

Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, thus banning the product is necessary to protect public health.

"Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health," said Dr. William Maisel, director of the Office of Product Evaluation and Quality in the FDA's Center for Devices and Radiological Health.
"Through advancements in medical science, there are now more treatment options available."

Source: https://www.fda.gov/news-events/press-announcements/fda-takes-rare-step-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior
Like
Comment
Share