FDA Bans Electrical Stimulation Devices for Aggressive, Self-Injurious Behavior

Regulatory NewsRegulatory News | 04 March 2020 |  By 

The US Food and Drug Administration (FDA) on Wednesday moved to ban electrical stimulation devices (ESDs) used to treat self-injurious or aggressive behavior, marking the third time in the agency’s history that it has exercised its authority to ban a medical device.
The ban comes nearly four years after FDA first proposed banning the devices, which are only in use at a single facility in the US, the Judge Rotenberg Educational Center in Canton, Massachusetts. FDA estimates the devices are being used on 45 to 50 patients at the facility.
In a final rule dated Friday, FDA says the ban on the devices will take effect after 30 days, though the agency is allowing a 180-day compliance window for devices in use on specific patients, “subject to a physician-directed transition plan.”
Previously, FDA had banned just two other devices, prosthetic hair fibers in 1983 and powdered medical gloves in 2016.
“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 William Maisel, director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health.
Those dangers include significant psychological and physiological harm to patients, such as worsening underlying symptoms, depression, anxiety, post-traumatic stress disorder, pain, burns and tissue damage.
FDA also asserts that newer treatments such as positive behavioral support can be used to treat self-injurious and aggressive behavior without harming patients.
“As the risks presented by ESDs meet the agency’s definition of unreasonable and substantial and cannot be corrected or eliminated through new or updated labeling, banning the product is necessary to protect public health,” FDA writes, noting that the ban does not impact other ESDs, such as those used for smoking cessation.
While the ban is now set to take effect, FDA has been criticized for taking too long to finalize the ban. In a letter to the agency last month, a group of Senate Democrats called on FDA to ban the devices by the end of the month, noting the agency missed its own deadline to finalize the ban in December 2019.
FDA, Federal Register Notice


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