RE: FDA Notice: Electroconvulsive Therapy Devices [74 Fed.Reg. 46607 (September 10, 2009)]
Dear Ms. Cook and associates :
The Delaware Developmental Disabilities Council (DDC) thanks you for this opportunity to comment on the Food and Drug Administration (FDA) Medical Devices: Neurological Devices; Electroconvulsive Therapy (ECT) Device; Establishing a Public Docket regulation that was published in the September 2009 Federal Register.
The DDC understands that the FDA is considering decreasing ECT from a Class III Device to a Class II Device.
The DDC strongly recommends that the ECT Device remain at Class III.
Our concerns focus primarily on safety, privacy, and potential side effects; such as, short and long term memory loss, brain damage, and permanent amnesia.
In researching these devices we find nationally a lack of regulatory and statutory requirements for safety, maintenance of the devices, and oversight of the ongoing calibration and functional services of the devices.
We request that the FDA continue to hold these devices at a Class III intervention and that the FDA continues to do everything possible to ensure the safety of these devices by providing the oversight it requires through safety and efficacy trials.
People with disabilities who receive this form of treatment rely on the FDA to provide the safety that they deserve.
The Delaware Developmental Disabilities Council is federally funded in compliance with the DD Act.
cc. The Honorable Thomas R. Carper, United States Senate
The Honorable Edward Kaufman, United States Senate
The Honorable Michael N. Castle, United States Congress
Linda Andre, Director – Committee for Truth in Psychiatry
STATE OF DELAWARE