ECT Device Reclassification Draft Guidance – Moira Dolan MD to the FDA, 2016

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Moira Dolan MD

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852

Comment for Docket No. 2014-N-1210 for “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment-Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses”.


I oppose reclassification of Electroconvulsive therapy devices.

The current effort is to reclassify Electroconvulsive therapy devices as Class II devices without requiring manufacturers to submit pre marketing approval (PMA). Class II devices are designed to perform as indicated without causing injury or harm to patient or user with minimal controls – controls such as labeling and instruction inserts. There is no other device that is currently in Class II that can cause seizures, cardiac standstill, life-threatening arrhythmia, flat-lining of brain electrical activity, numerous biochemical and cellular changes associated with brain injury, alterations in brain structures, hemorrhage, memory loss, and permanent cognitive deficits. Instead, devices in Class II are typically non-invasive, and include such benign items as condoms, air purifiers, digital thermometers, and paper surgical drapes.

This evidence was supposed to be evaluated by the Neurological Devices Panel in 2011/12. Detailed FDA testimony that I provided then specifically identified numerous significant deficiencies in the Panel’s own description of their medical literature review, delineating how their review failed to comply with a Government Accounting Office (GAO) mandate to consider the evidence. Anyone in a position of contributing to the reclassification activity bears the responsibility for protection of public health, and all are encouraged to reread the entirety of my 2012 testimony a copy of which is appended as Exhibit B hereto.

At this time I am submitting a new literature review identifying additional evidence, much of which has been published in the intervening 5 years, and none of which are addressed in the FDA’s proposed order listing references justifying the proposed reclassification. This is not intended to be comprehensive nor exhaustive, but focuses on concerns of machine safety, cardiovascular effects, evidence of brain damage and memory loss, with citations relating to miscellaneous adverse outcomes and questions of effectiveness. It is appended as Exhibit A hereto.

The above represents only a small fraction of the medical literature citations that could be supplied to document a wide array of adverse effects of ECT, ranging from serious to life threatening. This is not intended to be comprehensive nor exhaustive, for example I did not attempt to cover the consequences of ECT in persons with pre-existing physical brain abnormalities, the rate of dementia and coma, the comparative all-cause death rates, suicide, disability, the incidence of post-ECT epilepsy, bleeding, eye trauma, and much more.

In the interest of public safety, a device that has the potential to stun the heart causing the same residual disability as a massive heart attack, cause cardiac standstill and fatal arrhythmias, cause severe blood pressure swings that breech the blood brain barrier, and cause flat-lining of brain wave activity – should not be allowed to be down-classified in the absence of PMA studies.