Reclassify the ECT Device? – FDA Proposal of 12/29/2016

Edited February 14, 2016

TO ADDRESS FDA PROPOSAL RE: ELECTROSHOCK DEVICE – 12/29/2015 – The following information must be included with any comments to the FDA regarding the Proposal as posted in the Federal Register on December 29, 2015.

START: [Docket No. FDA-2014-N-1210] 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 for Certain Specified Intended Uses. STOP

VIII. Proposed Special Controls (FARCE – ABSURD – l.w.)
Several of the risks associated with ECT, including adverse reaction to anesthetic agents/neuromuscular blocking agents, cardiovascular complications, death, and pulmonary complications, are medical/physical risks related to the procedure involving use of the device. For these risks, safe use of the device is based on appropriate directions for use. FDA believes that labeling provisions are adequate to mitigate these risks, including:

Disclosure
Specific device use instructions
clinical training
Information on the patient population
biocompatibility testing
Labeling (majority of adverse events of ECT) alias – FARCE – ABSURD to suggest that identifying the risks on paper is an adequate form of mitigation; getting rid of the risks.

FDA INFORMATION WORTHY OF ATTENTION:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm240924.htm), there is insufficient evidence of effectiveness for indications including: schizophrenia, bipolar mania (and mixed states), schizoaffective disorder, schizophreniform disorder, and catatonia. [The preceding statement is FALSE]
See: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247595.pdf

LCDR CUNNINGHAM: Question Number 5.
Currently cleared IFUs, or indications for use, for ECT devices include the following:

a. Depression (unipolar and bipolar)
b. Schizophrenia
c. Bipolar manic (and mixed) states
d. Schizoaffective disorder
e. Schizophreniform disorder
f. Catatonia

Comment by LCDR Cunningham Followed Question number 5: Please provide your overall recommendation for the classification (Class I or Class II) of the ECT device for each of the above indications. I’m sorry, Class II or Class III. Of the ECT devices for each of the above indications. I was thinking Class I.

II. Regulatory History of the Device – FDA Proposal – last paragraph:

TRUE: [ On January 27-28, 2011, a meeting of the Neurological Devices Panel was held to discuss the classification of ECT devices for treatment of several disorders.

TRUE: There was panel consensus recommending class III for Schizophrenia, Bipolar manic states, Schizoaffective, and Schizophreniform disorder.

FALSE: The Panel did not reach consensus on the classification of ECT for depression (unipolar and bipolar) and catatonia.

TRUTH: The Advisory Panel of January 2011 DID REACH CONSENSUS for (a.) Depression (unipolar and bipolar)

TRUTH: The Advisory Panel of January 2011 did not reach consensus for (f.) Catatonia

SEE VOTE DETAILS with – Dr. Brott (Chair) for ( a.) depression (unipolar and bipolar)

Vote details for Category A. Depression (unipolar – bipolar)

David H. Mueller, M.S. – Class II (2) – p. 439 – Industry Rep.
E. Francine Stokes McElveen, J.D., M.S. – Class III (3) – p. 440 – Consumer Rep.
Michelle Carras – Class III (3) – p. 440 – Patient Rep.
Jonas H. Ellenberg, Ph.D. – Class III (3) – p. 440 – 442 – Temp. Non-Voting Member
Christopher A. Ross, M.D., Ph.D. – Class II (2) – p.442 – Temp. Non-Voting Member
Karen E. Anderson, M.D. – Class II (2) – p. 443 – Temp. Non-Voting Member
Mae O. Gordon, Ph.D. – Class III (3) – p. 443 – Temp. Non-Voting Member
David C. Good, M.D. – Class III (3) – p. 444 – 445 – Temp. Non-Voting Member
Guerry M. Peavy, Ph.D. – Class III (3) – p. 445 – Temp. Non-Voting Member
Glenn T. Stebbins, Ph.D. – Class III (3) – p. 446 – Temp. Non-Voting Member
Jane S. Paulsen, Ph.D. – Class III (3) – p. 446 – Temp. Non-Voting Member
Kevin Duff, Ph.D. – Class III (3) – p. 446 – Temp. Non-Voting Member
Andrew Winokur, M.D., Ph.D. – Class II (2) – p. 447-450 – Temp. Non-Voting Member
Scott Y.H. Kim, M.D. – Class II (2) – p. 450-454 (vote p. 451) – Temp. Non-Voting Member
William M. McDonald, M.D. – Class II (2) – p. 454-457 – Temp. Non-Voting Member
Wayne K. Goodman, Ph.D. – Class II (2) – p. 457-459 – Temp. Non-Voting Member
Karen B. Domino, M.D., M.P.H. – Class II (2) – p. 459 – Temp. Non-Voting Member

Consensus Vote = Maintain Class III (3) – Nine (9) Votes
Maintain Class II (2) = Eight (8) Votes

THE TRANSCRIPTS OF JANUARY 27-28, 2011, REFLECT THE VOTE BY THE FDA ADVISORY PANEL TO MAINTAIN CLASS III (3) FOR (a.) DEPRESSION (unipolar and bipolar).

IT IS IMPERATIVE THE FDA TAKE IMMEDIATE ACTION TO HALT THE RECLASSIFICATION PROCEDURE DUE TO THE MAJOR ERROR AS DOCUMENTED IN FDA PROPOSAL TO RECLASSIFY THE ELECTROCONVULSIVE THERAPY DEVICE INTO CLASS II (2)

The meetings of January 27-28, 2011 must be all inclusive: The Advisory Panel decision to maintain Class III must not be misinterpreted.

Transcripts of those meetings available here:

January 27, 2011

Click to access UCM247594.pdf

January 28, 2011

Click to access UCM247595.pdf

THE ANNOUNCEMENT IN THE FDA PROPOSAL – IS QUITE SIGNIFICANT

If the FDA proceeds with reclassification under FDASIA (Administrative Rule) they are exhibiting total disregard for the January 2011 Meetings; the Advisory Panel recommendation to maintain Class III for (a.) Depression (unipolar and bipolar) would be nullified. If that be the case then all testimonies received during the Open Public Docket are also nullified as if the Open Public Docket and January 27-28, 2011 never happened.

MY ANALYSIS OF THE PROPOSED ACTION: THE FDA HAS DISCOUNTED ALL DOCUMENTED ACCOUNTS OF PERSONAL INJURY AND IS HELL-BENT ON USING “SUPPORT THE ECONOMY” AS THEIR GROUNDS FOR RECLASSIFICATION.

Edited by Loretta
Speaker: FDA Open Public Docket – Gaithersburg, MD – January 27, 2011