FDA Proposed Reclassification of ECT Devices
March 22, 2016
Robert M. Califf, MD
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Dear Dr. Califf:
The American Psychiatric Nurses Association, an organization representing more than 10,000 practicing psychiatric-mental health nurses, appreciates the opportunity to submit comments to the Food and Drug Administration (FDA) concerning the proposed order related to electroconvulsive therapy (ECT) devices.
It is the position of the American Psychiatric Nurses Association (APNA) that Electroconvulsive Therapy (ECT) is a proven therapy and that further clinical trials are not necessary to establish its safety and efficacy. (Please see attached position statement.) There is a significant level of evidence demonstrated in over decades of scientific and clinical publications, supporting the efficacy and safety of ECT in various conditions. The efficacy of the treatment includes efficacy for major depression, mania, bipolar states, schizophrenia, catatonia and delusional disorders. The evidence does not meet the standard for placebo-controlled trials. Consistent with the existing evidence, APNA urges the FDA to re-classify ECT devices as a class II device that reflects its safety and efficacy in the treatment of depression.
As the leading clinical and research organization for psychiatric-mental health nurses, APNA keenly recognizes that stigma about psychiatric illness and about ECT can limit access. APNA believes that ECT operated by properly trained professionals and in circumstances of medical necessity for appropriately selected patients should remain widely available. ECT saves patient’s lives and barriers limiting access to this treatment must be overcome by a coalition of patient, families, the public and psychiatric leadership organizations.
Thank you for the opportunity to submit comments in support of the reclassification of ECT devices as a class II device.
Mary Ann Nihart, MA, APRN, PMHCNS-BC, PMHNP-BC