Mary Rosedale presented to the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are her remarks as published in the public record of the meeting.
My name is Mary Rosedale. I’m a board certified psychiatric nurse practitioner and an Assistant Professor of Nursing, and I’m here as a representative of the American Psychiatric Nurses Association which has prepared a position statement on this issue.
The American Psychiatric Nurses Association, APNA, was founded in 1986 and is the largest professional association of psychiatric nurses representing both psychiatric nurses at the basic level of practice, RNs, and psychiatric nurse practitioners and psychiatric clinical nurse specialists. APNA is the only psychiatric organization that is inclusive of all RNs in the United States as well as having international members and represents over 7,000 members. It also has a panel of mental health consumers that offer advice to the governing board in formulating policy statements.
We are pleased to offer comments in support of the use of electroconvulsive therapy in the treatment of severe depression that has been shown to be refractory to medication.
For more than seven decades, psychiatric mental health nurses have provided customized treatment to patients receiving ECT. In addition to advancing evidence-based treatment modifications and developing advanced practice nursing roles, psychiatric nurses have been vital patient advocates, assuring that patients receiving accurate information about ECT, educating the public and influencing public policy.
ECT is an effective treatment for severe depression. The literature on the efficacy of ECT for treatment of depression is as extensive as for almost any other medical treatment. Moreover, ECT is a rapidly acting treatment. Multiple trials of adequately administered ECT have demonstrated a speed of antidepressant response for patients experiencing severe major depressive episodes. For patients who urgently need relief of depressive symptoms, such as those who pose a danger to themselves or to others, ECT can be the treatment of choice. For patients who have not responded to or cannot tolerate medications, ECT may be the safest alternative.
Modern techniques and brief pulse devices have increased the safety of ECT. Morbidity and mortality are less than that of childbirth, with 1 to 2 deaths per 10,000 patients treated with ECT. Advances in anesthetic and ECT administrative techniques have greatly mitigated side effects.
The most significant concerns about ECT are the treatment-related cognitive impairment, but even this symptom has been markedly reduced with advances in ECT administration. ECT remains the treatment of choice for severely depressed patients with other concurrent health risks.
And so in conclusion, it is the position of the American Psychiatric Nurses Association that ECT is a proven therapy and that future and further clinical trials are not necessary to establish its safety and efficacy. APNA encourages the FDA to classify these devices in an appropriate manner to assure that patients have access to ECT while at the same time assuring that ECT devices function safely and in the manner intended. APNA believes that ECT operated by properly trained professionals and in circumstances of medical necessity offer patients with severe depression an option that would otherwise be unavailable. APNA stands ready to assist in the development of additional standards of practice in the application of ECT.
Thank you for your attention, and we urge you to reclassify these devices in a manner that provides the proper balance between access to evidence-based treatment and patient safety. Thank you.