Make Psychiatric-Mental Health Nursing’s Voice Heard

APNA asks that you send a comment to the FDA to support the reclassification of ECT devices from class III to class II. We believe that this is in the best interests of the patients we serve.

 APNA

The FDA proposes to reclassify ECT devices used for treating major depressive disorder from class III (high risk) to class II (low risk) and is requesting public comment on the safety and efficacy of this treatment (Deadline: March 28). A similar proposal in 2011 did not pass, which is why it is so important to make sure that psychiatric-mental health nurses make our voices heard now.
In 2011 the APNA Board of Directors approved a position statement supporting the use of electroconvulsive therapy in the treatment of severe depression that has been shown to be refractory to medication administration and urging the FDA to reclassify these devices in order to improve access to a potentially lifesaving treatment. APNA will be reiterating this position to the FDA through the following statement, which I encourage you to use as a guide for your own response:
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. Consistent with this, 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.
Nicholas Croce Jr., MS
3141 Fairview Park Drive, Suite 625
Falls Church, VA 22042
(2762)
www.apna.org

 

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