The FDA and ECT.
The FDA and ECT.
复制标题
FDA 和 ECT。
DOI：
10.1097/yct.0000000000000326
复制
发表时间：
2016
期刊：
影响因子：
--
通讯作者：
McCall,WVaughn
中科院分区：
文献类型：
--
作者：
McDonald,WilliamM;Weiner,RichardD;Fochtmann,LauraJ;McCall,WVaughn
电休克治疗（ECT）在美国的实践已经到了一个非常重要的时刻，我们相信这是一个关键时期，将对美国和其他国家的ECT实践产生长期影响。2015年12月29日，美国食品药品监督管理局（FDA）器械管理办公室提出了对ECT器械重新分类的新规则。该提案包括对ECT设备使用适应症的限制，以及需要向正在考虑ECT的患者及其家属发出的警告（拟议规则的全文[https：//www. gpo。gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592。pdf]和指导文件[http：//www. FDA. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM478942. pdf]可供查阅）。拟议器械标签要求的一些关键特征包括将器械的使用重新分类为限制性较低的II类，用于治疗“18岁或18岁以上患者中与重度抑郁症（MDD）或双相情感障碍（BPD）相关的重度重度抑郁发作（MDE），这些患者治疗抵抗或由于其精神或医学状况的严重性而需要快速反应”（尽管有警告或“特殊控制”）。虽然这是向前迈出的积极一步，但FDA标签建议，对于诊断为紧张症、精神分裂症、精神分裂症样障碍、情感障碍、双相躁狂或混合状态的患者以及18岁以下的患者，ECT器械仍属于限制性更强的类别（即III类）。电休克治疗设备标签也需要有特殊的控制措施，包括“描述使用ECT设备（也称为维持ECT）进行长期治疗的安全性和有效性的可用信息的限制的预防措施”。即使拟议的FDA器械分类和标签最终确定，医生也可能使用该器械“标签外”治疗其他疾病，如精神分裂症和紧张症或维持ECT。然而，我们担心标签上的文字可能会对ECT的可用性产生不利影响。保险公司很可能会拒绝承保不符合FDA批准的设备标签的治疗。此外，由于美国一直存在对医疗事故的担忧，从业者可能不愿意将ECT设备用于标签外适应症。毫无疑问，美国FDA的拟议标签也可能成为其他国家政府监督组织的典范，因此我们鼓励美国以外的临床医生和研究人员发表评论和进行科学讨论。为此，Journal of ECT编辑委员会欢迎来自世界各地的研究人员提交超过30年的论文。第一期《ECT杂志》（当时的标题为《惊厥治疗》）只有一篇来自美国境外（来自以色列）的作者的文章。相比之下，2016年的第一期包括来自中国、比利时、爱尔兰、澳大利亚、西班牙、荷兰、挪威、苏格兰、加拿大和美国的论文。这种国际视角在讨论基于来自世界各地的研究人员和从业者的证据的ECT临床管理的最佳实践中至关重要。例如，在2006年，同一年，
The practice of electroconvulsive therapy (ECT) in the United States has come to a very important juncture, and we believe this is a critical period that will have a long-term impact on ECT practice in the United States and potentially in other countries. On December 29, 2015, the Food and Drug Administration (FDA) Office of Device Management proposed new rules for the reclassification of ECT devices in the United States. The proposal includes limitations on the indications for use of ECT devices and warnings that will need to be given to patients and their families who are considering ECT (the full texts of the proposed rule [https://www. gpo. gov/fdsys/pkg/FR-2015-12-29/pdf/2015-32592. pdf] and guidance document [http://www. fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM478942. pdf] are available for review). Some key features of the proposed device labeling requirements include reclassifying the use of the devices into the less restrictive category II for the treatment of “severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition”(albeit with warnings or “special controls”). While this is a positive step forward, the FDA labeling proposes that ECT devices remain in a more restrictive category (ie, class III) for patients who are diagnosed with catatonia, schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar mania, or mixed states and for patients who are younger than 18 years. Electroconvulsive therapy device labeling would also be required to have special controls that include “a precaution that describes the limitations of available information on the safety and effectiveness of long-term treatment with the ECT device, also known as maintenance ECT.” Even if the proposed FDA device classification and labeling is finalized, a physician could presumably use the device “off-label” to treat other disorders such as schizophrenia and catatonia or to administer maintenance ECT. However, we are concerned that the labeling as written may have an adverse effect on the availability of ECT. Insurance companies may well deny coverage for treatments that are not in line with an FDA-approved labeling of the device. In addition, with ever present concerns about malpractice in the United States, practitioners may be reluctant to use ECT devices for an offlabel indication.No doubt the proposed US FDA labeling could also be a model for government oversight groups in other countries, so we would encourage commentary and scientific discussion from clinicians and researchers outside of the United States. To this end, the Journal of ECTeditorial board has welcomed submissions from investigators worldwide for over 30 years. The initial issue of Journal of ECT (then titled Convulsive Therapy) had only 1 article from an author outside the United States (from Israel). In comparison, the first issue in 2016 included papers from China, Belgium, Ireland, Australia, Spain, the Netherlands, Norway, Scotland, Canada, and the United States. This international perspective has been essential in discussing best practices in the clinical administration of ECT based on evidence from researchers and practitioners around the world. For example, in 2006, the same year that articles were