Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures. Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.

Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses. Final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).

Transcranial electrical stimulation nomenclature.

Transcranial electrical stimulation (tES) aims to alter brain function non-invasively by applying current to electrodes on the scalp. Decades of research and technological advancement are associated with a growing diversity of tES methods and the associated nomenclature for describing these methods. Whether intended to produce a specific response so the brain can be studied or lead to a more enduring change in behavior (e.g. for treatment), the motivations for using tES have themselves influenced the evolution of nomenclature, leading to some scientific, clinical, and public confusion. This ambiguity arises from (i) the infinite parameter space available in designing tES methods of application and (ii) varied naming conventions based upon the intended effects and/or methods of application. Here, we compile a cohesive nomenclature for contemporary tES technologies that respects existing and historical norms, while incorporating insight and classifications based on state-of-the-art findings. We consolidate and clarify existing terminology conventions, but do not aim to create new nomenclature. The presented nomenclature aims to balance adopting broad definitions that encourage flexibility and innovation in research approaches, against classification specificity that minimizes ambiguity about protocols but can hinder progress. Constructive research around tES classification, such as transcranial direct current stimulation (tDCS), should allow some variations in protocol but also distinguish from approaches that bear so little resemblance that their safety and efficacy should not be compared directly. The proposed framework includes terms in contemporary use across peer-reviewed publications, including relatively new nomenclature introduced in the past decade, such as transcranial alternating current stimulation (tACS) and transcranial pulsed current stimulation (tPCS), as well as terms with long historical use such as electroconvulsive therapy (ECT). We also define commonly used terms-of-the-trade including electrode, lead, anode, and cathode, whose prior use, in varied contexts, can also be a source of confusion. This comprehensive clarification of nomenclature and associated preliminary proposals for standardized terminology can support the development of consensus on efficacy, safety, and regulatory standards.

Electroconvulsive therapy: administrative codes, legislation, and professional recommendations.

Government regulatory involvement in electroconvulsive therapy (ECT) is due to several factors, including patient advocate groups, prior abuse by psychiatrists, and a general trend of state authority to move into areas traditionally governed by medical authorities. Regardless of the specific reasons, ECT is both highly effective in the treatment of many psychiatric disorders and heavily regulated by state administrative codes and legislation. The purpose of this article is to conduct a systematic review of the state administrative codes and legislation for the 50 states, the District of Columbia, and Puerto Rico and to compare the findings with professional recommendations for the administration of ECT.

Influence of anesthetic drugs and concurrent psychiatric medication on seizure adequacy during electroconvulsive therapy.

OBJECTIVE: Electroconvulsive therapy (ECT) is performed under anesthesia and muscle relaxation. Only well-generalized seizures seem to have the high "adequacy" or "quality" that have been claimed to reflect positive predictive power for the outcome of an ECT course. The induction of well-generalized seizures can be potentially influenced by several variables. One major variable is concurrent medication including anesthetic drugs, since most anesthetic drugs are potent anticonvulsives. We hypothesized a negative influence of anesthetics and benzodiazepines but a positive effect of antidepressants and antipsychotics concurrently applied during ECT on seizure adequacy. METHOD: We included inpatients (n = 41) with a DSM-IV-diagnosed major depressive episode treated with ECT (411 ECT sessions) during a period of 20 months (May 2005 to December 2006) in an open label and noncontrolled study. A repeated measurement regression analysis was performed with 8 seizure adequacy parameters as dependent variables. We indirectly quantified narcotic agent influence with bispectral index monitoring. RESULTS: In contrast to the impact of psychiatric comedication, this measure of "depth of narcosis" prior stimulation turned out to influence most seizure adequacy parameters in a highly significant manner. CONCLUSIONS: Thus, we concluded that the anticonvulsive properties of narcotic agents have much higher influence than concomitant psychotropic medication. Our data support the view that a significant influence of concurrent psychotropic drugs on seizure adequacy markers is missing, especially when directly compared with other confounders like stimulation energy, age, and depth of narcosis. The latter suggests to further prove the idea that lighter anesthesia is indeed an important tool to get patients faster into remission.

Clinical predictors of short-term outcome in electroconvulsive therapy.

OBJECTIVES: Electroconvulsive therapy (ECT) remains one of the most effective biological treatments for major depression. However, there is little information on the clinical use of ECT, and most studies were conducted before the introduction of newer antidepressants and before improvements in ECT delivery. This study examined ECT use in a university teaching hospital to determine predictors of short-term ECT outcome. METHODS: This was a retrospective chart review of ECT over the period 1994-1996. Data extracted from the chart included demographic information, clinical features of depression, and documented antidepressant trials. Outcome measures, based on the chart notes, included Clinical Global Impression (CGI) and cognitive side effects of ECT at 1 week post-ECT or at discharge if sooner. RESULTS: Of 174 patients who received ECT, 130 had a diagnosis of unipolar major depressive disorder. Of these 130 patients, 92% were refractory to at least 1 antidepressant medication. After a clinical course of ECT, 87% were rated as "much" or "very much" improved on the CGI. Moderate side effects were noted in 16% of patients, while only 7% had marked side effects. Medication resistance was not related to ECT response. No significant clinical predictors (symptoms, chronicity, number of antidepressant trials) of ECT outcome were found on a stepwise multiple-regression analysis. CONCLUSIONS: These results support previous studies showing that ECT results in very good short-term response in major depressive disorder and that the cognitive side effects of ECT are reasonable. Despite the limitations of this study (retrospective, chart review, global measures), the results will inform clinicians who are recommending ECT for their patients.

Electroconvulsive therapy in Parkinson's disease

Para evaluar el efecto de la terapia electroconvulsivante (TEC) en pacientes con enfermedad de parkinson, Nosotros condujimos un estudio abierto con un curso de siete días de TEC en seis pacientes con enfermedades de parkinson idiopática. El deterioro motor mejoró en todos los casos durante TEC. Esta mejoría fue sostenida en tres pacientes después de 30 días, y persistió hasta el día 60 en un paciente; los registros de depresión mejoraron en cuatro pacientes y los niveles séricos de prolactina estuvieron elevados con cinco pacientes durante la TEC, disminuyendo establemente después. La respuesta a la TEC observada en las valoraciones motoras, congnoscitivas o afectivas pereció que era independiente una de otra. La mejor respuesta en la ejecución motora se observó en aquellos pacientes con una evolución más corta de la enfermedad y etapas más bajas de discapacidad. El método de TEC utilizado en este estudio fue seguro y evitó la apnea o las contracciones musculares. Nosotros concluímos que la electroterapia perece que induce una respuesta favorable aunque afímera en la enfermedad de parkinson. Sin embargo, se deben de hacer estudios controlados a largo plazo. Otros métodos de electroestimulación más selectivos de vías dopaminérgicas se deben de investigar.