| Cautions and Warnings | ||
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ECT is a complex medical procedure. Its proper and safe conduct requires a staff of licensed healthcare professionals trained and experienced with its procedures, who have received clinical privileges for ECT from the appropriate hospital committee, and are thoroughly familiar with the medical literature concerning the risks, benefits, complications, and methods of ECT. This literature includes the major textbooks of ECT, publications about ECT that have appeared in the major journals of psychiatry, the Journal of ECT, and the American Psychiatric Association’s The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging – A Task Force Report (2001). Users of the Thymatron® System IV should read and follow the warnings and recommendations of this Task Force Report. A small minority of patients treated with ECT later report devastating cognitive consequences. Patients may indicate that they have dense amnesia extending far back into the past for events of personal significance or that broad cognitive function is so impaired that the patients are no longer able to engage in former occupations...in some patient self-reports of profound ECT- induced deficits may reflect objective loss of function...In rare cases, ECT may result in a dense and persistent retrograde amnesia extending to years..." The U.S. Food and Drug Administration (FDA) has indicated ECT for use in the treatment of severe major depressive episodes associated with major depressive disorder (MDD) or bipolar depressive disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. ECT has risks. Some patients will experience adverse events in conjunction with electroconvulsive therapy. Patients should be made aware of these risks and confirm that they fully understand them prior to consenting to therapy. The most common reported adverse effects of ECT are: headache, muscle soreness; mild to moderate pain/discomfort, including jaw pain, nausea, disorientation immediately after seizure induction, an memory dysfunction. Specific patient conditions may be associated with substantially increased risk from ECT. These include unstable or severe cardiovascular conditions (recent myocardial infarction, unstable angina, poorly-compensated congestive heart failure, severe valvular cardiac disease), vascular aneurysms susceptible to rupture with increased blood pressure, increased intracranial pressure, recent cerebral infarction, severe chronic obstructive pulmonary disease, asthma, pneumonia and anesthesia risk level ASA 4 or 5. Other serious adverse events have occurred, including adverse reaction to anesthetic agents / neuromuscular blocking agents; adverse skin reactions (e.g., skin burns); cardiac complications, including arrhythmia, ischemia/infarction (i.e., heart attack), acute hypertension, hypotension, and stroke; cognition and memory impairment; brain damage; dental/oral trauma; general motor dysfunction; physical trauma (i.e., if inadequate supportive drug treatment is provided to mitigate unconscious violent movements during convulsions); hypomanic or manic symptoms (e.g., treatment-emergent mania, postictal delirium or excitement); neurological symptoms (e.g., paresthesia, dyskinesias); tardive seizures; prolonged seizures; non-convulsive status epilepticus; pulmonary complications (e.g., aspiration/inhalation of foreign material, pneumonia, hypoxia, respiratory obstruction such as laryngospasm, pulmonary embolism, prolonged apnea); visual disturbance; auditory complications; onset/exacerbation of psychiatric symptoms; partial relief of depressive anergia enabling suicidal behavior; homicidality; substance abuse; coma; falls; and device malfunction (creating potential risks such as excessive dose administration). Severe adverse events are more likely in patients with pre-existing cardiac illness, compromised pulmonary status, a history of brain injury, or medical complications after earlier courses of anesthesia or ECT. Concurrent administration of antipsychotic (neuroleptic) medication may increase the risks of adverse cardiac, pulmonary, and neurological events, and falls. Concurrent administration of stimulants may increase the risks of cardiac and neurological complications, such as prolonged seizure. This information should be assessed in developing the treatment plan for a particular patient. Cognitive side effects are experienced in varying types and severity by ECT patients. Studies have shown that the methods used in ECT administration have a significant impact on the nature and magnitude of cognitive deficits. In general, the American Psychiatric Association recognizes that the following treatment parameters are each independently associated with more intense cognitive side effects: bilateral electrode placement; sine wave stimulation; high electrical dosage relative to seizure threshold, closely spaced treatments, larger numbers of treatments, concomitant psychotropic medications, and high dosage of barbiturate anesthetic agents. ECT may result in anterograde or retrograde amnesia. Such post-treatment amnesia typically dissipates over time; however, incomplete recovery is possible. In rare cases, patients may experience permanent memory loss or permanent brain damage. Users of Thymatron ECT devices should carefully follow the specific ECT treatment techniques and procedures outlined in Chapters 6-11 of the American Psychiatric Association’s The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging – A Task Force Report (2001) Please note that nothing in this document constitutes, or should be construed as, a claim by Somatics LLC that confusion, cognitive impairment, or memory loss (short-term, longterm, recent, remote, transient, or persistent), or structural brain change (brain damage) cannot occur as the result of ECT or the general anesthesia administered with ECT. Many patients experience temporary loss of recent or remote memories with ECT, particularly with traditional bilateral ECT. A few patients have reported experiencing persisting loss of memories or memory functions after ECT. Mental and physical illnesses, anesthesia, medications, and postponement of treatment each have their own adverse effects, which can be substantial. The outcome of ECT treatment depends on many clinical aspects outside the ECT device, including the physical, psychiatric and emotional condition of the patient prior to and at ECT, details of the ECT treatment other than the ECT device settings, including anesthesia and medication exposure. By using the Thymatron System IV, the user accepts responsibility for describing details of those and of pre-existing conditions including brain injury and atrophy, and cognitive difficulties, and for disclosing all appropriate information about risks of ECT to patients, their families and their guardians (if any). Somatics, LLC disclaims responsibility for any medical complications directly or indirectly resulting from the use of this product. Except as expressly provided by this limited warranty, SOMATICS, LLC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF ITS PRODUCTS WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, AND SOMATICS, LLC MAKES NO WARRANTY—EXPRESS OR IMPLIED —INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON- INFRINGEMENT OR COMPLIANCE WITH ANY FEDERAL, STATE OR LOCAL LAW, RULE OR REGULATION. IN ADDITION, SOMATICS, LLC EXPRESSLY DISCLAIMS TO THE FULLEST EXTENT ALLOWED BY LAW, RULE OR REGULATION ANY WARRANTY PROVIDED UNDER ANY LAW. |
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