Comments on FDA’s Proposed Reclassification of ECT Devices for Treating Severe Major Depressive Episodes

Coalition comments
on the Proposed Order
Reclassification of Electroconvulsive Therapy Devices
[Docket No. FDA-2014-N-1210]

 

As members of the Patient, Consumer, and Public Health Coalition, we are writing to strongly oppose the split classification of electroconvulsive (ECT) devices. This reclassification would make ECT devices used for treatment-resistant major depression or depression requiring a rapid response class II (special controls) and all other psychiatric indications class III.

An ECT device applies a brief intense electrical current to a patient’s head to intentionally induce a major motor seizure.1  These devices have only short-term benefits and are known to have serious risks and should only be used when the benefits are likely to outweigh the risks.  That requires clinical trials, inspections, and other safeguards that are part of the PMA review process.  Allowing any ECT devices to be cleared by the FDA through the 510(k) process for any indication puts patients at risk.

ECT can cause cardiac complications, prolonged or delayed onset seizures, and death.2 This risk for harm is not any less when the devices are used to treat depression versus other psychiatric diagnoses.  Eleven of the 14 risks identified by the FDA would be mitigated exclusively by labeling.  However, it is widely known that many doctors do not read the labels on devices carefully, if at all.

Even when the labeling and other controls are followed, the current treatment protocols for ECT devices still carry substantial risks for patients’ cognitive impairment.3 4 5 Studies demonstrate that the percentage of patients with complaints about ongoing memory problems even years after treatment ranges from 29 % to 67%.6 7 8 These memory deficits greatly affect patients’ lives, and an unknown proportion of these patients suffer very severe, persistent memory problems.9 10 11 12  Unfortunately, the percentage of patients who suffer severe memory problems is unknown because the FDA has not required such research. It is not possible to predict the extent to which patients will be affected by a given device and protocol or which patients will develop severe memory problems. 13 14

It would be very dangerous to patients if new ECT-like devices are approved without clinical trials. The strength of the current or voltage, as well as the length, pattern and waveform of the pulse affect the effectiveness and the extent of cognitive impairment.15 16  For example, cognitive impairments are less severe when a brief pulse or ultrabrief pulse is used as opposed to a sine wave because less energy is required to induce a seizure.

Once an ECT device is cleared as a 510(k) class II device, it would serve as a predicate for many other potentially dangerous devices.  In addition, if an ECT device can be cleared through the 510(k) process, device manufacturers have no incentive to apply for approval through the PMA process.  To pretend otherwise is fundamentally dishonest, since the devices could be used off-label for treatment of indications other than depression. The only way to ensure that the benefits outweigh the risks for any indication for which it is approved is to require a PMA review for these obviously high-risk devices.

In conclusion, ECT devices are potentially high-risk devices and should remain as class III and should be subject to PMA review for all indications. The risks for patients associated with down classification of ECT devices for depression greatly outweigh any presumed benefit.

American Medical Women’s Association
Connecticut Center for Patient Safety
MISSD
National Organization for Women
National Women’s Health Network
The TMJ Association
Washington Advocates for Patient Safety
WoodyMatters

 

The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of millions of patients, consumers, health-care professionals, scientists, and public health experts. The coalition can be reached through Stephanie Fox-Rawlings, Ph.D. at sfr@center4research.org or (202) 223-4000. 

 

 

 

  1. Code of Federal Regulations Title 21 Sec. 882.5940, “Electroconvulsive therapy device.” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=882.5940  
  2. Code of Federal Regulations, 21CFR882.5940. Identification of Electroconvulsive therapy device.  
  3. Sackeim HA. (2014). Autobiographical memory and ect: don’t throw out the baby. J ECT 30(3): 177–186.  
  4. Tor PC, Bautovich A, Wang MJ, Martin D, Harvey SB, Loo C (2015). A systematic review and meta-analysis of brief versus ultrabrief right unilateral electroconvulsive therapy for depression. J Clin Psychiatry 76(9):e1092-8.  
  5. Verwijk E, Comijs HC, Kok RM, Spaans HP, Stek ML, Scherder EJ. (2012). Neurocognitive effects after brief pulse and ultrabrief pulse unilateral electroconvulsive therapy for major depression: a review. J Affect Disord 140(3):233-43.  
  6. Chakrabarti S, Grover S, Rajagopal R (2010). Electroconvulsive therapy: a review of knowledge, experience and attitudes of patients concerning the treatment. World J Biol Psychiatry 11(3): 525-537.  
  7. Sienaert P1, De Becker T, Vansteelandt K, Demyttenaere K, Peuskens J. (2005). Patient satisfaction after electroconvulsive therapy. J ECT 21(4):227-31.  
  8. Rose D, Fleischmann P, Wykes T, Leese M, Bindman J. (2003). Patients’ perspectives on electroconvulsive therapy: systematic review. BMJ 326:1363.  
  9. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMcfm Manufacturer and User Facility Device Experience (MAUDE) Database.  
  10. Smith M, Vogler J, Zarrouf F, Sheaves C, Jesse J. (2009). Electroconvulsive therapy: the struggles in the decision-making process and the aftermath of treatment. Issues Ment Health Nurs 30:554–559  
  11. Vamos M (2008). The cognitive side effects of modern ECT: patient experience or objective measurement? J ECT 24: 18-24.  
  12. Donahue AB.(2000) Electroconvulsive therapy and memory loss: a personal journey. J ECT 16(2): 133-143.  
  13. Donel M. Martin, Verònica Gálvez, Colleen K. Loo (2015). Predicting retrograde autobiographical memory changes following electroconvulsive therapy: relationships between individual, treatment, and early clinical factors. Int J Neuropsychopharmacol 18(12): pyv067.  
  14. McClintock SM, Choi J, Deng ZD, Appelbaum LG, Krystal AD, Lisanby SH. (2014). Multifactorial determinants of the neurocognitive effects of electroconvulsive therapy. J ECT 30:165-176.  
  15. McClintock SM, Choi J, Deng ZD, Appelbaum LG, Krystal AD, Lisanby SH. (2014). Multifactorial determinants of the neurocognitive effects of electroconvulsive therapy. J ECT 30:165-176.  
  16. Prudic J (2008). Strategies to minimize cognitive side effects with ECT: aspects of ECT technique. J ECT 2008;24:46-51.