Deptt. of Psychopharmacology, NIMHANS, Bangalore-560029, India.
Indian J Psychiatry. 2003 Oct;45(4):239-43.
In India, the fidelity of electro convulsive therapy (ECT) devices is not regulated by any statutory body; as a result, it is conceivable that marketed devices may not meet the highest standards of quality. We therefore subjected 4 ECT devices, obtained from 4 different manufacturers, to quality testing in a biomedical engineering laboratory. The newest device was one month old, and the oldest device was 13 years old. Two devices were in regular use, and two were standby instruments, We found that not a single device was working in accordance with the manufacturer's specifications. One device was not working at all; one was delivering varying intensity, uninterrupted current rather than constant current brief pulses (whatever the settings applied); one was delivering blocks of pulses the description of which was enormously at variance with the instrument settings; and one device, the best of the four, was delivering brief-pulses with small errors in each setting that cumulated to an error of 49.3% at a common charge setting for clinical ECT. We conclude that clinicians must test the fidelity of their ECT devices at the time of purchase as well as at frequent intervals thereafter. Finally, the fidelity of ECT devices should be regulated by an appropriate statutory body in India.
在印度，没有任何法定机构监管电痉挛疗法（ECT）设备的准确性；因此，可以想象，市面上的设备可能无法达到最高质量标准。因此，我们在生物医学工程实验室对 4 种来自不同制造商的 ECT 设备进行了质量测试。最新的设备使用了一个月，最旧的设备使用了 13 年。两台设备在正常使用，两台是备用仪器。我们发现，没有一台设备符合制造商的规格。一台设备根本无法工作；一台设备发出的是强度不断变化的、非持续的电流，而不是恒定电流的短脉冲（无论应用何种设置）；一台设备发出的脉冲是块状的，其描述与仪器设置有很大出入；而其中一台设备，是四台设备中最好的一台，在每个设置下都能发出短脉冲，但在临床 ECT 的常见充电设置下，累计误差达到 49.3%。我们的结论是，临床医生必须在购买时以及之后的频繁时间间隔内测试其 ECT 设备的准确性。最后，印度应该有一个适当的法定机构来监管 ECT 设备的准确性。
