Dr Sushma Saroa, Anesthesiologist-Department of CT & MRI, Sir Ganga Ram Hospital
With continuous advancement in technology, anesthesiologists rely on these sophisticated devices to provide safe care to patients and feedback to manufacturers for further advancement of devices Physiological closed-loop controlled devices (PCLC) are an emerging technology that analyzes the specific data to regulate physiological variables by autonomous therapy. They play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during high workload and high-stress environments like in operating rooms, intensive care, and emergency medicine settings and mass casualties’ incidents to ensure adequate and timely therapy delivered automatically.
PCLC devices play an important role in operation theater for closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, closed-loop mechanical ventilation, and monitoring vitals. The anesthesiologist must consider before using the benefit–risk of devices and evaluate system design, system performance analysis, fault detection, fallback modes, user interfaces, and operational transparency. The closed-loop systems should prominently display whether control is on or off and the controller mode. The closed-loop systems should display a graphic trend of all relevant variables and parameters. Users should be able to monitor and track the input signal and the controller output, and also notify the auditory alarms with descriptive text messages required for safe operation.
The user should always be able to determine what the controller is doing, why it is doing it, and what it will do next. The risk with such devices may be from human error, or artifact in physiologic sensors, for example, invasive blood pressure, electroencephalogram, cardiac output, respiratory gases; and in mechanical sensor systems, for example, flows, pressures, and gas concentrations internal to machines. Still the challenges are related to design, development, and performance evaluation. So, PCLC medical device should be robust, stable, and effective in such an environment.