On October 13 and 14, Robert Loeb, M.D., a member and incoming chair of ASA’s Committee on Equipment and Facilities, presented on the potential benefits and challenges associated with Physiological Closed-Loop Controlled (PCLC) Devices at a Food and Drug Administration public workshop. The workshop focused on the design, development and performance evaluation of PCLC systems intended for use in critical care environments; specifically, closed-loop devices for anesthetic delivery, vasoactive drug and fluid delivery and mechanical ventilation.
Anesthesiology was a major focus of the workshop, on both the clinical and engineering side, with several ASA members participating, including: Maxime Cannesson, M.D., Ph.D.; Julian Goldman, M.D.; Jeff Mandel, M.D.; James Philip, M.D.; Steven Shafer, M.D.; Michael Kinsky, M.D.; Colin Mackinzie, M.B., Ch.B; and Steve Parker, M.D.
ASA also submitted formal comments leading up to the workshop.
Physiological closed-loop controlled (PCLC) systems are medical devices capable of autonomously regulating the administration rate of medications or fluids, or of ventilator settings, based on feedback from physiological sensors. Dr. Loeb’s presentation emphasized that the goal of these devices is to augment the physician, not replace them. These devices have the potential to reduce the workload of clinicians and autonomously titrate drugs, resulting in fewer over and under-dose events. In addition, more uniform control allows for less inter-patient variability.
However, Dr. Loeb also pointed out some potential drawbacks with PCLC devices. For example, sensor-level problems, such as artifact in physiologic sensors (e.g., invasive blood pressure, electroencephalogram, cardiac output, respiratory gases) could lead to inappropriate therapy. Dr. Loeb clarified that any potential problems relate to usability and other human factors issues. For instance, PCLC devices may be difficult to set-up, with the many parameters that must be entered. He also stated that it could be difficult for clinicians to recognize problems and resume control when PCLC devices fail or reach their limits.
ASA was pleased to participate in this workshop and will continue to monitor FDA action on PCLC devices.
Learn more about the FDA Workshop