FDA Approves GE Healthcare’s Automated Anesthesia Delivery Software

GE Healthcare received U.S. Food and Drug Administration (FDA) PMA approval for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS² anesthesia delivery system. The technology was initially released in Europe in 2010 and is currently used in over 100 countries.
 
Et-Control software semi-automates anesthesia delivery so providers can set targets for end-tidal oxygen and anesthetic agent. Once set, the software achieves and maintains those targets regardless of hemodynamic and metabolic status changes. Et Control software improves delivery accuracy and simplifies workflows while minimizing drug waste to lower care cost and greenhouse gas emissions.
 
According to the company Et Control software can help lower greenhouse gas emissions by 44%. It increases accuracy in maintaining target oxygen and anesthetic agent concentrations. Keystrokes can be reduced by half and potential OR cost savings of 27 % can be achieved through lower anesthetic agent spend and minimized waste.
 
“In the past, we continually adjusted vaporizer setting and fresh gas flow to control inspired concentration in an attempt to achieve and maintain the end-tidal concentration we wanted for our patients. To have direct control of the end-tidal concentration that reflects the drug level in the patient’s blood is a big step forward for our ability to personalize a patient’s care. Additionally, low-flow anesthesia has benefits for hospitals and the environment,” said Dr. Jim Philip, Anesthesiologist and Director of Clinical Bioengineering, Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital told the press.
 
“Anesthesia providers in the U.S. will have access to the most advanced anesthesia tools available to improve patient care,” said Eric Ruedinger, General Manager of GE Healthcare’s Anesthesia and Respiratory Care business. “As the long-standing global leader in anesthesia delivery, GE Healthcare invested in the development and clinical validation of this Et Control algorithm, and we are committed to creating clinically relevant solutions that will enhance anesthesia practices into the future.”
 
The approval was supported by the over 200 patient MASTER-Anesthesia Trial. It evaluated Et Control software against conventional anesthetic gas delivery methods during general anesthesia. With the approval, GE Healthcare aims to launch its Aisys CS² anesthesia delivery system with Et Control in this upcoming months.