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GE Healthcare nabs FDA approval for anesthesia delivery software

por John R. Fischer, Senior Reporter | April 11, 2022
Health IT
GE Healthcare's Aisys CS2Anesthesia Delivery System (Photo courtesy of GE Healthcare)
GE Healthcare has gotten the nod from the FDA for its End-tidal (ET) Control Software, which is designed to automate anesthesia delivery.

The Aisys CS2Anesthesia Delivery System allows anesthesia providers to create targets for end-tidal oxygen and anesthetic agents. The software can then reach and maintain those targets even if the patient’s hemodynamic and metabolic status changes during surgical procedures.

It is the only solution approved by the FDA for ET concentration control in the administration of general anesthesia in the U.S. "Clinicians can be confident that the information displayed is actually measured — not estimated. Responsiveness to changes in patient status is measured in milliseconds, and anesthetic delivery accuracy exceeds published performance specifications of other electronic and conventional anesthesia vaporizers," Eric Ruedinger, general manager of GE Healthcare’s anesthesia and respiratory care business, told HCB News.

Clinicians have traditionally had to spend much time manually and continually adjusting the vaporizer settings' fresh gas flow controls to set and maintain end-tidal concentration targets. The Aisys CS2Anesthesia Delivery System digitally controls its vaporizer, ventilator and gas delivery to reach and keep precise targets from changing.

By being digitally connected to the anesthesia system, the vaporizer provides audible and visual information to the clinician about the anesthetic drug agent levels to reduce the risk of not delivering enough anesthesia, which can lead to the patient awaking and resuming awareness during the procedure.

With the software, providers can also, together, potentially decrease greenhouse gas emissions by 44%, while achieving and maintaining anesthetic targets more accurately. Its semi-automation reduces manual keystrokes by 50%, meaning that providers can spend less time making adjustments and tend to their patients more. The reduction in anesthetic waste also brings down spending for anesthetic agents, which, in turn, reduces operating room costs by potentially up to 27%.

The FDA’s approval was based on results from a multicenter and multiyear study, the MASTER-Anesthesia Trial, which included over 200 patients. The software showed favorable outcomes in safety and effectiveness, compared to conventional anesthesia gas delivery methods. "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,” said Dr. Jim Philip, anesthesiologist and director of clinical bioengineering in the department of Anesthesiology, Perioperative and Pain Medicine at Brigham and Women's Hospital, in a statement.

The company released the Aisys CS2Anesthesia Delivery System in Europe in 2010 and today offers it in over 100 countries.

The company plans to launch the product in the U.S. in the coming months.

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