FDA Approves Software to Semiautomate Anesthesia Delivery

The US Food and Drug Administration (FDA) has approved the first software to semiautomate anesthesia delivery during surgery. The software, End-tidal (Et) Control, works with General Electric’s (GE’s) Aisys CS2 Anesthesia Delivery System and allows anesthesia providers to preset the desired end-tidal concentrations of oxygen and anesthetic agent. Once these target levels are set, the system can make adjustments to reach and maintain them throughout surgery.

The premarket approval was announced Monday, April 4, by GE Healthcare.

“A technology that gives us end-tidal control allows us to set the desired end-tidal concentration of anesthetic and oxygen and have the machine make all of the adjustments to get our patient to exactly that level of anesthesia,” said James H. Philip, MD, a senior consultant anesthesiologist and the director of the Anesthesia Clinical Biomedical Engineering Laboratory at Brigham and Women’s Hospital in Boston, in an interview with Medscape Medical News. While he is not currently affiliated with GE Healthcare, he served as a paid consultant for the company from April 2020 to December 2021 to educate on inhalation anesthesia kinetics, he noted.

Controlling anesthesia levels “has always been done by hand while trying to take care of the patient’s other needs, which are often many. This technical detail now can be done with an anesthesia machine that has end-tidal control software,” he said.

In addition to assisting anesthesia providers, the end-tidal control is more efficient, Philip said, and can help reduce drug waste. When manually adjusting fresh gas flow and vaporizer settings, a high flow of carrier gas goes through the vaporizer, he explained. A lot of the gas ends up going out the APL or pop-off valve, which wastes anesthetic. The semiautomated system is programmed to keep the fresh gas flow as low as possible while also reaching the end-tidal concentration, which ultimately results in less anesthetic being used.

This translates to savings for hospitals — because less anesthetic is being used per operation — and reduces the amount of greenhouse gas emissions. (Inhaled anesthetics are potent greenhouse gases, and wasted anesthetic is released into the environment.)

One 2013 analysis of over 3600 cases involving the use of general anesthesia found that use of automated control of end-tidal gases reduced costs by 27% and reduced greenhouse gas emissions by 44%.

“We within anesthesia and respiratory care at GE are very focused on bringing physicians the tools they need to drive the best possible outcome and to do it at the lowest cost,” said Eric Ruedinger, the general manager of anesthesia and respiratory care at GE Healthcare, in an interview with Medscape. As well as being efficient, the system allows anesthesia providers to spend more time focusing on the patient and the surgical environment, “rather than having to dedicate their time to dials and settings,” he added.

The approval was supported by data from a US multicenter clinical trial that included 208 patients aged 18 years and older. The study took place between June 2017 and July 2018. The end-tidal control feature was found to be noninferior to traditional anesthesia gas delivery methods in effectiveness and safety.

In an interview with Medscape, GE did not share the estimated cost of this software, but Philips noted that the addition of this software to the GE Aisys CS2 Anesthesia Delivery System “is not a large fraction of the cost of the machine itself, and the acquisition cost would be offset by savings on anesthetic waste.”

The Aisys CS2 Anesthesia Delivery System with end-tidal control is expected to be available for purchase within the next few months “as we get into the summer months and rolling into fall,” Ruedinger said.

Philip previously served as a consultant for GE, for which he provided education on inhalation anesthesia kinetics.

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