USA – GE Healthcare has received pre-market approval from the FDA for software that allows anesthesia providers to set end-tidal oxygen and anesthetic agent targets and reduces greenhouse gas emissions during surgery.
With its End-tidal (Et) Control technology, the company claims to be the only manufacturer to have received this approval for general anesthesia delivery.
According to the company, it first released the software in Europe in 2010 and now serves patients in over 100 countries. The approval process in the United States has taken years.
The FDA made its decision based on the results of a clinical trial involving more than 200 patients. Consequently, the company intends to launch the software in the United States in the coming months.
In general anesthesia, inhaled anesthetic agents are not only expensive, but also harmful to the environment.
The Et Control software semi-automates medication delivery while maintaining the provider’s target levels of oxygen and anesthetics.
“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.
In the absence of Et Control technology, providers must manually adjust these inflows during surgery, which is a time-consuming process that necessitates numerous interventions and has been shown to be less accurate.
GE Healthcare’s chief medical officer of Life Care Solutions John Beard highlighted that the software eliminates repetitive tasks and frees up the provider to focus on other responsibilities such as documentation, fluid administration, and communication with nursing staff.
The provider’s target levels are determined by the patient and factors such as their age, comorbidities, or the type of surgery, according to Beard, a process that requires a great deal of clinical judgment.
“That’s one of the complexities of anesthesia practice – not all patients are the same,” he said. He noted the software allows for these levels to be adjusted throughout the surgery as needed.
Early clinical data indicate that this technology can improve delivery accuracy, simplify workflows, reduce drug waste, lower costs, and reduce emissions.
According to the data, which the company cited in its announcement, its software has the potential to reduce emissions by 44 percent, manual provider keystrokes by 50 percent, and operating costs by 27 percent.