GE Healthcare has landed FDA pre-market approval for software that allows anesthesia providers to set targets for the end-tidal oxygen and anesthetic agents and reduces greenhouse gas emissions during surgery.
The company claims it is the only manufacturer to have gotten this approval for general anesthesia delivery with its End-tidal (Et) Control technology. It first released the software in Europe in 2010 and serves patients in more than 100 countries, according to the company. The approval process in the U.S. has taken years, the company told Fierce Healthcare. The FDA made its decision based on a clinical trial with more than 200 patients. The company is planning to launch the software in the U.S. in the coming months, it said in an announcement.
Inhaled anesthetic agents in general anesthesia are not only costly, but also harmful to the environment. The Et Control software semi-automates the medication’s delivery, maintaining target levels of oxygen and anesthetics set by the provider.
“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 announcement.
“Safe and effective anesthesia care involves delivering the amount of oxygen and the amount of anesthetic agent that particular patient requires for that particular surgery,” GE Healthcare’s chief medical officer of Life Care Solutions John Beard, M.D., told Fierce Healthcare.
In the absence of Et Control technology, providers rely on manually adjusting these inflows during surgery, a time-consuming process that requires many interventions and has been shown to be less accurate. The software eliminates repetitive tasks and frees up the provider to focus on other responsibilities, ranging from documentation to administering fluids or communicating with nursing staff, Beard said.
The target levels set by the provider depend on the patient and factors like their age, comorbidities or the type of surgery, Beard said, a process that requires a lot 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.
“This is one tool that we think helps to partially automate that process in a meaningful way,” Ruedinger told Fierce Healthcare. He emphasized the software’s high adoption rate outside the U.S., and that its benefits “have been demonstrated in studies in Europe in that real-world setting.”
Initial clinical data has shown this technology can improve delivery accuracy, simplify workflows, reduce drug waste, lower costs and reduce emissions. According to this data, which the company cited in its announcement, its software has the potential to reduce emissions by 44% and manual provider keystrokes by 50%, along with a potential 27% reduction in operating costs.