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Anesthesia Automation May Widen GI Professionals’ Use of Propofol
The SEDASYS system will allow nonanesthesia professionals to administer propofol during colonoscopy and esophagogastroduodenoscopy (EGD) procedures provided that certain requirements are met, according to HealthLeadersMedia.
In the past, the gastrointestinal (GI) treatment community has tried to get FDA permission to use propofol, but the SEDASYS system offers a way around the restriction in that it allows these professionals to use the drug without an FDA-approved change of the drug’s label.
Virginia Mason, a 336-licensed-bed hospital in Seattle that performed 9,468 colonoscopies and 4,876 EGDs in 2013, began using the system in September 2014. Otto S. Lin, MD, director of quality for the hospital's Digestive Disease Institute, had been monitoring development of SEDASYS and contacted the manufacturer once it was approved by the FDA. He says the system addresses two major issues: cost and access. The GI program was having trouble scheduling anesthesia professionals to meet demand. And, he says, gastroenterologists can deliver the same sedation care at a much lower cost using the SEDASYS system for low-risk patients.
Not everyone in the anesthesiology community is sold on the SEDASYS system. Concerns about safety led the FDA to reject the device the first time it came up for approval in 2010. A requirement for an intensive training program and postapproval clinical trials led to an FDA nod in 2013. The American Society of Anesthesiologists issued guidelines for the use of the device in 2014, but did not endorse the system.
Karen S. Sibert, MD, an associate professor of anesthesiology at Cedars-Sinai Medical Center in Los Angeles, has written about SEDASYS on the KevinMD blog. She says the device will work fine for routine procedures, but she cautions about the results in situations where there is no one in the room to handle complications. And those complications can come on very quickly. Propofol, Sibert says, can be a "very treacherous medicine," and anesthesiologists have nightmares about being called in to handle a complex breathing problem.
Source: HealthLeadersMedia, September 30, 2015.