After years of research, debate, and Food and Drug Administration review, the federal agency will allow nonanesthesia professionals to use a device that administers sedation during colonoscopy and esophagogastroduodenoscopy procedures, provided that certain requirements are met.
This article first appeared in the March 2015 issue of HealthLeaders magazine.
Increasingly, a colonoscopy team includes not just a gastroenterologist, but also an anesthesiologist. Not content with conscious sedation achieved through a combination of intravenous drugs, more patients and gastroenterologists are opting for deep sedation that only an anesthesia professional can deliver.
That scenario is about to change. After years of research, debate, and Food and Drug Administration review, the SEDASYS system is now available. The device, the federal agency states, will allow nonanesthesia professionals to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures "provided they have training that meets the requirements and in settings having immediate availability of an anesthesia professional as defined in the labeling."
The emergence of the SEDASYS system and other devices may herald the age of automation in anesthesia. Systems that aid humans in monitoring and responding to vital signs are already routinely used by anesthesiology professionals in Europe. Recent studies suggest the benefits of automated intubation and IV fluid systems. And researchers at McGill University in Canada are also working on the McSleepy, an automated monitoring and drug delivery device.
John Pawlowski, MD, PhD, is director of thoracic anesthesia at Beth Israel Deaconess Medical Center in Boston, a 649-licensed-bed facility with more than 800 full-time staff physicians. While his organization does not currently use SEDASYS, he says the approach is the "wave of the future" because not only are the automated systems more efficient, they are safer. "We never react as well in the third hour of a procedure as we do in the first hour of a procedure."
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.
Tinker Ready is a contributing writer at HealthLeaders Media.