Anesthesia adds risk and cost to the screening procedure, research shows, raising fresh questions about how providers weigh patient satisfaction against outcomes and profit.
New findings on risks associated with the use of anesthesia during colonoscopies and the demise of the first automated sedation device for use in such procedures add sparks to the debate over how sedation should be delivered in the endoscopy suite.
The decision to scrap Sedasys came last month. It had received FDA approval in 2013. Sedasys is a device designed to allow a gastroenterologist, rather than an anesthesiologist, to administer propofol, a powerful drug that offers heavier sedation but faster recovery than the combination of midazolam and fentanyl commonly used by gastroenterologists.
In a statement to HealthLeaders Media last week, Ethicon, the division of Johnson & Johnson that introduced and later withdrew the device, said:
"The Johnson & Johnson Medical Devices Companies are deeply committed to continuing to bring new, meaningful innovation to market that will enhance patient care and improve outcomes. There were no safety concerns that led to Ethicon's decision to exit the Sedasys business. This was a decision in line with our strategy to prioritize investments in high growth and strategic portfolio opportunities."
Although some guidelines aim to limit the use of anesthesia service to high-risk colonoscopy patients, the practice has risen significantly in recent years. And while it adds to the cost of the procedure, the practice is not limited to high-risk patients.
The use of anesthesia services for colonoscopy patients rose from approximately 14% in 2003 to more than 30% in 2009 to close to 50% in 2013, according to a series of reports from the Rand Corporation.
A study from the Rand Corporation and the Group Health Research Institute published in April in Gastroenterology, found that the risks of complications were 13% higher for colonoscopy patients who receive anesthesia services than those who do not.
"The widespread adoption of anesthesia services with colonoscopy should be considered within the context of all potential risks," researchers at University of Washington in Seattle concluded.
Some anesthesiologists warned that the Sedasys device could be dangerous if used off label. But after being turned down once, it won FDA approval and the American Society of Anesthesiologist issued guidelines for its use.
Jeffrey Apfelbaum, MD, the director of anesthesia services at the University of Chicago Medicine, was all set to try the device. He said the company demonstrated the device at the hospital and a group of gastroenterologists and nurses attended company sessions where they were trained on how to use Sedasys.
But Sedasys was pulled from the market before Apfelbaum was able to implement it at his facility.
"Anesthesiologists have a long history of embracing new technology and advances that improve patient care," he said. "This was the next, natural step in something we needed to explore."
Tinker Ready is a contributing writer at HealthLeaders Media.