Much used, expensive and, most importantly, difficult to clean, duodenoscopes are turning into a pain in the neck for everyone involved.
After years of trying to improve the safety of duodenoscopes, an instrument widely used by hospitals and physician practices in the U.S. for minimally invasive procedures in the small intestine, the Food and Drug Administration in late August recommended all facilities transition from reusable devices to ones that are partly or fully disposable.
Given the continued infection risk for patients with the current design of reprocessed duodenoscopes, hospitals and endoscopic practices should invest in the new scopes on the market with a disposable end cap “or to fully disposable duodenoscopes when they become available,” according to an FDA safety communication.
“We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time,” an FDA spokeswoman said in an email. “We are encouraging healthcare facilities purchasing new duodenoscopes to invest in the newer, innovative models and develop a transition plan to replace their conventional duodenoscopes with newer models.”
But the new recommendations are presenting challenges for providers, manufacturers and infection prevention specialists. While there is evidence that making a duodenoscope’s end cap disposable reduces germs left on the device, it doesn’t solve all the challenges to efficiently cleaning it, experts say. Further, creating a fully disposable duodenoscope opens up cost concerns along with skepticism around physician adoption. There are also worries about environmental waste considering duodenoscopes are used in more than 500,000 procedures annually in the U.S.
“Where are all of these scopes going? They need to be (disposed of) correctly so we’re not filling landfills with all of these disposable scopes,” said Catherine Bauer, immediate past president of the Society of Gastroenterology Nurses and Associates, which developed guidelines for cleaning the scopes.
The trouble with duodenoscopes began in 2013 when the instruments were linked to patients infected with the superbug known as CRE. Three patients at Ronald Reagan UCLA Medical Center died in 2015 from the infection after they underwent a procedure that uses the scope, endoscopic retrograde cholangiopancreatography.