No matter where in the world you may reprocess a GI endoscope, the process differs little. There are manufacturers’ instructions for use, local regulations, and society guidelines to follow.

And everyone follows them to the best of their ability, according to clinical training specialist Nick Bromiley on the Beyond Clean podcast. The whole system, however, “is flawed,” he added. “The cards are stacked against successful reprocessing.”

Why? There are some key differences in reprocessing in reprocessing standards and practices between the U.S. and the European Union, said Bromiley — who’s both a trainer and a technical expert in endoscope reprocessing — of Ambu USA, one of several competitors developing single-use endoscopes in part to address cross-contamination concerns after reprocessing.

“Right off the bat, the biggest difference is the [U.S. Food and Drug Administration],” he said. “The FDA obviously influences everything that goes on here in the U.S., but outside of the U.S., it bears no relevance at all.”

Some countries are more interested in FDA standards than others. The United Kingdom started a process for reprocessing in 1995 that became the basis for following standards that impact all of Europe. The biggest difference, Bromiley said, it that the U.S. has a single regulatory body while standards can differ in each country across Europe.

All this raises a question: Why do reprocessing standards differ globally when nothing else does, including infection outbreaks associated with reusable duodenoscopes?

“No idea,” Bromiley added. “The anatomy of human beings is the same globally. The endoscopes are the same globally. The reprocessing is the same globally and the issues are the same globally.”

For more on that issue and others — including challenges with sterilization and high-level disinfection and suggestions on how each can be improved — click here for the Beyond Clean episode.

Singleuseendoscopy.com is a learning center of Ambu USA, a single-use endoscope manufacturer.