A Cleaner Standard for Europe's Trickiest Endoscopes

ASP and FUJIFILM Healthcare Europe win CE mark for hydrogen peroxide sterilization of complex duodenoscopes across Europe

27 May 2026

European hospitals finally have a validated, regulatory-backed path to safer endoscope reprocessing. In January 2026, ASP and FUJIFILM Healthcare Europe secured CE mark approval for the ULTRA GI Cycle, a hydrogen peroxide gas plasma sterilization method designed specifically for duodenoscopes, instruments notorious for infection risk because of their complex internal channels.

Approved for use on the STERRAD 100NX Sterilizer with ALLClear Technology, the cycle eliminates all viable microorganisms, including bacterial spores. That takes reprocessing well beyond the high-level disinfection most European GI units have historically relied on. Validated for FUJIFILM's ED-840T and ED-840XT models, it is accessible via a cycle upgrade to hospitals already running the STERRAD platform, not a full equipment overhaul. Removing that capital barrier matters.

ASP President Chad Rohrer called the approval a meaningful step toward safer duodenoscope reprocessing across Europe. The company has also outlined a longer-term objective: partnering with device manufacturers to build hydrogen peroxide compatibility into future duodenoscope designs from the start.

Timing works in this approval's favour. Valued at USD 5.23 billion in 2026, Europe's sterilization equipment market is forecast to reach USD 7.75 billion by 2031, with EU MDR documentation requirements accelerating demand for formally approved sterile processing pathways. For sterile processing teams managing rising endoscopy volumes and tighter regulatory scrutiny, CE-marked sterilization offers both clinical assurance and a clean audit trail.

Gas plasma sterilization carries material compatibility constraints, and not all endoscope models currently qualify. Broader adoption depends on how quickly manufacturers integrate hydrogen peroxide compatibility into their design roadmaps. Still, the direction is clear: for complex flexible endoscopes, full sterilization is becoming the standard, not an upgrade.