A Safer Way to Clean Duodenoscopes Arrives in Europe

A new CE-marked hydrogen peroxide sterilization cycle takes on one of endoscopy's most persistent infection control challenges

24 Mar 2026

Duodenoscopes save lives. They also spread infections with uncomfortable ease. Their intricate internal channels defeat conventional disinfection methods, and contaminated instruments have been linked to patient outbreaks across European hospitals for years. A new product approval suggests the problem may finally be getting the treatment it deserves.

Advanced Sterilization Products (ASP) and FUJIFILM Healthcare Europe received CE mark approval in January for the ULTRA GI Cycle, a hydrogen peroxide gas plasma sterilization process validated for two FUJIFILM duodenoscope models. The cycle runs on ASP's existing STERRAD 100NX Sterilizer platform, meaning hospitals already using the system need only a software upgrade rather than new hardware. The barrier to entry is unusually low.

The timing is deliberate. European regulators are tightening sterilization requirements under the EU Medical Device Regulation while simultaneously pushing back against ethylene oxide, a widely used but environmentally problematic sterilant. Hydrogen peroxide gas plasma offers a low-temperature, residue-free alternative that fits neatly within both constraints.

Chad Rohrer, president of ASP, said the approval brings this sterilization method into routine clinical practice, giving European clinicians greater confidence in the safety of the instruments they rely on. The claim is meaningful: unlike promotional language about "next-generation solutions," validated low-temperature sterilization has a measurable impact on contamination risk that high-level disinfection, the current standard, cannot fully replicate.

The commercial logic behind the collaboration is as notable as the technology. Rather than leaving hospitals to piece together compatible products from separate suppliers, ASP and FUJIFILM co-validated an end-to-end pathway with regulatory approval included. Hospitals receive a solution that arrives pre-cleared for use, with liability distributed across two established names. ASP has indicated it intends to extend hydrogen peroxide compatibility to additional duodenoscope models, suggesting the partnership model could become a template for the sector.

The broader lesson is structural. Infection control in endoscopy has long suffered from a mismatch between instrument complexity and reprocessing capability. Closing that gap requires not just better chemistry, but tighter coordination between device makers and sterilization specialists. Europe's regulatory machinery, for once, may be nudging the industry in the right direction.