The Dirty Secret of the Endoscopy Suite Gets a Fix

ASP and FUJIFILM Healthcare Europe win CE approval for a hydrogen peroxide sterilization cycle for duodenoscopes

1 Apr 2026

Duodenoscopes have long been medicine's awkward problem. The flexible instruments used to examine the bile ducts and small intestine are clinically indispensable, yet their labyrinthine internal channels have repeatedly been implicated in patient contamination incidents. High-level disinfection, the standard reprocessing method, has not always been enough. European regulators have taken notice.

In January 2026, ASP and FUJIFILM Healthcare Europe announced that the ULTRA GI Cycle for the STERRAD 100NX Sterilizer had received CE mark approval. The cycle uses hydrogen peroxide gas plasma sterilization: a low-temperature process that can reach the intricate internal geometries of duodenoscopes without damaging heat-sensitive components. It applies a higher sterility assurance standard than disinfection alone, one that regulators and sterile processing teams have long sought for this instrument category.

Two FUJIFILM models, the ED-840T and ED-840XT, are currently validated for the cycle. Hospitals already running the STERRAD 100NX Sterilizer with ALLClear Technology can access it through a software upgrade rather than a full hardware replacement, a meaningful consideration for procurement teams working within tight capital budgets.

"By bringing hydrogen peroxide gas plasma sterilization into routine practice, we're giving clinicians greater confidence to focus on what matters most: their patients," said Chad Rohrer, President of ASP.

The commercial logic is straightforward. European hospitals face growing compliance pressure under the EU Medical Device Regulation, and a certified reprocessing pathway for one of the most scrutinised instrument types in clinical use offers both a cleaner audit trail and a defensible infection control position. For sterile processing departments, validation matters as much as efficacy.

ASP says its next priority is working with device manufacturers to ensure future duodenoscope designs incorporate hydrogen peroxide compatibility from the outset. If that ambition holds, the approval is less a product launch than a marker of shifting industry norms.

The harder question is whether adoption follows the technology. Upgrade pathways reduce cost barriers, but institutional inertia in hospital procurement is stubborn. A certified solution is a necessary condition for change in infection control practice. It has rarely, on its own, been a sufficient one.