Inside the Alliance Redefining Endoscope Safety Standards

A new certified partnership helps hospitals meet tougher EU sterilization rules while improving safety for patients undergoing endoscopy

20 Jan 2026

Cleaning a medical device sounds straightforward until that device is an endoscope. With long channels and complex internal parts, these tools have become a stubborn weak point in hospital infection control. Across Europe, regulators have taken notice, and expectations are rising fast.

Now, a new alliance aims to change how the problem is tackled. Advanced Sterilization Products and FUJIFILM Healthcare Europe have joined forces to rethink sterilization not as an afterthought, but as part of the device itself.

The focus of the partnership is gastrointestinal endoscopes, widely used for diagnosis and treatment, and notoriously difficult to clean thoroughly. Even small lapses in reprocessing can expose patients to serious risk. In recent years, European authorities have responded by tightening rules and demanding clearer proof that sterilization processes actually work in real clinical settings.

Out of that pressure came the ULTRA GI Cycle. Developed and certified jointly by the two companies, the cycle is designed around specific endoscope models rather than generic assumptions. It has earned CE marking, meaning the sterilization process itself meets European safety and performance standards.

For hospitals, that detail matters. The ULTRA GI Cycle can run on existing sterilization equipment, limiting the need for expensive upgrades at a time when many health systems are stretched thin.

Industry observers see this as part of a broader shift. Instead of treating sterilization as a downstream task handled in isolation, manufacturers are increasingly aligning devices and reprocessing systems from the start. The goal is consistency, traceability, and fewer weak links.

Company executives frame the partnership as a response to real clinical workflows, not just regulatory checklists. Regulators, meanwhile, are pushing for more documentation and proven performance across the lifecycle of reusable devices.

Training and system compatibility remain challenges, but most analysts believe the direction is clear. As scrutiny grows, collaborations like this are likely to become the norm, reshaping medical device reprocessing and raising expectations for safety across Europe.