
Understanding Endoscope Reprocessing
In this episode of MedDevice by Design, Ariana and Mark examine the complexities of endoscope reprocessing, one of the most difficult tasks in medical device hygiene. These devices contain intricate internal channels and delicate mechanisms that make both cleaning and disinfection incredibly labor-intensive. With endoscopes routinely used in clinical settings, ensuring they are safe to reuse is critical for patient safety and operator health.
Why Endoscopes Are So Hard to Clean
Mark explains that endoscopes are inserted into particularly contaminated environments and are often constructed from materials that cannot withstand high temperatures. This makes steam sterilization ineffective. Instead, hospitals rely on high-level disinfection—an extensive manual and automated cleaning process that includes enzymatic scrubbing, flushing internal ports, leak testing, and finally, drying and hanging.
Innovations in Endoscope Cleaning
To streamline this complex process, manufacturers have developed new automated solutions. The Steris Inspire 300, for instance, eliminates the need for manual cleaning between bedside wipe-down and automated disinfection. Other innovations include the Pentax Aqua Typhoon and Nanosonics Coris, which use entrapped bubbles or pulsatile flow to clean hard-to-reach channels. These advances aim to reduce the physical burden on staff while improving the reliability of endoscope reprocessing outcomes.
Is It Really Safe?
While current reprocessing methods report an adverse event rate of just 1 in 1.8 million, the challenge lies in consistent execution. Missed steps and usability challenges can introduce risk, despite the devices being considered technically safe. That’s why innovations in automated systems are so important—they minimize human error and optimize hygiene.
Explore more in this in-depth episode on one of the most underappreciated challenges in medtech cleaning protocols.
Correction: In this episode, we mistakenly refer to the Steris Inspire 3000 as the “Steris Inspire 300.” The correct name is Steris Inspire 3000. We apologize for the oversight.
Enjoying MedDevice by Design? Sign up to get new episodes sent to your inbox.
Related Resources

For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.

When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.

With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.

This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.