Endoscope Manual Cleaning: The Challenges that Impact Our Effectiveness

Cleaning verification and improved visual inspection requirements provides a better understanding of sterile processing practices, patterns and outcomes; it sheds light into how truly effective our processes are. With this added awareness we can recognize weaknesses in processes and target imperfections at their root. With quality management systems in place, we can improve handling, point of use treatment, and process flows. However, cleaning verification is still a reactionary measure and doesn’t directly correct the discrepancies that are identified. It is only one part of the whole in reprocessing improvements.

We see many proactive upgrades and improvements to our automated processes: pass-thru sterilizers and AERs, washer/disinfectors with attachments to hook up cannulated instruments to name some. But what about our manual cleaning process? What practices do we have that could be improved? We have automated flushing devices that aid in standardized and measurable consistency, automated leak testers and required soak times to ensure appropriate enzymatic contact time. But what about the manual process of brushing?

Brushing uses friction to loosen and sweep debris and gross soil from inside the channel, but often requires multiple passes. The quality of clean isn’t immediately identified without the use of borescope inspection or cleaning verification.

Challenge 1: Endoscope Design & Integrity

We know that endoscopes and reprocessing have been under stringent surveillance and for good reason! Ofstead and Associates released a graph showing a quarter over quarter increase in reports to the FDA of endoscope adverse events with insufficient reprocessing being a contributing factor. More than 8000 events were reported in Q2 of 2024 alone.

Scopes are complex in design and for nurses and technicians, much of the manual reprocessing is done blindly with little visualization during the cleaning phase. In addition to the complex design, there is also expected wear and tear that occurs with repetitive use. This wear and tear can lead to scratches and imperfections that go unidentified and are great area for harboring bacteria, bioburden and biofilm formation.

Complex design and integrity of channels leads to questions such as:

• Is the brush pliable enough to conform to the imperfections and brush away debris and bioburden that may be caught up in the crevices and scratches?
• How effective is the brush’s design? Is there validation behind the instructions for use that prove its impact on cleaning?
• Is the functionality in the design sufficient for variables in scope conditions and level of gross soil?

Challenge 2: Outdated technology

Technology such as automation, software and medical device design changes rapidly and often at a pace we can’t keep up with. Yet, we continue to see redundancy and little advancement in much of our manual processes and the tools provided to complete the work.

Manual cleaning can include leak testing, rinsing, soaking, brushing and flushing. Though some of these processes have been automated, there are still areas of opportunity  to improve our outcomes and ease the process on our technicians. Things like updated design, material compatibility and universal use can aid in outcomes, ease of accessibility and technician experience.

A process such as brushing can remain manual, but still have improvements. Using already existing technology like squeegee material, sweeping methods and bristle design and placement can result in a time savings, ergonomic improvements and ultimately cleaning effectiveness.

Challenge 3: Variance in practices

Variance in practices extends beyond tech-to-tech differences. We can see variance by the same tech that results from:

• Fatigue
• Reprocessing competency
• Environmental influences:
  • Scope volume
  • Scope types
  • Staffing availability
• Endoscope design
• Cleaning supply versatility

Look at your brush inventory and count the variety of brushes and the different brush manufacturers. Each one is probably slightly different than the other.

Variances to some degree are to be anticipated. However, as we continue to look at our practices against standards, regulations and best practices, it is with due diligence that we objectively look at what we can do to fall closer in line with standardized expectations and outcomes.

Conclusion:

From design to technology and the variety of materials and techniques, each factor can create a unique challenge that may not immediately pose a risk, but may lend to issues later on in the process.

Brushing is acknowledged as an important component to proper endoscope reprocessing practices (ANSI/AAMI ST91: 7.6) and worth further investigating to identify best practice and validation. Understanding the challenges, conducting risk analysis and researching updated practices and technology can improve support, processes and confidence in the quality of work complete.

Resources:

ANSI/AMI ST91: 2021