Breaking: New FDA Guidelines Change Everything for Endoscope Reprocessing

🔍 Key Developments in Endoscope Reprocessing

1. FDA Authorization of the CORIS System (March 21, 2025):
   On March 21, 2025, the FDA authorized the marketing of the CORIS System, the first automated endoscope channel cleaner utilizing the CORIS QUANTUM Cleaning Agent. This system is designed to clean endoscope channels of the Olympus EVIS EXERA III CF-HQ190L colonovideoscope, enhancing the cleaning process's efficacy and consistency.

2. Recognition of ANSI/AAMI ST91:2021 Standard:
   The FDA has recognized the ANSI/AAMI ST91:2021 standard, which provides comprehensive guidelines for processing flexible and semi-rigid endoscopes in healthcare facilities. This standard emphasizes the importance of thorough cleaning, disinfection, and sterilization processes to prevent infections associated with endoscope use.

3. Shift Towards Sterilization Over High-Level Disinfection:
   Recent studies and expert recommendations have highlighted the limitations of high-level disinfection, especially concerning complex endoscopic devices. There's a growing consensus on the need to transition towards sterilization methods, such as ethylene oxide (EO) sterilization, to ensure patient safety and reduce infection risks.

🗓️ Implementation Timeline

• Immediate Actions:

  • Healthcare facilities should assess their current endoscope reprocessing protocols in light of the FDA's authorization of new cleaning systems and recognized standards.

  • Training and education programs should be updated to reflect the latest best practices and technological advancements.

• Short-Term Goals (Next 6–12 Months):

  • Evaluate the feasibility of integrating automated cleaning systems like the CORIS System into existing workflows.

  • Begin the transition from high-level disinfection to sterilization methods for applicable endoscopic devices.gastroendonews.com+1fda.gov+1sterility.com+3ajicjournal.org+3verathon.com+3

• Long-Term Objectives:

  • Fully implement sterilization protocols for all semi-critical and critical endoscopic devices.

  • Continuously monitor and adapt to emerging guidelines and technological innovations in endoscope reprocessing.verathon.com+1ajicjournal.org+1

🧠 Final Thoughts

The landscape of endoscope reprocessing is undergoing significant changes, driven by technological advancements and a deeper understanding of infection control. Healthcare facilities must stay informed and proactive in adopting these changes to ensure patient safety and compliance with evolving standards.