Maximizing Effectiveness of Duodenoscope Reprocessing: An SPD Educator's Insights

 

Martin Li, M.A., CRCST, CER, CIS, CHL

 

Introduction

Duodenoscopies play a crucial role in endoscopic procedures, offering unparalleled access to the duodenum via the stomach (see photo 1 & 2 below). Despite their value, their intricate design presents significant reprocessing challenges. As a Sterile Processing Department (SPD) educator, this guide aims to emphasize the critical importance of reprocessing these complex instruments to prevent infection transmission. Here, we delve into the essential steps, challenges, and advancements in duodenoscopy reprocessing, highlighting the necessity of adhering to best practices.

Photo 1. from online for illustration purpose only

Photo 2. Courtesy of dream/time.com. Photo for illustration purpose only.

Background

Duodenoscopies are vital for diagnosing and treating gastrointestinal diseases. However, their complex structure, particularly the elevator mechanism, complicates cleaning and disinfection processes, heightening patient safety risks. Historical infection outbreaks linked to improperly reprocessed duodenoscopies underscore the urgent need for rigorous reprocessing standards (Centers for Disease Control and Prevention, 2008).

Challenges in Duodenoscope Reprocessing

The primary hurdles in duodenoscope reprocessing stem from their intricate design, which includes multiple long, narrow channels that harbor bacteria and are difficult to clean (Society of Gastroenterology Nurses and Associates, Inc., 2016). Additionally, inconsistencies in reprocessing protocols across healthcare facilities contribute to these challenges. Factors such as inadequate training, insufficient time and resources for proper reprocessing, and ineffective visual inspection methods exacerbate the problem (U.S. Food and Drug Administration, 2015).

The extra elevator guide wire (EGW) channel and the elevator housing mechanism at the distal tip add further complexity (Thieme E-Journals, 2017). The emergence of multidrug-resistant organisms (MDROs) compounds the issue, as current reprocessing methods have limitations (Centers for Disease Control and Prevention, 2008). Reports of infections despite adherence to existing protocols indicate a need for continuous improvement and innovation in reprocessing techniques (American Society for Gastrointestinal Endoscopy, 2017).

Failure of Duodenoscope Reprocessing

Failures in duodenoscope reprocessing can arise from unrecognized lapses and intrinsic design issues. Common causes include:

• Inadequate cleaning or drying due to lack of proper training and regular practice reviews (Healthcare Infection Control Practices Advisory Committee, 2014).
• Lack of standardized preventative maintenance schedules (Healthcare Infection Control Practices Advisory Committee, 2014).
• Design features that complicate cleaning (Healthcare Infection Control Practices Advisory Committee, 2014).
• Absence of validated standardized processes to assess cleaning effectiveness (Healthcare Infection Control Practices Advisory Committee, 2014).

Best Practices for Reprocessing

General Guidelines

According to AAMI Standard 91, the general reprocessing procedure for duodenoscopes mirrors that of other scope types. Key points include:

• Always follow manufacturer instructions for reprocessing (Centers for Disease Control and Prevention, 2008).
• Pay special attention to the EGW channel and elevator mechanism due to their complexity (U.S. Food and Drug Administration, 2015).
• Staff must be familiar with their specific scopes, recognizing whether channels are open or closed and understanding the corresponding cleaning protocols (Society of Gastroenterology Nurses and Associates, Inc., 2016).

Reprocessing the Elevator Mechanism

The elevator mechanism, a critical site for potential CRE bacteria survival, requires meticulous attention due to its complexity. This mechanism involves a hinged part connected to a wire, moving the cantilevered riser up and down. Its recessed housing can trap patient soil, forming biofilm and posing an infection risk (Thieme E-Journals, 2017).

Steps for Cleaning:

1. Pre-cleaning: Remove visible debris from the elevator housing and mechanism immediately to prevent drying (Healthcare Infection Control Practices Advisory Committee, 2014).
2. Manual Cleaning:
• Use the appropriate brush (Centers for Disease Control and Prevention, 2008).
• Brush thoroughly in front and behind the elevator (Thieme E-Journals, 2017).
• Move the elevator mechanism up and down during cleaning to ensure all surfaces are brushed (Thieme E-Journals, 2017).
• Ensure no debris remains, as it will solidify (Centers for Disease Control and Prevention, 2008).

Reprocessing the EGW Channel

Due to its small lumen, the EGW channel requires manual reprocessing at all steps. This involves:

• Pre-cleaning: Attach a special auxiliary cleaning adapter to the EGW channel, flush the channel, and follow with an air flush (Centers for Disease Control and Prevention, 2017).
• Manual Cleaning: Given the channel's small size, it is too narrow to brush; hence, high-pressure flushing is critical (Centers for Disease Control and Prevention, 2017).
• High-level Disinfection: Ensure the elevator is in a halfway position. There is concern that AERs might not provide enough pressure to clean the wire channel adequately (Centers for Disease Control and Prevention, 2017).

Microbial Survival in Reprocessing

Microbes can survive high-level disinfection (HLD) due to several factors:

• Inadequate Cleaning: For HLD to be effective, meticulous cleaning is essential. This includes using the correct brush, allocating sufficient time, and monitoring cleaning efficacy using ATP bioluminescence, protein, hemoglobin, and carbohydrate tests (Centers for Disease Control and Prevention, 2008).
• Biofilm Formation: Inadequate manual cleaning and drying support biofilm formation, which is highly resistant to disinfectants and challenging to remove once established. Effective brushing, flushing, and thorough drying are critical to preventing biofilm (Thieme E-Journals, 2017).
• Insufficient Contact Time: Proper microbial kill requires sufficient contact time with detergents and disinfectants, strictly following manufacturer recommendations (U.S. Food and Drug Administration, 2015).

Pre-cleaning and Manual Cleaning

Immediate pre-cleaning at the point of use, followed by meticulous manual cleaning, is crucial. This involves brushing and flushing channels to remove debris, preventing biofilm formation and ensuring subsequent disinfection steps are effective (Society of Gastroenterology Nurses and Associates, Inc., 2016).

High-level Disinfection

Using approved chemical agents and ensuring they contact every surface for the recommended duration is vital. This phase requires precision and adherence to manufacturer guidelines to eliminate harmful microorganisms effectively (Centers for Disease Control and Prevention, 2008).

Drying and Storage

Post-disinfection drying and proper storage are as critical as the cleaning steps, as moisture is a breeding ground for pathogens. Effective drying techniques and storage solutions are essential in mitigating recontamination risks (U.S. Food and Drug Administration, 2015).

Monitoring and Validation

Rigorous monitoring through culturing, ATP testing, and meticulous record-keeping ensures the effectiveness and compliance of reprocessing protocols. Regular microbiological surveillance of duodenoscopes and the use of process validation tools are recommended to maintain high standards (Beilenhoff et al., 2018).

Technological and Process Innovations

The advent of automated re-processors, single-use components, and advanced disinfection technologies like UV light represents significant progress in addressing reprocessing challenges. These innovations, along with potential AI integration for monitoring, pave the way for safer endoscopic procedures. Single-use duodenoscopes are gaining traction for their ability to eliminate cross-contamination risks and streamline the reprocessing workflow (MarkWide Research, 2024).

Regulatory and Policy Considerations

Adherence to FDA guidelines and international standards is essential. Healthcare institutions play a critical role in enforcing these policies, with patient safety and legal implications at stake. Policies must evolve alongside technological advancements to close any safety protocol gaps comprehensively (U.S. Food and Drug Administration, 2015).

Training and Education

Comprehensive staff training, continuous education, and a culture of safety are the cornerstones of effective duodenoscope reprocessing. Simulation-based and hands-on training methods should be integral to preparing SPD staff for the complexities of reprocessing. Ensuring all personnel involved are well-trained and updated with the latest protocols and technologies is crucial for maintaining high infection control standards (Centers for Disease Control and Prevention, 2008).

Future Directions and Research

Ongoing research aimed at enhancing reprocessing technologies and methodologies is vital. The potential of AI and machine learning in refining these processes, along with global collaborative efforts for standardization, holds promise for addressing current challenges and anticipating future needs. Continuous improvement in protocols and adopting innovative technologies are essential in mitigating infection risks and enhancing patient safety (Visrodia et al., 2017).

Conclusion

The effectiveness of duodenoscope reprocessing is not merely a matter of protocol adherence but a cornerstone of patient safety. As SPD educators, advocating for best practices, embracing innovations, and instilling a culture of compliance and continuous improvement is paramount. Our commitment to excellence in every step of the reprocessing cycle ensures that patient care is never compromised.

By prioritizing education, adherence to guidelines, and openness to technological advancements, we can tackle reprocessing challenges head-on, ensuring the safety and efficacy of duodenoscope reprocessing. Our dedication to this cause will continue to play a crucial role in safeguarding patient health and advancing the field of endoscopy.

References

1.      Beilenhoff, U., et al. (2018). ESGE-ESGENA Position Statement on Quality Assurance in Endoscopy Reprocessing: Microbiological Surveillance Testing in Endoscope Reprocessing in Europe. Endoscopy.

2.      Centers for Disease Control and Prevention. (2008). Guidelines for Disinfection and Sterilization in Healthcare Facilities.

3.      Centers for Disease Control and Prevention. (2017). Interim duodenoscope culture method.

4.     Healthcare Infection Control Practices Advisory Committee. (2014). Outbreaks related to the use of duodenoscopes and future directions. http://www.cdph.ca.gov/programs/hai/Documents/HAI-AC-HICPAC-072014.pdf

5.     MarkWide Research. (2024). Duodenoscope Market 2024-2032: Size, Share, Growth.

6.     Society of Gastroenterology Nurses and Associates, Inc. (2016). SGNA Standards: Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes.

7.    Thieme E-Journals. (2017). Endoscopy 2017; 49(11): 1098-1106 DOI: 10.1055/s-0043-120523.

8.    U.S. Food and Drug Administration. (2015). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.

9.    Visrodia, K., et al. (2017). Reprocessing of single-use endoscopic variceal band ligation devices: a pilot study. Endoscopy.