Large Single Center Comparison of Novel and Reusable Duodenoscopes Shows Similar Contamination Rates That Do Not...

Area of Science:

• Gastroenterology
• Infectious Disease Control
• Medical Device Safety

Background:

• Limited data exists comparing contamination rates between reusable and novel duodenoscopes.
• The clinical impact of bacterial contamination in novel duodenoscopes remains unclear.
• This study addresses the need for comparative data on duodenoscope contamination.

Purpose of the Study:

• To evaluate and compare the pathogenic bacterial contamination rates of novel duodenoscopes with disposable caps and reusable duodenoscopes.
• To assess the clinical implications for patients exposed to contaminated duodenoscopes.

Main Methods:

• An observational study was conducted to assess bacterial contamination in reusable and novel duodenoscopes.
• Positive cultures from duodenoscopes led to patient chart reviews for blood culture data and sepsis indicators.
• Sepsis was evaluated using quick sequential organ failure assessment and systemic inflammatory response syndrome criteria.

Main Results:

• The contamination rate for reusable duodenoscopes was 0.80%, while novel duodenoscopes showed 0.0% contamination.
• No statistically significant difference in contamination rates was observed between the two types of duodenoscopes (P = 0.141).
• Gram-negative rods were identified in 4 positive cultures from reusable duodenoscopes; however, no exposed patients developed infection or sepsis.

Conclusions:

• Bacterial contamination rates are similar for novel duodenoscopes with disposable caps and reusable duodenoscopes.
• The low contamination rates observed support the efficacy of current high-level disinfection practices.
• Consistent adherence to disinfection protocols is crucial regardless of duodenoscope generation.