Prospective microbiologic evaluation of the forceps elevator in closed-channel duodenoscopes after reprocessing

Area of Science:

• Infection control in healthcare settings
• Medical device reprocessing efficacy
• Gastroenterology and Hepatology

Background:

• Endoscopes are known vectors for bacterial transmission in healthcare.
• Multidrug-resistant infections linked to reprocessed duodenoscopes, particularly after endoscopic retrograde cholangiopancreatography.
• Difficulties in reprocessing duodenoscopes, especially the forceps elevator, contribute to contamination.

Purpose of the Study:

• To prospectively evaluate the efficacy and safety of current reprocessing procedures for Olympus TJF-Q180V duodenoscopes.
• To address concerns raised by the FDA regarding closed-channel duodenoscope reprocessing.
• To assess the risk of bacterial contamination in a clinical setting.

Main Methods:

• Prospective collection of microbiologic surveillance samples from 6 TJF-Q180V duodenoscopes.
• Sampling occurred from August 2015 to March 2016 at the Division of Gastroenterology and Hepatology.
• ESwab collection system used for all samples.

Main Results:

• A total of 237 microbiologic samples were collected from the forceps elevator.
• No microorganism growth was detected in any of the collected samples.
• This indicates successful bacterial removal with the current reprocessing protocol.

Conclusions:

• Diligent adherence to validated reprocessing standards, per manufacturer recommendations, can ensure the safe use of closed-channel endoscopes.
• Further development of validated adaptations for closed-channel duodenoscopes is necessary for simpler and safer reprocessing.
• Establishment of comprehensive postmarket surveillance is crucial for ongoing safety assurance.