Novel cleaning method for flexible GI endoscopes
Tracks
Plenary Session
| Sunday, May 19, 2024 |
| 11:30 AM - 11:40 AM |
| Grand Ballroom |
Overview
Dr Karen Vickery
Speaker
Dr Karen Vickery
Macquarie University
Novel cleaning method for flexible GI endoscopes
Abstract
Introduction
Flexible endoscopes have been associated with the greatest number of patient infections when compared to other reusable medical devices. The evidence shows patient ready endoscopes can be contaminated despite high level disinfection (HLD) or sterilisation, warranting review of upstream processes. Ineffective manual cleaning of endoscope channels is a root cause of biofilm formation and persistent contamination. The need for enhanced cleaning approaches is underscored by recent evidence demonstrating the resistance of some biofilms to high level disinfectants. Biofilm removal has not historically been a requirement for cleaning validation of endoscopes. Alfa’s published model represents the build-up of tough biofilm during the clinical turnaround of endoscopes. The objective of this study is to assess the performance of an automated endoscope channel cleaner (AECC) under development to address biofilm removal using this model.
Methods
The performance of the AECC was compared to standard manual cleaning according to the instructions for use against cyclic build-up biofilm in simulated suction/biopsy and air/water endoscope channels (polytetrafluorethylene channels of 1.8 m in length). Residual biofilm was assessed after extraction using total organic carbon, protein and bacterial viability. The results were compared to ISO 15883-5:2021 recognised alert levels, and to manual cleaning in matched channels.
Results
The AECC significantly outperformed MC in biofilm removal across both simulated suction/biopsy and air/water endoscope channels (p<0.001). In suction/biopsy channels both cleaning methods reduced protein and total organic carbon to below the ISO 15883-5:2021 internationally recognised alert levels (3 µg/cm2 for protein and 6 µg/cm2 for total organic carbon). AECC significantly outperformed MC across all markers, reducing protein to below the limit of quantitation and Pseudomonas aeruginosa to below the limit of detection. In air/water channels manual cleaning failed with little impact versus positive control. AECC reduced both protein and P. aeruginosa to below the limit of detection and total organic carbon to below the alert level in these channels. The novel technology showed significantly improved biofilm removal in channels tested.
Conclusion
Current manual cleaning methods are unable to remove cyclic build up biofilm from the air/water channels of flexible GI endoscopes. While further clinical studies are needed, AECC shows potential to deliver enhanced cleaning over current practice to all endoscope channels and may thereby address infection risk.
Flexible endoscopes have been associated with the greatest number of patient infections when compared to other reusable medical devices. The evidence shows patient ready endoscopes can be contaminated despite high level disinfection (HLD) or sterilisation, warranting review of upstream processes. Ineffective manual cleaning of endoscope channels is a root cause of biofilm formation and persistent contamination. The need for enhanced cleaning approaches is underscored by recent evidence demonstrating the resistance of some biofilms to high level disinfectants. Biofilm removal has not historically been a requirement for cleaning validation of endoscopes. Alfa’s published model represents the build-up of tough biofilm during the clinical turnaround of endoscopes. The objective of this study is to assess the performance of an automated endoscope channel cleaner (AECC) under development to address biofilm removal using this model.
Methods
The performance of the AECC was compared to standard manual cleaning according to the instructions for use against cyclic build-up biofilm in simulated suction/biopsy and air/water endoscope channels (polytetrafluorethylene channels of 1.8 m in length). Residual biofilm was assessed after extraction using total organic carbon, protein and bacterial viability. The results were compared to ISO 15883-5:2021 recognised alert levels, and to manual cleaning in matched channels.
Results
The AECC significantly outperformed MC in biofilm removal across both simulated suction/biopsy and air/water endoscope channels (p<0.001). In suction/biopsy channels both cleaning methods reduced protein and total organic carbon to below the ISO 15883-5:2021 internationally recognised alert levels (3 µg/cm2 for protein and 6 µg/cm2 for total organic carbon). AECC significantly outperformed MC across all markers, reducing protein to below the limit of quantitation and Pseudomonas aeruginosa to below the limit of detection. In air/water channels manual cleaning failed with little impact versus positive control. AECC reduced both protein and P. aeruginosa to below the limit of detection and total organic carbon to below the alert level in these channels. The novel technology showed significantly improved biofilm removal in channels tested.
Conclusion
Current manual cleaning methods are unable to remove cyclic build up biofilm from the air/water channels of flexible GI endoscopes. While further clinical studies are needed, AECC shows potential to deliver enhanced cleaning over current practice to all endoscope channels and may thereby address infection risk.
Biography
Dr Vickery is Honorary Scientific Director of the Surgical Infection Research Group, at the Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney Australia. Dr Vickery has been at the forefront of research into detecting biofilm associated with breast implant failure, and endoscope and environmental surfaces decontamination failures. Her research aims to prevent healthcare associated infections by focusing on both surgical strategies for preventing biofilm infection of medical implants, treating biofilm infections of chronic wounds and strategies that improve instrument and environmental decontamination. Her expertise in decontamination has led to membership of expert advisory committees for the Australian Therapeutic Goods Administration (TGA), GENCA and Standards Australia.
