Analysis: Overcoming Human Factors Challenges of Endoscope Culturing with Turbulent Fluid Flow.

Abstract

The lifesaving diagnoses and procedures performed with endoscopes are a vital part of modern healthcare. However, endoscopes are difficult to clean, particularly because of the persistence of biofilms. This creates challenges for manufacturers, healthcare facilities, sterile processing department (SPD) staff, and regulatory agencies seeking to ensure that these complex devices are processed and stored safely and responsibly. This analysis reviews current studies of endoscope processing, focusing on persistent problems with human factors challenges created by current cleaning and sampling methods. It also looks at cleaning verification, highlights the academic call to include microbial surveillance as a necessary task, and identifies an emerging technology—turbulent fluid flow (TFF)—that may help to fill the gaps in this area. Many reports from the Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database demonstrate that flexible endoscopes can inadvertently cause patient harm due to inadequate removal of soil, such as protein and bacterial bioburden, and improper high-level disinfection (HLD) and sterilization after use. In one surveillance study reported in the MAUDE database, a duodenoscope cultured positive for Staphylococcus aureus bacteria after processing. It was reported that the facility failed to properly perform visual checks to determine whether debris was removed and that multiple steps were missed during processing. Residual soil that is not removed from endoscopes during manual cleaning reduces the effectiveness of HLD and sterilization, placing patients at risk for exposure to other patients’ tissue, secretions, and potential pathogens. Studies have described the practical challenges of establishing functional protocols for endoscope processing. These studies point out that the previous explanation for processing failures was primarily based on human factors. A closer examination of the designs of endoscopes and the processes of the cleaning identified daunting challenges related to both vision and memory. Because of limited time and resources of SPDs for verification testing of flexible endoscopes, there is a lack of feedback on cleaning efficacy. Implementation of this testing may help identify processing failures before they pose potential risks to patient safety. One such innovation that can be incorporated into verification testing is TFF. This emerging technology enhances the flushing of endoscope channels for better extraction and can subsequently provide more reliable samples for both cleaning verification and microbial surveillance of flexible endoscopes.