New Duodenoscope Surveillance Sampling & Culturing protocols released

This protocol was developed to detect organisms of concern, some of which have been associated with infectious outbreaks. It is important to note that these protocols are not intended to be used during a suspected outbreak linked to inadequately reprocessed endoscopes; guidance on sampling during outbreaks is not included in this document. The results from this protocol also cannot be used to certify that an endoscope is sterile.

Early detection

While current U.S. guidelines for endoscope reprocessing and infection control do not recommend endoscope surveillance sampling and culturing, some U.S. healthcare facilities have successfully implemented routine or periodic surveillance sampling and culturing of reprocessed duodenoscopes to provide an early notice of potential problems.

Microbiological sampling and culturing of duodenoscopes requires taking samples of duodenoscope channels and the distal end, and then culturing those samples to detect bacteria contamination on or within the duodenoscope after reprocessing.

This document provides definitions and is divided into three sections.

• Section 1 provides an overview and introduction to the sampling and culturing protocols.
• Section 2 outlines the materials and methods for duodenoscope sampling, to be conducted by appropriate personnel who are familiar with handling duodenoscopes.
• Section 3 outlines four different techniques for culturing samples from duodenoscopes, to be conducted by appropriate microbiology laboratory staff, and includes suggested initial limits for microbiological cutoffs based on expert opinion.

The document also includes two appendixes.

• Appendix 1 includes suggested volumes for endoscope channels of various sizes.
• Appendix 2 includes images of duodenoscope sampling to demonstrate duodenoscope design features and sampling equipment.

Guidance is also provided on how to interpret the culture results for high concern organisms and low- to moderate-concern organisms. It provides suggested responses for a healthcare facility to follow from the culture results (classifying the results into four categories: action, alert, modified action and no action). Suggested responses are provided. For example, if a high-concern organism is detected from a reprocessed endoscope, it necessitates that the endoscope be removed from use.

Further, the guidance recommends that healthcare facilities have a plan to include a risk/safety management response, including potential patient notification and follow up when high-concern organisms are cultured from reprocessed endoscopes.

The document is available online (free of charge) at: https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/UCM597949.pdf.