US Endoscopy Study: Sampling, Culturing, and Evaluating Correctly

  • A post-market surveillance study of duodenoscope reprocessing performed by OLYMPUS in the USA provides important insights into endoscope sampling and culturing [1].

  • The study has shown that implementing a sampling and culturing program helps to increase patient safety and improves internal quality assurance.

  • Taking samples is complex and requires staff having specific knowledge and training.

In a multi-year post-market surveillance study of duodenoscope reprocessing [1], OLYMPUS collected, cultured, and analyzed more than 2000 samples from 21 different study sites in the USA. The outcome from this study is as follows: The benefit of sampling and culturing is supporting the identification of contaminated endoscopes before they are used in patients. It also helps to early identify endoscope washer–disinfector (EWD/AER) maintenance errors and lapses in reprocessing.

In the USA, the protocol “Duodenoscope Surveillance Sampling and Culturing: Reducing the Risks of Infection” is usually consulted when implementing a sampling and culturing program. This protocol was published in 2018 by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the American Society for Microbiology (ASM).

Sampling requires solid expert knowledge

The sampling of endoscopes is complex. Among other things, it involves selecting suitable (critical) sites on the endoscope, applying aseptic technology, and using sterile consumables and suitable personal protective equipment. The sampling environment and how the sample is packaged and sent are also subject to specific requirements. To ensure that all steps are performed correctly, staff must be specially trained and additional required materials must be planned.

Analyzing and understanding laboratory reports

Care should also be taken when selecting the laboratory that will perform the culturing, to ensure that a high-quality procedure will be used. As soon as the laboratory reports are available, the results must be evaluated and analyzed. If microorganisms are detected, the type and number of identified microorganisms will determine which measures need to be taken. For example, one possible consequence is that a contaminated endoscope needs to be taken out of service and re-sampled, or sent in for manufacturer repair.

You can find out more about this topic in OLYMPUS’s current white paper: Tips, Tricks and Insights for Implementation and Management of an Endoscope Sampling and Culturing Program.

Sources and further readings

  1. Data on File, Olympus Corporation of the Americas