Elsevier

Gastrointestinal Endoscopy

Volume 87, Issue 1, January 2018, Pages 104-109.e3
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
Implementation of a systematic culturing program to monitor the efficacy of endoscope reprocessing: outcomes and costs

https://doi.org/10.1016/j.gie.2017.05.001Get rights and content

Background and Aims

In 2015, the U.S. Food and Drug Administration and Centers for Disease Control and Prevention (CDC) issued guidance for duodenoscope culturing and reprocessing in response to outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) duodenoscope-related infections. Based on this guidance, we implemented best practices for reprocessing and developed a systematic process for culturing endoscopes with elevator levers. The aim of this study is to report the outcomes and direct costs of this program.

Methods

First, clinical microbiology data from 2011 to 2014 were reviewed retrospectively to assess for possible elevator lever-equipped endoscope-related CRE infections. Second, a program to systematically culture elevator lever-equipped endoscopes was implemented. Each week, about 25% of the inventory of elevator lever-equipped endoscopes is cultured based on the CDC guidelines. If any cultures return bacterial growth, the endoscope is quarantined pending repeat culturing. The costs of the program, including staff time and supplies, have been calculated.

Results

From 2011 to 2014, none of 17 patients with documented CRE infection had undergone ERCP or endoscopic ultrasound in the previous 36 months. From June 2015 to September 2016, 285 cultures were performed. Three (1.1%) had bacterial growth, 2 with skin contaminants and 1 with an oral contaminant. The associated endoscopes were quarantined and reprocessed, and repeat cultures were negative. The total estimated cost of our program for an inventory of 20 elevator lever-equipped endoscopes was $30,429.60 per year ($1521.48 per endoscope).

Conclusions

This 16-month evaluation of a systematic endoscope culturing program identified a low rate of positive cultures after elevator lever endoscope reprocessing. All positive cultures were with non-enteric microorganisms. The program was of modest cost and identified reprocessing procedures that may have led to a low rate of positive cultures.

Introduction

Since 2008, multiple outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) duodenoscope-related infections have been reported.1, 2, 3 As a multidrug-resistant organism, CRE can cause serious infections with limited treatment options and a resultant high mortality.4 Duodenoscopes possess an elevator mechanism that allows for advanced endoscopic maneuvers but pose a challenge for reprocessing and decontamination. Linear-array echoendoscopes (LAEs) are also equipped with an elevator lever that facilitates diagnostic and therapeutic maneuvers and have also been shown to be at risk for persistent bacterial contamination.5

In 2015, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) issued guidance for duodenoscope culturing and reprocessing in response to these outbreaks.6, 7, 8 These guidelines noted that routine culturing could be considered to assess the adequacy of reprocessing; however, the frequency of culturing was not specified. Furthermore, the American Society for Gastrointestinal Endoscopy (ASGE) and the American Gastroenterological Association (AGA) provided recommendations, which included the periodic culturing of elevator lever-equipped endoscopes.9, 10 Multiple different strategies to prevent duodenoscope-related transmission of infection have been proposed, including quarantine protocols, different culturing methods and frequencies, gas sterilization with ethylene oxide, and double reprocessing cycles.9, 11, 12, 13 However, the effectiveness of these programs as well as their financial implications remain unclear.

A multidisciplinary process for systematic sampling and culturing of elevator lever-equipped endoscopes was developed and implemented at our institution in June 2015. The aims of this study are to assess if previous known CRE infections were potentially associated with procedures using elevator lever-equipped endoscopes and to assess the effectiveness of this culturing program and the costs associated with its implementation.

Section snippets

Setting

Penn Medicine is comprised of, among other entities, 4 hospitals with 2503 hospital beds, ranging from community to quaternary care. An average of 2300 endoscopic procedures using elevator lever-equipped endoscopes are performed annually. Informed consent for procedures with elevator lever-equipped endoscopes includes education regarding the possible risks of infection during the procedure. The risk of CRE infection is not directly addressed routinely.

Best practices

Best practices for endoscopic reprocessing

Retrospective review of CRE infections

During the 4-year period from 2011 to 2014, review of clinical microbiology data identified 17 patients with CRE blood or abdominal infections reported to the CDC National Healthcare Safety Network. Of these 17 CRE infections, 10 were intra-abdominal, 6 were from a surgical site, and 1 was blood borne. None of these 17 patients had undergone a procedure with an elevator lever-equipped endoscope in the 36 months before their CRE infection.

Elevator lever-equipped endoscope culturing

From June 2015 to September 2016, a total of 285

Discussion

Several recent duodenoscope-associated CRE outbreaks have prompted re-evaluation of existing reprocessing and culturing practices.1, 2, 3 Action plans have been developed by the FDA, CDC, AGA, and ASGE, and among the different points addressed by these plans, periodic culturing of elevator lever-equipped endoscopes has been recommended; however, a specific protocol and frequency for such culturing has not been clearly defined.6, 7, 8, 9, 10 A multidisciplinary team from gastroenterology,

References (19)

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Cited by (20)

  • Technological review: developments in innovative duodenoscopes

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    Given the higher rates of infection transmission identified from duodenoscopes, it is likely that the potential for transmission of pathogenic organisms because of incomplete reprocessing is a problem inherent to current reusable duodenoscope design.29 Multiple studies have compared the effectiveness of duodenoscope reprocessing methods and/or suggested improvements to reprocessing.7,30-60 To date, however, no reprocessing strategy for reusable duodenoscopes has completely eliminated the growth of bacteria on surveillance cultures.

  • American Society for Gastrointestinal Endoscopy Infection Control Summit: updates, challenges, and the future of infection control in GI endoscopy

    2021, Gastrointestinal Endoscopy
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    Similar outbreaks have been reported across Europe and Asia.13-20 Further investigations after these outbreaks have yielded contamination rates among duodenoscopes and echoendoscopes ranging from .7% to 60% with high-concern organism culture-positive rates on duodenoscopes ranging from .9% to 1.9%.4,21-26 When data from these major outbreaks were used, an attack rate (ie, likelihood of developing an infection after exposure with a contaminated duodenoscope) was calculated to be 18.9%.

  • Nationwide risk analysis of duodenoscope and linear echoendoscope contamination

    2020, Gastrointestinal Endoscopy
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    Recent studies assessing surveillance,9,13,17,53 culture and quarantine strategies,8,9,54,55 double high-level disinfection,14,56 and ethylene oxide sterilization11 have reported promising lower contamination rates, showing that reduction of contamination is feasible. In addition to the assessed interventions, the lower rates may also be the result of continuous feedback and raised alertness by the culture results for these studies,9,14,55,56 or less-sensitive sampling and culture methods. By not sampling all potential sites (eg, not including a channel brush54,55 or channel flushes14), incubating cultures for only 48 hours,14,54,56 or focusing only on carbapenem-resistant Enterobacteriaceae as the primary outcome,11 contaminated endoscopes can be deemed false-negative, while still being a vector for transmission with subsequent infection.

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DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.

If you would like to chat with an author of this article, you may contact Dr Ma at [email protected].

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