Duodenoscope reprocessing surveillance with adenosine triphosphate testing and terminal cultures: a clinical pilot study

Visrodia, Kavel; Hanada, Yuri; Pennington, Kelly; Tosh, Pritish K.; Topazian, Mark D.; Petersen, Bret T.

doi:10.1016/j.gie.2017.03.1544

Cited by 47 publications

(39 citation statements)

References 15 publications

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“…Primary studies on reprocessing effectiveness conducted by our research team have found contamination rates exceeding 50% when robust sampling and testing methods were used . Based on our study findings, results recently reported by others, and our experience with microbial culturing, we are concerned that the low rates of microbial growth reported in the reviewed sheath studies may have been because of sampling and testing methods that were insufficient to detect contamination. Given the growing awareness of patient safety issues surrounding the use of flexible endoscopes, additional research is needed.…”

Section: Discussionsupporting

confidence: 49%

“…Microbial contamination levels on reusable components of sheathed endoscopes were extremely low (0% to 2%) . This is a key finding given recent studies that have determined reusable endoscope reprocessing methods are not consistently effective, with more than 20% of unsheathed endoscopes harboring viable microbes after cleaning and HLD . Bacteria have been found on unsheathed endoscopes even after sterilization, with 13% of unsheathed ureteroscopes and 22% of unsheathed duodenoscopes harboring live bacteria …”

Section: Discussionmentioning

confidence: 97%

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A Systematic Review of Disposable Sheath Use During Flexible Endoscopy

Ofstead¹,

Hopkins²,

Quick³

et al. 2019

AORN Journal

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Flexible endoscopes are exposed to blood, mucus, and other secretions during procedures. Single-use sheaths are designed to prevent contact between contaminants and reusable endoscope components. This systematic review examined findings from 22 studies that assessed endoscopic sheath use during urologic, gastrointestinal, or respiratory procedures. The evidence showed that sheaths were durable and yielded faster endoscope turnover times because their reusable components did not require high-level disinfection or sterilization. After a brief learning period, health care providers successfully assembled and maneuvered sheathed endoscopes. Patients generally did not experience greater discomfort during procedures in which sheaths were used. Microbial cultures of sheathed endoscopes were negative or similar to unsheathed endoscopes. More research is needed to evaluate the potential effect of disposable sheaths on infection risks. The evidence suggests that sheaths are a viable option for reliably providing a barrier between endoscopes and patients without affecting the quality of endoscopic procedures.

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Section: Discussionsupporting

confidence: 49%

Section: Discussionmentioning

confidence: 97%

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy

Ofstead¹,

Hopkins²,

Quick³

et al. 2019

AORN Journal

View full text Add to dashboard Cite

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“…Duodenoscopes are complex reusable devices that are composed of hard-to-clean components, particularly the elevator mechanism. Previous studies have demonstrated higher ATP levels in samples from the elevator compared with samples from the working channel of conventional duodenoscopes with a fixed distal cap [6,7,12,14,27]. In the study by the Indiana group focusing on the impact of double HLD, the water irrigated from both working channels and the elevator of conventional duodenoscopes with fixed distal caps was randomly selected for bacterial culture.…”

Section: Discussionmentioning

confidence: 99%

“…Previous full publications were based on a higher cutoff value (200 RLU) and the specimens were obtained from the suction channel rather than from the elevator; the results from those studies showed that contamination was present [7,8]. Subsequent studies using the cutoff value of 200 RLU still showed the inconsistent relationship between ATP and culture results [10,[12][13][14]. Based on these previous data, the 2018 CDC guidelines postulated the ATP test as a useful marker for the scope cleaning process but its sensitivity was not sufficient to be used as a marker for the adequacy of the HLD process [5].…”

Section: Managementmentioning

confidence: 99%

“…As the microbiologic testing of duodenoscopes is costly and requires 72 hours for culture, it remains to be evaluated whether this quarantine approach is practical and financially feasible in endoscopy centers with limited budgets. Recently, several studies have proposed the use of the adenosine triphosphate (ATP) test as an alternative method of point-ofcare testing (POCT) to evaluate bacterial contamination and organic residue in duodenoscopes after HLD [6][7][8][9][10][11][12][13][14][15][16]. However, the recommended cutoff value of ATP to determine scope contamination has not been determined [6][7][8][9][10][11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

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A newly designed duodenoscope with detachable distal cap significantly reduces organic residue contamination after reprocessing

et al. 2020

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Background A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high-level disinfection (HLD). Methods During December 2018–April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n = 54), the distal cap of the duodenoscope was detached before manual cleaning. In group B (n = 54), the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs). Results After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 % vs. 75.9 %; P < 0.001; relative risk 0.49, 95 % confidence interval 0.33–0.71), and also confirmed by median ATP values (45.2 vs. 141.0 RLU; P < 0.001). In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group. Conclusions The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.

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Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

et al. 2023

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ImportanceInfection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument.ObjectiveTo determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.Design, Setting, and ParticipantsIn this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible.InterventionThe intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.Main Outcomes and MeasuresCoprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.ResultsFrom December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes.Conclusions and RelevanceIn this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP.Trial RegistrationClinicalTrials.gov Identifier: NCT04040504

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Duodenoscope reprocessing surveillance with adenosine triphosphate testing and terminal cultures: a clinical pilot study

Cited by 47 publications

References 15 publications

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy

A newly designed duodenoscope with detachable distal cap significantly reduces organic residue contamination after reprocessing

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography

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