Disposable Gastrointestinal Scopes: A Systematic Review.

OBJECTIVE: Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes. MATERIALS AND METHODS: For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023. RESULTS: In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis. CONCLUSIONS: After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.

Endoscope sampling and culturing methods.

BACKGROUND: Contamination rates reported in the literature for patient-ready flexible endoscopes vary from 0.4% to 49%. Unfortunately, the comparison and interpretation of these results is almost impossible since several factors including sampling and culturing methods, target levels for contamination, or definition of indicator micro-organisms vary widely from one study to the other. AIM: To compare the efficacy of six duodenoscope sampling and culturing methods by means of extraction efficacy comparison, while at the same time identifying key parameters that provide optimal microbial recovery. METHODS: The duodenoscope sample extraction efficacy of each method was assessed using the repetitive recovery method described in ISO 11737-1: 2018. FINDINGS: Mean overall bioburden extraction efficacy varied from 1% for the Australian method to 39% for the French one. The lowest endoscope sample extraction efficacy was associated with the absence of any neutralizer, friction, or tensioactive agent, and when only a small portion of the sampling solution collected was inoculated on to culture media. The efficacy of the sampling and culturing methods also varied according to the nature of micro-organisms present in the endoscope, and the time between sampling and culturing. CONCLUSION: This study supports the need for a harmonized and standardized sampling and culturing method for flexible endoscopes.

A search strategy for detecting duodenoscope-associated infections: a retrospective observational study.

BACKGROUND: Duodenoscope-associated infections (DAIs) are exogenous infections resulting from the use of contaminated duodenoscopes. Though numerous outbreaks of DAI have involved multidrug-resistant micro-organisms (MDROs), outbreaks involving non-MDROs are also likely to occur. Detection challenges arise as these infections often resolve before culture or because causative strains are not retained for comparison with duodenoscope strains. AIM: To identify and analyse DAIs spanning a seven-year period in a tertiary care medical centre. METHODS: This was a retrospective observational study. Duodenoscope cultures positive for gastrointestinal flora between March 2015 and September 2022 were paired with duodenoscope usage data to identify patients exposed to contaminated duodenoscopes. Analysis encompassed patients treated after a positive duodenoscope culture and those treated within the interval from a negative to a positive culture. Patient identification numbers were cross-referenced with a clinical culture database to identify patients developing infections with matching micro-organisms within one year of their procedure. A 'pair' was established upon a species-level match between duodenoscope and patient cultures. Pairs were further analysed via antibiogram comparison, and by whole-genome sequencing (WGS) to determine genetic relatedness. FINDINGS: Sixty-eight pairs were identified; of these, 21 exhibited matching antibiograms which underwent WGS, uncovering two genetically closely related pairs categorized as DAIs. Infection onset occurred up to two months post procedure. Both causative agents were non-MDROs. CONCLUSION: This study provides crucial insights into DAIs caused by non-MDROs and it highlights the challenge of DAI recognition in daily practice. Importantly, the delayed manifestation of the described DAIs suggests a current underestimation of DAI risk.

Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope.

BACKGROUND AND AIMS: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. METHODS: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. RESULTS: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. CONCLUSION: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

Bacterial bioburden of duodenoscope elevator mechanism in different reprocessing stages.

Over the past decade, infections linked to duodenoscopes have become a significant concern, primarily due to the intricate design of the elevator mechanism. Currently, there is limited evidence regarding the bacterial contamination level of the elevator mechanism after clinical use and throughout its various reprocessing stages. This study utilized the swab culture technique to examine the bacterial contamination on the duodenoscope elevator mechanism after clinical use and after 3 reprocessing stages at a Center of tertiary hospital. Our findings revealed severe bacterial contamination after clinical usage, emphasizing that the effectiveness of manual cleaning greatly influences the subsequent high-level disinfection quality.

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection 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. Objective: To 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 Participants: In 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. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary 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. Results: From 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 Relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT04040504.

The management of endoscopic retrograde cholangio- pancreatography-related infections risk: results of an italian survey at regional level.

Background and aim: Among the Endoscopic retrograde cholangiopancreatography (ERCP) adverse events, an increasingly arising problem is the transmission of Multi Drug Resistant (MDR) Bacteria through duodenoscopes. The aim of this survey was to evaluate the current clinical practice of management of ERCP associated infections in Emilia-Romagna, Italy. Methods: An online survey was developed including 12 questions on management of ERCP associated infections risk. The survey was proposed to all 12 endoscopy centers in Emilia Romagna that perform at least > 200 ERCPs per year. Results: 11 centers completed the survey (92%). Among all risk factors of ERCP infections, hospitalization in intensive care units, immunosuppressant therapies, and previous MDR infections have achieved a 80 % minimum of concurrence by our respondents. The majority of them did not have a formalized document in their hospital describing categories and risk factors helpful in the detection of patients undergoing ERCP with an high-level infective risk (9/11, 82%). Most centers (8/11, 72%) do not perform screening in patients at risk of ERCP infections. Post procedural monitoring is performed by 6 of 11 centers (55%). Conclusion: Our survey showed that, at least at regional level, there is a lack of procedures and protocols related to the management of patients at risk of ERCP infections.

Higher yield in duodenoscope cultures collected with addition of neutralizing agent.

AIM: Microbiological cultures are the gold standard in the monitoring of duodenoscope reprocessing. However, many different sampling and culturing techniques are used, making it difficult to compare results. The latest Centers for Disease Control and Prevention protocol advises the use of a neutralizer to deactivate any remaining disinfectants in the samples. This study compared culturing results of duodenoscope samples collected with and without addition of a neutralizer. METHODS: Six duodenoscopes were soiled with gut bacteria in a non-clinical experimental setting and reprocessed afterwards. Samples of the tip and working channel were collected immediately after decontamination or after drying. Dey-Engley (DE) broth was added as a neutralizer to the samples of four duodenoscopes; samples for the other two duodenoscopes were collected without the addition of DE broth. RESULTS: Post-decontamination cultures were significantly more likely to be positive for growth of the applied micro-organisms in the group of samples with DE broth (88.1% vs 20.2%; P<0.0001). Post-drying samples were significantly more likely to be positive in the group of samples without DE broth (75.7% vs 33.4%; P<0.001). CONCLUSION: The addition of DE broth to samples collected from wet duodenoscopes increases the yield of those cultures. Remaining disinfectants in wet duodenoscopes can lead to false-negative results. This can be overcome by adding a neutralizer, such as DE broth, to the samples. The higher yield after drying in the group without neutralizer could be due to biofilm formation in these two duodenoscopes, but this was not investigated. Standardization of the sampling method can help to compare both clinical and study results regarding duodenoscope contamination.

Microbiological surveillance post-reprocessing of flexible endoscopes used in digestive endoscopy: a national study.

INTRODUCTION: Microbiological surveillance of endoscopes is a safety measure for verifying the quality of reprocessing procedures and identifying contaminated devices, but duodenoscope-related outbreaks are still reported. AIM: To assess the effectiveness of duodenoscope reprocessing procedures in Italy. METHODS: Between December 2019 and April 2020, data obtained from microbiological surveillance post-reprocessing in 15 Italian endoscopy units were collected. Sampling was carried out after reprocessing or during storage in a cabinet. In keeping with international guidelines and the Italian position paper, the micro-organisms were classified as high-concern organisms (HCOs) and low-concern organisms (LCOs). FINDINGS: In total, 144 samples were collected from 51 duodenoscopes. Of these, 36.81% were contaminated: 22.92% were contaminated with HCOs and 13.89% were contaminated with LCOs [2.08% with an LCO load of 11-100 colony-forming units (CFU)/device and 0.69% with an LCO load of >100 CFU/device]. The contamination rate was 27.5% in samples collected after reprocessing, 40% in samples collected during storage in a cabinet that was compliant with EN 16442:2015 (C-I), and 100% in samples collected during storage in a cabinet that was not compliant with EN 16442:2015 (NC-I). The respective HCO rates were 15.00%, 27.27% and 66.67%. Correlation between LCO contamination and storage time was demonstrated (Spearman's rho=0.3701; P=0.0026). The Olympus duodenoscope TJFQ180V demonstrated the lowest rate of contamination (29.82%), although the contamination rate was 100% for duodenoscopes stored in an NC-I cabinet. CONCLUSION: Microbiological surveillance, along with strict adherence to reprocessing protocols, may help to detect endoscope contamination at an early stage, and reduce the risk of duodenoscope-associated infections.

Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared with duodenoscopes with fixed distal caps: a randomized trial.

BACKGROUND AND AIMS: Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD). METHODS: Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing. RESULTS: After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively). CONCLUSIONS: After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

Assessment of postmanual cleaning adenosine triphosphate tests to prevent the use of contaminated duodenoscopes and linear echoendoscopes: the DETECT study.

BACKGROUND AND AIMS: We investigated whether the use of postmanual cleaning adenosine triphosphate (ATP) tests lowers the number of duodenoscopes and linear echoendoscopes (DLEs) contaminated with gut flora. METHODS: In this single-center before-and-after study, DLEs were ATP tested after cleaning. During the control period, participants were blinded to ATP results: ATP-positive DLEs were not recleaned. During the intervention period, ATP-positive DLEs were recleaned. DLEs underwent microbiologic sampling after high-level disinfection (HLD) with participants blinded to culture results. RESULTS: Using 15 endoscopes of 5 different DLE types, we included 909 procedures (52% duodenoscopes, 48% linear echoendoscopes). During the intervention period, the absolute rate of contamination with gut flora was higher (16% vs 21%). The main analysis showed that contamination was less likely to occur in the intervention period (odds ratio, .32; 95% credible interval [CI], .12-.85). A secondary analysis showed that this effect was based on 1 particular duodenoscope type (estimated probability, 39% [95% CI, 18%-64%] vs 9% [95% CI, 2%-21%]), whereas no effect was seen in the other 4 DLE types. In detail, of the 4 duodenoscopes of this type, 2 had lower contamination rates (69% vs 39% and 36% vs 10%). During the control period, both these duodenoscopes had multiple episodes with ongoing contamination with the same microorganism that ended weeks before the start of the intervention period (ie, they were not terminated by ATP testing). CONCLUSIONS: Postmanual cleaning ATP tests do not reduce post-HLD gut flora contamination rates of DLEs. Hence, postcleaning ATP tests are not suited as a means for quality control of endoscope reprocessing.

Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps.

BACKGROUND AND AIMS: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval. METHODS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. RESULTS: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common. CONCLUSIONS: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events.

Disposable duodenoscopes. Is healthcare system affordability the main hindrance?

The performance of an endoscopic procedure involves introducing an endoscope through the mouth or the anus, which may potentially lead to lethal infection. The risk increases when complex and difficult-to-clean scopes are used, as in the case of duodenoscopes. Side-viewing duodenoscopes are complex in design, with the camera and working channel exit located on one side of the endoscope's distal end, and with an elevator nail also located at this point for catheter redirection. This complex design may facilitate the presence of blind areas not easy to access for cleaning, resulting in suboptimal disinfection of the duodenoscope and therefore a higher risk of bacterial infection. This is of particular importance in particularly vulnerable patients like those who are immunosuppressed (e.g., transplanted patients) or have a malignant disease and are receiving chemotherapy. Moreover, in the era of ¨superbugs¨, like carbapenem-resistant Enterobacteriaceae, infection outbreaks related to endoscopic retrograde cholangiopancreatography (ERCP) have been reported with a significant mortality rate.

A Novel Flocked Swab Protocol Proves to Be an Effective Method for Culturing Elevator-Containing Endoscopes.

BACKGROUND: The challenging disinfection process for the elevator mechanism on duodenoscopes and linear echoendoscopes has been identified as a source of clinically significant bacterial transmission. Despite increased awareness, there continues to be a lack of definitive guidelines for bacterial culturing protocols for elevator-containing endoscopes. AIMS: To compare two different prospective bacterial surveillance protocols for duodenoscopes and linear echoendoscopes with regard to accuracy, efficiency, and cost. METHODS: Consecutive duodenoscopes and linear echoendoscopes used at a single tertiary care center were reprocessed following hospital and manufacturer guidelines, dried using an automatic endoscope-drying machine, and hung overnight in an upright position. Following reprocessing, culture samples were sequentially obtained from each endoscope using two methods, first, the brush protocol followed immediately by the swab protocol. RESULTS: A total of 532 primary cultures were collected from 17 duodenoscopes and eight linear echoendoscopes. Of these, 266 cultures gathered using the brush protocol were negative, while 266 cultures gathered using the swab protocol resulted in three positive cultures (1.1%). Positive cultures showed Enterobacter cloacae and Klebsiella pneumoniae from one duodenoscope and two linear echoendoscopes. Yearly, the brush protocol amounts to approximately 520 nursing hours, and the swab protocol takes an estimated 42 nursing hours. Annually, the swab protocol could save over $26,500 and 478 nursing hours. CONCLUSIONS: The proposed swab protocol was superior to the brush protocol when evaluating the presence of residual bacteria on elevator-containing endoscopes following reprocessing and saves cost and nursing hours.

Risk evaluation of duodenoscope-associated infections in the Netherlands calls for a heightened awareness of device-related infections: a systematic review.

BACKGROUND: The risk of exogenous infections from endoscopic procedures is often cited as almost negligible (1 infection in 1.8 million procedures); however, this risk is based on older literature and does not seem to match the number of infectious outbreaks due to contaminated duodenoscopes reported after endoscopic retrograde cholangiopancreatography (ERCP). Using Dutch data, we aimed to estimate the minimum risk of duodenoscope-associated infection (DAI) and colonization (DAC) in patients undergoing ERCP. METHODS: A systematic literature search identified all DAI outbreaks in the Netherlands reported between 2008 and 2019. Included cases were confirmed by molecular matching of patient and duodenoscope cultures. Risk ratios were calculated based on the total number of ERCPs performed during the study period. RESULTS: Three outbreaks were reported and published between 2008 and 2018, including 21 confirmed DAI cases and 52 confirmed DAC cases. The estimated number of ERCPs performed during the same period was 181 209-227 006. The calculated minimum estimated DAI risk was approximately 0.01 % and the minimum estimated DAC risk was 0.023 %-0.029 %. CONCLUSIONS: The estimated risk of DAI in Dutch ERCP practice was at least 180 times higher than previously published risk estimates. The actual risk is likely to be (much) higher due to underreporting of infections caused by multidrug-resistant organisms and sensitive bacteria. Greater awareness by healthcare personnel involved in endoscopy and endoscope cleaning is required, as well as innovative technical solutions to contain and ultimately eliminate DAIs.

Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy.

Introduction: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high-level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device-related outbreaks.Areas covered: This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue.Expert Opinion: Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the health-care system. Single-use duodenoscopes eliminate both the risk of device-related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.

A Manufacturer and User Facility Device Experience Analysis of Upper Aerodigestive Endoscopy Contamination: Is Flexible Laryngoscopy Different?

OBJECTIVES/HYPOTHESIS: Several recent studies have observed a high incidence of duodenoscope microbial contamination and an association of contamination with healthcare-acquired infections. This study sought to quantify nasopharyngoscope microbial contamination relative to that of other endoscope categories and characterize the manufacturers, outcomes, and microbial profiles associated with these cases. STUDY DESIGN: Retrospective, cross-sectional study. METHODS: A total of 3,865 adverse events were collected from 2013 to 2019 using the US Food and Drug Administration Manufacturer and User Facility Device Experience database. The fraction of total device failures associated with contamination was quantified for nasopharyngoscopes, bronchoscopes, duodenoscopes, and gastroscopes. Odds ratios of nasopharyngoscope contamination compared to that of bronchoscopes, duodenoscopes, or gastroscopes were calculated, and significance was assessed by χ2 analysis. The Kruskal-Wallis test was used for nonparametric testing of significance. RESULTS: Nasopharyngoscope device failures were reported at an incidence of 0.646 per month; 34.1% involved contamination, comparable to the frequency observed for bronchoscopes (23.4%, P = .118), duodenoscopes (29.2%, P = .493), and gastroscopes (45.3%, P = .178). The frequency of device contamination was observed to be significantly higher for a particular endoscope manufacturer regardless of endoscope category (Kruskal-Wallis P = .021). In instances of contamination, nasopharyngoscopes were significantly less associated with patient harm or death than bronchoscope (odds ratio [OR] = 10.2) and duodenoscope (OR = 4.81) cases. CONCLUSIONS: Although the rates of contamination were comparable across all endoscope categories, nasopharyngoscope contamination was less commonly associated with patient harm or death. In an era of rising healthcare costs, determining adequate disinfection standards for nasopharyngoscopes and their impact on patient safety is crucial. LEVEL OF EVIDENCE: NA Laryngoscope, 131:598-605, 2021.