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Single-use duodenoscopes: The next disruptor or passing fad?
... In this work, by defining a framework for the strong sustainability of medical technologies and practice, we outline a roadmap for developing and evaluating the sustainability of medical devices in a multidisciplinary manner. In this light, we focus on the case study of the current trend toward disposable endoscopes [12], [13]. We analyze the arguments that are weighed in comparing single-use and reusable endoscopes, considering the strong sustainability framework. ...
... It is also essential to clarify the type of device and procedure considered to justify the development of disposable devices. The trend to single-use was initiated for duodenoscopes, where the endoscopic retrograde cholangiopancreatography (ERCP) procedure involves a high risk of cross-contamination because of the intricate and difficult-to-clean apparatus [12]. This trend was accelerated for bronchoscopes due to the concern generated by COVID-19. ...
... Regarding clinical sustainability, many arguments have been made regarding the safety and effectiveness of disposable devices compared to single-use devices. In addition to the risk of infection discussed above, several studies concluded that, despite slightly worse technical performance (e.g., image quality [27]), single-use devices can be used safely and effectively [8], [12]. Other arguments put forward by the manufacturers include the ready-to-use aspect of the devices since there is no need to wait for them to be reprocessed. ...
... This higher healthcare utilization and economic burden may be due to procedure-related factors such as the need for additional protective equipment during ERCP, higher incidence of post-procedural complications due to increasingly complex patients, and longer recovery times post-procedure, coupled with patient and hospital-related factors i.e. patient complexity, high comorbidity burden, private isolation rooms, multi-disciplinary team management, and the need for additional trained nursing staff. Furthermore, some centers implemented the use of singleuse duodenoscopes for ERCP to prevent transmission of the virus, which were significantly more expensive than reusable duodenoscope and may have added to the costs [28]. PEP is a relatively well-known complication of ERCP with an incidence rate ranging from 3 to 15% in the general population [29][30][31][32][33]. ...
Background/Objectives
COVID-19 impacts technical success of endoscopic retrograde cholangiopancreatography (ERCP). In this study, we aimed to assess the influence of COVID-19 on hospitalizations that underwent ERCP.
Methods
We identified all adult COVID-19 and non-COVID-19 hospitalizations that underwent ERCP in the United States using the National Inpatient Sample for 2020. Hospitalization characteristics, clinical outcomes, and complications were compared between the two groups.
Results
In 2020, 2015 COVID-19 and 203,094 non-COVID-19 hospitalizations underwent ERCP. The COVID-19 cohort had a higher mean age (60.3 vs 55.6 years, p < 0.001) and a higher proportion of Blacks and Hispanics compared to the non-COVID-19 cohort. After adjusting for confounders, the COVID-19 cohort had higher all-cause inpatient mortality (4.77 vs 1.45%, aOR 4.09, 95% CI 2.50–6.69, p < 0.001), mean length of stay (LOS) [10.19 vs 5.94 days, mean difference: 3.88, 95% CI 2.68–5.07, p < 0.001] and mean total hospital charges (THC) [96,398, mean difference: 46,367, 95% CI 21,776–70,957, p < 0.001] compared to the non-COVID-19 cohort. Increasing age, higher Charlson Comorbidity Index, and post-ERCP pancreatitis were identified to be independent predictors of inpatient mortality for COVID-19 hospitalizations that underwent ERCP. Furthermore, the COVID-19 cohort had higher odds of developing post-ERCP pancreatitis (PEP) (11.55 vs 7.05%, aOR 1.64, 95% CI 1.19–2.25, p = 0.002) compared to the non-COVID-19 cohort, after adjusting for confounders. However, there was no statistical difference in the rates of bowel perforations and post-ERCP hemorrhage between the two groups.
Conclusion
COVID-19 hospitalizations that underwent ERCP had higher inpatient mortality, mean LOS, mean THC, and odds of developing PEP compared to the non-COVID-19 cohort.
... 6 Benefit for selected patients. It has been proposed that immunocompromised patients or those with multidrug-resistant bacteria are likely to benefit from single-use endoscopes, but the theoretical advantages of this strategy remain to be proven in comparative studies [149]. Available data on single-use endoscopes, mainly duodenoscopes (▶ Table 5, ▶ Table 6), comprise cost-effectiveness analyses based on heterogeneous assumptions [137][138][139] and studies limited to reports of technical feasibility and procedural safety [152,154,[157][158][159][160][161]. ...
Climate change and the destruction of ecosystems by human activities are among the greatest challenges of the 21st century and require urgent action. Health care activities significantly contribute to the emission of greenhouse gases and waste production, with gastrointestinal (GI) endoscopy being one of the largest contributors. This Position Statement aims to raise awareness of the ecological footprint of GI endoscopy and provides guidance to reduce its environmental impact. The European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) outline suggestions and recommendations for health care providers, patients, governments, and industry. Main statements 1 GI endoscopy is a resource-intensive activity with a significant yet poorly assessed environmental impact. 2 ESGE-ESGENA recommend adopting immediate actions to reduce the environmental impact of GI endoscopy. 3 ESGE-ESGENA recommend adherence to guidelines and implementation of audit strategies on the appropriateness of GI endoscopy to avoid the environmental impact of unnecessary procedures. 4 ESGE-ESGENA recommend the embedding of reduce, reuse, and recycle programs in the GI endoscopy unit. 5 ESGE-ESGENA suggest that there is an urgent need to reassess and reduce the environmental and economic impact of single-use GI endoscopic devices. 6 ESGE-ESGENA suggest against routine use of single-use GI endoscopes. However, their use could be considered in highly selected patients on a case-by-case basis. 7 ESGE-ESGENA recommend inclusion of sustainability in the training curricula of GI endoscopy and as a quality domain. 8 ESGE-ESGENA recommend conducting high quality research to quantify and minimize the environmental impact of GI endoscopy. 9 ESGE-ESGENA recommend that GI endoscopy companies assess, disclose, and audit the environmental impact of their value chain. 10 ESGE-ESGENA recommend that GI endoscopy should become a net-zero greenhouse gas emissions practice by 2050.
* Joint first authors
Introduction
There are limited data comparing the contamination rates of reusable and novel duodenoscopes with disposable components. The clinical implications of novel duodenoscope bacterial contamination are also unknown. This study aimed to evaluate the rate of pathogenic bacterial contamination of novel and reusable duodenoscopes and assess the clinical implications for patients exposed to contaminated duodenoscopes.
Methods
We conducted an observational study of the bacterial contamination of reusable duodenoscopes and novel duodenoscopes with disposable caps (which do not have disposable elevators). Following identification of positive cultures from duodenoscopes, corresponding patient charts were reviewed for blood culture data or evidence of sepsis by quick sequential organ failure assessment (qSOFA) and systemic inflammatory response syndrome (SIRS) criteria.
Results
The contamination rate of reusable duodenoscopes was 0.80% (95% CI -0.05, 1.65%). The contamination rate of novel duodenoscopes was 0.0%.The contamination rates were not significantly different (p = 0.141). In reusable duodenoscopes, > 1 colony-forming unit (CFU) of gram-negative rods was identified in 4 positive cultures. None of the patients exposed to a positive culture had an existing infection nor developed bacteremia or sepsis after ERCP.
Discussion
Our data suggest bacterial contamination rates of novel duodenoscopes with disposable caps and reusable duodenoscopes are similar. The low contamination rates in this study support consistent high-level disinfection practices regardless of duodenoscope generation.
Goals:
This study aims to investigate associated mortality with inpatient endoscopic retrograde cholangiopancreatography (ERCP) with and without resistant infections. The co-primary objective compares frequencies of inpatient ERCP with resistant infections to overall hospitalizations with resistant infections.
Background:
The risks of inpatient antibiotic-resistant organisms are known, but the associated mortality for inpatient ERCP is unknown. We aim to use a national database of hospitalizations and procedures to understand trends and mortality for patients with antibiotic-resistant infections during inpatient ERCP.
Study:
The largest publicly available all-payer inpatient database in the United States (National Inpatient Sample) was used to identify hospitalizations associated with ERCPs and antibiotic-resistant infections for MRSA, VRE, ESBL, and MDRO. National estimates were generated, frequencies were compared across years, and multivariate regression for mortality was performed.
Results:
From 2017 to 2020, national weighted estimates of 835,540 inpatient ERCPs were generated, and 11,440 ERCPs had coincident resistant infections. Overall resistant infection, MRSA, VRE, and MDRO identified at the same hospitalization of inpatient ERCPs were associated with higher mortality (OR CI(95%): Overall: 2.2(1.77-2.88), MRSA: 1.90 (1.34-2.69), VRE: 3.53 (2.16-5.76), and MDRO: 2.52 (1.39-4.55)). While overall hospitalizations with resistant infections have been decreasing annually, there has been a yearly increase in admissions requiring ERCPs with simultaneous resistant infections (P=0.001-0.013), as well as infections with VRE, ESBL, and MDRO (P=0.001-0.016). Required Research Practices for Studies Using the NIS scoring was 0, or the most optimal.
Conclusions:
Inpatient ERCPs have increasing coincident resistant infections and are associated with higher mortality. These rising infections during ERCP highlight the importance of endoscopy suite protocols and endoscopic infection control devices.
Background:
Pancreatic surgery is characterized by high morbidity and mortality. Biliary colonization may affect clinical outcomes in these patients.
Aims:
This study aimed to verify whether bacteriobilia and multidrug resistance (MDR) detected during and after pancreatic surgery may have an impact on post-operative outcomes.
Methods:
Data from patients undergoing pancreatic surgery involving bile duct transection (2016-2022) in two high-volume centers were analyzed in relationship to overall morbidity, major morbidity and mortality after pancreato-duodenectomy (PD) or total pancreatectomy (TP). Simple and multivariable regressions were used.
Results:
227 patients submitted to PD (n=129) or TP (n=98) were included. Of them, 133 had preoperative biliary drainage (BD; 56.6%), mostly with the employment of endoscopic stents (91.7%). Bacteriobilia was detected in 111 patients (48.9%), and remarkably, observed in patients with BD (p=0.001). In addition, 25 MDR pathogens were identified (22.5%), with a significant prevalence in patients with BD. Multivariable regression analysis showed BD was strongly related to MDR isolation (odds ratio [OR]: 5.61; p=0.010). MDR isolation was the main factor linked to a higher number of major complications (OR: 2.75; p=0.041), including major infection complications (OR: 2.94; p=0.031).
Conclusions:
Isolation of MDR from biliary swab during PD or TP significantly increases the risk of a worse post-operative outcome. Pre-operative precautions could improve patient safety.
Background Qualified reprocessing, of which meticulous channel brushing is the most crucial step, is essential for prevention and control of endoscopy-associated infections. However, channel brushing is often omitted in practice. This study aimed to evaluate the effect of an automated flexible endoscope channel brushing system (AECBS) on improving the quality of endoscope reprocessing.
Methods This prospective, randomized controlled study was conducted between 24 November 2021 and 22 January 2022 at Renmin Hospital of Wuhan University, China. Eligible endoscopes were randomly allocated to the auto group (channels brushed by AECBS) or the manual group (channels brushed manually), with sampling and culturing after high-level disinfection and drying. The primary end point was the proportion of endoscopes with positive cultures.
Results 204 endoscopes in the auto group and 205 in the manual group were analyzed. The proportion of endoscopes with positive cultures was significantly lower in the auto group (15.2 % [95 %CI 10.7 %–21.0 %]) than in the manual group (23.4 % [95 %CI 17.9 %–29.9 %]).
Conclusions AECBS could effectively reduce bioburden and improve reprocessing quality of gastroscopes and colonoscopes. AECBS has the potential to replace manual brushing and lower the risk of endoscopy-associated infections, providing a new option for the optimization of reprocessing.
Objective
Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
Design
Patients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.
Results
98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air–water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.
Conclusion
Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.
Trial registration number
Clinicaltrials.gov number: NCT04143698
Background and aims:
Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience.
Methods:
Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events (SAEs).
Results:
Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954) and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0, range 1.0-10.0, P = .840) were similar for "expert" versus "less-expert" endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grade 1-2 versus grade 3-4 (P < .001). SAEs were reported in 13 (6.5%) patients.
Conclusions:
In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinicaltrials.gov, Number: NCT04223830.).
Background & aims:
Single-use duodenoscopy is one strategy to decrease infectious outbreaks associated with endoscope reuse. The aim of this study was to test the feasibility, preliminary safety and performance of a new single-use duodenoscope in a clinical setting.
Methods:
We conducted a multicenter case series of ERCP using a single-use duodenoscope from April to May 2019. Patients aged 18 years and older without altered pancreaticobiliary anatomy were consecutively screened at 6 academic medical centers, and eligible patients were enrolled. Seven expert endoscopists performed 13 roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only), then 60 ERCPs in separate patients. Outcomes were ERCP completion for the intended clinical indication, crossover from single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events assessed at 72 hours and 7 days.
Results:
Thirteen (100%) roll-in maneuvers were completed using the single-use duodenoscope. ERCPs had American Society for Gastrointestinal Endoscopy procedural complexity Grade 1 (least complex)-7 (11·7%), Grade 2-26 (43·3%), Grade 3-26 (43·3%) and Grade 4 (most complex)-1 (1·7%). Fifty-eight (96.7%) ERCPs were completed using the single-use duodenoscope only and 2 (3.3%) using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients experienced post-ERCP pancreatitis, 1 had a post-sphincterotomy bleed, and 1 with preexisting infection worsened and required rehospitalization.
Conclusions:
Expert endoscopists completed ERCPs with a wide range of complexity using a single-use duodenoscope in nearly all cases. This represents a new alternative to decrease ERCP-related infection transmission risk. Clinicaltrials.gov no: NCT03701958.
Background:
We identified an outbreak of AmpC-producing Escherichia coli infections resistant to third-generation cephalosporins and carbapenems (CR) among 7 patients who had undergone endoscopic retrograde cholangiopancreatography at hospital A during November 2012-August 2013. Gene sequencing revealed a shared novel mutation in a bla CMY gene and a distinctive fumC/ fimH typing profile.
Objective:
To determine the extent and epidemiologic characteristics of the outbreak, identify potential sources of transmission, design and implement infection control measures, and determine the association between the CR E. coli and AmpC E. coli circulating at hospital A.
Methods:
We reviewed laboratory, medical, and endoscopy reports, and endoscope reprocessing procedures. We obtained cultures from endoscopes after reprocessing as well as environmental samples and conducted pulsed-field gel electrophoresis and gene sequencing on phenotypic AmpC isolates from patients and endoscopes. Cases were those infected with phenotypic AmpC isolates (both carbapenem-susceptible and CR) and identical bla CMY-2, fumC, and fimH alleles or related pulsed-field gel electrophoresis patterns.
Results:
Thirty-five of 49 AmpC E. coli tested met the case definition, including all CR isolates. All cases had complicated biliary disease and had undergone at least 1 endoscopic retrograde cholangiopancreatography at hospital A. Mortality at 30 days was 16% for all patients and 56% for CR patients. Two of 8 reprocessed endoscopic retrograde cholangiopancreatography scopes harbored AmpC that matched case isolates by pulsed-field gel electrophoresis. Environmental cultures were negative. No breaches in infection control were identified. Endoscopic reprocessing exceeded manufacturer's recommended cleaning guidelines.
Conclusion:
Recommended reprocessing guidelines are not sufficient.
Importance
Carbapenem-resistant Enterobacteriaceae (CRE) producing the New Delhi metallo-β-lactamase (NDM) are rare in the United States, but have the potential to add to the increasing CRE burden. Previous NDM-producing CRE clusters have been attributed to person-to-person transmission in health care facilities.Objective
To identify a source for, and interrupt transmission of, NDM-producing CRE in a northeastern Illinois hospital.Design, Setting, and Participants
Outbreak investigation among 39 case patients at a tertiary care hospital in northeastern Illinois, including a case-control study, infection control assessment, and collection of environmental and device cultures; patient and environmental isolate relatedness was evaluated with pulsed-field gel electrophoresis (PFGE). Following identification of a likely source, targeted patient notification and CRE screening cultures were performed.Main Outcomes and Measures
Association between exposure and acquisition of NDM-producing CRE; results of environmental cultures and organism typing.Results
In total, 39 case patients were identified from January 2013 through December 2013, 35 with duodenoscope exposure in 1 hospital. No lapses in duodenoscope reprocessing were identified; however, NDM-producing Escherichia coli was recovered from a reprocessed duodenoscope and shared more than 92% similarity to all case patient isolates by PFGE. Based on the case-control study, case patients had significantly higher odds of being exposed to a duodenoscope (odds ratio [OR], 78 [95% CI, 6.0-1008], P < .001). After the hospital changed its reprocessing procedure from automated high-level disinfection with ortho-phthalaldehyde to gas sterilization with ethylene oxide, no additional case patients were identified.Conclusions and Relevance
In this investigation, exposure to duodenoscopes with bacterial contamination was associated with apparent transmission of NDM-producing E coli among patients at 1 hospital. Bacterial contamination of duodenoscopes appeared to persist despite the absence of recognized reprocessing lapses. Facilities should be aware of the potential for transmission of bacteria including antimicrobial-resistant organisms via this route and should conduct regular reviews of their duodenoscope reprocessing procedures to ensure optimal manual cleaning and disinfection.
Reprocessing medical devices in health care settings: validation methods and labeling guidance for industry and food and drug administration staff
- Fda Safety Communication
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning
- Fda Safety Communication
Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity
- Slivka A.
- Ross A.S.
- Sejpal D.V.
- Petersen B.T.
- Bruno M.J.
- Pleskow D.K.
- Muthusamy V.R.
- EXALT Single-use Duodenoscope Study Group