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Polymers Jun 2023New hydrogels nanocomposites, based on iminoboronate hydrogels and ZnO nanoparticles (ZnO-NPs), were obtained and characterised in order to develop a new class of...
New hydrogels nanocomposites, based on iminoboronate hydrogels and ZnO nanoparticles (ZnO-NPs), were obtained and characterised in order to develop a new class of disinfectants able to fight the nosocomial infections produced by duodenoscopes investigation procedures. The formation of the imine linkages between chitosan and the aldehyde was demonstrated using NMR and FTIR spectroscopy, while the supramolecular architecture of the developed systems was evaluated via wide-angle X-ray diffraction and polarised optical microscopy. The morphological characterisation of the systems via scanning electron microscopy revealed the highly porous structure of the materials, in which no ZnO agglomeration could be observed, indicating the very fine and homogenous encapsulation of the nanoparticles into the hydrogels. The newly synthetised hydrogels nanocomposites was proven to have synergistic antimicrobial properties, being very efficient as disinfectants against reference strains as: , , and .
PubMed: 37376315
DOI: 10.3390/polym15122669 -
Endoscopy International Open Jun 2023Single-use duodenoscopes can prevent transmission of microorganisms through contaminated reusable duodenoscopes. Concerns regarding their economic and environmental...
Single-use duodenoscopes can prevent transmission of microorganisms through contaminated reusable duodenoscopes. Concerns regarding their economic and environmental impact impede the transition to single-use duodenoscopes. This study investigated the costs associated with two scenarios in which single-use duodenoscopes are used in patients carrying multidrug-resistant microorganisms (MDROs). Break-even costs for single-use duodenoscopes were calculated for two scenarios in which patients were screened for MDRO carriage before undergoing endoscopic retrograde cholangiopancreatography (ERCP). Only direct costs related to the endoscopy were taken into consideration. In Scenario 1, patients were screened through microbiological culturing with a lag time in receiving the test result. In Scenario 2, screening was performed using GeneXpert analysis providing a rapid read-out. Calculations were performed using data from a Dutch tertiary care center and also with US healthcare data. In the Dutch situation, single-use duodenoscopes needed to be priced at a maximum of € 140 to € 250 to break-even. In the US analyses, break-even costs varied widely, depending on the duodenoscope-associated infection costs used, ERCP volume, and infection risk. The break-even costs in Scenario 1 ranged between $78.21 and $2,747.54 and in Scenario 2, between $248.89 and $2,209.23. This study showed that a crossover scenario in which single-use duodenoscopes are only used in patients carrying MDROs could be an economically viable alternative to a complete transition to single-use duodenoscopes. In the Dutch setting, single-use duodenoscopes need to be priced much lower than in the United States to reach a per-procedure cost that is comparable with a scenario using reusable duodenoscopes exclusively.
PubMed: 37304249
DOI: 10.1055/a-2064-9721 -
Bioengineering (Basel, Switzerland) Apr 2023Endoscopic retrograde cholangiopancreatography (ERCP) is crucial to the treatment of biliopancreatic diseases with iatrogenic perforation as a potential complication. As...
BACKGROUND
Endoscopic retrograde cholangiopancreatography (ERCP) is crucial to the treatment of biliopancreatic diseases with iatrogenic perforation as a potential complication. As of yet, the wall load during ERCP is unknown, as it is not directly measurable during an ERCP in patients.
METHODS
In a life-like, animal-free model, a sensor system consisting of five load cells was attached to the artificial intestines (sensors 1 + 2: pyloric canal-pyloric antrum, sensor 3: duodenal bulb, sensor 4: descending part of the duodenum, sensor 5: distal to the papilla). Measurements were made with five duodenoscopes (n = 4 reusable and n = 1 single use).
RESULTS
Fifteen standardized duodenoscopies were performed. Peak stresses were found at the antrum during the gastrointestinal transit (sensor 1 max. 8.95 N, sensor 2 max. 2.79 N). The load reduced from the proximal to the distal duodenum and the greatest load in the duodenum was discovered at the level of the papilla in 80.0% (sensor 3 max. 2.06 N).
CONCLUSIONS
For the first time, intraprocedural load measurements and exerting forces obtained during a duodenoscopy for ERCP in an artificial model were recorded. None of the tested duodenoscopes were classified as dangerous for patient safety.
PubMed: 37237593
DOI: 10.3390/bioengineering10050523 -
Clinical Endoscopy Jan 2024Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in...
BACKGROUND/AIMS
Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in endoscopy and accessories. This study evaluated our experience with a rotatable sphincterotome in cases of difficult cannulation.
METHODS
We retrospectively reviewed ERCP cases using TRUEtome, a rotatable sphincterotome, as a rescue device for cannulation at a cancer institute in Japan from October 2014 to December 2021.
RESULTS
TRUEtome was used in 88 patients. Duodenoscopes were used for 51 patients, while single-balloon enteroscopes (SBE) were used for 37 patients. TRUEtome was used for biliary and pancreatic duct cannulation (84.1%), intrahepatic bile duct selection (12.5%), and strictures of the afferent limb (3.4%). Cannulation success rates were similar in the duodenoscope and SBE groups (86.3% vs. 75.7%, p=0.213). TRUEtome was more commonly used in cases with steep cannulation angles in the duodenoscope group and in cases requiring cannulation in different directions in the SBE group. There were no significant differences in adverse events between the two groups.
CONCLUSION
The cannulation sphincterotome was useful for difficult cannulations in both unaltered and surgically altered anatomies. It may be an option to consider before high-risk procedures such as precut and endoscopic ultrasound-guided rendezvous techniques.
PubMed: 37157962
DOI: 10.5946/ce.2022.248 -
Endoscopy International Open Apr 2023Drying after cleaning and disinfection is essential in the reprocessing of endoscopes since microorganisms can grow and form biofilms on wet surfaces. In this...
Drying after cleaning and disinfection is essential in the reprocessing of endoscopes since microorganisms can grow and form biofilms on wet surfaces. In this experimental non-clinical study, we investigated the efficacy of a novel, fast-drying method when reprocessing duodenoscopes. During a series of 40 tests, three duodenoscopes were exposed to an artificial test soil containing supraphysiological loads of four types of gut microorganisms in a non-clinical ERCP simulation, followed by reprocessing and drying with the PlasmaTYPHOON. Cultures of the distal tip and working channel were acquired immediately after automated decontamination and after drying with the PlasmaTYPHOON. Cobalt chloride paper tests and borescope inspections were used to evaluate drying efficacy. Contamination of the working channels dropped from 86.4 % post-decontamination to 33.6 % post-drying, with 94 % of the positive post-drying samples belonging to one duodenoscope. This duodenoscope showed persistent contamination with in the working channel. The other two duodenoscopes only showed low levels of in post-decontamination channel samples, but not after drying. Cobalt chloride paper tests and borescope inspections revealed good drying efficacy. Positive cultures for gut microorganisms were often found in wet endoscopes post-decontamination. The PlasmaTYPHOON is an effective fast-drying method capable of abolishing nearly all remaining microorganisms after decontamination provided no biofilm has developed, even when using a supraphysiological concentration of bacterial load. The clinical use of the PlasmaTYPHOON has the potential to reduce endoscope contamination, the use of wet contaminated endoscopes and therefore the risk of patient infection.
PubMed: 37124714
DOI: 10.1055/a-2017-3872 -
BMC Gastroenterology Apr 2023Endoscopic retrograde cholangiography (ERC) possesses a translocation risk of microbes to the biliary system. We studied bile contamination during ERC and its impact on...
BACKGROUND
Endoscopic retrograde cholangiography (ERC) possesses a translocation risk of microbes to the biliary system. We studied bile contamination during ERC and its impact on patients' outcome in a real-life-situation.
METHODS
Ninety-nine ERCs were analyzed and microbial samples were taken from the throat before and from bile during ERC and from irrigation fluid of the duodenoscope before and after ERC.
RESULTS
91.2% of cholangitis patients had detectable microbes in the bile (sensitivity 91%), but the same was true for 86.2% in the non-cholangitis group. Bacteroides fragilis (p=0.015) was significantly associated with cholangitis. In 41.7% of ERCs with contaminated endoscopes these microbes were found in the bile after the procedure. Analysis of duodenoscopes' irrigation liquid after ERC matched the microbial bile analysis of these patients in 78.8%. Identical microbial species were in throat and in bile samples of the same ERC in 33% of all cases and in 45% in the non-cholangitis group. Transmission of microbes to the biliary tract did not result in more frequent cholangitis, longer hospital stays, or worse outcome.
CONCLUSIONS
During ERC bile samples are regularly contaminated with microbes of the oral cavity but it did not affect clinical outcome.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Biliary Tract; Cholangiography; Biliary Tract Surgical Procedures; Cholangitis; Microbiota
PubMed: 37013522
DOI: 10.1186/s12876-023-02721-7 -
The Science of the Total Environment Jun 2023Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally... (Review)
Review
A review of Spaulding's classification system for effective cleaning, disinfection and sterilization of reusable medical devices: Viewed through a modern-day lens that will inform and enable future sustainability.
Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally proposed in 1957, remains widely used for defining the disinfection and sterilization of contaminated re-usable medical devices and surgical instruments. Screening PubMed and Scopus databases using a PRISMA guiding framework generated 272 relevant publications that were used in this review. Findings revealed that there is a need to evolve how medical devices are designed, and processed by cleaning, disinfection (and/or sterilization) to mitigate patient risks, including acquiring an infection. This Spaulding Classification remains in use as it is logical, easily applied and understood by users (microbiologists, epidemiologists, manufacturers, industry) and by regulators. However, substantial changes have occurred over the past 65 years that challenge interpretation and application of this system that includes inter alia emergence of new pathogens (viruses, mycobacteria, protozoa, fungi), a greater understanding of innate and adaptive microbial tolerance to disinfection, toxicity risks, increased number of vulnerable patients and associated patient procedures, and greater complexity in design and use of medical devices. Common cited examples include endoscopes that enable non- or minimal invasive procedures but are highly sophisticated with various types of materials (polymers, electronic components etc), long narrow channels, right angle and heat-sensitive components and various accessories (e.g., values) that can be contaminated with high levels of microbial bioburden and patient tissues after use. Contaminated flexible duodenoscopes have been a source of several significant infection outbreaks, where at least 9 reported cases were caused by multidrug resistant organisms [MDROs] with no obvious breach in processing detected. Despite this, there is evidence of the lack of attention to cleaning and maintenance of these devices and associated equipment. Over the last few decades there is increasing genomic evidence of innate and adaptive resistance to chemical disinfectant methods along with adaptive tolerance to environmental stresses. To reduce these risks, it has been proposed to elevate classification of higher-risk flexible endoscopes (such as duodenoscopes) from semi-critical [contact with mucous membrane and intact skin] to critical use [contact with sterile tissue and blood] that entails a transition to using low-temperature sterilization modalities instead of routinely using high-level disinfection; thus, increasing the margin of safety for endoscope processing. This timely review addresses important issues surrounding use of the Spaulding classification system to meet modern-day needs. It specifically addresses the need for automated, robust cleaning and drying methods combined with using real-time monitoring of device processing. There is a need to understand entire end-to-end processing of devices instead of adopting silo approaches that in the future will be informed by artificial intelligence and deep-learning/machine learning. For example, combinational solutions that address the formation of complex biofilms that harbour pathogenic and opportunistic microorganisms on the surfaces of processed devices. Emerging trends are addressed including future sustainability for the medical devices sector that can be enabled via a new Quintuple Helix Hub approach that combines academia, industry, healthcare, regulators, and society to unlock real world solutions.
Topics: Humans; Artificial Intelligence; Cross Infection; Disinfectants; Disinfection; Endoscopes; Equipment Contamination
PubMed: 36963674
DOI: 10.1016/j.scitotenv.2023.162976 -
Endoscopy International Open Mar 2023The contamination level of ready-to-use endoscopes published in the literature varies from 0.4 % to 49.0 %. Unfortunately, the comparison and the interpretation of...
The contamination level of ready-to-use endoscopes published in the literature varies from 0.4 % to 49.0 %. Unfortunately, the comparison and the interpretation of these results are quite impossible, given the limited number of samples and sites included and the differences observed between sampling, culturing methods, and interpretation criteria. The objective of this retrospective study was to analyze the results of 90,311 endoscope samples collected between 2004 and 2021 in 490 private or public hospitals in France. Through the full test period, the mean ratio of endoscopes at the action level was 12.6 % (19.5 % including alert level). Of the endoscopy units, 23.0 % had a ratio of compliant endoscopes ≤ 70.0 %. The overall microbial quality of gastroscopes, duodenoscopes, and colonoscopes is improving year by year, whereas an opposite trend is observed for ultrasound endoscopes and bronchoscopes. In 2021, following French guidelines, 13.0 % of the endoscopes should have been quarantined and 8.1 % were at the alert level, meaning that the contamination level of 21.1 % of the endoscopes exceeded what was defined as a maximum acceptable value. This study demonstrates that additional efforts, including implementation of microbial surveillance strategies using a standardized sampling method and periodic observational audits, must be made to improve the overall microbiological quality of endoscopes and reduce the risk associated with their use.
PubMed: 36937825
DOI: 10.1055/a-1991-1391 -
JGH Open : An Open Access Journal of... Feb 2023Adenosine triphosphate (ATP) bioluminescence assay is widely adopted in the West to allow rapid evaluation of endoscopes for bacteriologic/biologic residue, but this...
BACKGROUND AND AIM
Adenosine triphosphate (ATP) bioluminescence assay is widely adopted in the West to allow rapid evaluation of endoscopes for bacteriologic/biologic residue, but this practice is rarely adopted in Asia. In this continuous quality improvement program, we evaluated the utility of ATP in bacteriologic surveillance on endoscope reprocessing.
METHODS
A total of 456 samples (304 ATP samples and 152 culture samples) of 38 flexible endoscopes were assessed after routine clinical use in a private hospital in Hong Kong. Endoscopes were assessed with an ATP system and bacterial cultures at different time points during the reprocessing.
RESULTS
After pre-cleaning, the ATP values ranged from 228 to 65 163 relative light units (RLU) through all endoscope types. After manual cleaning, ATP values were decreased to 7-81 RLU (median, 19 RLU) for endoscope surface and 3-671 RLU (median, 12 RLU) for channel rinsate. There was a significant reduction in ATP levels between pre-cleaning and after manual cleaning. One of the 38 (2.6%) endoscopes (a duodenoscope) had an ATP value of 671 RLU from channel rinsate, which exceeded the benchmark for cleanliness of >200 RLU, and was sent back for re-cleaning. All endoscopes cultured no bacteria after high-level disinfection (HLD) by automated endoscope reprocessor (AER) and storage up to 24 h. ATP values were <200 RLU for all endoscopes after HLD and storage.
CONCLUSIONS
Adenosine triphosphate bioluminescence assay offers a rapid, practical, and cost-effective alternative for detection of endoscope microbial residue as well as a routine monitoring tool for endoscope cleanliness in the clinical setting.
PubMed: 36852145
DOI: 10.1002/jgh3.12863 -
BMJ Open Sep 2022Contaminated reprocessed duodenoscopes pose a serious threat to patients in the endoscopy unit. Despite manufacturer changes to reprocessing guidelines, 20% of...
OBJECTIVE
Contaminated reprocessed duodenoscopes pose a serious threat to patients in the endoscopy unit. Despite manufacturer changes to reprocessing guidelines, 20% of reprocessed duodenoscopes meet criteria for quarantine-level contamination based on microbiological or ATP testing. We aimed to examine risk factors for postendoscopic retrograde cholangiopancreatography (ERCP) infection.
DESIGN
Retrospective cohort analysis.
SETTING
US Medicare Fee-For-Service claims (2015-2021) and all-payer data (2017).
PARTICIPANTS
In the Medicare data, 823 575 ERCP procedures were included. The all-payer five-state data, 16 609 procedures were included.
INTERVENTIONS
ERCP was identified by Current Procedural Terminology and International Classification of Disease (ICD) procedure codes. We identified inpatient infections using ICD diagnosis codes.
OUTCOME MEASURES
A logistic regression model predicted risk factors for infections occurring within 7-day and 30-day periods following ERCP. 7-day and 30-day all-cause hospitalisations and post-ERCP pancreatitis were also examined.
RESULTS
Post-ERCP infection occurred within 3.5% of 7-day and 7.7% of 30-day periods in Medicare. Disposable duodenoscopes were billed in 711 procedures, with 1.4% (n=10, 7-day) and 3.5% (n=25, 30-day) post-ERCP infections. Urgent ERCPs were the strongest risk factor for infections in the 7-day period (OR 3.3, 95% CI 3.2 to 3.4). Chronic conditions, sex (male), age (older) and race (non-white) were also risk factors. In the all-payer five-state data, fewer infections (2.4%, 7 days) were observed. No difference arose between Medicare and other payers for 7-day period infections (OR 1.0, 95% CI 0.7 to 1.3).
CONCLUSIONS
Urgent ERCPs, patient chronic conditions and patient demographics are post-ERCP infection risk factors. Patients with infection risk factors should be targeted for specialised infection control prevention measures, including disposable duodenoscopes.
Topics: United States; Humans; Male; Aged; Retrospective Studies; Cholangiopancreatography, Endoscopic Retrograde; Equipment Contamination; Medicare; Risk Factors
PubMed: 36691191
DOI: 10.1136/bmjopen-2022-065077