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Digestive Diseases and Sciences Feb 2020Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known procedure with both diagnostic and therapeutic utilities in managing pancreaticobiliary conditions.... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known procedure with both diagnostic and therapeutic utilities in managing pancreaticobiliary conditions. With the advancements of endoscopic techniques, ERCP has become a relatively safe and effective procedure. However, as ERCP is increasingly being utilized for different advanced techniques, newer complications have been noticed. Post-ERCP complications are known, and mostly include pancreatitis, infection, hemorrhage, and perforation. The risks of these complications vary depending on several factors, such as patient selection, endoscopist's skills, and the difficulties involved during the procedure. This review discusses post-ERCP complications and management strategies with new and evolving concepts.
Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Cholangiopancreatography, Endoscopic Retrograde; Cholangitis; Cholecystitis; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Infections; Intestinal Perforation; Pancreatic Ducts; Pancreatitis; Patient Selection; Postoperative Complications; Postoperative Hemorrhage; Risk Factors; Stents
PubMed: 31792671
DOI: 10.1007/s10620-019-05970-3 -
Gastrointestinal Endoscopy Clinics of... Oct 2020Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with... (Review)
Review
Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.
Topics: Biofilms; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Duodenoscopy; Endosonography; Equipment Contamination; Equipment Design; Fomites; Humans; Infection Control
PubMed: 32891223
DOI: 10.1016/j.giec.2020.05.002 -
Gastrointestinal Endoscopy Clinics of... Oct 2020With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies... (Review)
Review
With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies continue to release updated recommendations. Despite general guideline similarities, there are differences. Although adherence to guidelines does not entirely eliminate pathogen contamination or transmission, it is critical to strictly adhere to updated guidelines for maximum risk reduction. In the United States, the Food and Drug Administration and Centers for Disease Control and Prevention continue to offer updates regarding improved duodenoscope reprocessing techniques and endoscope design. This article critically analyzes currently available national and international duodenoscope reprocessing guidelines.
Topics: Centers for Disease Control and Prevention, U.S.; Cholangiopancreatography, Endoscopic Retrograde; Consensus; Cross Infection; Duodenoscopes; Duodenoscopy; Guidelines as Topic; Humans; Infection Control; Societies, Medical; United States; United States Food and Drug Administration
PubMed: 32891231
DOI: 10.1016/j.giec.2020.06.008 -
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 Feb 2022
Topics: Cross Infection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 34412140
DOI: 10.1055/a-1507-5196 -
Clinical Gastroenterology and... Jul 2020
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Humans
PubMed: 32173482
DOI: 10.1016/j.cgh.2020.03.010 -
Chest Feb 2020Several recent cases associating cleaned and high-level disinfected duodenoscopes with outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and related... (Review)
Review
Several recent cases associating cleaned and high-level disinfected duodenoscopes with outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and related multidrug-resistant organisms (MDROs) may cause bronchoscopists, pulmonologists, and other stakeholders to inquire about the effectiveness of today's practices for reprocessing flexible bronchoscopes. The primary objectives of this study were to address this question and investigate the risk of bronchoscopes transmitting infections of CRE and related MDROs. The published literature and the US Food and Drug Administration's medical device database of adverse events were searched beginning in 2012, when endoscopy first emerged as a recognized risk factor for transmission of CRE. The Internet was also searched during this same time frame to identify other relevant cases. Several cases associating reprocessed bronchoscopes with infections of CRE or a related MDRO were identified. This study's findings suggest that bronchoscopes may pose an underrecognized potential for transmission of CRE and related MDROs, warranting greater public awareness, enhanced preventive measures, and updated reprocessing guidance. This study's data also suggest that the cleaning and high-level disinfection of bronchoscopes performed in accordance with published guidelines and manufacturer instructions may not always be sufficiently effective to eliminate this risk. Several factors were identified that can adversely affect a bronchoscope's reprocessing and pose a risk of transmission of these multidrug-resistant bacteria, including use of a damaged or inadequately serviced bronchoscope, and formation of an inaccessible biofilm. Recommendations are provided to improve the safety of flexible bronchoscopes, including supplementing their reprocessing with an enhanced measure such as sterilization when warranted, and strict adherence to a periodic servicing and maintenance schedule consistent with the bronchoscope manufacturer's instructions.
Topics: Anti-Bacterial Agents; Bronchoscopes; Bronchoscopy; Carbapenem-Resistant Enterobacteriaceae; Colistin; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Enterobacteriaceae Infections; Equipment Contamination; Equipment Reuse; Humans; Klebsiella Infections; Klebsiella pneumoniae; Pseudomonas Infections; Pseudomonas aeruginosa; beta-Lactam Resistance
PubMed: 31421109
DOI: 10.1016/j.chest.2019.08.003 -
Endoscopy Nov 2022
Topics: Humans; Duodenoscopes; Decontamination; Equipment Contamination; Disinfection
PubMed: 35863342
DOI: 10.1055/a-1866-3886 -
Gastrointestinal Endoscopy Clinics of... Oct 2020Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to... (Review)
Review
Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to endoscopic transmission of the infections between patients, primarily from duodenoscopes. These outbreaks have focused the attention of endoscope manufacturers, professional societies, and regulatory agencies on improving the reprocessing of these devices. The key steps in this process are point-of-use precleaning, leak testing, manual cleaning, high-level disinfection, and finally drying and storage. The promise of these initial efforts suggest that the aim of minimizing and ultimately eliminating events of endoscope-/duodenoscope-associated transmission of infectious organisms between patients can be achieved.
Topics: Cross Infection; Disease Outbreaks; Disinfection; Duodenoscopes; Endoscopes; Fomites; Guideline Adherence; Humans; Infection Control
PubMed: 32891224
DOI: 10.1016/j.giec.2020.06.002 -
European Journal of Clinical... Dec 2019Flexible digestive endoscopes are used for the management of various conditions with hundreds of thousands of therapeutic procedures performed worldwide each year.... (Review)
Review
Flexible digestive endoscopes are used for the management of various conditions with hundreds of thousands of therapeutic procedures performed worldwide each year. Duodenoscopes are indispensable tools for the delivery of minimally invasive vital care of numerous pancreaticobiliary disorders. Despite the fact that nosocomial infections after endoscopic retrograde cholangiopancreatography (ERCP) have always been among the most frequently cited postprocedural complications, recent emergence of duodenoscope-transmitted multiple drug-resistant bacterial infections has led to intense research and debate yet with no clearly delineated solution. Duodenoscope-transmitted nosocomial infections have become one of the most visible topics in the recent literature. Hundreds of high-impact articles have therefore been published in the last decade. This review article discusses how such infections were seen in the past and what is the current situation in both research and practice and thus tries to solve some of the unanswered questions for the future. With the persistence of nosocomial infections despite strict adherence to both manufacturer-issued reprocessing protocols and international guidelines and regulations, an urgent and proper microbiologically driven common action is needed for controlling such nosocomial worldwide threat.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disinfection; Duodenoscopes; Equipment Contamination; Equipment Reuse; Humans; Infection Control; Risk Factors
PubMed: 31482418
DOI: 10.1007/s10096-019-03671-3