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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 -
World Journal of Gastrointestinal... Jan 2019Per-oral pancreatoscopy (POPS) is an endoscopic procedure to visualize the main pancreatic duct. POPS specifically has the advantage of direct visualization of the... (Review)
Review
Per-oral pancreatoscopy (POPS) is an endoscopic procedure to visualize the main pancreatic duct. POPS specifically has the advantage of direct visualization of the pancreatic duct, allowing tissue acquisition and directed therapies such as stones lithotripsy. The aim of this review is to analyze and summarize the literature around pancreatoscopy. Pancreatoscopy consists of the classic technique of the mother-baby method in which a mini-endoscope is passed through the accessory channel of the therapeutic duodenoscope. Pancreatoscopy has two primary indications for diagnostic purpose. First, it is used for visualization and histological diagnosis of intraductal papillary mucinous neoplasms. In these cases, POPS is very useful to assess the extent of malignancy and for the study of the intraductal papillary mucinous neoplasm in order to guide the surgery resection margins. Second, it is used to determine pancreatic duct strictures, particularly important in cases of chronic pancreatitis, which is associated with both benign and malignant strictures. Therefore POPS allows differentiation between benign and malignant disease and allows mapping the extent of the tumor prior to surgical resection. Also tissue sampling is possible, but it can be technically difficult because of the limited maneuverability of the biopsy forceps in the pancreatic ducts. Pancreatoscopy can also be used for therapeutic purposes, such as pancreatoscopy-guided lithotripsy in chronic painful pancreatitis with pancreatic duct stones. The available data for the moment suggests that, in selected patients, pancreatoscopy has an important and promising role to play in the diagnosis of indeterminate pancreatic duct strictures and the mapping of main pancreatic duct intraductal papillary mucinous neoplasms. However, further studies are necessary to elucidate and validate the pancreatoscopy role in the therapeutic algorithm of chronic pancreatitis.
PubMed: 30705729
DOI: 10.4253/wjge.v11.i1.22 -
Clinical Endoscopy Mar 2022Unlike simple forward-viewing endoscopes such as gastroscope or colonoscope, duodenoscope houses much more complex design to fulfil its function. This design differences... (Review)
Review
Unlike simple forward-viewing endoscopes such as gastroscope or colonoscope, duodenoscope houses much more complex design to fulfil its function. This design differences leave duodenoscopes more prone to contamination from inadequate disinfection process and potential dissemination of pathogens. Recent reports on dissemination of infection through the duodenoscope mandated an overhaul of duodenoscope utilization including development of a disposable duodenoscope. This article reviews the current state of disposable duodenoscope development, including reported early efficacy as well as its future direction and utilization.
PubMed: 34154307
DOI: 10.5946/ce.2021.075 -
Life (Basel, Switzerland) Aug 2023Duodenoscope-related infections are a major concern in medicine and GI endoscopy, especially in fragile patients. Disposable duodenoscopes seem to be the right tool to... (Review)
Review
Duodenoscope-related infections are a major concern in medicine and GI endoscopy, especially in fragile patients. Disposable duodenoscopes seem to be the right tool to minimize the problem: a good choice for patients with many comorbidities or with a high risk of carrying multidrug resistant bacteria. Urgent endoscopy could also be a good setting for the use of single-use duodenoscopes, especially when the risk of the infection cannot be evaluated. Their safety and efficacy in performing ERCP has been proven in many studies. However, randomized clinical trials and comparative large studies with reusable scopes are lacking. Moreover, the present early stage of their introduction on the market does not allow a large economical evaluation for each health system. Thus, accurate economical and safety comparisons with cap-disposable duodenoscopes are needed. Moreover, the environmental impact of single-use duodenoscopes should be carefully evaluated, considering the ongoing climate change. In conclusion, definitive guidelines are needed to choose wisely the appropriate patients for ERCP with disposable duodenoscopes as the complete switch to single-use duodenoscopes seems to be difficult, to date. Many issues are still open, and they need to be carefully evaluated in further, larger studies.
PubMed: 37629551
DOI: 10.3390/life13081694 -
World Journal of Gastrointestinal... Jan 2014Peroral cholangioscopy is an important tool for diagnosis and treatment of various biliary disorders. Peroral cholangioscopy can be performed by using a dedicated...
Peroral cholangioscopy is an important tool for diagnosis and treatment of various biliary disorders. Peroral cholangioscopy can be performed by using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope, or by direct insertion of a small-diameter endoscope into the bile duct. Direct peroral cholangioscopy refers to insertion of an ultraslim endoscope directly into the bile duct for visualization of the biliary mucosa and lumen. This approach provides a valuable and economic solution for diagnostic and therapeutic applications in the biliary tree. Compared to ductoscopy using a dedicated cholangioscope, the direct approach has several advantages and disadvantages. In this editorial, I discuss the advantages, disadvantages, and possible future developments pertaining to direct peroral cholangioscopy.
PubMed: 24527174
DOI: 10.4253/wjge.v6.i1.1 -
Antimicrobial Resistance and Infection... Dec 2021Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a... (Review)
Review
Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.
Topics: Anti-Bacterial Agents; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Enterobacteriaceae; Enterobacteriaceae Infections; Equipment Contamination; Equipment Reuse; Humans; Infection Control; United States; United States Food and Drug Administration
PubMed: 34949217
DOI: 10.1186/s13756-021-01037-z -
Seminars in Interventional Radiology Aug 2021Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic technique in which a specialized side-viewing endoscope is guided into the duodenum, allowing for... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic technique in which a specialized side-viewing endoscope is guided into the duodenum, allowing for instruments to access the biliary and pancreatic ducts. ERCP was initially developed as a diagnostic tool as computed tomography was in its infancy during that time. ERCP has evolved since its inception in the 1960s to becoming not only a valuable diagnostic resource but now an effective therapeutic intervention in the treatment of various biliary disorders. The most common biliary interventions performed by ERCP include the management of biliary obstructions for benign and malignant indications. Additionally, endoscopic ultrasound (EUS) has been increasingly utilized in diagnosing and intervening on pancreaticobiliary lesion. This article will discuss the various methods currently available for various endoscopic biliary interventions and future interventional techniques. For the management of biliary strictures, EUS can be utilized with fine need aspiration, while ERCP can be used for the placement of various stents and diagnostic modalities. Another example is radiofrequency ablation, which can be used for the treatment of hilar strictures. Achieving bile duct access can be challenging in patients with complicated clinical scenarios; other techniques that can be used for bile duct access include EUS-guided rendezvous approach, transluminal approach, Choleodochoduodenostomy, and hepatogastrostomy, along with gaining access in complicated anatomy such as in patients with Rou-en-Y anatomy. Another useful endoscopic tool is nonsurgical drainage of the gallbladder, which can be a suitable option when patients are not optimal surgical candidates. There has also been an increase in outpatient utilization of ERCP, which was previously seen as a predominantly inpatient procedure in the past. Possible future evolutions of biliary interventions include robotic manipulation of a duodenoscope and direct infusion of chemotherapeutic or immunomodulatory agents into the pancreaticobiliary tree. These advancements will depend on parallel advancements in other imaging and laboratory as well as breakthrough technology or techniques by other disciplines including interventional radiology and minimally invasive surgery.
PubMed: 34393338
DOI: 10.1055/s-0041-1731266 -
Endoscopy International Open Dec 2020Recent outbreaks of duodenoscope-associated multidrug-resistant organisms (MDROs) have brought attention to the infection risk from procedures performed with... (Review)
Review
Recent outbreaks of duodenoscope-associated multidrug-resistant organisms (MDROs) have brought attention to the infection risk from procedures performed with duodenoscopes. Prior to these MDRO outbreaks, procedures with duodenoscopes were considered safe and low risk for exogenous infection transmission, provided they were performed in strict accordance with manufacturer instructions for use and multisociety reprocessing guidelines. The attention and efforts of the scientific community, regulatory agencies, and the device industry have deepened our understanding of factors responsible for suboptimal outcomes. These include instrument design, reprocessing practices, and surveillance strategies for detecting patient and instrument colonization. Various investigations have made it clear that current reprocessing methods fail to consistently deliver a pathogen-free instrument. The magnitude of infection transmission has been underreported due to several factors. These include the types of organisms responsible for infection, clinical signs presenting in sites distant from ERCP inoculation, and long latency from the time of acquisition to infection. Healthcare providers remain hampered by the ill-defined infectious risk innate to the current instrument design, contradictory information and guidance, and limited evidence-based interventions or reprocessing modifications that reduce risk. Therefore, the objectives of this narrative review included identifying outbreaks described in the peer-reviewed literature and comparing the findings with infections reported elsewhere. Search strategies included accessing peer-reviewed articles, governmental databases, abstracts for scientific conferences, and media reports describing outbreaks. This review summarizes current knowledge, highlights gaps in traditional sources of evidence, and explores opportunities to improve our understanding of actual risk and evidence-based approaches to mitigate risk.
PubMed: 33269310
DOI: 10.1055/a-1264-7173 -
EClinicalMedicine Aug 2020Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly...
BACKGROUND
Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data.
METHODS
We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies.
FINDINGS
We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%).
INTERPRETATION
This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies.
FUNDING
The authors received no financial support for the research, authorship, and/or publication of this article.
PubMed: 32954234
DOI: 10.1016/j.eclinm.2020.100451 -
Clinical Endoscopy Sep 2015A duodenoscope has a very complex structure that contains many small parts which make reprocessing more challenging. The difficulty in cleaning duodenoscopes contributes... (Review)
Review
A duodenoscope has a very complex structure that contains many small parts which make reprocessing more challenging. The difficulty in cleaning duodenoscopes contributes to a higher risk of infection than that of conventional gastrointestinal endoscopes. However, a duodenoscope shares similar disinfection process with other gastrointestinal endoscopes. Recent outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) infections associated with duodenoscopes used for endoscopic retrograde cholangiopancreatography procedures have raised many concerns worldwide. Duodenoscope-associated infections involving CRE or other multidrug-resistant bacteria pose a great threat to patients undergoing procedures using duodenoscopes and should be dealt with a great concern. Updated guidelines regarding cleaning and disinfection of duodenoscope needs to be developed urgently to prevent transmission of infection and ensure patient safety. Meanwhile, healthcare staff should pay special attention to thorough cleaning and disinfection of duodenoscopes.
PubMed: 26473116
DOI: 10.5946/ce.2015.48.5.361