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.

Endoscopic mask innovation and protective measures changes during the coronavirus disease-2019 pandemic: Experience from a Chinese hepato-biliary-pancreatic unit.

Endoscopy is widely used as a clinical diagnosis and treatment method for certain hepatobiliary and pancreatic diseases. However, due to the distinctive epidemiological characteristics of severe acute respiratory syndrome coronavirus 2, the virus causing coronavirus disease-2019 (COVID-19), healthcare providers are exposed to the patient's respiratory and gastrointestinal fluids, rendering endoscopy a high risk for transmitting a nosocomial infection. This article introduces preventive measures for endoscopic treatment enacted in our medical center during COVID-19, including the adjustment of indications, the application of endoscope protective equipment, the design and application of endoscopic masks and splash-proof films, and novel recommendations for bedside endoscope pre-sterilization.

In Vivo Evaluation of a Miniaturized Fluorescence Molecular Tomography (FMT) Endoscope for Breast Cancer Detection Using Targeted Nanoprobes.

In this study, in vivo animal experiments with 12 nude mice bearing breast-cancer-patient-tissue-derived xenograft (PDX) tumors were performed aiming to verify the imaging capability of a novel miniaturized fluorescence molecular tomography (FMT) endoscope, in combination with targeted nanoparticle-near-infrared (NIR) dye conjugates. Tumor-bearing mice were divided into two groups by systematic injection with urokinase plasminogen activator receptor-targeted (n = 7) and nontargeted (n = 5) imaging nanoprobes as a contrast agent, respectively. Each mouse was imaged at 6, 24, and 48 h following the injection of nanoprobes using the FMT endoscope. The results show that systemic delivery of targeted nanoprobes produced a 4-fold enhancement in fluorescence signals from tumors, compared with tumors that received nontargeted nanoprobes. This study indicates that our miniaturized FMT endoscope, coupled with the targeted nanoparticle-NIR dye conjugates as a contrast agent, has high sensitivity and specificity, and thus great potential to be used for image-guided detection and removal of a primary tumor and local metastatic tumors during surgery.

Transparent antifouling material for improved operative field visibility in endoscopy.

Camera-guided instruments, such as endoscopes, have become an essential component of contemporary medicine. The 15-20 million endoscopies performed every year in the United States alone demonstrate the tremendous impact of this technology. However, doctors heavily rely on the visual feedback provided by the endoscope camera, which is routinely compromised when body fluids and fogging occlude the lens, requiring lengthy cleaning procedures that include irrigation, tissue rubbing, suction, and even temporary removal of the endoscope for external cleaning. Bronchoscopies are especially affected because they are performed on delicate tissue, in high-humidity environments with exposure to extremely adhesive biological fluids such as mucus and blood. Here, we present a repellent, liquid-infused coating on an endoscope lens capable of preventing vision loss after repeated submersions in blood and mucus. The material properties of the coating, including conformability, mechanical adhesion, transparency, oil type, and biocompatibility, were optimized in comprehensive in vitro and ex vivo studies. Extensive bronchoscopy procedures performed in vivo on porcine lungs showed significantly reduced fouling, resulting in either unnecessary or ∼10-15 times shorter and less intensive lens clearing procedures compared with an untreated endoscope. We believe that the material developed in this study opens up opportunities in the design of next-generation endoscopes that will improve visual field, display unprecedented antibacterial and antifouling properties, reduce the duration of the procedure, and enable visualization of currently unreachable parts of the body, thus offering enormous potential for disease diagnosis and treatment.

Reprocessing of flexible endoscopes and endoscopic accessories used in gastrointestinal endoscopy: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA) - Update 2018.

This Position Statement from the European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology Nurses and Associates (ESGENA) sets standards for the reprocessing of flexible endoscopes and endoscopic devices used in gastroenterology. An expert working group of gastroenterologists, endoscopy nurses, chemists, microbiologists, and industry representatives provides updated recommendations on all aspects of reprocessing in order to maintain hygiene and infection control.

ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883-5.

1 Prerequisites. The clinical service provider should obtain confirmation from the endoscope washer-disinfector (EWD) manufacturer that all endoscopes intended to be used can be reprocessed in the EWD. 2 Installation qualification. This can be performed by different parties but national guidelines should define who has the responsibilities, taking into account legal requirements. 3 Operational qualification. This should include parametric tests to verify that the EWD is working according to its specifications. 4 Performance qualification. Testing of cleaning performance, microbiological testing of routinely used endoscopes, and the quality of the final rinse water should be considered in all local guidelines. The extent of these tests depends on local requirements. According to the results of type testing performed during EWD development, other parameters can be tested if local regulatory authorities accept this. Chemical residues on endoscope surfaces should be searched for, if acceptable test methods are available. 5 Routine inspections. National guidelines should consider both technical and performance criteria. Individual risk analyses performed in the validation and requalification processes are helpful for defining appropriate test frequencies for routine inspections.

Performance of a fully disposable, digital, single-operator cholangiopancreatoscope.

Background and study aim Our aim was to evaluate the first use in humans of a new, single-use, digital, single-operator intraductal cholangiopancreatoscopy system (IDCP). Patients and methods Data were collected retrospectively from four US institutions between February 2015 and April 2015. The visual impression of neoplasia or benign findings with IDCP was determined by the performing endoscopist. High grade dysplasia, intraductal papillary mucinous neoplasm, neuroendocrine tumor, and malignancy were categorized as neoplasia. Benign disease was defined as the absence of neoplasia during ≥ 6 months of follow-up. Results Patients (n = 108) with indeterminate strictures, dilatation, or difficult stones underwent IDCP. Of 74 patients with indeterminate stricture or dilatation, 29 (39 %) had neoplasia, of which 25 were confirmed by miniature biopsy forceps, 2 by surgical pathology, and 2 by the presence of metastatic disease on follow-up imaging. In patients with benign disease, 15 had concentric stenosis or normal/erythematous changes, 5 had low papillary mucosal projections, 6 had coarse granular mucosa, and 4 had nodular mucosa. Findings in patients with neoplastic disease included dilated, tortuous vessels ("tumor vessels"; n = 13), irregular margins with partial occlusion of the lumen (infiltrative stricture, n = 12), villous or nodular mass (n = 9), and finger-like villiform projections (n = 5). Operating characteristics for indeterminate stricture or dilatation were: 97 % sensitivity, 93 % specificity, 90 % positive predictive value, 98 % negative predictive value. Targeted biopsy yielded 86 % sensitivity and 100 % specificity. Stone clearance was noted in all cases. Adverse events occurred in 3 %. Conclusion The new IDCP system provides enhanced image resolution, and may improve the ability to target difficult stones and diagnose indeterminate strictures.

Review of Techniques to Achieve Optical Surface Cleanliness and Their Potential Application to Surgical Endoscopes.

A clear visualization of the operative field is of critical importance in endoscopic surgery. During surgery the endoscope lens can get fouled by body fluids (eg, blood), ground substance, rinsing fluid, bone dust, or smoke plumes, resulting in visual impairment. As a result, surgeons spend part of the procedure on intermittent cleaning of the endoscope lens. Current cleaning methods that rely on manual wiping or a lens irrigation system are still far from ideal, leading to longer procedure times, dirtying of the surgical site, and reduced visual acuity, potentially reducing patient safety. With the goal of finding a solution to these issues, a literature review was conducted to identify and categorize existing techniques capable of achieving optically clean surfaces, and to show which techniques can potentially be implemented in surgical practice. The review found that the most promising method for achieving surface cleanliness consists of a hybrid solution, namely, that of a hydrophilic or hydrophobic coating on the endoscope lens and the use of the existing lens irrigation system.

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high.

[Some Thoughts on Risk Prevention of Endoscopic Instruments].

There is a certain risk of nosocomial infection within the use of endoscopic instruments including trocars for laparoscope use. Attention should be paid to the content of the product manual in the seventh chapter of the industry standard YY 0672.1-2008. This paper proposes some comments and suggestions on this issue. We suggest there should add some contents in product manual.

The vacuum cleaner effect in minimally invasive percutaneous nephrolitholapaxy.

INTRODUCTION: Percutaneous stone removal increasingly plays an important role among the different approaches of interventional stone therapy, particularly since the development of miniaturized instruments is resulting in lower morbidity for the patients. One major drawback of smaller instruments is the increased difficulty of stone retrieval after disintegration due to the reduced tract diameter. This results in longer operation time and the need of additional tools such as disposable retrieval baskets. One of the key factors in the development of minimally invasive percutaneous nephrolitholapaxy (MIP) was the design of an Amplatz sheath which provides a built-in vacuum cleaner effect for stone retrieval. METHODS: A series of flow analyses with the gauges and shapes of the most commonly used nephroscopes and sheaths in percutaneous nephrolitholapaxy was performed by computational fluid dynamics. Flow velocity and direction in front of the nephroscope were computed and visualized by the software. RESULTS: In our study, the vacuum cleaner effect developed exclusively when a round-shaped nephroscope was used (Nagele Miniature Nephroscope System, Karl Storz GmbH & Co. KG) and depended on the relation between nephroscope diameter and inner sheath diameter. The strongest effect was observed with a 12 F nephroscope and an inner sheath diameter of 15 F. It did not develop when an oval- or crescent-shaped nephroscope was used. In front of the distal end of the round-shaped nephroscope, a slipstream develops, induced by the excursive change of width of the fluid flow on the outlet of the flushing canal. This allows the adhesion of a stone fragment in the eddy while the fluid flow is circulating around the stone. CONCLUSION: This study illustrates and explains the vacuum cleaner effect which has been detected in the development of the Nagele Miniature Nephroscope System used in MIP. It combines the reduced morbidity of smaller kidney puncture diameters with the benefit of quick and complete stone removal.

[Quality control research of cold light source of endoscope].

This paper introduced the significance parameters of the quality control of cold light source of endoscope, expounded the importance and necessity of quality control of cold light source; it investigated several manufacturers, analyzed and discussed the main causes of the cold light source uneven, in order to realized the standard management and effective supervision on the cold light source, at the end, the next step quality control work was brought out, which provide technical support for quality supervision of cold light source.

Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3).

BACKGROUND: Screening colonoscopy (SC) outcome quality is best determined by the adenoma detection rate (ADR). The substantial variability in the ADRs between endoscopists may reflect different skills, experience and/or equipment. OBJECTIVE: To analyse the potential factors that may influence ADR variance, including case volume. DESIGN: 12,134 consecutive SCs (mean age 64.5 years, 47% men) from 21 Berlin private-practice colonoscopists were prospectively studied during 18 months. The data were analysed using a two-level mixed linear model to adequately address the characteristics of patients and colonoscopists. The ADR was regressed after considering the following factors: sex, age, bowel cleanliness, NSAID intake, annual SC case volume, lifetime experience, instrument withdrawal times, instrument generations used, and the number of annual continuing medical education (CME) meetings attended by the physician. The case volume was also retrospectively analysed from the 2007 national SC registry data (312,903 colonoscopies and 1004 colonoscopists). RESULTS: The patient factors that correlated with the ADR were sex, age (p<0.001) and low quality of bowel preparation (p=0.005). The factors that were related to the colonoscopists were the number of CME meetings attended (p=0.012) and instrument generation (p=0.001); these factors accounted for approximately 40% of the interphysician variability. Within a narrow range (6-11 min), the withdrawal time was not correlated with the ADR. Annual screening case volume did not correlate with the ADR, and this finding was confirmed by the German registry data. CONCLUSIONS: The outcome quality of screening colonoscopies is mainly influenced by individual colonoscopist factors (ie, CME activities) and instrument quality. CLINICAL TRIAL REGISTRATION NUMBER: Clinical Trial Gov Registration number: NCT00860665.

Endoscope channel drying, storage, and conditions after reprocessing: How safe are they in clinical practice?

INTRODUCTION AND AIMS: Adequate drying and proper storage of flexible endoscopes are essential for maintaining quality in their reprocessing. The aim of the present study was to evaluate the drying stages, storage, and channel conditions of endoscopes through borescope inspection. MATERIAL AND METHODS: The personnel responsible for endoscope reprocessing were interviewed. Storage conditions at 10 endoscopy facilities were inspected and an internal examination of the channels and ports of the stored equipment was carried out, utilizing a borescope. A total of 74 stored endoscope channels were evaluated. RESULTS: Only 10% of the facilities inspected utilized transport cases for storage and only 10% had rooms exclusively used for storage. Sixty percent of the facilities did not perform any shelf-life control. All the channels evaluated were scratched and fluids were present on 69% of them. CONCLUSIONS: Endoscope reprocessing can be improved through the implementation of drying and storage control and validation tools, as well as the use of borescopes and periodic clinical audits.

Adverse staff health outcomes associated with endoscope reprocessing.

There are occupational challenges associated with cleaning, disinfecting, storing, and transporting flexible endoscopes. Although the Occupational Safety and Health Administration (OSHA) has set standards to protect the safety of health workers in the United States, the standards are not specific to endoscope reprocessing, and the general standards that are in place are not fully implemented. Furthermore, adverse staff outcomes may not be fully preventable. To assess the evidence for adverse outcomes in staff associated with endoscope reprocessing, a literature review was performed in the PubMed database for articles on this topic published between Jan. 1, 2007 and March 7, 2012. Eight studies were identified, mainly European, which reported numerous adverse outcomes to healthcare personnel associated with endoscope reprocessing including respiratory ailments and physical discomfort. More scientifically rigorous studies are required to comprehensively describe adverse health outcomes in personnel engaged in reprocessing, particularly in the United States, and examine whether increased automation of the reprocessing process leads to decreased adverse health outcomes for staff.

Validation of sleep nasendoscopy for assessment of snoring with bispectral index monitoring.

Bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalogram during sedation and general anaesthesia to assess the level of consciousness and depth of anaesthesia. BIS monitoring, whilst performing sleep nasendoscopy (using midazolam and propofol), has helped validate depth of sedation and allowed comparison with levels of sedation of control patients during natural sleep. A prospective study of 30 patients with snoring undergoing sleep nasendoscopy with BIS monitoring was conducted. BIS monitoring was recorded throughout the procedure and assessment of snoring was made at the appropriate level of sedation and snoring. BIS values were compared with control patients. The 30 patients undergoing sleep nasendoscopy had average BIS values ranging from 50.72 to 61.2. Similar results were seen with BIS and oxygen saturation in the control group. BIS monitoring provides an adjunct to the assessment of sleep nasendoscopy in determining the level of sedation required for snoring assessment. Comparable BIS values and oxygen saturation levels were obtained between controls and patients during sedation-induced sleep, thus validating the role of sleep nasendoscopy.

[Endoscopic diagnostics and treatment of submucous tumors of the upper gastrointestinal tract].

The endoscopic ultrasonography (EUS) is considered to be the leading method of diagnostic of the submucous gastrointestinal tumors. Results of diagnostics and treatment of submucous tumors of the upper gastrointestinal tract in 38 patients were analyzed. EUS was performed in 37 (97,4%) of patients, which allowed to detect the origin, size and localization of the tumor. The differential diagnostic algorithm was suggested together with certain indications for various surgical treatment modalities. Thereby, endoscopic ablation is reasonable when the tumor invades not deeper than muscle plate of mucosa or the submucose layer. Laparoscopic full-layer resection of the organ wall is necessary when the tumor invades the muscle layer. Larger tumors or those of any size, but with preoperative signs of high malignancy must be eradicated through laparotomy, meeting all principles of oncology.

Heads-up Surgery: Endoscopes and Exoscopes for Otology and Neurotology in the Era of the COVID-19 Pandemic.

A new era of surgical visualization and magnification is poised to disrupt the field of otology and neurotology. The once revolutionary benefits of the binocular microscope now are shared with rigid endoscopes and exoscopes. These 2 modalities are complementary. The endoscope improves visualization of the hidden recesses through the external auditory canal or canal-up mastoidectomy. The exoscope provides an immersive visual experience and superior ergonomics compared with binocular microscopy. Endoscopes and exoscopes are poised to disrupt the standard of care for surgical visualization and magnification in otology and neurotology.