Reprocessing Of Flexible Endoscopes Research Articles

Predictive Analysis of Endoscope Demand in Otolaryngology Outpatient Settings

Background: There has been a trend to transit reprocessing of flexible endoscopes from a high-level disinfectant (HLD) centralized manner to sterilization performed by nursing staff in some Ear, Nose, and Throat (ENT) clinics. In doing so, the clinic nursing staff are responsible for predicting and managing clinical demand for flexible endoscopes. The HLD disinfection process is time-consuming and requires specialized training and competency to be performed safely. Solely depending on human expertise for predicting the flexible endoscope demands is unreliable and produced a concern of an inadequate supply of devices available for diagnostic purposes. Method: The demand for flexible endoscopes for future patient visits has not been well studied but can be modeled based on patients’ historical information, provider, and other visit-related factors. Such factors are available to the clinic before the visit. Binary classifiers can be used to help inform the sterile processing department of reprocessing needs days or weeks earlier for each patient. Results: Among all our trained models, Logistic Regression reports an average AUC ROC score of 89% and accuracy of 80%. Conclusion: The proposed framework not only significantly reduces the reprocessing efforts in terms of time spent on communication, cleaning, scheduling, and transferring scopes, but also helps to improve patient safety by reducing the exposure risk to potential infections.

UV light-based reprocessing of flexible endoscopes without working channel in Oto-Rhino-Laryngology: an effective method?

BackgroundReprocessing of flexible endoscopes (FEs) is often expensive, time consuming, and becomes increasingly complex, due to rising demands of hygiene. After beneficial results in reprocessing of rigid endoscopes using Impelux™ UV-C light technology, we tested the same method for reprocessing of FEs without working channel.Materials and methodsTesting was performed on FEs without working channel after routine clinical use (transnasal flexible endoscopy). Disinfection consisted of mechanical precleaning and 60 s exposure to Impelux™ UV-C light technology. Bacterial contamination was tested on 50 FEs before and after disinfection. Further 50 FEs regarding protein residuals. The absolute effectiveness of the D60 was tested on 50 test bodies (RAMS) with a standardized contamination of 107 colony-forming units (CFU) of Enterococcus faecium.ResultsThe FEs were contaminated with a high average value of 916.7 CFU (± 1057 CFU) after clinical usage. After reprocessing, an average contamination of 2.8 CFU (± 1.6) on 14% (n = 7) of the FEs was detected consisting of non-pathogenic species, the remaining FE were sterile. After reprocessing, all FEs were protein-free (< 1 μg). The artificially contaminated test bodies showed no remaining bacterial contamination after disinfection, resulting in an average absolute germ reduction of about 107 CFU.ConclusionImpelux™ UV-C light technology efficiently reduces bacterial contamination of FEs and might be useful in daily practice.

Scoping out the Situation-One Hospital's Review of Flexible Endoscope Handling and Reprocessing Methods Within Acute Care and Ambulatory Settings

<h3>Background</h3> Literature recognizes the risks of inadequately reprocessed flexible endoscopes. Our growing academic medical center and ambulatory settings perform various methods of handling and reprocessing flexible endoscopes. We recognized the need to evaluate methods used in each location with a goal to standardize processes. <h3>Methods</h3> Using endoscopy and sterile processing department best practices as a standard for flexible endoscope reprocessing, direct observations were completed in 12 locations of the inpatient and outpatient settings over a 6 month period by a multidisciplinary team. An extensive auditing tool was used to identify stable practices and variances related to flexible endoscope cleaning and disinfection, storage, handling, transport, and documentation processes. Data was reviewed at multiple meetings during the process with leadership and staff from each location. A gap analysis was then performed based on evaluations completed in each location. <h3>Results</h3> Deviations were identified when compared to best practices used in endoscopy and sterile processing departments. Variations included methods for cleaning and disinfection, times manual cleaning is initiated, identification of reprocessing date versus expiration date, methods used for documentation, documentation of cleaning stages, methods for documenting patient traceability, methods for transporting, designs of storage cabinets, competencies and certifications, use of personal protective equipment, and repair procedures. <h3>Conclusions</h3> Our study found that adopting standardized processes is ideal to provide the most consistent method for flexible endoscope reprocessing. Due to environmental and monetary constraints in certain locations, deviations in best practice are allowed to continue at this time. All methods adhere to manufacturer instructions for use and ensure effective, safe handling and reprocessing of flexible endoscopes.

Key steps in flexible endoscope reprocessing.

Key steps in flexible endoscope reprocessing.

Worldwide practices on flexible endoscope reprocessing

BackgroundEndoscopy related infections represent an important threat for healthcare systems worldwide. Recent outbreaks of infections with multidrug resistant micro-organisms have highlighted the problems of contaminated endoscopes. Endoscopes at highest risk for contamination have intricate mechanisms, multiple internal channels and narrow lumens that are especially problematic to clean. In light of raised awareness about the necessity for meticulous reprocessing of all types of endoscopes, a call for international collaboration is needed. An overview is presented on current practices for endoscope reprocessing in facilities worldwide.MethodAn electronic survey was developed and disseminated by the International Society for Antimicrobials and Chemotherapy. The survey consisted of 50 questions aimed at assessing the reprocessing of flexible endoscopes internationally. It covered three core elements: stakeholder involvement, assessment of perceived risks, and reprocessing process.ResultsThe survey received a total of 165 completed responses from 39 countries. It is evident that most facilities, 82% (n = 136), have a standard operating procedure. There is, however a lot of variation within the flexible endoscope reprocessing practices observed. The need for regular training and education of reprocessing practitioners were identified by 50% (n = 83) of the respondents as main concerns that need to be addressed in order to increase patient safety in endoscope reprocessing procedures.ConclusionThis international survey on current flexible endoscope reprocessing identified a large variation for reprocessing practices among different health care facilities/countries. A standardised education and training programme with a competency assessment is essential to prevent reprocessing lapses and improve patient safety.

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.

Use of adenosine triphosphate to audit reprocessing of flexible endoscopes with an elevator mechanism

There have been reported outbreaks of carbapenem-resistant Enterobacteriaceae infections linked to endoscopes with elevator mechanisms. Adenosine triphosphate (ATP) testing has been used as a marker for bioburden and monitoring manual cleaning for flexible endoscopes with and without an elevator mechanism. The objective of this study was to determine whether routine ATP testing could identify areas of improvement in cleaning of endoscopes with an elevator mechanism. ATP testing after manual cleaning of TJF-Q180V duodenoscopes and GF-UCT180 linear echoendoscopes (Olympus America Inc, Center Valley, PA) was implemented. Samples were tested from the distal end, the elevator mechanism, and water flushed through the lumen of the biopsy channel. Data were recorded and compared by time point, test point, and reprocessing technician. Overall failure rate was 6.99% (295 out of 4,219). The highest percentage of failed ATP tests (17.05%) was reported in the first quarter of routine testing, with an overall decrease in rates over time. The elevator mechanism and working channel lumen had higher failure rates than the distal end. Quality of manual cleaning between reprocessing technicians showed variation. ATP testing is effective in identifying residual organic material and improving quality of manual cleaning of endoscopes with an elevator mechanism. Cleaning efficacy is influenced by reprocessing technicians and location tested on the endoscope. Close attention to the working channel and elevator mechanism during manual cleaning is warranted.

Effect evaluation of adenosine triphosphate bioluminescence test on quality monitoring of flexible endoscope reprocessing

Objective To evaluate the efficacy of adenosine triphosphate (ATP) bioluminescence test on quality monitoring of flexible endoscope reprocessing. Methods The patient-used gastroscopes were randomly assigned to two groups after standard reprocessing by one nurse. The group A were assessed by ATP test followed by microbiological surveillance test after cleaning and disinfection; and the gastroscopes in group B were tested in a reverse order. The biological load after endoscopic cleaning and disinfection were compared between ATP test and microbiological surveillance, and the correlation of the two tests on quality assessing of endoscopic cleanliness and disinfection were analyzed. Results A total of 51 samples were valid. The qualified rate of cleaning was 45.1% (23/51) detected by ATP test, and the qualified rate of disinfection was 92.2% (47/51) detected by microbiological surveillance. There was no statistical difference in cleaning qualification rate (50.0% VS 40.0%, χ2=0.515, P=0.473) and disinfection qualification rate (96.2% VS 88.0%, χ2=0.316, P=0.574) between the two groups. The logarithmic value of relative light unit (RLU) of ATP test after cleaning was higher than the value after disinfection (1.68±0.50 VS 0.88±0.49, t=2.335, P=0.024). For gastroscopes disinfected appropriately, the RLU logarithmic value of ATP test after cleaning (t=2.505, P=0.016) and disinfection (t=2.485, P=0.016) were lower than that of disqualification. The correlation between the value of ATP test and the colony forming units of microbiological surveillance after cleaning was not statistically significant (r=0.199, P=0.171), but there was a low correlation between the two monitoring results after disinfection (r=0.391, P=0.005). There was a low correlation between the value of ATP test after cleaning and the colony forming units of microbiological surveillance after disinfection (r=0.301, P=0.032). Conclusion ATP bioluminescence test can be used to evaluate the trend of endoscopic biological load change and the quality of flexible endoscope reprocessing. Key words: Endoscopes, gastrointestinal; Quality control; Disinfection; Fluorometry

Tolerance of Pseudomonas aeruginosa in in-vitro biofilms to high-level peracetic acid disinfection

Biofilm has been suggested as a cause of disinfection failures in flexible endoscopes where no lapses in the decontamination procedure can be identified. To test this theory, the activity of peracetic acid, one of the widely used disinfectants in the reprocessing of flexible endoscopes, was evaluated against both planktonic and sessile communities of Pseudomonas aeruginosa. To investigate the ability of P.aeruginosa biofilm to survive high-level peracetic acid disinfection. The susceptibility of planktonic cells of P.aeruginosa and biofilms aged 24, 48, 96, and 192 h to peracetic acid was evaluated by estimating their viability using resazurin viability and plate count methods. The biomass of the P.aeruginosa biofilms was alsoquantified using Crystal Violet assay. Planktonic cells of P.aeruginosa were treated with 5-30 ppm concentration of peracetic acid in the presence of 3.0 g/L of bovine serum albumin (BSA) for 5 min. Biofilms of P.aeruginosa were also treated with various peracetic acid concentrations (100-3000 ppm) for 5 min. Planktonic cells of P.aeruginosa were eradicated by 20 ppm of peracetic acid, whereas biofilms showed an age-dependent tolerance to peracetic acid, and 96 h biofilm was only eradicated at peracetic acid concentration of 2500 ppm. Ninety-six-hour P.aeruginosa biofilm survives 5 min treatment with 2000 ppm of peracetic acid, which is the working concentration used in some endoscope washer-disinfectors. This implies that disinfection failure of flexible endoscopes might occur when biofilms build up in the lumens of endoscopes.

Sa1042 Use of Adenosine Triphosphate to Audit Reprocessing of Flexible Endoscopes With an Elevator Mechanism

Sa1042 Use of Adenosine Triphosphate to Audit Reprocessing of Flexible Endoscopes With an Elevator Mechanism

Current Practice of Duodenoscope Reprocessing.

Numerous outbreaks of duodenoscope-associated transmission of multi-drug resistant bacteria have recently been reported. Unlike prior episodes of endoscope-transmitted infections, the latest outbreaks have occurred despite strict adherence to duodenoscope reprocessing guidelines. The current standard for all flexible endoscope reprocessing includes pre-cleaning, leak testing, an additional manual cleaning step, and high-level disinfection. When these steps are strictly followed, the risk of infection transmission during endoscopy is exceedingly rare. However, due to its complex design, the duodenoscope may not be able to be adequately disinfected using the current reprocessing standards. Supplemental measures to enhance scope reprocessing have subsequently been recommended to reduce the infection risk in patients undergoing endoscopic retrograde cholangiopancreatography. These methods are likely short-term solutions that have yet to be validated regarded their effectiveness. Additional approaches to monitor the quality of duodenoscope reprocessing may also be useful. Ultimately, a definitive, yet logistically feasible, method of duodenoscope reprocessing is required to ensure the safety of our patients.

In-Use Evaluation of Peracetic Acid for High-Level Disinfection of Endoscopes.

Many high-level disinfectants have been used for disinfection of endoscopes such as 2% glutaraldehyde (GA), 0.55% ortho-phthalaldehyde (OPA), and peracetic acid (PAA). Both GA and OPA are widely used in disinfection of endoscopes and have been previously discussed, but there is little research on the practical use of PAA as an endoscope disinfectant. An experimental model of a flexible gastrointestinal endoscope being contaminated with 9 strains of microorganism was designed. After the cleaning and disinfecting procedure was completed, we evaluated the biocidal activity (850 ppm PAA, 2% GA, and 0.55% OPA) on our flexible gastrointestinal endoscope model. We also evaluated sterilization effectiveness of PAA on other bacteria, including some antibiotic-resistant bacteria (methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and Clostridium difficile). The residual bacterial colony count number of the PAA-disinfected endoscope was significantly lower than that of the GA- and OPA-disinfected endoscopes. The biocidal effect and efficiency of the endoscope disinfection by PAA appeared to be better than either the GA- or OPA-disinfected endoscope. PAA has demonstrated a good sterilization effect on other bacterial species; of particular note are common antibiotic-resistant bacteria such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and Clostridium difficile. The results of this study demonstrate that PAA is a fast and effective high-level disinfectant for use in the reprocessing of flexible endoscopes.

Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy

Flexible endoscopy is a widely used diagnostic and therapeutic procedure. Contaminated endoscopes are the medical devices frequently associated with outbreaks of health care-associated infections. Accurate reprocessing of flexible endoscopes involves cleaning and high-level disinfection followed by rinsing and drying before storage. Most contemporary flexible endoscopes cannot be heat sterilized and are designed with multiple channels, which are difficult to clean and disinfect. The ability of bacteria to form biofilms on the inner channel surfaces can contribute to failure of the decontamination process. Implementation of microbiological surveillance of endoscope reprocessing is appropriate to detect early colonization and biofilm formation in the endoscope and to prevent contamination and infection in patients after endoscopic procedures. This review presents an overview of the infections and cross-contaminations related to flexible gastrointestinal endoscopy and bronchoscopy and illustrates the impact of biofilm on endoscope reprocessing and postendoscopic infection.

P07.02 Glutaraldehyde and other aldehyde resistant bacteria associated with the use of washer-disinfectors used in the reprocessing of flexible endoscopes

P07.02 Glutaraldehyde and other aldehyde resistant bacteria associated with the use of washer-disinfectors used in the reprocessing of flexible endoscopes

Exploring Human Factors in Endoscope Reprocessing

The goal of this research is to study the human factors that influence the reprocessing of flexible endoscopes. This paper will report on the preliminary findings from a heuristic evaluation of current reprocessing procedures from an ongoing multi-method study and will discuss the implications of the results for future research purposes.

Computer-aided recording of automatic endoscope washing and disinfection processes as an integral part of medical documentation for quality assurance purposes.

BackgroundThe reprocessing of medical endoscopes is carried out using automatic cleaning and disinfection machines. The documentation and archiving of records of properly conducted reprocessing procedures is the last and increasingly important part of the reprocessing cycle for flexible endoscopes.MethodsThis report describes a new computer program designed to monitor and document the automatic reprocessing of flexible endoscopes and accessories in fully automatic washer-disinfectors; it does not contain nor compensate the manual cleaning step. The program implements national standards for the monitoring of hygiene in flexible endoscopes and the guidelines for the reprocessing of medical products. No FDA approval has been obtained up to now. The advantages of this newly developed computer program are firstly that it simplifies the documentation procedures of medical endoscopes and that it could be used universally with any washer-disinfector and that it is independent of the various interfaces and software products provided by the individual suppliers of washer-disinfectors.ResultsThe computer program presented here has been tested on a total of four washer-disinfectors in more than 6000 medical examinations within 9 months.ConclusionsWe present for the first time an electronic documentation system for automated washer-disinfectors for medical devices e.g. flexible endoscopes which can be used on any washer-disinfectors that documents the procedures involved in the automatic cleaning process and can be easily connected to most hospital documentation systems.

Qualitätssicherungsvereinbarung Koloskopie: Eine Ergebnisevaluierung aus Nord-Württemberg 2003 – 2007

Diverse problems with the hygienically correct reprocessing of endoscopes and resulting transmissions of pathogens over the last decades are well documented. As a consequence, the worldwide first evidence-based compulsory guidelines for all endoscopy units in clinics and practices were implemented in Germany in 2002. The presented study reports for the first time ever on a detailed outcome evaluation of these guidelines. Data of all routine and all required 1st and 2nd re-examinations of endoscopes from all units (clinics and practices) performing endoscopy in the district of Nord-Württemberg, Germany, between 2003 and 2007 were analysed. A significant (p < 0.0001) overall decrease of insufficiently sterilised endoscopes was found during the observation period. The proportion of required re-examinations in clinics was below 10 % already in 2003 and remained within single figure percentages over the following years. In doctors' practices, however, in 2003 nearly every second routine examination of endoscopes required a re-examination and a significant (p < 0.0001) decrease of these figures was only found from 2004 onwards. A significant trend (p < 0.01) of re-processing techniques away from manual techniques towards fully automated procedures could be documented. No significant changes with respect to the localisation or the spectrum of the detected pathogens during control examinations were found. The presented outcome evaluation demonstrates that the implementation of stringent compulsory guidelines in Germany (and the conditional refund from the public health system for screening procedures linked to them) resulted in a substantial and significant improvement of hygiene in the re-processing of flexible endoscopes.

ESGE–ESGENA guideline: Cleaning and disinfection in gastrointestinal endoscopy

1. Introduction2. Definition of terms3. Endoscopy-related infections4. Principles of infection control5. Chain of infection6. Health and safety of endoscopy personnel7. General requirements7.1. Classification of endoscopic equipment7.2. Aims of the reprocessing procedure7.3. Staff requirements7.4. Reprocessing room7.5. The reprocessing procedure7.6. Manual versus automated reprocessing8. Process chemicals8.1. Detergents8.1.1. Detergents with enzymatic boosters8.1.2. Detergents with alkaline boosters8.1.3. Detergents with enzymatic and alkaline boosters8.1.4. Detergents containing antimicrobial active substances8.2. Disinfectants8.2.1. Glutaraldehyde8.2.2. Orthophthalaldehyde (OPA)8.2.3. Peracetic acid (PAA)8.2.4. Chlorine dioxide8.2.5. Electrolytically generated disinfectants8.3. Rinse aid8.4. Combination of products from different manufacturers8.5. Change of products9. Reprocessing of endoscopes9.1. Manual cleaning9.1.1. Pre-cleaning in the endoscopy room9.1.2. Manual cleaning in the reprocessing room9.2. Reprocessing in washer-disinfectors9.2.1. Definition and process basics for washer-disinfectors9.2.2. Process specifications for washer-disinfectors9.2.3. Specific recommendations for washer-disinfectors9.2.4. Advantages and disadvantages of washer-disinfectors9.3. Reprocessing in automated disinfection devices9.3.1. Definition and process basics for automated disinfection devices9.3.2. Process specifications for automated disinfection devices9.3.3. Specific recommendations for automated disinfection devices9.3.4. Advantages and disadvantages of automated disinfection devices9.4. Manual reprocessing of endoscopes9.4.1. Definition and process basics for manual reprocessing9.4.2. Process specifications for manual reprocessing9.4.3. Advantages and disadvantages of manual reprocessing9.5. Drying, storage and reuse of endoscope10. Quality assurance10.1. Documentation10.2. Maintenance of washer-disinfectors and automated disinfection devices10.3. Process validation and microbiological surveillance10.4. Outbreak management11. Reprocessing of endoscopic accessories11.1. General recommendations11.2. Process specifications11.2.1. Manual cleaning11.2.2. Reprocessing in washer-disinfectors11.2.3. Manual reprocessing11.2.4. Sterilization11.2.5. Storage11.3. Specific recommendations11.3.1. Biliary and pancreatic procedures11.3.2. Injection needles11.3.3. Biopsy forceps11.3.4. Water bottle and its connectors12. AppendicesAppendix 1: Manual cleaning of flexible endoscopesAppendix 2: Reprocessing of flexible endoscopes in washer-disinfectors and automated disinfection devicesAppendix 3: Manual reprocessing of flexible endoscopesAppendix 4: Manual reprocessing of reusable endoscopy accessoriesAppendix 5: Reprocessing of endoscopic accessories in washer-disinfectors and automated disinfection devices13. References

Infection control during GI endoscopy

This is one of a series of statements discussing the use of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy (ASGE) prepared this text. In preparing this guideline, a search of the medical literature was performed by using PubMed, supplemented by accessing the "related articles" feature of PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. The recommendations were based on reviewed studies and were graded on the strength of the supporting evidence (Table 1). This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.

Application of environmental sampling to flexible endoscope reprocessing: the importance of monitoring the rinse water.

The routine sampling of environmental surfaces within a healthcare facility is generally not recommended by the Centers for Disease Control and Prevention (CDC), the Association for the Advancement of Medical Instrumentation (AAMI), and several other healthcare organizations. There are a few circumstances, however, for which some organizations do recommend this practice. For instance, the CDC and the Association for Professionals in Infection Control and Epidemiology (APIC) recommend environmental sampling as clinically required during an outbreak investigation. The CDC and AAMI also recommend routine sampling of the rinse water used during hemodialyzer (but not endoscope) reprocessing. The rationale for this recommendation is based in part on reports of pyrogenic responses, patient infections, and bacteremia due to waterborne, gram-negative bacteria during hemodialysis. To determine whether the basis for this rationale might similarly apply to the rinse water used during endoscope reprocessing, the Food and Drug Administration's medical device reporting database, the endoscope reprocessing literature, and other sources were reviewed. The results of this review indicate that nosocomial outbreaks linked to endoscopes contaminated with gram-negative bacteria have been frequently reported. As a result, for several reasons, including to minimize the risk of patient infection due to gram-negative bacteria following endoscopy, this article recommends routine microbiologic sampling of the rinse water used during endoscope reprocessing.