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Atwood BI, Eberhardt GL, Smith JD, Lawton DN, Macdonald EM, Romito K. A Clean You Can Trust: Using an Evidence-Based Bundle to Transform Point-of-Use Treatment for Reusable Medical Devices at a Military Treatment Facility. Mil Med 2025; 190:e1318-e1325. [PMID: 39302736 DOI: 10.1093/milmed/usae453] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Revised: 07/26/2024] [Accepted: 09/07/2024] [Indexed: 09/22/2024] Open
Abstract
INTRODUCTION Throughout surgical and invasive procedures, reusable instruments and flexible endoscopes become soiled with organic and inorganic materials. When these substances are permitted to dry, a matrix of microbial cells, called biofilm, forms on the surface of devices, irreversibly binding and subsequently impeding the disinfection and sterilization process. To prevent biofilm formation from occurring, devices must be continuously flushed and wiped with water throughout the procedure and at the end of the case. This process, known as point-of-use treatment (POUT), is the critical first step in the decontamination of medical devices. Poor compliance with POUT can increase patient morbidity and mortality and result in failing hospital accreditation. MATERIALS AND METHODS An interdisciplinary team used the Plan-Do-Study-Act (PDSA) to develop and implement an audit assessing 29 evidence-based criteria for POUT treatment. Each PDSA cycle supported evidence-based opportunities addressing feedback, workflow analysis, policy development, competency assessment creation, training module development, and infection prevention grand rounds. Four audits were performed over ten months to achieve improved organizational POUT compliance. RESULTS Implementing recurrent PDSA cycles that included audits with feedback led to an evidence-based bundle of policies, competencies, and training for 34 different clinical areas. These interventions resulted in a 26% compliance increase (66% to 92%). Program-specific improvements included flexible endoscopes (+4%) and reusable instruments (+20%). CONCLUSIONS Multimodal evidence-based initiatives to improve compliance with workflow processes is a translatable POUT evidence-based practice project for similar Defense Health Agengy facilities. Workflow processes can be vetted and distributed using interdisciplinary teams to ensure viability, sustainability, and conformity with organizational requirements, resulting in a more ready force.
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Affiliation(s)
- Bethany I Atwood
- Uniformed Services University of the Health Sciences, Graduate School of Nursing, Bethesda, MD 20814, USA
| | - Gina L Eberhardt
- CNSCI, Madigan Army Medical Center, Joint Base Lewis-McCord, WA 98431, USA
| | - Joshua D Smith
- Surgical Services, Womack Army Medical Center, Fort Bragg, NC 28310, USA
| | - Danielle N Lawton
- Operating Room, 96th Medical Group, Eglin Air Force Base, FL 32542, USA
| | - Erin M Macdonald
- Operating Room, Naval Medical Center Portsmouth, Portsmouth, VA 23708, USA
| | - Kenneth Romito
- Uniformed Services University of the Health Sciences, Graduate School of Nursing, Bethesda, MD 20814, USA
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Kumar H, Dhali A, Maity R, Biswas J. Efficacy of spray flushing in the reprocessing of flexible endoscopes. World J Gastrointest Endosc 2025; 17:100298. [PMID: 39850913 PMCID: PMC11752462 DOI: 10.4253/wjge.v17.i1.100298] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2024] [Revised: 12/31/2024] [Accepted: 01/09/2025] [Indexed: 01/16/2025] Open
Abstract
This article comments on the article by Du et al, who conducted a randomized controlled trial aiming at evaluating the effectiveness of a novel spray flushing system in cleaning flexible endoscopes while minimizing damage to the working channels. We share our perspective on the importance of improving endoscope reprocessing methods. The findings highlight the spray flushing system's capacity to improve cleaning efficacy while minimizing damage, suggesting that it might be important in enhancing endoscope reprocessing procedures.
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Affiliation(s)
- Harendra Kumar
- General Medicine, Dow University of Health Sciences, Karachi 74200, Pakistan
| | - Arkadeep Dhali
- Academic Unit of Gastroenterology, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield S10 2JF, United Kingdom
- School of Medicine and Population Health, University of Sheffield, Sheffield S10 2HQ, United Kingdom
- Deanery of Clinical Sciences, University of Edinburgh, Edinburgh EH16 4SB, United Kingdom
- School of Medicine, University of Leeds, Leeds LS2 9JT, United Kingdom
| | - Rick Maity
- General Medicine, Institute of Post Graduate Medical Education and Research, Kolkata 700020, India
| | - Jyotirmoy Biswas
- General Medicine, College of Medicine and Sagore Dutta Hospital, Kolkata 700058, India
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van der Ploeg K, Vos MC, Erler NS, Bulkmans AJC, Mason-Slingerland BCGC, Severin JA, Bruno MJ. Impact of duodenoscope reprocessing factors on duodenoscope contamination: a retrospective observational study. J Hosp Infect 2024; 154:88-94. [PMID: 39389430 DOI: 10.1016/j.jhin.2024.09.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2024] [Revised: 08/21/2024] [Accepted: 09/23/2024] [Indexed: 10/12/2024]
Abstract
BACKGROUND Despite adherence to reprocessing protocols, duodenoscopes frequently remain contaminated, highlighting significant knowledge gaps in reprocessing efficiency. AIM To identify risk factors in duodenoscope reprocessing procedures affecting contamination rates. METHODS Cultures from Pentax ED34-i10T2 duodenoscopes collected between February 2022 and December 2023 were included. Contamination was determined by the presence of micro-organisms of gut or oral origin (MGO). Data on duodenoscope use, reprocessing lead times and personnel were retrieved from electronic medical records. Risk factors were derived from reprocessing guidelines and literature. These included a delay >30 min in initiating manual cleaning, manual cleaning duration of ≤5 min, drying time <90 min, personnel reprocessing frequency, and storage exceeding seven days. A logistic mixed-effects model evaluated these factors' impact on duodenoscope contamination. FINDINGS Out of 307 duodenoscope cultures, 58 (18.9%) were contaminated with MGO. Throughout the study period, the duodenoscopes underwent 1296 reprocessing cycles. Manual cleaning times of ≤5 min significantly increased contamination odds (adjusted odds ratio (aOR): 1.61; 95% confidence interval (CI): 1.10-2.34; P = 0.01). Increased usage of a duodenoscope was associated with reduced odds of contamination (aOR: 0.80; 95% CI: 0.64-0.995; P = 0.045). Other studied risks showed no clear association with contamination rates. CONCLUSION Manual cleaning times of ≤5 min increased the odds of contamination with MGO. Delays in reprocessing initiation and incomplete drying, traditionally considered as risk factors, were not associated with an increased risk of contamination in this study. Future research should explore whether enhanced surveillance of reprocessing times can mitigate duodenoscope contamination.
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Affiliation(s)
- K van der Ploeg
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands; Department of Medical Microbiology and Infectious Diseases, Erasmus MC University Medical Center, Rotterdam, The Netherlands
| | - M C Vos
- Department of Medical Microbiology and Infectious Diseases, Erasmus MC University Medical Center, Rotterdam, The Netherlands
| | - N S Erler
- Department of Biostatistics, Erasmus MC University Medical Centre, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - A J C Bulkmans
- Department of Quality Assurance and Regulatory Affairs Office, Medical Technology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands
| | - B C G C Mason-Slingerland
- Department of Medical Microbiology and Infectious Diseases, Erasmus MC University Medical Center, Rotterdam, The Netherlands
| | - J A Severin
- Department of Medical Microbiology and Infectious Diseases, Erasmus MC University Medical Center, Rotterdam, The Netherlands
| | - M J Bruno
- Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
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Eberhardt GL, Atwood BI, Smith JD. Point of Use Treatment for Medical Devices: From Bedside to Battlefield. Mil Med 2024; 189:e1910-e1916. [PMID: 38198220 DOI: 10.1093/milmed/usad499] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Revised: 12/13/2023] [Accepted: 12/22/2023] [Indexed: 01/12/2024] Open
Abstract
INTRODUCTION Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations. MATERIALS AND METHODS The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords "point of use," "point of use cleaning," "POU," "instrument," "high-level disinfection," "endoscope," and "clean." Articles were limited to "English" and "human" from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence. RESULTS The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions. CONCLUSION Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs.
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Affiliation(s)
- Gina L Eberhardt
- Graduate School of Nursing, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA
| | - Bethany I Atwood
- Graduate School of Nursing, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA
| | - Joshua D Smith
- Graduate School of Nursing, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA
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Mahoney LB, Walsh CM, Lightdale JR. Promoting Research that Supports High-Quality Gastrointestinal Endoscopy in Children. Curr Gastroenterol Rep 2023; 25:333-343. [PMID: 37782450 DOI: 10.1007/s11894-023-00897-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/17/2023] [Indexed: 10/03/2023]
Abstract
PURPOSE OF REVIEW Defining and measuring the quality of endoscopic care is a key component of performing gastrointestinal endoscopy in children. The purpose of this review is to discuss quality metrics for pediatric gastrointestinal endoscopy and identify where additional research is needed. RECENT FINDINGS Pediatric-specific standards and indicators were recently defined by the international Pediatric Endoscopy Quality Improvement Network (PEnQuIN) working group through a rigorous guideline consensus process. Although the aim of these guidelines is to facilitate best practices for safe and high-quality gastrointestinal endoscopy in children, they highlight the pressing need to expand upon the body of evidence supporting these standards and indicators as predictors of clinically relevant outcomes. In this review, we propose and discuss ideas for several high-yield research topics to engage pediatric endoscopists and promote best practices in pediatric endoscopy.
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Affiliation(s)
- Lisa B Mahoney
- Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, 300 Longwood Ave, Boston, MA, 02115, USA
| | - Catharine M Walsh
- Division of Gastroenterology, Hepatology and Nutrition and the Research and Learning Institutes, The Hospital for Sick Children, Department of Paediatrics and the Wilson Centre, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Jenifer R Lightdale
- Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, 300 Longwood Ave, Boston, MA, 02115, USA.
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Lisotti A, Fusaroli P, Napoleon B, Cominardi A, Zagari RM. Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection - from bench studies to clinical evidence. World J Methodol 2022; 12:122-131. [PMID: 35721249 PMCID: PMC9157629 DOI: 10.5662/wjm.v12.i3.122] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/28/2021] [Revised: 01/16/2022] [Accepted: 03/16/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Several strategies have been implemented to reduce or abolish the life-threatening risk of endoscopic retrograde cholangiopancreatography (ERCP)-related multidrug-resistant infections due to duodenoscopes contaminations; among those strategies, serial microbiologic tests, thorough reprocessing schedules, and use of removable scope cap have been adopted, but the potential cross-infection risk was not eliminated. AIM To review available evidence in the field of single-use duodenoscopes (SUD) use for ERCP. METHODS An overview on ongoing clinical studies was also performed to delineate which data will become available in the next future. RESULTS One bench comparative study and four clinical trials performed with EXALT model-D (Boston Scientific Corp., United States) have been identified. Of them, one is a randomized controlled trial, while the other three studies are prospective single-arm, cross-over studies. Pooled technical success rate (4 studies, 368 patients) was 92.9% [95% confidence interval (CI): 89.9-95.5; I 2: 11.8%]. Pooled serious adverse event (4 studies, 381 patients) rate was 5.9% [3.7%-8.5%; I 2: 0.0%]. CONCLUSION Although few clinical trials are available, evidence is concordant in identifying an absolute feasibility and safety and feasibility for SUD use for ERCP. The expertise and quality of evidence in this field are going to be improved by further large clinical trials;data on cost-effectiveness and environmental impact will be needed for a worldwide spread of SUD use for ERCP.
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Affiliation(s)
- Andrea Lisotti
- Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola 40026, BO, Italy
| | - Pietro Fusaroli
- Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola 40026, BO, Italy
| | - Bertrand Napoleon
- Gastroenterology Unit, Hôpital privé Jean Mermoz - Ramsay Générale de Santé, Lyon 69008, FR, France
| | - Anna Cominardi
- Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola 40026, BO, Italy
| | - Rocco Maurizio Zagari
- Dipertimento Di Scienze Mediche e Chirurgiche, Università di Bologna, Policlinico San Orsola Malpighi, Bologna 40138, Italy
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Garcia NB, Oliveira ACD. Storage of gastrointestinal endoscopes: when is the safe time for re-use? Rev Bras Enferm 2022; 75:e20210216. [DOI: 10.1590/0034-7167-2021-0216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2020] [Accepted: 10/13/2021] [Indexed: 11/22/2022] Open
Abstract
ABSTRACT Objectives: to identify the safe storage time for the use of flexible gastrointestinal endoscopes after high-level disinfection, as well as the defining criteria for this time. Methods: an integrative literature review was carried out in the Virtual Health Library, PubMed, Scopus, and Web of Science, considering original articles published since 2000. Results: eleven articles were selected, whose storage times ranged from 1 to 56 days, with a predominance of one to seven days (73%). Several criteria were used to define this time, predominantly the premise of efficient processing (100%), use of alcohol flush (64%), use of drying cabinets (18%), among others. Conclusions: the criteria for determining the storage time did not show a consensus for clinical practice. Expanding the discussion of this theme with the definition of the minimum necessary conditions is of fundamental importance for the reduction of risks and safety of the procedure and the patient.
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Heuvelmans M, Wunderink HF, van der Mei HC, Monkelbaan JF. A narrative review on current duodenoscope reprocessing techniques and novel developments. Antimicrob Resist Infect Control 2021; 10:171. [PMID: 34949217 PMCID: PMC8697464 DOI: 10.1186/s13756-021-01037-z] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2021] [Accepted: 11/19/2021] [Indexed: 11/10/2022] Open
Abstract
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.
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Affiliation(s)
- Maarten Heuvelmans
- Department of Medical Microbiology, University Medical Center Utrecht, G04.643, PO box 85500, 3508GA, Utrecht, The Netherlands.
| | - Herman F Wunderink
- Department of Medical Microbiology, University Medical Center Utrecht, G04.643, PO box 85500, 3508GA, Utrecht, The Netherlands
| | - Henny C van der Mei
- Department of Biomedical Engineering, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands
| | - Jan F Monkelbaan
- Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands
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