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The utility of lighted magnification and borescopes for visual inspection of flexible endoscopes

Open AccessPublished:September 05, 2022DOI:https://doi.org/10.1016/j.ajic.2022.08.026

      Highlights

      • Initiating visual inspection identified defects in 100% of processed endoscopes.
      • Magnification and borescopes identified scopes that needed recleaning or repair.
      • Damage included scratches, channel shredding, dents, and adhesive disintegration.
      • Debris included accessories and white, black, brown, yellow/green, and red residue.
      • Fluid droplets or white domes were observed in more than half of endoscopes.

      Abstract

      Introduction

      Infections have been linked to damaged or contaminated endoscopes with visible defects. Endoscope processing standards and guidelines state endoscopes should be visually inspected every time they are used. This study evaluated a new visual inspection program using magnification and borescopes in an endoscopy department that had not previously utilized these tools.

      Methods

      Site personnel were given visual inspection tools and training before systematically examining fully processed endoscopes twice during a 2-month period. A risk assessment protocol was used to determine whether endoscopes required recleaning, repair, or other action. Findings were documented using log sheets, photographs, and videotapes.

      Results

      Visible damage and residue or debris were observed in 100% of 25 endoscopes at both assessments, and 76% required repair. Defects at baseline included scratches (88%); channel shredding or peeling (80%); adhesive band disintegration (80%); residual soil or debris (white 84%; black 68%; brown 40%; yellow/green 36%; and orange/red 8%); retained fluid (52%); and dents (40%). Findings were similar at follow-up.

      Discussion/Conclusions

      Visual inspection with magnification and borescopes identified actionable defects that could interfere with processing effectiveness in 100% of endoscopes. Infection preventionists have a critical role to play in supporting processing personnel now that standards, guidelines, and manufacturer instructions recommend enhanced visual inspection of every endoscope, every time.

      Key Words

      Flexible endoscopes are essential tools used for minimally invasive screening, diagnostic, and therapeutic procedures.
      • Day LW
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      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      ,
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      Reusable endoscopes must be sterilized or high-level disinfected (HLD) between uses.
      • Day LW
      • Muthusamy VR
      • Collins J
      • et al.
      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      SGNA
      Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.
      • Van Wicklin SA
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      Guideline for processing flexible endoscopes.
      Prior to sterilization or HLD, endoscopes should be cleaned and inspected to ensure that they are free from damage or residual soil that could impact outcomes.
      • Day LW
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      • Collins J
      • et al.
      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      SGNA
      Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.
      • Van Wicklin SA
      • Conner R
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      Guideline for processing flexible endoscopes.
      Outbreaks
      • Galdys AL
      • Marsh JW
      • Delgado E
      • et al.
      Bronchoscope-associated clusters of multidrug-resistant Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae.
      • Kumarage J
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      • Hoffman P
      • Taori SK.
      Transmission of MDR Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: the fragility of endoscope decontamination.
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      Independent root cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to an outbreak of multidrug-resistant Klebsiella pneumoniae.
      and injuries
      Food and Drug Administration
      Olympus Medical Systems Corp. Evis Lucera Bronchovideoscope 7599661.
      ,
      Food and Drug Administration
      Olympus Medical Systems Corp. Evis Exera III Colonovideoscope 9699365.
      have been linked to damaged and contaminated endoscopes. During several superbug outbreaks among patients undergoing bronchoscopy, ureteroscopy, or duodenoscopy, visible defects or soil were discovered in the implicated endoscopes only after numerous patients were infected.
      • Galdys AL
      • Marsh JW
      • Delgado E
      • et al.
      Bronchoscope-associated clusters of multidrug-resistant Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae.
      • Kumarage J
      • Khonyongwa K
      • Khan A
      • Desai N
      • Hoffman P
      • Taori SK.
      Transmission of MDR Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: the fragility of endoscope decontamination.
      • Rauwers AW
      • Troelstra A
      • Fluit AC
      • et al.
      Independent root cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to an outbreak of multidrug-resistant Klebsiella pneumoniae.
      ,
      • Wendorf KA
      • Kay M
      • Baliga C
      • et al.
      Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.
      To reduce risk, current standards, guidelines, and manufacturer instructions recommend every endoscope be inspected using lighted magnification and suggest that borescopes may be used to inspect channels.
      • Day LW
      • Muthusamy VR
      • Collins J
      • et al.
      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      ,
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      ,
      • Van Wicklin SA
      • Conner R
      • Spry C.
      Guideline for processing flexible endoscopes.
      ,
      Olympus America Inc
      The use of Borescopes to Inspect Channels of Olympus Flexible Endoscopes.
      These guidelines state that visual inspection should be performed before, during, and after the procedure,
      • Day LW
      • Muthusamy VR
      • Collins J
      • et al.
      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      after cleaning, and before sterilization or disinfection to evaluate endoscopes and accessories for cleanliness, moisture, changes in appearance, missing parts, integrity and function of components, and physical or chemical damage.
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      ,
      • Van Wicklin SA
      • Conner R
      • Spry C.
      Guideline for processing flexible endoscopes.
      New standards recommend personnel be trained on using borescopes,
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      but endoscope manufacturers have not yet disseminated guidance on how to perform borescope examinations and discern whether findings are normal or represent defects that require repair, additional cleaning, or other action. Researchers have developed a borescope scoring mechanism to categorize visible damage and residue
      • Barakat MT
      • Girotra M
      • Huang RJ
      • Banerjee S.
      Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).
      and provided guidance on setting up a borescope inspection program and using tools such as swabs, brushes, and laboratory tests to determine the nature of debris and residue discovered inside scopes.
      • Ofstead CL
      • Hopkins KM.
      Sterilization Central: the value of borescopes in detecting damage, soil, fluid, and foreign objects in flexible endoscopes.
      Studies that used borescopes have identified visible defects in nearly 100% of previously uninspected endoscopes, including residual soil, debris, retained fluid, and damage.
      • Barakat MT
      • Girotra M
      • Huang RJ
      • Banerjee S.
      Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).
      ,
      • Liu TC
      • Peng CL
      • Wang HP
      • Huang HH
      • Chang WK.
      SpyGlass application for duodenoscope working channel inspection: Impact on the microbiological surveillance.
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Eiland JE
      • Wetzler HP.
      Residual moisture and waterborne pathogens inside flexible endoscopes: evidence from a multisite study of endoscope drying effectiveness.
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Johnson EA
      • Eiland JE
      • Wetzler HP.
      The effectiveness of sterilization for flexible ureteroscopes: a real-world study.
      • Ofstead CL
      • Quick MR
      • Wetzler HP
      • et al.
      Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.
      • Ofstead CL
      • Wetzler HP
      • Eiland JE
      • Heymann OL
      • Held SB
      • Shaw MJ.
      Assessing residual contamination and damage inside flexible endoscopes over time.
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      • Thaker AM
      • Kim S
      • Sedarat A
      • Watson RR
      • Muthusamy VR.
      Inspection of endoscope instrument channels after reprocessing using a prototype borescope.
      In some cases, new scratches and channel shredding appeared within a few uses
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Johnson EA
      • Eiland JE
      • Wetzler HP.
      The effectiveness of sterilization for flexible ureteroscopes: a real-world study.
      ,
      • Thaker AM
      • Kim S
      • Sedarat A
      • Watson RR
      • Muthusamy VR.
      Inspection of endoscope instrument channels after reprocessing using a prototype borescope.
      and critical defects requiring repair were observed.
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Johnson EA
      • Eiland JE
      • Wetzler HP.
      The effectiveness of sterilization for flexible ureteroscopes: a real-world study.
      ,
      • Ofstead CL
      • Wetzler HP
      • Eiland JE
      • Heymann OL
      • Held SB
      • Shaw MJ.
      Assessing residual contamination and damage inside flexible endoscopes over time.
      ,
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      Given that researchers have also detected soil and microbial bioburden on more than 50% of fully-processed endoscopes,
      • Ofstead CL
      • Quick MR
      • Wetzler HP
      • et al.
      Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.
      • Ofstead CL
      • Wetzler HP
      • Eiland JE
      • Heymann OL
      • Held SB
      • Shaw MJ.
      Assessing residual contamination and damage inside flexible endoscopes over time.
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      ,
      • Visrodia K
      • Hanada Y
      • Pennington KM
      • Tosh PK
      • Topazian MD
      • Petersen BT.
      Duodenoscope reprocessing surveillance with adenosine triphosphate testing and terminal cultures: a clinical pilot study.
      there is a clear need to improve visual inspection practices to ensure that endoscopes are free of visible damage and soil before each procedure.
      Recent guidelines call for more research on borescope inspections.
      • Day LW
      • Muthusamy VR
      • Collins J
      • et al.
      Multisociety guideline on reprocessing flexible GI endoscopes and accessories.
      Due to increased interest in visual inspection, the aim of this quality improvement (QI) initiative was to evaluate the utility of a new visual inspection program using lighted magnification and borescopes in an endoscopy department that had not previously utilized these tools.

      Study methods

      Setting

      This study was conducted in a large urban hospital with a new endoscopy manager who identified several areas for improvement, including the need for visual inspection training and tools such as magnifying glasses and borescopes. This study was approved by hospital administrators, the infection prevention manager, and the institutional review board as a QI initiative that did not involve human research subjects.

      Visual inspection training and tools

      Endoscopy personnel received several hours of training from researchers with extensive experience inspecting endoscopes. To ensure consistency, researchers prepared a visual inspection guide with illustrations of the components to be inspected and the angle, distance, and lighting necessary to obtain comparable photographs of endoscopes. To aid interpretation, the guide included examples of brand-new endoscopes and various defects.
      Visual inspections were performed on a stainless-steel table covered with clean absorbent pads in a procedure room with good lighting. Photographs were taken of external surfaces with a tablet camera (Tab M8HD, Lenovo; Quarry Bay, Hong Kong) and internal surfaces with 2 200cm long, 1.9mm diameter borescopes (Digital Inspection Scope Model BOR-2000 with Cantel Scope Viewer Software, Clarus Medical, LLC. Minneapolis, MN).
      Cantel Medical
      Digital Inspection Scope Instructions for Use Model BOR-2000.
      Magnifying glasses (Handheld multi-magnifier MAG-310, Healthmark Industries, Fraser, MI), absorbent swabs, brushes, forceps, syringes, and sterile water were occasionally used to investigate findings.

      Visual inspection protocol

      Researchers developed a protocol and log sheet to guide systematic inspection and photography of external components, including the serial number plate, control handle, valve housings, biopsy port, boot junction, insertion tube, bending section, distal end glue bands, and distal tip. For internal inspections, the borescope was slowly advanced from the instrument/biopsy port to the distal end, with photos of the serial number, biopsy port, bifurcation, channel initiation, channel body, bending section, and just inside the distal end. Borescopes were also used to inspect the bending section of the channel from the distal end and components on the distal tip (eg, objective lens, light sources, waterjet, and auxiliary water channel outlets, and elevator mechanism or ultrasound tip when present), bending section adhesive bands, and any other component that appeared to have abnormalities warranting further inspection. Following each inspection, borescopes were cleaned and disinfected with 2 disinfectant wipes per manufacturer instructions for use.
      A representative sample of the fleet was inspected during 1-week assessment periods at baseline and 2 months later in 2021. Fully processed endoscopes were inspected after they had been stored overnight or longer. Inspections were performed by 2 GI nurse managers with coaching and oversight by the research team. Endoscopes were processed again following inspection.

      Risk assessment protocol (RAP)

      Researchers customized a RAP in collaboration with managers of the endoscopy unit, perioperative services, infection prevention, risk, quality, and regulatory to support decision-making when visible defects were observed. This involved documenting the identification of defects described in current guidelines,
      ANSI/AAMI
      ST91: 2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities.
      SGNA
      Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.
      • Van Wicklin SA
      • Conner R
      • Spry C.
      Guideline for processing flexible endoscopes.
      such as retained fluid; soil, debris, or foreign substances; discoloration; corrosion or rust; scratches, channel peeling or shredding; cracks; or dents, kinks, or buckling. The RAP specified that the endoscopy manager be informed whenever an inspection identified substantial irregularities, including visible blood or organic soil, the occlusion of channels or ports by debris or foreign objects, and cracked lenses or significant abnormalities of the distal end or bending section. It described action steps for responding to findings, such as repeating the cleaning process for visibly soiled endoscopes, sending substantially damaged endoscopes for repair, and informing stakeholders in any cases involving potential patient exposure. After each visual inspection episode, the research team and GI manager discussed findings and used the RAP to determine whether the endoscope could be processed and returned to service or required additional intervention.

      Results

      Endoscope characteristics and repair history

      Twenty-five of the department's 37 endoscopes were inspected at baseline and 2 months later (Table 1). The endoscopes had been acquired 2-18 years before baseline and used for 48 to 1,732 procedures. Colonoscopes and gastroscopes were used more frequently than specialty GI endoscopes or bronchoscopes. In the year before the study, 5 (20%) had undergone maintenance or repair, 2 of which were repaired immediately prior to the study (Table 1).
      Table 1Endoscope characteristics and maintenance history
      Scope IDBaseline characteristicsRepaired due to visual inspection
      Age (yrs)Cumulative usesMonths since last repairAfter baselineAfter follow-up
      Gast 1368121RefurbishRepair
      Gast 2371626RepairRefurbish
      Gast 333382RepairNone
      RAP was activated due to visible defects, but no repair records were found.
      Gast 4N/A7630
      Endoscope was repaired immediately before the assessment.
      None
      RAP was activated due to visible defects, but no repair records were found.
      Repair
      Gast 537242NoneNone
      RAP was activated due to visible defects, but no repair records were found.
      Ped Gast 61133539RefurbishRefurbish
      ERCP 71076014RefurbishNone
      ERCP 81026225RepairNone
      ERCP 9533117RepairNone
      Bleeder 107108N/ARepairNone
      Bleeder 111847345NoneRepair
      EUS 128N/A15NoneRepair
      EUS 1315N/A12RefurbishNone
      Colon 144>1,00026NoneNone
      Colon 154>96025RepairNone
      Colon 1641,05915RepairNone
      Colon 1741,00626RepairNone
      Colon 18N/A1,027N/ARefurbishRefurbish
      Colon 19499326RepairNone
      Ped Colon 20499215RepairNone
      Ped Colon 21Loaner1,732N/ARepairNone
      Bronch 2274828NoneNone
      Ther Bronch 2374700
      Endoscope was repaired immediately before the assessment.
      NoneNone
      EBUS 2428315NoneRefurbish
      EBUS 2575617NoneNone
      Abbreviations: Gast, gastroscope; Ped gast, pediatric gastroscope; ERCP, duodenoscope used for endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasound; Bleeder, dual channel therapeutic gastroscope used for bleeding and other complex interventions; Colon, colonoscope; Ped colon,pediatric colonoscope; Bronch, bronchoscope; Ther Bronch, therapeutic bronchoscope; EBUS, endobronchial ultrasound bronchoscope; N/A, data not available from site records.
      low asterisk Endoscope was repaired immediately before the assessment.
      low asterisklow asterisk RAP was activated due to visible defects, but no repair records were found.
      At both assessments, visible damage and residue or debris were observed on or inside 100% of fully processed endoscopes. During the 2-month study period, 20/25 (80%) endoscopes required repair or refurbishment due to findings from visual inspections at baseline (16/25; 64%) and follow-up (8/25; 32%), and several endoscopes required repair more than once. After baseline, the manufacturer determined that 11 endoscopes required repairs (mean cost: $4,300) and 5 required refurbishment (mean cost: $11,200). Refurbishment was required for 4 endoscopes at follow-up. During the study period, endoscopes used for upper GI procedures required more frequent and extensive repairs than those used for lower GI or respiratory procedures (Table 1).

      External defects

      The most common external defect at baseline was disintegration of the adhesive bands at proximal and distal ends of the bending section or adhesive surrounding distal tip components (20/25; 80%). Disintegrated glue bands were generally gray and often had visible pitting, cracks, and jagged edges (Fig 1A-D), which contrasted with shiny black coverings present in new endoscopes (Fig 1E-G). In some cases, close inspection of the distal tip using a borescope held parallel to the insertion tube revealed gaps between the glue band and endoscope body (Fig 1H-J), and yellow soil was observed in a gap under the adhesive of 1 colonoscope (Fig 1J). Although distal ends of most endoscopes were repaired or refurbished after baseline, adhesive band degradation was commonly observed at follow-up.
      Fig 1
      Fig 1Examples of adhesive deterioration at baseline in fully processed endoscopes. (A-D) Bending section and distal tip; (E-G) New distal end and tip for comparison; (H-I) Gapping of distal adhesive band; (J) Gapping with yellow debris.
      External scratches, gouges, and dents were occasionally observed at both assessments, and foreign debris was observed on 2 distal ends. In 1 case, it appeared there was yellow debris near a duodenoscope's elevator mechanism, but it was not clearly visible in photographs taken with a camera (Fig 2A, B). When a borescope was used to improve visualization, a fuzzy chunk of yellow debris was evident (Fig 2C). Site personnel were unable to remove the debris and the duodenoscope was sent for repair. In another case, when comparing baseline photos with images taken during follow-up inspections, researchers noticed that the distal end of an EUS endoscope appeared to have changed and suspected that foreign material may have been retained in the distal balloon attachment groove (Fig 2D, E). Site personnel determined that a portion of a balloon was stuck in the groove and removed it (Fig 2F).
      Fig 2
      Fig 2Examples of fully processed endoscopes with retained foreign debris: in the elevator mechanism of a duodenoscope (A-C), the distal end of an EUS endoscope (D-F), and the distal end of a therapeutic bronchoscope (G-I).

      Internal defects

      Borescope examinations were completed for the entire instrument channel except in EBUS bronchoscopes. They were too small for the borescopes used in this study so only ports and channel outlets were examined.
      Small fragments of white debris were observed inside most endoscopes at baseline, with numerous particles evident near the distal ends of several endoscopes (Fig 2G). Site personnel suspected it was lint introduced by supposedly “lint-free” towels used for drying. Technicians re-reprocessed a bronchoscope with numerous particles (Fig 2G) and researchers used a borescope to confirm the white particles were gone (Fig 2H) before videotaping the drying process, which revealed that lint accumulated in the channel as the towel was passed over the distal end (Fig 2I).
      At baseline, droplets were visible inside 13/25 (52%) endoscopes stored vertically in conventional cabinets at least overnight (Fig 3A-C). Following baseline, the facility switched to horizontal storage in drying cabinets that circulated air through channels (Endodry Storage and Drying System, Medivators, Minneapolis, MN). At follow-up, droplets were observed in 4/22 (18%) endoscopes stored at least overnight (Fig 3D). Upon discovering retained fluid at follow-up, personnel reported that at least 1 endoscope had not been properly seated in the drying cabinet. Follow-up inspections revealed white domes that initially appeared to be droplets in 14/25 (56%) of endoscopes (Fig 3E, F), including 4 gastroscopes, 3 colonoscopes, 2 EUS endoscopes, a bleeder gastroscope, 2 bronchoscopes, and 2 EBUS bronchoscopes. These domes were not impacted by the passage of the borescope, brushes, or swabs, which should have flattened or removed droplets.
      Fig 3
      Fig 3Examples of residual fluid (A-F) and soil and debris (G-L) in fully processed endoscopes.
      At baseline, debris was found on the distal end or in the channel of almost every endoscope. It was white in 21/25 (84%); black in 18/25 (68%); brown in 10/25 (40%); yellow/green in 9/25 (36%); and orange/red in 2/25 (8%). The yellow/green residue was frequently harbored in scratches (Fig 3G) and on fragments of channel lining that protruded into the channel (Fig 3H). Findings were similar at follow-up, though less yellow/green residue was observed and there were fewer tiny white particles (ie, lint).
      One colonoscope (Colon 15) was subjected to additional rounds of cleaning after substantial debris and tiny strings were observed in the channel, and repeat examinations continued to detect visible soil. To investigate the impact of brushing on soil, a borescope was inserted into the channel via the distal end to directly observe the process (Fig 3J). The soil moved around and aggregated in the channel (Fig 3K), but it was not removed by brushing or flushing with a syringeful of water. Researchers then attempted to remove the soil using additional water and a squeegee-style channel cleaning device (Pull-Thru Cleaning Brush, Medivators), which emerged with black soil on it. Repeat borescope exams identified brownish-orange debris persisting inside the distal end. Researchers then directly observed the technician clean the endoscope and confirmed the steps were properly performed. A subsequent borescope exam determined that there was less visible debris, no black strings, and nothing brown or orange inside the channel. However, a swab passed through the channel emerged with small black particles (Fig 3L). The endoscope was subjected to a fifth round of cleaning and reinspection before being deemed clean.
      Borescope exams revealed that most channels had sustained damage, with dents (10/25; 40%) (Fig 4A), scratches (22/25; 88%), and shredding, peeling, or filamentous debris (20/25; 80%) evident. Figure 4B and C illustrate the appearance of filamentous debris due to the disruption of colonoscope channels. Several gastroscopes with substantial channel shredding or filaments at baseline were found to have damaged channels at follow-up as well, even though the bending sections and distal ends appeared to be intact (Fig 4D-L). Two of the gastroscopes shown in Figure 4 had been repaired (Gast 3) or refurbished (Gast 1) following the baseline, and repair records were incomplete for the third (Gast 4).
      Fig 4
      Fig 4Channel damage including dents (A) and shredding in colonoscopes (B, C), with shredding in gastroscopes at baseline and follow-up compared with the appearance of their distal ends (D-L).

      Discussion

      During this study, visual inspection with magnification and borescopes identified actionable defects that could interfere with reprocessing effectiveness in 100% of fully processed endoscopes. Previous publications described defects discovered by researchers,
      • Barakat MT
      • Girotra M
      • Huang RJ
      • Banerjee S.
      Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video).
      ,
      • Ofstead CL
      • Quick MR
      • Wetzler HP
      • et al.
      Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.
      ,
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      ,
      • Thaker AM
      • Kim S
      • Sedarat A
      • Watson RR
      • Muthusamy VR.
      Inspection of endoscope instrument channels after reprocessing using a prototype borescope.
      ,
      • Wallace M
      • Keck TR
      • Dixon H
      • Yassin MH.
      Borescope examination and microbial culture findings in endoscopes at a tertiary care hospital in Pittsburgh, Pennsylvania.
      rather than nursing staff or reprocessing technicians. In this study, endoscopy personnel mastered the use of visual inspection tools with just a few hours of training and support by the research team. Their new skills in visual inspection allowed them to identify and handle issues that could impact infection control and patient safety. However, routine visual inspections were not always conducted by endoscopy personnel due to time constraints related to staffing shortages and high procedural volumes.
      The adhesive band disintegration found on 80% of endoscopes was concerning because non-intact surfaces can harbor soil and bioburden. In fact, yellow soil was observed in adhesive gaps, and sharp edges could injure patients or personnel handling the endoscopes. In 2021, the Food and Drug Administration announced a recall due to adhesive deterioration or other damage that “may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion” and emphasized that contaminated endoscopes present a risk of infection for patients.
      FDA
      Class 2 Device Recall Olympus TJF-Q180V.
      During this study, black, brown, and yellow/green debris or residue were commonly found in scratches and distal ends of endoscopes, indicating cleaning failures in damaged endoscopes. Tiny white particles found inside channels of several endoscopes were determined to be lint from drying endoscope exteriors with cloths that were not truly “lint-free.” The novel method of using a borescope for direct observation during processing activities revealed that manual cleaning with a bristle brush moved soil around inside the channel, but did not remove it. Other studies using advanced microscopy of endoscope channels also found brushing moved protein and microbes around without removing them.
      • Herve R
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      Current limitations about the cleaning of luminal endoscopes.
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      • Keevil CW.
      Persistent residual contamination in endoscope channels; A fluorescence epimicroscopy study.
      Scratches and shredding observed in channels of almost every endoscope, including those that were recently repaired or refurbished, echo previous findings by others who found that channels sustained damage within a few months of use and accumulated visible defects over time.
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      ,
      • Thaker AM
      • Kim S
      • Sedarat A
      • Watson RR
      • Muthusamy VR.
      Inspection of endoscope instrument channels after reprocessing using a prototype borescope.
      The present study found substantial channel shredding in endoscopes with intact distal ends, which suggests that visual inspection of external surfaces is not sufficient. Others have found organic residue and bioburden more strongly adhered to endoscope surfaces with defects than to new surfaces.
      • Herve R
      • Keevil CW.
      Current limitations about the cleaning of luminal endoscopes.
      • Herve RC
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      Persistent residual contamination in endoscope channels; A fluorescence epimicroscopy study.
      • Lee DH
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      Increasing potential risks of contamination from repetitive use of endoscope.
      Researchers from the Food and Drug Administration found gram-negative bacteria too numerous to count in gastroscopes and determined that cells often reside in grooves or other channel defects, which “may be favorable sites for buildup biofilm formation.”
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      • et al.
      Fluorescence microscopy–based protocol for detecting residual bacteria on medical devices.
      The clinical implications of such defects have been described by outbreak investigators. One investigation determined that multidrug-resistant Pseudomonas aeruginosa and Klebsiella pneumoniae were harbored in a bronchoscope channel with physical defects and retained soil observed during borescopy.
      • Galdys AL
      • Marsh JW
      • Delgado E
      • et al.
      Bronchoscope-associated clusters of multidrug-resistant Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae.
      In another outbreak, 2 implicated ureteroscopes harboring multidrug-resistant P. aeruginosa had disrupted internal and external surfaces.
      • Kumarage J
      • Khonyongwa K
      • Khan A
      • Desai N
      • Hoffman P
      • Taori SK.
      Transmission of MDR Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: the fragility of endoscope decontamination.
      Researchers hypothesized that structural damage may adversely impact channel cleaning.
      • Kumarage J
      • Khonyongwa K
      • Khan A
      • Desai N
      • Hoffman P
      • Taori SK.
      Transmission of MDR Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: the fragility of endoscope decontamination.
      In a recent study, researchers performed microbial cultures and borescope exams and found multiple defects, including red debris inside bronchoscope distal ends. They determined the debris was from the use of endoscope tip protectors, which they discontinued as a result of this finding.
      • Wallace M
      • Keck TR
      • Dixon H
      • Yassin MH.
      Borescope examination and microbial culture findings in endoscopes at a tertiary care hospital in Pittsburgh, Pennsylvania.
      A 2017 review described 26 outbreaks of infection linked to inadequate drying and storage of diverse types of endoscopes.
      • Kovaleva J.
      Endoscope drying and its pitfalls.
      In the current study, retained fluid droplets observed in 52% of endoscopes at baseline indicated a need for better drying methods, and the site subsequently installed drying cabinets. The observation of fluid in channels of several endoscopes stored in the new drying cabinets alerted site personnel that improperly seated endoscopes were not being dried and they retrained staff on proper cabinet loading.
      Dry white domes were observed in 56% of channels after storage in new drying cabinets. Researchers subsequently learned that clinicians at this site commonly use infant gas relief drops containing simethicone to reduce bubbles and foaming and improve visualization during GI endoscopy. One hypothesis is that horizontal storage in drying cabinets desiccated residual simethicone or soil, leaving behind dome-shaped shells. Van Stiphout et al. reported being unable to remove simethicone that had crystallized inside channels of 16 colonoscopes, and expressed concern that such deposits could occlude channels or increase the risk for biofilm formation.
      • van Stiphout SH
      • Laros IF
      • van Wezel RA
      • Gilissen LP.
      Crystallization in the waterjet channel in colonoscopes due to simethicone.
      Per the RAP, 20/25 (80%) endoscopes were sent for repair due to defects observed during baseline visual inspection, and many required repairs again during the 2-month period. These findings are troubling because most endoscopes at this site were not maintained in the year prior to the study and numerous critical defects were observed when visual inspection using the recommended tools commenced. GI endoscopes required more maintenance than bronchoscopes, possibly due to higher procedural usage. More research is needed to assess the durability of reusable endoscopes and determine the financial impact of additional maintenance and loaners needed as a result of visual inspection.
      A 2019 study found that 36% of sterile processing technicians performed visual inspection with an unaided eye, and magnification and borescopes were rarely used (18% and 14% respectively).
      • Ofstead C
      • Hopkins K
      • Eiland J
      • Wetzler H.
      Endoscope reprocessing: current practices and challenges in the field.
      Although GI personnel in the current study received training, magnifying glasses, and borescopes as part of the QI initiative, they missed defects on distal ends of endoscopes, such as a chunk of yellow debris and a retained balloon fragment, that were identified by the researchers. Front-line personnel need better training programs and guidance, including reference tools illustrating the desired appearance of certain components. To prevent the use of endoscopes with retained debris or other critical defects, it may be necessary to implement safeguards such as automated uploads of photographs that compare current state with desired state for certain endoscope components through the use of artificial intelligence. Previous studies have detected viable, culturable microbes, including high-concern organisms and waterborne pathogens linked to inadequate drying, on endoscopes that were observed to have visible defects.
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Eiland JE
      • Wetzler HP.
      Residual moisture and waterborne pathogens inside flexible endoscopes: evidence from a multisite study of endoscope drying effectiveness.
      • Ofstead CL
      • Heymann OL
      • Quick MR
      • Johnson EA
      • Eiland JE
      • Wetzler HP.
      The effectiveness of sterilization for flexible ureteroscopes: a real-world study.
      • Ofstead CL
      • Quick MR
      • Wetzler HP
      • et al.
      Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.
      ,
      • Ofstead CL
      • Wetzler HP
      • Heymann OL
      • Johnson EA
      • Eiland JE
      • Shaw MJ.
      Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: results of visual inspections, biochemical markers, and microbial cultures.
      It is clear that visual inspection with lighted magnification is a necessary “safety timeout”
      SGNA
      Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.
      to protect patients from injuries and infections due to damaged or contaminated endoscopes. Infection preventionists have a critical role to play in supporting processing personnel now that standards, guidelines, and IFU align with strong recommendations for enhanced visual inspection of every endoscope, every time. Given the current low guideline adherence in the field, the high documented rate of endoscopes with damage or defects, and constant pressure to move faster,
      • Ofstead C
      • Hopkins K
      • Eiland J
      • Wetzler H.
      Endoscope reprocessing: current practices and challenges in the field.
      infection preventionists should take the lead in ensuring personnel have sufficient time, equipment, and support to conduct inspections and address findings.

      Limitations

      This study was conducted in the GI department of an urban hospital, and the findings may not be generalizable to other settings. The borescopes used during this study were adequate for inspecting instrument channels of GI endoscopes, but they were too large to fit inside the channels of certain bronchoscopes. Thus, any defects inside those channels were undetected and the findings may underrepresent the prevalence of defects that could have been identified if smaller borescopes had also been used. Usage and repair data were not available for several endoscopes due to administrative limitations at the site. The impact of the missing data on findings is unknown.

      Conclusions

      This study contributes to the evidence supporting routine visual inspection using magnification and borescopes, as these tools were needed to identify retained fluid, debris, and defects that could impact processing effectiveness and patient safety. The findings demonstrated that external inspection alone is insufficient to identify endoscopes with critical defects, and recent maintenance did not guarantee that the endoscopes were free from damage. Processing personnel will need support and collaboration with infection prevention to ensure they have the time and resources necessary to conduct visual inspection of endoscopes in a way that adheres to standards and enhances patient safety.

      Acknowledgments

      The authors are grateful for the active participation by site personnel in the quality improvement initiative and study. The study was supported in part by research grants from Medivators/Cantel and Steris, who were not involved in designing or conducting the study, analyzing data, interpreting results, or preparing this manuscript, and they did not review a draft before submission.

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