Abstract
Background: Infections and injuries have been linked to endoscopes with visible damage or residue. Guidelines recommend visual inspection to identify endoscopes requiring repair or further cleaning. This study sought to evaluate the impact of routine borescope inspections on repair frequency and costs.
Methods: Retrospective analysis was performed on a database of endoscope repairs compiled for a three-year period by a large academic medical center that began performing borescope inspections for every endoscope after manual cleaning. Endpoints included total number of repairs, total repair cost, mean cost per repair, mean turnaround time per repair, and procedural usage between repairs. Subgroup analysis was performed to identify repair patterns by endoscope type.
Results: The total cost of repairs decreased from $1,212,702 in 2022 to $724,419 in 2024. The number of repairs required annually was similar over time, but reductions occurred in the proportion of repairs classified as major (12.1% to 3.2%) and the mean cost per repair ($4,426 to $2,337; P < 0.001). Mean turnaround time for repairs decreased (from 24.1 to 15.5 days; P < 0.001). Mean number of uses between repairs increased over time (from 52.1 to 87.2; P < 0.001), and the facility decreased the size of the endoscope fleet from 593 to 508.
Conclusion: Significant reductions in endoscope repair frequency and cost occurred over time in a large, centralized endoscope processing department that performed borescope inspections of every endoscope after manual cleaning.
Infections and injuries have been linked to flexible endoscopes found to have visible damage or residue.1–4 The Food and Drug Administration's Manufacturer and User Facility Device Experience database includes hundreds of adverse event reports documenting patient injuries due to the use of endoscopes with visible damage. In some of these cases, the bending section rubber had frayed or ripped, allowing the underlying metal mesh and wires to protrude and tear patient tissue, resulting in injuries requiring treatment.3,4
Because of the risk of infection or injury related to the use of dirty or damaged endoscopes, standards and guidelines from the United States, Europe, and Australia recommend that every time endoscopes are processed, the devices should be visually inspected to detect damage or residual soil that could affect functionality or patient safety.5–9 These guidelines specify that good lighting and magnification should be used to visually inspect endoscopes before use, during and after the procedure, and after cleaning to facilitate identifying defects on external surfaces.5–9
During several outbreak investigations, soil, biofilm, and/or damage were observed inside endoscopes only after investigators disassembled the endoscopes to fully inspect them.10–12 Direct visual inspection of interior components of endoscopes is not possible without special equipment,6 and guidelines describe the use of borescopes to inspect interior surfaces of flexible endoscopes.5–7,9 These narrow-diameter, nonlumened endoscopic devices fit inside endoscope ports and channels and are designed for visual inspection of surfaces that cannot be directly observed by sterile processing department (SPD) staff.6,7 They allow staff to identify damage, foreign debris, biological material, and other residues that can be removed prior to attempting sterilization or high-level disinfection (HLD).6,7
Current guidelines state that facilities should routinely use borescopes to inspect channels of endoscopes before HLD or sterilization7 or recommend using borescopes during training and competency testing.5 According to manufacturers, any endoscope with visible damage must be returned for repair, as processing may not be effective if the endoscope surfaces are not intact. To our knowledge, current manufacturer instructions for use (IFUs) for endoscopes do not specifically recommend using a borescope to inspect interior surfaces.
In position statements from 2021, gastrointestinal (GI) endoscopy societies raised concerns about the merit of borescope examinations and stated that more evidence was needed before the societies would recommend the routine use of borescopes.5,9 Although borescopes have been used to inspect lumens of surgical instruments since 2011,13–15 researchers involved in early studies on the use of borescopes for inspecting flexible endoscopes acknowledged that no common lexicon exists for describing defects or rating their severity.16–18 These researchers relied on endoscope manufacturers to determine whether the defects were severe enough to merit repair or refurbishment.17,18
Since 2017, the use of borescopes has become more common, and a large body of evidence now demonstrates the utility of borescopes for identifying whether endoscopes require additional cleaning, drying, or repair.19–24 Several studies have performed sequential borescope examinations and found that defects accumulated over time,18,25 with new defects evident inside GI endoscopes within one to two months of procedural use.16,20,26 Ureteroscopes were even more fragile, sustaining visible damage during every use, with repairs or refurbishment necessary after only 27 uses (14 h) of procedural use.27 During several studies that assessed endoscopes that were considered ready for patient use in nonoutbreak settings, viable microbes were found in 28% to 71% of samples from endoscopes that had visible defects,18,21,28,29 which underscores the need to identify endoscopes with damage or retained soil.
Although routine borescope exams could identify endoscopes with damage or debris that remains after cleaning, clinicians, administrators, and frontline SPD staff have raised concerns about the impact of routine borescope exams on repair cost and availability of endoscopes. These concerns seem well founded, as researchers who performed borescope inspections on previously uninspected endoscopes found most or all of the endoscopes had visible defects requiring recleaning or repair.18,20,26,29 The necessary repairs were extensive and expensive, and one recent study reported that 20 of 25 inspected endoscopes required repair or refurbishment, with average costs of $4,300 and $11,200, respectively.26
Beyond limited cost data generated by researchers noted above, the financial implications of borescope inspections are not well characterized, and data are lacking on the incidence and cost of defects found by technicians during routine practice.
This study sought to evaluate the impact of implementing a visual inspection program on repair costs and efficiency over time in a setting with a longstanding program for routine borescope inspections.
Methods
This study was conducted in a large academic medical center with a fleet of more than 500 flexible endoscopes that are used for procedures in 25 departments. Since 2017, processing for all these endoscopes has been performed in a centralized department that specializes in HLD and sterilization for heat-sensitive instruments that cannot be autoclaved. On a typical weekday in 2024, technicians processed and inspected 175 flexible endoscopes. During 2022–23, the daily procedural volume varied from 110 to 150 endoscopes. During the entire three-year study period, technicians performed a total of approximately 109,000 borescope inspections.
Processing involved pretreatment by procedural staff at the point of use, leak testing, and manual cleaning in accordance with national standards, guidelines, and manufacturers’ IFUs. Biochemical tests for residual organic soil (ATP, blood, carbohydrates, and/or protein) were done to verify cleaning effectiveness, and visual inspection was performed using lighted magnification and borescopes prior to sterilization or HLD in automated systems.
Endoscopes were dried in cabinets that circulated filtered air through channels to ensure they were completely dry before subsequent procedural use or storage. All supervisors, managers, and SPD educators were certified by the Healthcare Sterile Processing Association (HSPA; Certified Registered Central Service Technician) or the Certification Board for Sterile Processing and Distribution (CBSPD; Certified Sterile Processing and Distribution Technician). Technicians working in the centralized HLD unit were required to hold the Certified Flexible Endoscope Reprocessor certification from CBSPD, and all supervisors and managers in the HLD area also held the Certified Endoscope Reprocessor certification from HSPA. Technicians were required to be board certified within two years of employment (93% currently certified), and they were also provided with extensive training that includes methods for performing visual inspection prior to processing endoscopes.
Borescope Use
The facility initially acquired a borescope and began using it to inspect flexible endoscopes in 2016. During the first year of borescope use, SPD staff determined that manual cleaning of channels was not reliably effective and implemented quality improvements based on their observations. During 2017–19, as the centralized HLD department expanded to handle processing for specialty clinics that had previously processed their own endoscopes, technicians inspected every endoscope to determine whether it was clean and intact. Any defects were addressed before subsequent use.
Use of borescopes continued to expand, from inspecting each endoscope annually, to quarterly, and then to monthly. Since 2022, technicians have been using borescopes to inspect every endoscope after being manually cleaned. At the time of writing, the facility had seven borescopes of various brands and sizes, which have the capability to capture photographs and videos during inspections. Defects were documented electronically and reviewed by supervisors.
Design and Data Source
This study involved retrospective analysis of data compiled by facility staff for every endoscope that required repair during the study period, including the serial number, brand, type and model, department of use, procedural usage since last repair, type of damage reported on the repair request, repair cost, and repair turnaround time. All researchers had advanced training and extensive experience with endoscope processing, quality assurance, and borescope examinations. The study did not involve human subjects or identifiable patient information and thus did not require review by the facility’s institutional review board.
Outcomes
The primary study outcomes were the total number of repairs and total repair cost during a three-year period following the implementation of routine inspection of every endoscope every time it was processed. Secondary outcomes included the mean cost per repair, mean turnaround time for repair, and mean procedural usage between repairs over time. Individual repairs were categorized in $2,000 increments to characterize the distribution of repair costs over time (minor <$4,000; moderate $4,000–8,000; major >$8,000). Subgroup analyses were performed to assess number of repairs, repair costs, and turnaround time for different models of endoscopes.
Data Analysis and Statistical Methods
Data were extracted from Excel 365 spreadsheets (Microsoft Corp., Redmond, WA) that contained data for fiscal years 2022–24 (beginning in July 2021 and ending in June 2024). Statistical analysis was performed using R Studio (version 4.4.0; R Studio; Boston, MA). Descriptive statistics (including means and medians) and frequency distributions were calculated for selected variables. One-way analysis of variance with post hoc Tukey honestly significant difference test was used to evaluate the differences among means for cost, turnaround time, and procedural usage over time (2022–24), as well as for endoscope models. P < 0.05 was considered statistically significant.
Results
During the study period, the facility had more than 500 flexible endoscopes, including colonoscopes, gastroscopes, duodenoscopes, endoscopic ultrasound devices, choledocoscopes, bronchoscopes, intubation scopes, ear-nose-throat endoscopes, cystoscopes, ureteroscopes, and neurologic endoscopes. The fleet included endoscopes manufactured by Fujifilm (Tokyo, Japan; predominantly GI endoscopes), Olympus (Tokyo, Japan; predominantly respiratory endoscopes, with some GI endoscopes), Karl Storz (Charlton, MA; ear, nose, and throat [ENT] and urology endoscopes), and Richard Wolf (Knittlingen, Germany; urology endoscopes).
In 2022, technicians began performing visual inspection with borescopes every time an endoscope was processed (Figure 1). They performed approximately 109,000 borescope exams during fiscal years 2022–24, and endoscopes were sent for repair 881 times (8 of 1,000 uses) during the study period. Toward the end of the study period, inspections resulted in an average of one endoscope being sent for repair per day (of 175 procedures). Reasons for requesting repairs were assigned by technicians who identified defects. These included leak test failures, visible defects, image quality issues, and other problems.
Figure 1.
Using a borescope to inspect flexible endoscopes.
Repairs were performed by original equipment manufacturers and third-party repair facilities. The total number of repairs annually increased slightly during the study period (274 in 2022, 297 in 2023, and 310 in 2024) and varied considerably by quarter (range 43–96; lowest during fourth quarters and highest during first quarters each year; Figure 2).
Figure 2.
Number of endoscope repairs during the study period, by quarter.
From 2022 to subsequent years, the total repair costs for the endoscope fleet decreased (Figure 3A) and the mean cost per repair decreased significantly (P < 0.001; Figure 3B). The proportion of repairs classified as “major” decreased over time, with a large increase in the proportion requiring repairs that cost under $2,000 (Figure 3C).
Figure 3.
A: Total repair cost for the endoscope fleet, by fiscal year. B: Mean cost per repair, by fiscal year. C: Distribution of costs per repair, by fiscal year.
The mean turnaround time for repairs decreased significantly, from an average of 24.1 days during fiscal year 2022 to 15.5 during fiscal year 2024 (P < 0.001; Figure 4A). During this time period, the mean number of procedural uses between repairs increased significantly (from 52.1 to 87.2, P < 0.001; Figure 4B).
Figure 4.
A: Mean turnaround time for repairs (days) during the study period, by quarter. B: Mean number of procedural uses between repairs.
During the study period, the number of endoscopes in the fleet decreased from 593 in 2022 to 508 in 2024 (Table 1). Notable reductions were observed in the number of GI endoscopes required to meet procedural needs. The frequency and cost of repairs differed by type of endoscope, with ureteroscopes requiring more frequent repairs than other types of endoscopes (Table 2). In 2024, clinicians were able to get more uses between repairs than in 2022 for gastroscopes (159 vs. 41, P < 0.001) and colonoscopes (206 vs. 46, P < 0.001) due to continued quality improvements.
Table 1.
Endoscope fleet size, total repair cost, and total repairs by endoscope type (2022–24). Abbreviations used: ENT, ear, nose, and throat; ERCP, endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasound.
Table 2.
Repair characteristics by endoscope type (2022–24). Abbreviations used: ENT, ear, nose, and throat; ERCP, endoscopic retrograde cholangiopancreatography; EUS, endoscopic ultrasound; NA, not applicable.
Discussion
This study found a significant reduction in annual repair costs over time after technicians began using borescopes to inspect every endoscope after manual cleaning in a large, centralized HLD department with consistent adherence to standards and guidelines. The reduction in endoscope fleet maintenance costs was financially meaningful for the institution, costing $488,283 less in 2024 than in 2022 (Figure 3A). These financial savings were found in an era when costs for healthcare-related equipment, supplies, and labor have increased. Routine borescope inspections allowed technicians to identify defects before they were severe, and significant reductions occurred in the proportion requiring extensive repairs and the mean cost per repair (Figure 3C). During a three-year period when technicians performed approximately 109,000 borescope inspections, endoscopes were sent for repair 881 times (8 of 1,000 processing cycles). This type of preventive action seems imperative given evidence of microbes persisting in a high proportion of endoscopes with visible defects18,21,28,29 and multidrug-resistant infections being linked to dirty or damaged endoscopes.10–12
The number of repairs varied by quarter, with the most repairs generally being required during Q1 (July to September) and the least repairs being required during Q4 (April to June) each year of study. The SPD staff in this facility were highly trained and stable throughout the year, with numerous long-time employees. The reasons for this seasonal variation are unknown, but staff speculated that it may be due to the influx of new residents and fellows who are inexperienced in the use of flexible endoscopes of specific brands and models and may inadvertently damage the devices.
In tandem with these cost reductions, researchers observed a significant decrease in the turnaround time required for repairs. By improving the efficiency of processing and maintenance, the facility was able to downsize its overall endoscope fleet size (from 593 to 508 endoscopes during the study period), despite expanding the number of bronchoscopes and ENT endoscopes due to increased procedural volume in new departments (Table 1). Fewer colonoscopes and gastroscopes were needed for procedural use when staff performing HLD were confident that endoscopes sent for repair would likely be returned to service within two weeks, rather than the 24 days required before routine borescope inspections were implemented. The differences in repair patterns by endoscope type was notable, with urology endoscopes and bronchoscopes requiring repair more frequently than colonoscopes or gastroscopes (Table 2). Repairs tended to be more expensive for longer, more complex endoscopes with multiple channels (e.g., colonoscopes) and those with special components (e.g., elevator on ERCP scopes, ultrasound transducer on EUS scopes), with lengthier repair turnaround times (Table 2). Other researchers have reported that smaller-caliber endoscopes require more frequent repair than conventional endoscopes because they are more fragile.30
Reducing the need for repairs contributes to meeting the environmental sustainability goals set by American and European endoscopy societies31,32 in several ways. The fleet size reduction required technicians to repeat processing for fewer endoscopes that had reached their expiration date (“hang-time” limit) without being used for a procedure. Minimizing processing cycles due to hangtime limits contributes to the environmental sustainability of endoscopy by reducing the usage of water, electricity, detergents, disinfectants, single-use brushes, personal protective equipment, and other materials used for processing endoscopes.
A previous multisite study estimated the burden of processing bronchoscopes that had reached hang-time limits. It was done several hundred times each year in two of the institutions, resulting in 1.87 to 3.1 processing cycles being performed for each procedural use. In 2019, these researchers concluded that eliminating repeat processing due to excessive fleet size could result in substantial savings due to the cost of consumable supplies ($58–80) and hands-on staff time ($31–41 in 2019 dollars) for each processing cycle.33 Reductions in workload may be beneficial given staffing shortages in many SPDs. In addition, processing only endoscopes used for procedures may reduce risk of staff exposure34 or injuries related to processing endoscopes causing pain or discomfort, which have been reported to affect more than 40% of these workers.35
Previously, functional issues with endoscopes were commonly discovered in the procedure room, and staff would have to obtain a second endoscope to complete the case. This interfered with procedural flow and time efficiency, thereby affecting clinicians, SPD staff, and patients. Further, it required both endoscopes to be returned for processing and assessment of the need for repairs. The reduction in endoscopes that malfunctioned during a procedure had a positive impact on clinicians’ relationships with procedure room and SPD staff.
Clinicians and administrators commonly raise concerns about the time required to perform borescope examinations. The findings of the current study provide important context for considering the burdens and benefits of adding this step to the workflow. Historically, the total annual cost for repairs in the institution described here had been $3.86 million prior to the centralization of processing for flexible endoscopes. By 2022, endoscopes used in more than 25 departments were being transported to a specialized unit for processing endoscopes, ultrasound probes, and other heat-sensitive instruments with HLD or low-temperature sterilization. By 2022, the optimization of processing workflows had already resulted in major reductions in repair costs (to $1,212,702 annually). The current protocol involved the routine performance of several quality assurance steps that typically required less than 10 minutes per endoscope (2 min for leak testing, 3 min for cleaning verification testing, and 3–5 min for visual inspection). SPD staff became more efficient with borescope exams as their use became routine. The implementation of visual inspection using borescopes occurred incrementally over time and resulted in a further reduction of repair cost (to an annual cost of $724,419 in fiscal year 2024).
Researchers in China reported that borescope inspections of 213 endoscopes required at least 10 minutes and allowed the detection of abnormalities in 100% of GI endoscopes, including scratches in 91.5%, adherent peel in 48.5%, and black or yellow discoloration in 49.5%.20 They inspected 27 new endoscopes after zero, one, and seven days of use. By seven days, new scratches appeared on polytetrafluoroethylene and metal surfaces, and the number of endoscopes with damage and residues increased significantly after 18 months of use.20
The institution in the current study continued to seek strategies for reducing damage requiring repair. Decommissioned endoscopes were used for training new HLD department staff, and new technicians were required to demonstrate competency in processing and inspection using borescopes before being allowed to process clinically used endoscopes. At the time of writing, new endoscopy residents and fellows spent a half a day in the special endoscope processing unit to learn the methods used to process and inspect endoscopes between uses. They participated in borescope examinations and frequently expressed surprise that it was possible to “scope the scope.” This introduction to the internal architecture of endoscopes has enhanced relationships with the SPD and raised staff awareness of the need to be careful when handling endoscopes. The additional training and early recognition of visible defects has contributed to the reduction in the need for major repairs in this facility.
This study showed the value of phased implementation of borescope examinations in conjunction with centralization and other quality improvements. Any facility considering the implementation of borescope inspections should consider doing a cost-benefit analysis prior to initiating borescope exams to help them identify factors that could optimize the benefits of such inspections while containing time and costs. The reduction in available endoscopes due to the time required to repair the devices should be included in the statistical model if the facility anticipates that this could result in lost revenue.
This study provides real-world reference data to use as inputs when other institutions develop their own cost-benefit analysis models. As part of a new program, facilities should track their repair costs to determine trends and support efforts to rightsize the endoscope fleet. In addition, to reduce damage due to usage and handling, training programs should address both SPD staff and clinicians who use endoscopes. This is particularly important in teaching facilities where new residents and fellows are learning how to use these fragile instruments.
Limitations
This study was performed in a single site, which was a large teaching hospital that centralizes processing of endoscopes and adheres to national standards and guidelines. The technicians were highly trained, certified, and received ongoing continuing education, which may not be similar to other settings and therefore may limit generalizability.
Although a strong temporal relationship existed between initiation of routine borescope exams and reduction in the need for major repairs and repair costs, certainty about causality cannot be established, as other unknown factors may have contributed. Compiling and analyzing data to determine how many unique endoscopes required more than one repair within a certain period of time may be beneficial, as this may support strategies for fleet maintenance timing and budget. That said, the evidence clearly demonstrated that implementation of routine borescope exams did not adversely affect cost or efficiency.
The study involved only three years of data, and the trajectory for future costs is unknown. The cost savings likely were underestimated because the data did not include expenses related to the reduction in repeat processing that occurred when the fleet was downsized. More research is needed to determine the benefits realized from fleet reduction (e.g., less need for endoscope storage space, less staff time and materials for processing unused scopes that expired, lower annual maintenance fees due to the smaller fleet size).
In addition, facilities might experience other benefits that were not included in this study, such as reductions in complaints by clinicians about endoscopes in poor repair or procedural delays due to endoscopes that malfunctioned during procedures. Researchers did not review repair reports or assess differences in repair cost or turnaround by manufacturer or third-party repair companies; therefore, further research on these factors is merited. In addition, evaluating the impact of targeted training of technicians and clinicians on repair costs, as well as the cost and time to perform borescope exams, would be beneficial.
Conclusion
These findings illustrate the benefit of routine visual inspection using borescopes for productivity and cost savings, as technicians identified endoscopes in need of recleaning or repair before extensive, costly repairs were required. This facilitated optimal maintenance and rightsizing of the endoscope fleet, which reduces the burden of endoscopy on HLD department staff, the facility, and the environment while enhancing patient safety.
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