The Impact of Single-Use Cystoscopes on Clinical Time Workflow in an Outpatient Setting.

OBJECTIVE: To evaluate the change in overall clinical encounter time and clinical capacity after transitioning to single-use cystoscopes (Ambu A/S, Ballerup, Denmark) in an outpatient urology setting. METHODS: A single-institution prospective study in an outpatient urology procedure clinic was performed. Discrete categories for each portion of nursing care responsibilities were defined, and time spent during each category was recorded. Two separate clinic days were observed and analyzed: one where the clinic exclusively used reusable cystoscopes and the other after the transition to single-use cystoscopes occurred. Additionally, clinic schedules were reviewed from all procedure clinics in the 3-month periods before and after the transition to single-use cystoscopes. Outcomes included overall clinical encounter time and the number of procedures per clinic day. RESULTS: There were 12 flexible cystoscopies performed during each of the observed clinic days. Preliminary cystoscope cleaning and transportation tasks by nursing staff were eliminated when utilizing single-use cystoscopes. Average total encounter time decreased from 66 to 44 minutes, resulting in a 34% reduction in clinical encounter time. The median number of flexible cystoscopy procedures increased after the transition from 9 (IQR 7-12) to 16 (IQR 11-17), representing a 78% increase (P = .003). CONCLUSION: Transition to a completely single-use cystoscopy outpatient procedure clinic improved clinical efficiency and facilitated an increased number of procedures per clinic day.

Institutional Micro-Cost Comparative Analysis of Reusable vs Single-use Cystoscopes With Assessment of Environmental Footprint.

OBJECTIVE: To conduct a comparative cost analysis between single-use and reusable cystoscopes from a national healthcare system perspective and assess the environmental footprint. METHODS: Single-center micro-cost analysis of reusable vs single-use cystoscopes used institutional data. The cost breakdown included capital, reprocessing, repair, procedure, and environmental impact expenses. Data collection occurred in 2022, utilizing registered data, observations, and expert opinions. Depreciation was applied over 5 years for reusable cystoscopes and 8 years for the automated endoscope reprocessor. Deterministic sensitivity analyses gauged result robustness to input variations. Lastly, an assessment of the environmental footprint, focusing on water consumption and waste generation, was conducted. RESULTS: Per-procedure cost associated with reusable cystoscopes was €332.46 vs €220.19 associated with single-use, resulting in savings of €112.27. When projecting these costs per procedure with the number of procedures performed in 2022 (1186), comparing the costs of procedures performed in 1 year with reusable endoscopes (€394,295.86) to the costs of the exact number of procedures performed with disposable endoscopes (€261,149.37), a saving of €133,146.49 could be achieved. Additionally, after continuous use of single-use endoscopes, procedures were scheduled every 20 minutes instead of every 30 minutes. This adjustment allowed for 15 daily procedures instead of 10 while maintaining the same shift. This suggests potential advantages in terms of improved organizational impact and reduced waiting lists. Ultimately, the decreased environmental impact favored the adoption of single-use cystoscopes. CONCLUSION: Our study presents an opportunity for organizational development in response to the evolving external environment, considering user needs, market dynamics, and competition with other facilities.

Workflow efficiencies for flexible cystoscopy: comparing single-use vs reusable cystoscopes.

BACKGROUND: Flexible cystoscopy is a common procedure to diagnose and treat lower urinary tract conditions. Single-use cystoscopes have been introduced to eliminate time-consuming reprocessing and costly repairs. We compared the hands-on labor time differences between flexible reusable cystoscopes versus Ambu's aScope™ 4 Cysto (aS4C) at a large urology Ambulatory Surgery Center (ASC). METHODS: Reusable and single-use cystoscopy procedures were shadowed for timestamp collection for setup and breakdown. A subset of reusable cystoscopes were followed through the reprocessing cycle. T-tests were calculated to measure the significance between groups. RESULTS: The average hands-on time necessary for reusable cystoscope preparation, breakdown, and pre-cleaning was 4'53″. Of this, 2'53″ were required for preparation, while 2'0″ were required for breakdown and pre-cleaning. The average hands-on time for reprocessing for reusable was 7'1" per cycle. The total time for single-use scopes was 2'22″. Of this, 1'36″ was needed for single-use preparation, and 45 s for breakdown. Compared to reusable cystoscopes, single-use cystoscopes significantly reduced pre and post-procedure hands-on labor time by 2'31", or 48%. When including reprocessing, total hands-on time was 80% greater for reusable than single-use cystoscopes. CONCLUSION: Single-use cystoscopes significantly reduced hands-on labor time compared to reusable cystoscopes. On average, the facility saw a reduction of 2'31″ per cystoscope for each procedure. This translates to 20 additional minutes gained per day, based on an 8 procedures per day. Utilizing single-use cystoscopes enabled the facility to reduce patient wait times, decrease turnaround times, and free up staff time.

Forgotten ureteral stents: a systematic review of literature.

BACKGROUND: The forgotten ureteral stents (FUS) is one of the late complications of stent placement. This systematic review summarized different aspects of FUS and focused on the problems and solutions related to FUS. METHODS: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. PubMed® and Embase® were searched from inception until October 1st, 2022. Eligible studies were those defining FUS as a stent unintentionally left in situ longer than at least 2 months. RESULTS: Total 147 studies with 1292 patients were finally included. The mean indwelling time of FUS was 33.5 months (range from 3 months to 32 years). The most common initial cause for stent placement was adjunct treatment to urolithiasis (79.2%). The major forgetting reasons were patient-related (83.9%), which included poor compliance, lapse in memory, and misconceptions about the necessity of timely removal. Primary presenting complaints were flank pain (37.3%), lower urinary tract symptoms (33.3%), and hematuria (22.8%). Encrustation (80.8%) and urinary tract infections (40.2%) were the most common complications detected in patients with FUS. Computed tomography evolving as a preferred imaging test (76.1%) was indispensable for evaluating encrustation, migration, fracture and other complicated situations in patients with FUS. Besides, evaluation of kidney function and infection status was also of great importance. Multiple and multimodal procedures (59.0%) were often necessitated to achieve the stent-free status, and were mostly endoscopic procedures. Cystoscope was most commonly used (64.8%). Retrograde ureteroscopy (43.4%) and antegrade stent removal (31.6%) were often used when dealing with more complicated situations. Extracorporeal shockwave lithotripsy (30.4%) was often used as adjunctive to other endoscopic procedures, but it sometimes failed. The decision regarding the choice of treatment is based on the volume and site of encrustation, the direction of migration, the site of fracture, kidney function and other urinary comorbidities. CONCLUSIONS: FUS not only pose hazard to patients' health, but also impose a huge economic burden on medical care. Thorough preoperative evaluation is fundamental to developing the treatment strategy. The management of FUS should be individualized using different treatment modalities with their advantages to minimize patients' morbidities. Prevention is better than cure. Strengthening health education and setting a tracking program are of great importance to the prevention of FUS.

Time Efficiency and Performance of Single-Use vs Reusable Cystoscopes: A Randomized Benchtop and Simulated Clinical Assessment.

Introduction: A flexible cystoscope is an indispensable tool for urologists, facilitating a variety of procedures in both the operating room and at bedside. Single-use cystoscopes offer benefits including accessibility and decreased burden for reprocessing. The aims of this study were to compare time efficiency and performance of single-use and reusable cystoscopes. Methods: Ten new Ambu® aScope™ 4 Cysto single-use and two Olympus CYF-5 reusable cystoscopes were compared in simulated bedside cystoscopy and benchtop testing. Ten urologists performed simulated cystoscopy using both cystoscopes in a randomized order. Times for supply-gathering, setup, cystoscopy, cleanup, and cumulative time were recorded, followed by a Likert feedback survey. For benchtop assessment, physical, optical, and functional specifications were assessed and compared between cystoscopes. Results: The single-use cystoscope demonstrated shorter supply-gathering, setup, cleanup, and cumulative times (824 vs 1231 seconds; p < 0.05) but a comparable cystoscopy time to the reusable cystoscope (202 vs 212 seconds; p = 0.32). The single-use cystoscope had a higher image resolution, but a narrower field of view. Upward deflection was greater for the single-use cystoscope (214.50° vs 199.45°; p < 0.01) but required greater force (2.5 × ). The working channel diameter and irrigation rate were greater in the reusable cystoscope. While the single-use cystoscope lacked tumor enhancing optical features, it had higher Likert scale scores for Time Efficiency and Overall Satisfaction. Conclusion: The single-use cystoscope demonstrates comparable benchtop performance and superior time efficiency compared to reusable cystoscopes. However, the reusable cystoscope has superior optical versatility and flow rate. Knowledge of these differences allows for optimal cystoscope selection based on procedure indication.

Single-use digital flexible cystoscope for double J removal versus reusable instruments: a prospective, comparative study of functionality, risk of infection, and costs.

BACKGROUND: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. METHODS: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. RESULTS: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. CONCLUSIONS: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found.

Conversion to Disposable Cystoscopes Decreased Post-procedure Encounters and Infections Compared to Reusable Cystoscopes.

INTRODUCTION: We evaluated for differences in post-procedure 30-day encounters or infections following office cystoscopy using disposable vs reusable cystoscopes. METHODS: Cystoscopies performed from June to September 2020 and from February to May 2021 in our outpatient practice were retrospectively reviewed. The 2020 cystoscopies were performed with reusable cystoscopes, and the 2021 cystoscopies were performed with disposable cystoscopes. The primary outcome was the number of post-procedural 30-day encounters defined as phone calls, patient portal messages, emergency department visits, hospitalizations, or clinic appointments related to post-procedural complications such as dysuria, hematuria, or fever. Culture-proven urinary tract infection within 30 days of cystoscopy was evaluated as a secondary outcome. RESULTS: We identified 1,000 cystoscopies, including 494 with disposable cystoscopes and 506 with reusable cystoscopes. Demographics were similar between groups. The most common indication for cystoscopy in both groups was suspicion of bladder cancer (disposable: 153 [30.2%] and reusable: 143 [28.9%]). Reusable cystoscopes were associated with a higher number of 30-day encounters (35 [7.1%] vs 11 [2.2%], P < .001), urine cultures (73 [14.8%] vs 3 [0.6%], P = .005), and hospitalizations attributable to cystoscopy (1 [0.2%] vs 0 [0%], P < .001) than the disposable scope group. Positive urine cultures were also significantly more likely after cystoscopy with a reusable cystoscope (17 [3.4%] vs 1 [0.2%], P < .001). CONCLUSIONS: Disposable cystoscopes were associated with a lower number of post-procedure encounters and positive urine cultures compared to reusable cystoscopes.

The impact of single-use digital flexible cystoscope for double J removal on hospital costs and work organization: A multicentric evaluation.

BACKGROUND: Isiris-α® is a single-use digital flexible cystoscope with an integrated grasper designed for double J (DJ) stent removal. Aim of this study was to conduct a multicentric evaluation of the costs and criticalities of stent removals performed with Isiris®-α in different hospitals and health systems, as compared to other DJ removal procedures. METHODS: After gathering 10 institutions worldwide with experience on Isiris-α®, we performed an analysis of the reported costs of DJ removal with Isiris-α®, as compared to the traditional reusable equipment used in each institution. The cost evaluation included instrument purchase, Endoscopic Room (EnR)/ Operatory Room (OR) occupancy, medical staff, instrument disposal, maintenance, repairs, decontamination or sterilization of reusable devices. RESULTS: The main factor affecting the costs of the procedure was OR/EnR occupancy. Decontamination and sterilization accounted for a less important part of total costs. Isiris-α® was more profitable in institutions where DJ removal is usually performed in the EnR/OR, allowing to transfer the procedure to outpatient clinic, with a significant cost saving and EnR/OR time saving to be allocated to other activities. In the only institution where DJ removal was already performed in outpatient clinics, there is a slight cost difference in favor of reusable instruments in high-volume institutions, given a sufficient number to guarantee the turnover. CONCLUSION: Isiris-α® leads to significant cost benefit in the institutions where DJ removal is routinely performed in EnR/OR, and brings significant improvement in organization, cost impact and turnover.

Prospective Analysis of Versatility and User Satisfaction with a Novel Single-Use Cystoscope with Working Channel.

INTRODUCTION: In the present study, a prospective systematic assessment of the clinical utility of the Ambu® aScopeTM 4 Cysto Reverse Deflection with regard to image quality, maneuverability, and navigation in an outpatient and inpatient setting was performed. MATERIALS AND METHODS: A prospective multicenter study was performed for evaluation of the instrument during routine cystoscopy. We evaluated the clinical performance of the instruments using a standardized user questionnaire in different categories including image quality, treatment success, imaging of all areas of the urinary bladder, quality of navigation, flexibility of the endoscope, and satisfaction with the device. Statistical analyses were performed by SPSS using the Kruskal-Wallis and Wilcoxon-Mann-Whitney tests. A p value of p ≤ 0.05 was defined as statistically significant. RESULTS: A total of 200 cystoscopies were performed, and the questionnaire response rate was 100%. The image quality was rated as very good in 65.5% (n = 131), good in 30.5% (n = 61), and neutral in 4% (n = 8) of cases. The criteria for poor or very poor were not mentioned. The characteristic "treatment success based on image quality" was also evaluated as very good in 49% (n = 98) and good in 50.5% (n = 101). The analysis revealed a very good or good overall impression of the examiners in all cases. Replacement of the cystoscope was not necessary during any of the examinations. However, in 3 cases, technical difficulties were documented. Further analysis of the data showed that physicians with less professional experience rated the visualization of the urinary bladder (p = 0.007) and the treatment success with regard to image quality significantly worse (p = 0.007). CONCLUSION: The Ambu® aScope™ 4 Cysto Reverse Deflection shows high satisfaction values among users in clinical routine. In analogy to other studies with flexible endoscopes, urologists with more professional experience show higher satisfaction values than examiners with less training in flexible endoscopy.

Utilising alternative cystoscopic schedules to minimise cost and patient burden after trimodality therapy for muscle-invasive bladder cancer.

BACKGROUND: To assess urinary symptoms and urine cytology as screening tools for cystoscopic detection of local recurrence after bladder-preserving trimodality treatment (TMT). METHODS: Patients with muscle-invasive bladder cancer receiving definitive TMT follow-up three monthly for 2 years, six monthly for the next 3 years and then yearly, with a clinical review, urine cytology and cystoscopy at each visit (triple assessment, TA). Grade 2+ cystitis/haematuria absent/present was scored 0/1, and urine cytology reported negative/suspicious or positive was scored 0/1, respectively. The performance of these two parameters for predicting local recurrence in cystoscopic biopsy was tested. Other hypothetical surveillance schedules included cystoscopy on alternate visits (COAV), or suspected recurrence (COSR), six-monthly COSR and six-monthly TA. RESULTS: A total of 630 follow-up visits in 112 patients with 19 recurrences (7 muscle invasive, 12 non-muscle invasive) at a median follow-up of 19 months were analysed. The sensitivity and specificity of clinical symptoms were 47.4% and 92%, and for urine cytology 58% and 85%, respectively. The combination of clinical symptoms and cytology (COSR) was 95% sensitive and 78% specific for local recurrence but 100% sensitive for muscle-invasive recurrence. Both COAV and COSV schedules showed a high area under the curve (AUC) for detecting local recurrence (COAV = 0.84, COSR = 0.83), muscle-invasive recurrence (AUC = 0.848 each) and non-muscle-invasive recurrence (COAV = 0.82, COSR = 0.81); reducing the need for TAs by 64% and 67% respectively, and overall cost by 18% and 33%, respectively. CONCLUSION: Cystoscopy at suspected recurrence during follow-up is safe and the most cost-effective for detecting muscle-invasive local recurrences, while cystoscopy at alternate visits may be more optimal for detecting any local recurrence.

Single-Use Versus Reusable Cystoscope for Ureteral Stent Removal: A Comparative Study of Perceived Pain and Procedure Times.

INTRODUCTION: The aim of this study was to compare the IsirisTM cystoscope with a common reusable flexible cystoscope in terms of patient perceived pain and endoscopy time in the ureteral stent removal setting. MATERIALS AND METHODS: A non-randomized prospective study comparing the IsirisTM single-use cystoscope with a reusable flexible cystoscope. A visual analogue scale (VAS) was used for pain assessment and endoscopy time was recorded in seconds. Univariate and multivariate analyses were performed to assess the correlation between endoscope type and clinical variables with VAS score and endoscopy time. RESULTS: A total of 85 patients were included in the study: 53 in the disposable cystoscope group and 32 in the reusable cystoscope group. Ureteral stent extraction was successful in all cases. The mean VAS score was similar between groups (single-use group was 2.09 +/- 2.53 vs 2.53 +/- 2.14 in the reusable cystoscope group) (p = 0.13). Same was observed endoscopy time (74.92 +/- 74.45 s. in the single-use group vs 98.87 +/- 153.33 s. in the reusable group) (p = 0.07). Age (coefficient ß = -0.36, p < 0.04) and body mass index (BMI) (coefficient ß = -0.22, p < 0.02) were inversely correlated with perceived pain during ureteral stent removal, measured by VAS score. CONCLUSIONS: Ureteral catheter removal with a flexible cystoscope is a well-tolerated procedure in patients. Older age and high BMI are associated with better intervention tolerance. Use of a single-use flexible cystoscope is comparable to that of a common flexible cystoscope in terms of pain and endoscopy time.

Wireless Cystoscope the Future of Cystoscopy (With Video).

Background: The first modern cystoscope was developed with the invention of rod lens and optical fibers in the 1960s. Since then, many advances have been made in functionality and camera image analysis. The cost of purchasing equipment and volume of the endoscopic tower remains a challenge and a barrier to the spread of cystoscopy. Urinary tract injury is a significant complication in women undergoing gynecologic surgery. Selective intraoperative cystoscopy at laparoscopic hysterectomy or complex pelvic surgery is valuable for recognizing lower urinary tract injuries. We have developed a novel wireless cystoscope for performing diagnostic and operative cystoscopy. Methods: The new wireless cystoscopic setup consists of a rigid cystoscope 4 mm, 30° that joins a modified action camera to a c-mount adapter f 18-35 mm and a portable led light source. Results: The new setup has so far been effectively used in more than 50 diagnostic cystoscopies and pigtail catheter replacements without complications. Two cases performed with the new setup are presented in the video. Conclusions: The new cystoscopic setup has the advantage of a wireless video camera, 4K ultraHD, and is easy setup. Due to its low cost and portability, the wireless cystoscope is easy to obtain and use. Also, it is invaluable and ergonomic in managing the integrity or pathology of the bladder, urethra, and ureters.

Environmental impact of single-use and reusable flexible cystoscopes.

OBJECTIVES: To compare the carbon footprint and environmental impact of single-use and reusable flexible cystoscopes. MATERIALS AND METHODS: We analysed the expected clinical lifecycle of single-use (Ambu aScope™ 4 Cysto) and reusable (Olympus CYF-V2) flexible cystoscopes, from manufacture to disposal. Performance data on cumulative procedures between repairs and before decommissioning were derived from a high-volume multispecialty practice. We estimated carbon expenditures per-case using published data on endoscope manufacturing, energy consumption during transportation and reprocessing, and solid waste disposal. RESULTS: A fleet of 16 reusable cystoscopes in service for up to 135 months averaged 207 cases between repairs and 3920 cases per lifecycle. Based on a manufacturing carbon footprint of 11.49 kg CO2 /kg device for reusable flexible endoscopes and 8.54 kg CO2 /kg device for single-use endoscopes, the per-case manufacturing cost was 1.37 kg CO2 for single-use devices and 0.0017 kg CO2 for reusable devices. The solid mass of single-use and reusable devices was 0.16 and 0.57 kg, respectively. For reusable devices, the energy consumption of reusable device reprocessing using an automated endoscope reprocessor was 0.20 kg CO2 , and per-case costs of device repackaging and repair were 0.005 and 0.02 kg CO2 , respectively. The total estimated per-case carbon footprint of single-use and reusable devices was 2.40 and 0.53 kg CO2 , respectively, favouring reusable devices. CONCLUSION: In this lifecycle analysis, the environmental impact of reusable flexible cystoscopes is markedly less than single-use cystoscopes. The primary contributor to the per-case carbon cost of reusable devices is energy consumption of reprocessing.

Life Cycle Assessment of Reusable and Disposable Cystoscopes: A Path to Greener Urological Procedures.

BACKGROUND: The environmental impact of reusable and disposable devices is unclear; reuse is expected to reduce the carbon footprint, but the environmental impact of reprocessing of reusable devices is increasingly being questioned. OBJECTIVE: The aim was to provide the first rigorous life cycle assessment of reusable and disposable flexible cystoscopes. DESIGN, SETTING, AND PARTICIPANTS: We performed a life cycle assessment of reusable flexible cystoscopes and the aS4C single-use cystoscope (aScope; Ambu, Ballerup, Denmark). For the aScope, the complete lifespan of the scope was evaluated, including raw material extraction, material formulation, component production, product assembly, distribution, transportation after use, and final disposal. For reusable cystoscopes, we limited our analysis to their reprocessing, using a model consisting of standard high-level disinfection with peracetic acid. The environmental impact was evaluated by an independent third-party consulting company APESA (Technopole Hélioparc, Pau, France) dedicated to such risk assessments. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The environmental footprint of both cystoscopes was assessed using five environmental impact categories, namely, climate change, mineral resource depletion, ecotoxicity, acidification, and eutrophication. To perform the life cycle assessment, Simapro v9.3.3 software was used and the Ecoinvent v3.5 database was employed as the primary life cycle inventory database. A Monte Carlo analysis was used to account for the inherent uncertainty in life cycle inventory data and the variability in material and energy consumption for each type of flexible cystoscope. RESULTS AND LIMITATIONS: By only comparing the disinfection reprocessing of reusable cystoscopes with the complete lifespan of the single-use cystoscope, the use of the aScope would allow a reduction of at least 33% in the climate change category, 50% in the mineral resources' depletion category, 51% in the ecotoxicity category, 71% in the acidification category, and 49% in the eutrophication category. Our results cannot be generalized to all health care facilities as we studied only one type of reprocessing method and one disposable flexible cystoscope. CONCLUSIONS: Disinfection reprocessing of reusable cystoscopes was found to have a significantly larger environmental footprint and impact than the whole lifespan of the single-use cystoscope aScope. PATIENT SUMMARY: Using a cradle-to-grave life cycle analysis, we showed that the environmental footprint of a flexible cystoscopy procedure can be reduced by using a disposable cystoscope instead of a reusable cystoscope.

Clinical Utility of a Single-Use Flexible Cystoscope Compared with a Standard Reusable Device: A Randomized Noninferiority Study.

Objective: A noninferiority assessment of single-use digital flexible cystoscopy (FC) compared with standard reusable FC for bladder cancer surveillance, and investigation of lower urinary tract symptoms. Patients and Methods: Patients requiring FC who met inclusion criteria were randomly assigned to have their procedure performed using a single-use cystoscope (Ambu® aScope™ 4 Cysto System) or a standard reusable cystoscope (Olympus CYF-VH flexible video cystoscope). Primary outcomes were noninferiority of the single-use cystoscope, in terms of effective procedure completion rate, image quality, light quality, and maneuverability. Secondary objectives compared safety, operative, and perioperative time. The noninferiority margin was set at -10%. Results: One hundred one patients completed the study (n = 50 trial, n = 51 control). All primary outcomes demonstrated noninferiority of the single-use cystoscope, compared with standard reusable FC. Effective completion rate, image quality, light quality, and maneuverability between single-use and reusable cystoscopes were 100% and 98% (confidence interval [CI]: -0.059 to 0.019); 96% and 100% (CI: -0.014 to 0.092); 98% and 100% (CI: -0.018 to 0.058); and 98% and 100% (CI: -0.018 to 0.058). There was no difference in operation time (p = 0.415) or total theater use time (p = 0.441) between groups. Adverse event rates were 4.08% and 4.16% in the trial group and control groups, respectively. Conclusion: The single-use Ambu flexible cystoscope is noninferior to standard FC in terms of procedure completion and light quality, image quality, and maneuverability. Single-use flexible cystoscopes are an effective and safe alternative to reusable flexible cystoscopes and may act as a suitable alternative or adjunct in the urologist's armamentarium.

Post-cystoscopy infections and device malfunctions in reprocessed flexible cystoscopes in a national database.

INTRODUCTION: Flexible cystoscopes can be multi-use devices that visually inspect genitourinary structures such as the bladder and urethra. The objective of this study is to characterize the adverse events and associated device malfunctions of reusable flexible cystoscopes and to provide information on contamination and post-procedural infections. MATERIALS AND METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all adverse events and device malfunctions related to the use of flexible cystoscopes between January 2015 and December 2020. The MAUDE adverse event classification system was used to standardize the severity of complications and special focus was taken to identify clusters of events related to a single device. RESULTS: A total of 335 adverse events related to flexible cystoscopes were identified. Most adverse events associated with patient harm were caused by infection (n = 121), which included 19 cases of sepsis, one ICU admission, and one death. Among the infections, 29 cases showed growth of the same organism in both the device and patient. There were five infectious outbreaks identified and each outbreak was attributed to a single cystoscope. Other adverse events included mechanical malfunction (n = 6) and allergic reaction (n = 1). CONCLUSIONS: Our findings highlight the risk of post-procedural infection associated with flexible cystoscope contamination. Further studies are needed to characterize the prevalence and incidence of flexible cystoscope contamination and to develop strategies to prevent post-procedural infection.