Endourology and Stones Prospective Evaluation of Refurbished Flexible Ureteroscope Durability Seen in a Large Public Tertiary Care Center With Multiple Surgeons Robert I. Carey, Christopher J. Martin, and Jacob R. Knego OBJECTIVE MATERIALS AND METHODS
RESULTS
CONCLUSION
To evaluate the durability and cost of maintenance for outsourced, refurbished flexible ureteroscopes. Ureteroscope usage and repair were prospectively recorded over a 365-day period at a large 836bed public hospital. Cases were performed by 14 different urologists using either refurbished DUR-8 or DUR-8 Elite model ureteroscopes. Retrograde cases involving calculi, urothelial carcinoma, stricture, and diagnostic evaluations were included. Ureteroscope repairs were performed by a single outsourced repair vendor, not the original manufacturer. A total of 501 ureteroscopic cases involving 550 ureteroscope usages were performed over a 365-day period. Semirigid ureteroscopes were used for 281 (56.1%) cases and refurbished flexible ureteroscopes for 220 (43.9%). The reason for the ureteroscopy was calculi in 386 (77.0%) cases, urothelial carcinoma in 32 (6.4%), stricture in 36 (7.2%), and diagnostic in 47 (9.4%). No repairs were needed during this period for semirigid scopes. Ureteral access sheaths were used in 82 (37.7%) of the cases. A total of 32 instances of catastrophic breakage occurred. Each newly refurbished ureteroscope was used for an average of 6.9 times before incurring further damage requiring repair. Refurbished flexible ureteroscopes that have undergone comprehensive repair are extremely fragile in the setting of multiple surgeon users in a large public hospital that uses central processing for sterilization and storage. This poor durability results in significant maintenance, repair, and administrative inconvenience that should be considered along with the purchase price. UROLOGY -: -e-, 2014. 2014 Elsevier Inc.
he use of flexible ureteroscopy has become widespread for the diagnosis and treatment of benign and malignant conditions of the upper urinary tract. Although flexible ureteroscopes have improved in terms of technical specifications and surgical capability, the fragility of these easily injured instruments remains a significant problem. The cost and administrative burden of purchasing and maintaining flexible ureteroscopes have been the subject of much debate.1 Variables of scope manufacturer, mechanism of cleaning,2 site of sterile processing,3 use of accessory equipment, and performance characteristics of the scope4 have been evaluated for the effect on durability. Independent multi-institutional randomized trials have yielded conflicting results regarding which manufacturer’s scopes are the most durable.5,6 Direct comparisons have suggested that new ureteroscopes may be more durable and cost-effective than refurbished ones.
T
Clearly, more data are required to determine the optimal means of providing flexible ureteroscopy at the most reasonable cost. This article addresses not only the frequency and cause of damage to refurbished ureteroscopes at a tertiary care center, but also assesses the cost and administrative concerns with maintaining an inventory of flexible ureteroscopes that have been exclusively provided by an outsourced repair vendor. This study was not designed to follow individual scopes or individual surgeons, but rather to evaluate a supply of scopes to a diverse group of surgeons at one hospital. The durability of an individual flexible ureteroscope or collection of new ureteroscopes has been well studied.2 In contrast, our article evaluates the durability of refurbished ureteroscopes provided by an outsourced vendor and how this impacts the ability of the hospital to provide adequate ureteroscopes to perform surgery reliably.
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Florida State University College of Medicine, Sarasota, FL Reprint requests: Robert I. Carey, M.D., Ph.D., F.A.C.S., Florida State University College of Medicine, 1921 Waldemere Street, Suite 310, Sarasota, FL 34239. E-mail: [email protected] Submitted: April 30, 2013, accepted (with revisions): January 18, 2014
MATERIALS AND METHODS
ª 2014 Elsevier Inc. All Rights Reserved
Prospective data collection of all ureteroscope cases performed at an 836-bed public tertiary care center from November 2010 to November 2011 was maintained and assessed in an 0090-4295/14/$36.00 http://dx.doi.org/10.1016/j.urology.2014.01.022
1
Institutional Review Boardeapproved database. A total of 501 cases were performed, including both semirigid and flexible scopes. All flexible ureteroscopies were performed using refurbished DUR-8 or DUR-8 Elite ureteroscopes provided to the hospital by an outsourced vendor PACES (Suwannee, GA). There were no new ureteroscopes used in this study. Retrograde ureteroscopies for renal and ureteral calculi, urothelial carcinoma, stricture, and diagnostic evaluations were included. Flexible ureteroscopes were passed over Sensor wires (Boston Scientific) only. The cases were performed by 14 different board-certified urologists. Ureteroscope repair was performed through PACES, and all repairs were associated with engineer’s reports of the damage incurred. Routine cleaning and maintenance of our ureteroscopes were performed through central sterile processing independent of the cystoscopy suites and did not have personnel dedicated to ureteroscope maintenance. All assembled components were separated, and the nondeflected (straight) shaft was cleaned in a protein-dissolving enzymatic detergent using appropriate brushes and cotton cloth. The working channel was flushed with the solution using a syringe. The scope was then rinsed thoroughly with warm water, dried with an air jet and clean towel, and then placed into a Sterrad NX system sterilizer. Storage of processed ureteroscopes was in a central location, and scopes were transported to the cystoscopy suite and opened immediately before use (Fig. 1). Catastrophic damage is defined as inability of the ureteroscope to perform its function as judged by the operating surgeon. Routinely through this study, minor fiberoptic or deflection damage was tolerated by the surgeons, until the breakage was so severe as to prevent usage.
Figure 1. The paradigm of supply and repair of outsourced refurbished ureteroscopes to our institution.
RESULTS A total of 501 ureteroscopic cases involving 550 ureteroscope uses were performed over a 365-day period. Semirigid ureteroscopes were used for 281 (56.1%) cases and refurbished flexible ureteroscopes for 220 (44%). No repairs were needed during this period for semirigid scopes. A total of 32 instances of catastrophic flexible ureteroscope breakage requiring send out for full repair was documented, thus indicating an average of 6.9 usages of a newly refurbished ureteroscopes were obtained before incurring yet further catastrophic damage and requiring repair. The average cost of repair per flexible ureteroscope was $4181.80. This did not take into account the ureteroscope that was beyond repair. The total cost of refurbishment for all the flexible ureteroscopes over a 1-year period was $129,635.65. For the 220 cases for which a flexible ureteroscope was used, this corresponds to amortized cost of $589.25 per case, not counting the original cost of the purchase price of the refurbished ureteroscopes. The new DUR-8 Elite (44 usages) and DUR-8s repaired by the original manufacturer (11.1 usages) are taken from the study by Carey et al2 and compared with the DUR-8s refurbished in this study by an outsourced vendor which showed only 6.9 usages per breakage event (Fig. 2). Retrograde cases for stone extraction formed most cases for both flexible and rigid ureteroscopes. The total 2
Figure 2. The new DUR-8 Elite (44 usages) and DUR-8s repaired by the original manufacturer (11.1 usages) are taken from Carey et al (J Urology 2006;176(2):607-610) and compared with the DUR-8s refurbished in this study by an outsourced vendor which showed only 6.9 usages per breakage event.
number of rigid cases was 281 (56.1%), comprising 222 (79.0%) anterograde and/or retrograde stones, 16 (5.69%) ureteral strictures, 20 (7.1%) tumors, and 23 (8.2%) diagnostic procedures. The total number of flexible cases was 220 (43.9%), comprising 164 (74.5%) anterograde and/or retrograde stones, 20 (9.1%) strictures, 12 (5.5%) tumors, and 24 (10.1%) diagnostic procedures. Ureteral access sheaths were used in 82 (37.7%) of the flexible ureteroscope cases. Operative reports from engineers reveal several main types of damage to the ureteroscopes. Of the 32 breakages for which ureteroscopes were sent for repair, 29 ureteroscopes had to have the image bundle, light guide lenses, biopsy channel, coil pipes, angulation cables, and bending sheath replaced. These same 29 ureteroscopes had to have the back focus adjusted and mask UROLOGY
-
(-), 2014
reset. Only 1 flexible ureteroscope was deemed beyond repair. Only 1 of the flexible ureteroscopes required only a flush port replacement. One ureteroscope had major fluid intrusion, whereas 8 exhibited lesser fluid intrusion, and 13 exhibited damage to the bending sheath. Nine had leakage to the biopsy channel. Nine exhibited combinations of fluid intrusion, bending sheath destruction, or biopsy channel leakage. Other miscellaneous complaints included stained image bundles, cracked lens, poor fiber optics, and broken flex mechanisms.
COMMENT The subject of flexible ureteroscope durability and repair is a timely and unsolved problem of contemporary urology. Randomized controlled trials and large retrospective analyses have all concluded that flexible ureteroscopes are extremely fragile, and the cost of ureteroscope maintenance and repair is burdensome.2,5 As early as 2004, Landman et al1 found significant variability in the overall costs of small flexile ureteroscopes and concluded that institutions should consider the purchase price, durability, repair cost, and associated warranties before investment in flexible ureteroscopy. Carey et al2 reported a retrospective review of 601 ureteroscopic cases in a large county hospital with multiple surgeon users. There were 53 reports of ureteroscope damage. In this study, new ureteroscopes were substantially more durable than ones refurbished by the original manufacturer, and the authors noted that after damage occurred to a ureteroscope, more damage occurred rapidly. A new DUR-8 ureteroscope in this study provided 48 usages, whereas refurbished ones provided fewer (mean 11.1 and median 8 usages) before needing comprehensive repair. This study found that the cost of maintaining an older ureteroscope should be carefully considered relative to the cost of a new ureteroscope. A randomized, prospective, multi-institutional trial by Monga et al6 confirmed the fragility of flexible ureteroscopes. In 192 patients studied, the number of cases completed before repair ranged from 3.25 to 14.4 depending on the manufacturer. Of note, 97% of the ureteroscope entries in this study were through a ureteral access sheath compared with 37.7% in our study. In another randomized, prospective, multi-institutional trial of 175 patients, Knudsen et al5 evaluated the use of a new ureteroscope up to the time at which a first major repair was needed. They found that the average number cases performed before repair varied from 5.3 to 18.0 depending on the manufacturer, and the average amount of time in the urinary tract varied from 107.6 to 624.3 minutes. Comparison of manufacturers, although interesting, can be misleading as these 2 randomized studies came to opposite conclusions; one showed the DUR-8 to be the most durable ureteroscope, whereas the other showed it to be the least durable. UROLOGY
-
(-), 2014
Independent analysis of repairs of ureteroscopes from a single manufacturer was undertaken by Canales et al.4 A total of 341 repairs were evaluated through a comprehensive inspection identifying the site of injury, component injured, and the mechanism of injury. The most common site of ureteroscope damage was found to be at the distal tip where loss of deflection and vision caused the scope to be sent for repair. The authors proposed that improvement in form and function of the distal tip (specifically the bending rubber component) should decrease maintenance expenses.4 These findings helped to initiate interest in the creation of improved materials and the concept of a disposable tip to a reusable flexible ureteroscope. The fragility and documented expense of purchasing and maintaining our current generation of flexible ureteroscopes have led to the consideration of a disposable ureteroscope. The SemiFlex Scope disposable flexible ureteroscope has been evaluated with in vitro comparison with commercially available reusable scope and found to have an acceptable active tip deflection, field of view, and flow rate.7 The practicality and cost-effectiveness of this strategy is yet to be determined. The durability of 2 new Flex-X ureteroscopes was increased to more than 100 cases by Defidio et al8 by adhering to strict protective criteria. Laser fibers and wires were always passed with the scope straight and work with the scope fully deflected was minimized. Ureteral access sheaths were used in all cases that required re-entry. Pressure irrigation was avoided. Lower pole calculi were routinely relocated to a more accessible calyx. Access to the upper tract was always over a safety guide wire (Bentson 0.03500 Teflon-coated floppy tipped) into a ureter that was routinely predilated by passage of a 9.5F semirigid ureteroscope over the wire into the renal pelvis. Cleaning and sterilization were performed by dedicated cystoscopy suite personnel. The working channels of the scopes were cleaned with a syringe, and the scopes were immersed in a detergent solution for 20 minutes, followed by sterilization by immersion in Cidex for 30 minutes. This promising study was limited in that only 2 ureteroscopes were evaluated. Also, the method of sterilization with Cidex, although known to be protective to the ureteroscope, is not likely to be acceptable to most hospitals because of the toxicity and disposal risks associated with Cidex.9 Flexible ureteroscope breakage may occur intraoperatively through torsion, laser fire, or blunt injury. However, damage may also occur through cleaning, handling, sterile processing, and storage. Semins et al3 evaluated the effect of having the dedicated urology nursing staff perform all sterile processing and handling within the urology suite without involvement of central processing. As expected, this study found no ureteroscope damage occurred as the result of processing. Furthermore, the amortized cost of ureteroscope usage per case dropped from $418.19 per case in the previous year where central processing was used to $120.63 cost per use in the year 3
with in-cystoscopy suite processing. Although this arrangement is clearly desirable to standardize and personalize ureteroscope processing, it may not be practical for many hospitals to commit its limited personnel and resources for this task. Our study is limited in that we have only 1 year’s worth of data and 550 ureteroscope usages. However, that number is actually large compared with most published series.2-8 Our study used only outsourced refurbished ureteroscopes. New ureteroscopes were not included; however, the durability of new ureteroscopes and ones refurbished by the original manufacturer is already known.2 There is variability in the origin, mechanism of damage, and number of damages incurred for each refurbished ureteroscope. However, it is the paradigm of the hospital to use refurbished ureteroscopes rather than purchase new ones, and the durability of these refurbished scopes is the subject in question. Ureteroscope sterile processing was done in a central facility not controlled inside the cystoscopy suite, thus leaving room for anonymous processing damage to occur. Although it is known that having individual accountability for scope processing within the cystoscopy suite reduces damage, hospitals are reluctant to dedicate personnel for such purpose. This matter of hospital policy is part of the process that is being scrutinized in this article. There were multiple surgeon users of the ureteroscopes, each with varying skill, experience, and levels of training. Each surgeon presents different risks for ureteroscope damage. However, this shared usage of ureteroscopes mimics the reality in most large county hospitals, and it is not practical within the design of our study to obtain reliable data on the behavior and results of individual surgeons. The damage incurred by each ureteroscope before being sent out for repair was not standardized, but rather the ureteroscope was sent for repair when the operating urologist deemed the ureteroscope to be unfit for usage. Significant, catastrophic fluid intrusion, flexible mechanism damage, and fiberoptic damage were documented in the engineers’ reports for all cases sent for repair. Our study evaluates only the number of usages (cases) and not the duration or difficulty of each case, which may be highly variable. However, our series spanned an entire year with no cases being excluded and should be representative of the annual caseload expected in our hospital. Our study documents the reality of refurbished flexible ureteroscope damage, repair, and expense seen in a large county hospital with a high volume of ureteroscopic cases over the course of 1 year. There is substantial fragility seen in refurbished ureteroscopes obtained from an
4
outsourced vendor, used by multiple surgeons, and then cleaned and stored through a central sterile processing facility in house. Our amortized cost of repair of $589.25 per case does not include the initial purchase price of a suitable inventory of scopes nor the extreme administrative cost and inconvenience associated with frequent send outs for repair. Our findings are consistent with previous studies that have suggested that the cost of maintaining an inventory of older, refurbished ureteroscopes may be greater than the cost of purchasing and maintaining new ones.
CONCLUSION Refurbished flexible ureteroscopes that have undergone comprehensive repair are extremely fragile in the setting of multiple surgeon users in a large public tertiary care center that uses central processing for sterilization and storage. The high frequency of damage and repair seen in this study results in significant administrative inconvenience and cost. The durability of outsourced, refurbished flexible ureteroscopes, cost of repair, and the initial purchase cost must be considered. Our study suggests that acquiring refurbished ureteroscopes from an outsourced vendor is an expensive, unreliable means to provide flexible ureteroscopes to a large, high surgical volume hospital. References 1. Landman J, Lee DI, Lee C, et al. Evaluation of overall costs of currently available small flexible ureteroscopes. Urology. 2003;62: 218-222. 2. Carey RI, Gomez CS, Maurici G, et al. Frequency of ureteroscope damage seen at a tertiary care center. J Urol. 2006;176:607-610. 3. Semins MJ, George S, Allaf ME, et al. Ureteroscope cleaning and sterilization by the urology operating room team: the effect on repair costs. J Endourol. 2009;23:903-905. 4. Canales BK, Gleason JM, Hicks N, et al. Independent analysis of Olympus flexible ureteroscope repairs. Urology. 2007;70: 11-15. 5. Knudsen B, Miyaoka R, Shah K, et al. Durability of the nextgeneration flexible fiberoptic ureteroscopes: a randomized prospective multi-institutional clinical trial. Urology. 2010;75:534-538. 6. Monga M, Best S, Venkatesh R, et al. Durability of flexible ureteroscopes: a randomized, prospective study. J Urol. 2006;176:137-141. 7. Boylu U, Oommen M, Thomas R, et al. In vitro comparison of a disposable flexible ureteroscope and conventional flexible ureteroscopes. J Urol. 2009;182:2347-2351. 8. Defidio L, Dominicis MD, Gianfrancesco LD, et al. Improving flexible ureterorenoscope durability up to 100 procedures. J Endourol. 2012;126:1329-1334. 9. McDougall EM, Alberts G, Deal KJ, et al. Does the cleaning technique influence the durability of the
RESULTS
CONCLUSION
To evaluate the durability and cost of maintenance for outsourced, refurbished flexible ureteroscopes. Ureteroscope usage and repair were prospectively recorded over a 365-day period at a large 836bed public hospital. Cases were performed by 14 different urologists using either refurbished DUR-8 or DUR-8 Elite model ureteroscopes. Retrograde cases involving calculi, urothelial carcinoma, stricture, and diagnostic evaluations were included. Ureteroscope repairs were performed by a single outsourced repair vendor, not the original manufacturer. A total of 501 ureteroscopic cases involving 550 ureteroscope usages were performed over a 365-day period. Semirigid ureteroscopes were used for 281 (56.1%) cases and refurbished flexible ureteroscopes for 220 (43.9%). The reason for the ureteroscopy was calculi in 386 (77.0%) cases, urothelial carcinoma in 32 (6.4%), stricture in 36 (7.2%), and diagnostic in 47 (9.4%). No repairs were needed during this period for semirigid scopes. Ureteral access sheaths were used in 82 (37.7%) of the cases. A total of 32 instances of catastrophic breakage occurred. Each newly refurbished ureteroscope was used for an average of 6.9 times before incurring further damage requiring repair. Refurbished flexible ureteroscopes that have undergone comprehensive repair are extremely fragile in the setting of multiple surgeon users in a large public hospital that uses central processing for sterilization and storage. This poor durability results in significant maintenance, repair, and administrative inconvenience that should be considered along with the purchase price. UROLOGY -: -e-, 2014. 2014 Elsevier Inc.
he use of flexible ureteroscopy has become widespread for the diagnosis and treatment of benign and malignant conditions of the upper urinary tract. Although flexible ureteroscopes have improved in terms of technical specifications and surgical capability, the fragility of these easily injured instruments remains a significant problem. The cost and administrative burden of purchasing and maintaining flexible ureteroscopes have been the subject of much debate.1 Variables of scope manufacturer, mechanism of cleaning,2 site of sterile processing,3 use of accessory equipment, and performance characteristics of the scope4 have been evaluated for the effect on durability. Independent multi-institutional randomized trials have yielded conflicting results regarding which manufacturer’s scopes are the most durable.5,6 Direct comparisons have suggested that new ureteroscopes may be more durable and cost-effective than refurbished ones.
T
Clearly, more data are required to determine the optimal means of providing flexible ureteroscopy at the most reasonable cost. This article addresses not only the frequency and cause of damage to refurbished ureteroscopes at a tertiary care center, but also assesses the cost and administrative concerns with maintaining an inventory of flexible ureteroscopes that have been exclusively provided by an outsourced repair vendor. This study was not designed to follow individual scopes or individual surgeons, but rather to evaluate a supply of scopes to a diverse group of surgeons at one hospital. The durability of an individual flexible ureteroscope or collection of new ureteroscopes has been well studied.2 In contrast, our article evaluates the durability of refurbished ureteroscopes provided by an outsourced vendor and how this impacts the ability of the hospital to provide adequate ureteroscopes to perform surgery reliably.
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Florida State University College of Medicine, Sarasota, FL Reprint requests: Robert I. Carey, M.D., Ph.D., F.A.C.S., Florida State University College of Medicine, 1921 Waldemere Street, Suite 310, Sarasota, FL 34239. E-mail: [email protected] Submitted: April 30, 2013, accepted (with revisions): January 18, 2014
MATERIALS AND METHODS
ª 2014 Elsevier Inc. All Rights Reserved
Prospective data collection of all ureteroscope cases performed at an 836-bed public tertiary care center from November 2010 to November 2011 was maintained and assessed in an 0090-4295/14/$36.00 http://dx.doi.org/10.1016/j.urology.2014.01.022
1
Institutional Review Boardeapproved database. A total of 501 cases were performed, including both semirigid and flexible scopes. All flexible ureteroscopies were performed using refurbished DUR-8 or DUR-8 Elite ureteroscopes provided to the hospital by an outsourced vendor PACES (Suwannee, GA). There were no new ureteroscopes used in this study. Retrograde ureteroscopies for renal and ureteral calculi, urothelial carcinoma, stricture, and diagnostic evaluations were included. Flexible ureteroscopes were passed over Sensor wires (Boston Scientific) only. The cases were performed by 14 different board-certified urologists. Ureteroscope repair was performed through PACES, and all repairs were associated with engineer’s reports of the damage incurred. Routine cleaning and maintenance of our ureteroscopes were performed through central sterile processing independent of the cystoscopy suites and did not have personnel dedicated to ureteroscope maintenance. All assembled components were separated, and the nondeflected (straight) shaft was cleaned in a protein-dissolving enzymatic detergent using appropriate brushes and cotton cloth. The working channel was flushed with the solution using a syringe. The scope was then rinsed thoroughly with warm water, dried with an air jet and clean towel, and then placed into a Sterrad NX system sterilizer. Storage of processed ureteroscopes was in a central location, and scopes were transported to the cystoscopy suite and opened immediately before use (Fig. 1). Catastrophic damage is defined as inability of the ureteroscope to perform its function as judged by the operating surgeon. Routinely through this study, minor fiberoptic or deflection damage was tolerated by the surgeons, until the breakage was so severe as to prevent usage.
Figure 1. The paradigm of supply and repair of outsourced refurbished ureteroscopes to our institution.
RESULTS A total of 501 ureteroscopic cases involving 550 ureteroscope uses were performed over a 365-day period. Semirigid ureteroscopes were used for 281 (56.1%) cases and refurbished flexible ureteroscopes for 220 (44%). No repairs were needed during this period for semirigid scopes. A total of 32 instances of catastrophic flexible ureteroscope breakage requiring send out for full repair was documented, thus indicating an average of 6.9 usages of a newly refurbished ureteroscopes were obtained before incurring yet further catastrophic damage and requiring repair. The average cost of repair per flexible ureteroscope was $4181.80. This did not take into account the ureteroscope that was beyond repair. The total cost of refurbishment for all the flexible ureteroscopes over a 1-year period was $129,635.65. For the 220 cases for which a flexible ureteroscope was used, this corresponds to amortized cost of $589.25 per case, not counting the original cost of the purchase price of the refurbished ureteroscopes. The new DUR-8 Elite (44 usages) and DUR-8s repaired by the original manufacturer (11.1 usages) are taken from the study by Carey et al2 and compared with the DUR-8s refurbished in this study by an outsourced vendor which showed only 6.9 usages per breakage event (Fig. 2). Retrograde cases for stone extraction formed most cases for both flexible and rigid ureteroscopes. The total 2
Figure 2. The new DUR-8 Elite (44 usages) and DUR-8s repaired by the original manufacturer (11.1 usages) are taken from Carey et al (J Urology 2006;176(2):607-610) and compared with the DUR-8s refurbished in this study by an outsourced vendor which showed only 6.9 usages per breakage event.
number of rigid cases was 281 (56.1%), comprising 222 (79.0%) anterograde and/or retrograde stones, 16 (5.69%) ureteral strictures, 20 (7.1%) tumors, and 23 (8.2%) diagnostic procedures. The total number of flexible cases was 220 (43.9%), comprising 164 (74.5%) anterograde and/or retrograde stones, 20 (9.1%) strictures, 12 (5.5%) tumors, and 24 (10.1%) diagnostic procedures. Ureteral access sheaths were used in 82 (37.7%) of the flexible ureteroscope cases. Operative reports from engineers reveal several main types of damage to the ureteroscopes. Of the 32 breakages for which ureteroscopes were sent for repair, 29 ureteroscopes had to have the image bundle, light guide lenses, biopsy channel, coil pipes, angulation cables, and bending sheath replaced. These same 29 ureteroscopes had to have the back focus adjusted and mask UROLOGY
-
(-), 2014
reset. Only 1 flexible ureteroscope was deemed beyond repair. Only 1 of the flexible ureteroscopes required only a flush port replacement. One ureteroscope had major fluid intrusion, whereas 8 exhibited lesser fluid intrusion, and 13 exhibited damage to the bending sheath. Nine had leakage to the biopsy channel. Nine exhibited combinations of fluid intrusion, bending sheath destruction, or biopsy channel leakage. Other miscellaneous complaints included stained image bundles, cracked lens, poor fiber optics, and broken flex mechanisms.
COMMENT The subject of flexible ureteroscope durability and repair is a timely and unsolved problem of contemporary urology. Randomized controlled trials and large retrospective analyses have all concluded that flexible ureteroscopes are extremely fragile, and the cost of ureteroscope maintenance and repair is burdensome.2,5 As early as 2004, Landman et al1 found significant variability in the overall costs of small flexile ureteroscopes and concluded that institutions should consider the purchase price, durability, repair cost, and associated warranties before investment in flexible ureteroscopy. Carey et al2 reported a retrospective review of 601 ureteroscopic cases in a large county hospital with multiple surgeon users. There were 53 reports of ureteroscope damage. In this study, new ureteroscopes were substantially more durable than ones refurbished by the original manufacturer, and the authors noted that after damage occurred to a ureteroscope, more damage occurred rapidly. A new DUR-8 ureteroscope in this study provided 48 usages, whereas refurbished ones provided fewer (mean 11.1 and median 8 usages) before needing comprehensive repair. This study found that the cost of maintaining an older ureteroscope should be carefully considered relative to the cost of a new ureteroscope. A randomized, prospective, multi-institutional trial by Monga et al6 confirmed the fragility of flexible ureteroscopes. In 192 patients studied, the number of cases completed before repair ranged from 3.25 to 14.4 depending on the manufacturer. Of note, 97% of the ureteroscope entries in this study were through a ureteral access sheath compared with 37.7% in our study. In another randomized, prospective, multi-institutional trial of 175 patients, Knudsen et al5 evaluated the use of a new ureteroscope up to the time at which a first major repair was needed. They found that the average number cases performed before repair varied from 5.3 to 18.0 depending on the manufacturer, and the average amount of time in the urinary tract varied from 107.6 to 624.3 minutes. Comparison of manufacturers, although interesting, can be misleading as these 2 randomized studies came to opposite conclusions; one showed the DUR-8 to be the most durable ureteroscope, whereas the other showed it to be the least durable. UROLOGY
-
(-), 2014
Independent analysis of repairs of ureteroscopes from a single manufacturer was undertaken by Canales et al.4 A total of 341 repairs were evaluated through a comprehensive inspection identifying the site of injury, component injured, and the mechanism of injury. The most common site of ureteroscope damage was found to be at the distal tip where loss of deflection and vision caused the scope to be sent for repair. The authors proposed that improvement in form and function of the distal tip (specifically the bending rubber component) should decrease maintenance expenses.4 These findings helped to initiate interest in the creation of improved materials and the concept of a disposable tip to a reusable flexible ureteroscope. The fragility and documented expense of purchasing and maintaining our current generation of flexible ureteroscopes have led to the consideration of a disposable ureteroscope. The SemiFlex Scope disposable flexible ureteroscope has been evaluated with in vitro comparison with commercially available reusable scope and found to have an acceptable active tip deflection, field of view, and flow rate.7 The practicality and cost-effectiveness of this strategy is yet to be determined. The durability of 2 new Flex-X ureteroscopes was increased to more than 100 cases by Defidio et al8 by adhering to strict protective criteria. Laser fibers and wires were always passed with the scope straight and work with the scope fully deflected was minimized. Ureteral access sheaths were used in all cases that required re-entry. Pressure irrigation was avoided. Lower pole calculi were routinely relocated to a more accessible calyx. Access to the upper tract was always over a safety guide wire (Bentson 0.03500 Teflon-coated floppy tipped) into a ureter that was routinely predilated by passage of a 9.5F semirigid ureteroscope over the wire into the renal pelvis. Cleaning and sterilization were performed by dedicated cystoscopy suite personnel. The working channels of the scopes were cleaned with a syringe, and the scopes were immersed in a detergent solution for 20 minutes, followed by sterilization by immersion in Cidex for 30 minutes. This promising study was limited in that only 2 ureteroscopes were evaluated. Also, the method of sterilization with Cidex, although known to be protective to the ureteroscope, is not likely to be acceptable to most hospitals because of the toxicity and disposal risks associated with Cidex.9 Flexible ureteroscope breakage may occur intraoperatively through torsion, laser fire, or blunt injury. However, damage may also occur through cleaning, handling, sterile processing, and storage. Semins et al3 evaluated the effect of having the dedicated urology nursing staff perform all sterile processing and handling within the urology suite without involvement of central processing. As expected, this study found no ureteroscope damage occurred as the result of processing. Furthermore, the amortized cost of ureteroscope usage per case dropped from $418.19 per case in the previous year where central processing was used to $120.63 cost per use in the year 3
with in-cystoscopy suite processing. Although this arrangement is clearly desirable to standardize and personalize ureteroscope processing, it may not be practical for many hospitals to commit its limited personnel and resources for this task. Our study is limited in that we have only 1 year’s worth of data and 550 ureteroscope usages. However, that number is actually large compared with most published series.2-8 Our study used only outsourced refurbished ureteroscopes. New ureteroscopes were not included; however, the durability of new ureteroscopes and ones refurbished by the original manufacturer is already known.2 There is variability in the origin, mechanism of damage, and number of damages incurred for each refurbished ureteroscope. However, it is the paradigm of the hospital to use refurbished ureteroscopes rather than purchase new ones, and the durability of these refurbished scopes is the subject in question. Ureteroscope sterile processing was done in a central facility not controlled inside the cystoscopy suite, thus leaving room for anonymous processing damage to occur. Although it is known that having individual accountability for scope processing within the cystoscopy suite reduces damage, hospitals are reluctant to dedicate personnel for such purpose. This matter of hospital policy is part of the process that is being scrutinized in this article. There were multiple surgeon users of the ureteroscopes, each with varying skill, experience, and levels of training. Each surgeon presents different risks for ureteroscope damage. However, this shared usage of ureteroscopes mimics the reality in most large county hospitals, and it is not practical within the design of our study to obtain reliable data on the behavior and results of individual surgeons. The damage incurred by each ureteroscope before being sent out for repair was not standardized, but rather the ureteroscope was sent for repair when the operating urologist deemed the ureteroscope to be unfit for usage. Significant, catastrophic fluid intrusion, flexible mechanism damage, and fiberoptic damage were documented in the engineers’ reports for all cases sent for repair. Our study evaluates only the number of usages (cases) and not the duration or difficulty of each case, which may be highly variable. However, our series spanned an entire year with no cases being excluded and should be representative of the annual caseload expected in our hospital. Our study documents the reality of refurbished flexible ureteroscope damage, repair, and expense seen in a large county hospital with a high volume of ureteroscopic cases over the course of 1 year. There is substantial fragility seen in refurbished ureteroscopes obtained from an
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outsourced vendor, used by multiple surgeons, and then cleaned and stored through a central sterile processing facility in house. Our amortized cost of repair of $589.25 per case does not include the initial purchase price of a suitable inventory of scopes nor the extreme administrative cost and inconvenience associated with frequent send outs for repair. Our findings are consistent with previous studies that have suggested that the cost of maintaining an inventory of older, refurbished ureteroscopes may be greater than the cost of purchasing and maintaining new ones.
CONCLUSION Refurbished flexible ureteroscopes that have undergone comprehensive repair are extremely fragile in the setting of multiple surgeon users in a large public tertiary care center that uses central processing for sterilization and storage. The high frequency of damage and repair seen in this study results in significant administrative inconvenience and cost. The durability of outsourced, refurbished flexible ureteroscopes, cost of repair, and the initial purchase cost must be considered. Our study suggests that acquiring refurbished ureteroscopes from an outsourced vendor is an expensive, unreliable means to provide flexible ureteroscopes to a large, high surgical volume hospital. References 1. Landman J, Lee DI, Lee C, et al. Evaluation of overall costs of currently available small flexible ureteroscopes. Urology. 2003;62: 218-222. 2. Carey RI, Gomez CS, Maurici G, et al. Frequency of ureteroscope damage seen at a tertiary care center. J Urol. 2006;176:607-610. 3. Semins MJ, George S, Allaf ME, et al. Ureteroscope cleaning and sterilization by the urology operating room team: the effect on repair costs. J Endourol. 2009;23:903-905. 4. Canales BK, Gleason JM, Hicks N, et al. Independent analysis of Olympus flexible ureteroscope repairs. Urology. 2007;70: 11-15. 5. Knudsen B, Miyaoka R, Shah K, et al. Durability of the nextgeneration flexible fiberoptic ureteroscopes: a randomized prospective multi-institutional clinical trial. Urology. 2010;75:534-538. 6. Monga M, Best S, Venkatesh R, et al. Durability of flexible ureteroscopes: a randomized, prospective study. J Urol. 2006;176:137-141. 7. Boylu U, Oommen M, Thomas R, et al. In vitro comparison of a disposable flexible ureteroscope and conventional flexible ureteroscopes. J Urol. 2009;182:2347-2351. 8. Defidio L, Dominicis MD, Gianfrancesco LD, et al. Improving flexible ureterorenoscope durability up to 100 procedures. J Endourol. 2012;126:1329-1334. 9. McDougall EM, Alberts G, Deal KJ, et al. Does the cleaning technique influence the durability of the
