Hergott, Christopher A. MD, FRCPC, FCCP*; MacEachern, Paul MD, FRCPC, FCCP†; Stather, David R. MD, FRCPC, FCCP†; Tremblay, Alain MDCM, FRCPC, FCCP†
*Division of Respirology, Critical Care, and Sleep Medicine, University of Saskatchewan, Saskatoon, Saskatchewan
†Division of Respiratory Medicine, University of Calgary, Calgary, Alberta, Canada
Disclosure: The University of Calgary receives grant money from Olympus Canada to fund an interventional fellowship program and an endobronchial ultrasound educational course. The authors have no conflicts of interest to disclose.
Reprints: Christopher A. Hergott, MD, FRCPC, FCCP, Division of Respirology, Critical Care, and Sleep Medicine, University of Saskatchewan; 5th Floor Ellis Hall, Room 544, Royal University Hospital, 103 Hospital Drive, Saskatoon, Saskatchewan, Canada, S7N 0W8 (e-mail: email@example.com).
Received for publication November 30, 2009; accepted May 12, 2010
Institution at which work was carried out: University of Calgary.Drs Hergott and Tremblay shared equally in collating data and preparing the manuscript.
Background: The development of endobronchial ultrasound (EBUS) has revolutionized the diagnostic approach to lung cancer and mediastinal lymphadenopathy. The capital costs associated with implementing EBUS are easily obtained from manufacturers, but the ongoing maintenance and repair costs are unknown.
Objective: The purpose of this study was to delineate the maintenance and repair costs associated with EBUS.
Methods: For the period between October 2005 and June 30, 2009, the number of procedures and the maintenance and repair costs for both EBUS and flexible bronchoscopes were recorded. Two BF-160UCF-OL8 (Olympus, Canada) linear convex EBUS bronchoscopes were used for EBUS procedures during the course of the study. Total costs were calculated on a yearly basis and on a per procedure basis for EBUS and standard bronchoscopes and are presented in Canadian and US dollars ($1 CAN=$0.88 USD).
Results: During the period of October 2005 and June 2009, a total of 949 linear convex EBUS procedures and 2767 flexible bronchoscopies were carried out. During this period, 13 separate repair issues were encountered with the EBUS bronchoscopes and control unit. The total cost for maintenance and repair of the EBUS and flexible bronchoscopes was $110,151.46 ($96,933.28 USD) and $67,301.49 ($59,225.31 USD), respectively. The average cost per procedure for EBUS and flexible bronchoscopy was $116.00 ($102.08 USD) and $24.32 ($21.42 USD), respectively.
Conclusions: The cost of EBUS repairs per procedure is significant and illustrates the importance of understanding the ongoing maintenance issues inherent in these delicate pieces of medical equipment.
The development of endobronchial ultrasound (EBUS) has revolutionized the field of bronchoscopy. The use of the linear convex ultrasound bronchoscope is playing an ever more prominent role in the diagnosis of pulmonary and mediastinal diseases. The use of EBUS in the diagnosis and staging of lung cancer is gaining increased popularity given the consistently reported high sensitivity and specificity of this procedure, with a recent meta-analyses showing a pooled sensitivity of 0.93 and specificity of 1.001 and similar findings in a systematic review.2 Its usefulness in the diagnosis of sarcoidosis is also promising3–5 and EBUS has been shown to be superior to standard transbronchial needle aspiration (TBNA).6 Given these results, EBUS may be in a position to replace TBNA and mediastinoscopy in many clinical situations.
The implementation of EBUS requires training in the use of the linear convex bronchoscope and more importantly a familiarity with the interpretation of the ultrasound images provided by the scope.7 In addition, there are significant costs involved in the implementation of EBUS. The initial capital costs of the equipment required for EBUS and dedicated aspiration needles are easily obtained from manufacturers, but the ongoing maintenance and repair costs of these bronchoscopes are not known. The Calgary Health Region has been using EBUS for the diagnosis of mediastinal and hilar lymphadenopathy and in the staging of lung cancer since 2005, with nearly 1000 procedures carried out to date. In this study, we present our maintenance and repair costs for our linear convex EBUS bronchoscopes over a 4-year period.
The setting for this study was a university-based teaching hospital. All EBUS procedures were carried out or supervised by interventional pulmonary medicine (IPM) specialists. Two IPM physicians with prior experience using radial EBUS and standard TBNA initiated the EBUS program. The IPM program subsequently added 2 additional IPM physicians. The IPM physicians who initiated the EBUS program did so at a time when linear convex EBUS was first made commercially available. They had extensive prior experience with radial EBUS and conventional TBNA. Both are fellowship-trained IPM physicians. The newest IPM faculty trained at the University of Calgary and each had performed more than 200 EBUS procedures before joining the faculty. IPM fellows carried out the majority of EBUS procedures. IPM fellows have completed their internal medicine and pulmonary fellowship training and on average will have performed more than 150 bronchoscopies. Pulmonary fellows may have assisted in carrying out a limited number of EBUS bronchoscopies. Almost all of the pulmonary fellows participating in the EBUS procedures would be in their second year of fellowship training, having already completed more than 50 flexible bronchoscopies. Respiratory therapists dedicated to the bronchoscopy suite assist in all bronchoscopic procedures. The respiratory therapists attended in-service training provided by industry representatives on the use and proper handling of EBUS bronchoscopes.
Linear convex EBUS procedures are carried out for the diagnosis of abnormal mediastinal and hilar lymphadenopathy and for lung cancer staging. All procedures are done through an oral approach via a Tudor-Williams airway under conscious sedation.
Two BF-160UCF-OL8 (Olympus, Canada) linear convex EBUS bronchoscopes were used for EBUS procedures during the course of the study. EBUS-specific disposable biopsy needles (NA-201SX-4022-B; Olympus, Canada) were used for all TBNA procedures. The majority of videoendoscopes used for standard bronchoscopy procedures included the BF-1T160 and BF-P160 (Olympus, Canada) bronchoscopes. Procedures and bronchoscopes used in the operating room and in intensive care units are not included in this study.
The period of study includes the initial implementation of linear EBUS in our center in October of 2005 to June 30, 2009. Yearly procedure volumes were recorded for all bronchoscopies and for linear EBUS procedures specifically. During this time, all repair issues required for the 2 EBUS bronchoscopes and the costs incurred in carrying out the appropriate repairs were recorded. In addition, all repairs for the standard bronchoscopes were noted.
Total costs were calculated on a yearly basis and on a per procedure basis for EBUS and standard bronchoscopes. All funds are expressed in Canadian dollars, unless otherwise specified. Conversion to United States dollars (USD) is based on the currency conversion rate at the time of manuscript preparation (1$CAN=0.88$US).
During the period between October 2005 and June 2009, a total of 949 linear convex EBUS procedures and a total of 2767 flexible bronchoscopies were carried out. The volume of EBUS procedures increased every year in absolute numbers and as a percentage of all procedures, from 28% in 2006 to 50% in the first half of 2009 (Table 1).
During this time period, 13 separate repair issues were encountered with the EBUS bronchoscopes and control unit. The total cost for maintenance and repair of the EBUS bronchoscopes for this time period was $110,151.46 ($96,933.28 USD) (Table 1). This represents a repair cost of $116.00 ($102.08 USD) per procedure and an average repair cost of $8473.19 ($7456.41 USD). The cost of EBUS repairs per procedure increased after the first year of use, but seemed stable in the subsequent years. Repairs to EBUS bronchoscopes were not more common in any specific time of year. During the same time period, the total cost for maintenance and repair of the flexible bronchoscopes was $67,301.49 ($59,225.31 USD), at an average cost of $24.32 ($21.42 USD) per procedure. Almost all repairs of EBUS bronchoscopes involved damage to the insertion tube, moisture invasion, breakage of the image guide bundle, and damage to the U-cord. EBUS bronchoscopes were always repaired and never replaced. In some situations, the manufacturer did supply a loaner scope when an EBUS bronchoscope needed repair. The average time that a scope was away for repair was not recorded. A service contract for EBUS bronchoscopes was not available.
Our study suggests that repair costs to EBUS bronchoscopes are significant and need to be considered when planning the introduction of this technique in any medical center. Especially in a high-volume center, these repair costs can be substantial and can strain bronchoscopy budget if not incorporated in yearly operating budgets up front. We hope that such data are of use given the unpredictability of these repairs and the earlier lack of data regarding this issue with EBUS equipment.
As a result of the complexity of the EBUS bronchoscopes, the cost per repair for EBUS scopes was particularly high even if channel leaks and damaged insertion tubes were the usual problems, as is seen with standard bronchoscopes. In fact, only 2 repairs were related solely to the ultrasound component (one for a scope and one for the control unit). With respect to the control unit, it would no longer scan and the primary circuit board had failed. No inciting event for this repair was ever identified and further information from the manufacturer was not available.
Data have been published regarding repair costs of standard bronchoscopes. In one study, the repair costs incurred for flexible bronchoscopes over a period of 4½ years costs totaled $89,863.11(USD),8 which averaged out to $23.48 in 1989 USD per procedure, or $40.49 USD if adjusted for inflation.9 Our repair for flexible bronchoscopes over a similar time period was considerably less at $24.32 ($21.40 USD), although a more recent study from Slovenia reported a much lower cost of 5.25 € ($7.37 USD) per procedure. The lower costs in this latter study were attributed to an educational program for users, an approach which has also been found to reduce repair costs by others.10 Other factors may account for variability in repairs for standard scopes, such as frequency of use in the intensive care unit, use of videoendoscopes versus fiberoptic scopes, use of TBNA needles, and the presence of trainees. The number of conventional TBNA biopsies carried out using the regular flexible bronchoscope was not recorded. As EBUS TBNA became the test of choice when TBNA was required, undoubtedly fewer conventional TBNAs were carried out. The fact that TBNA was done more commonly using EBUS may be a reason for lower repair costs for flexible bronchoscopes compared with those costs published earlier by other groups.8 Nevertheless, our repair costs for standard bronchoscope seem to be in line with those reported by others. Given that our standard bronchoscope repair costs are similar to those of other groups, it is likely that our EBUS repair costs are generalizable to other groups as well.
Some researchers have attempted to classify their repairs based on whether or not the damage was caused by human error and was thus preventable,8,11,12 suggesting that as many as 87% of flexible bronchoscopy repairs may be preventable. In our investigation, we could not always determine a specific incident or cause leading to damage to the EBUS bronchoscopes, so could not estimate how many of these repairs were preventable. Greater than 90% of the damage to the scopes included moisture invasion in the insertion tube or damage to the U-cord. Information provided by the manufacturer suggests this could occur because of needle puncture of the biopsy channel, scope handling, and reprocessing. As an inciting event could not be identified, it is difficult to ascribe one specific cause to the damage and need for repair. Bronchoscopes are delicate instruments that must be handled with care. In addition to the usual care required to use a flexible bronchoscope, there are very specific measures that are important in minimizing the possibility of damage to an EBUS bronchoscope. The importance of proper scope position and needle retraction during manipulation of TBNA needles was emphasized in one publication in which a significant number of bronchoscope repairs were felt to result from TBNA procedures.8 The EBUS needle is somewhat more forgiving than standard TBNA needles in that the sharp tip of the needle reliably retracts to the correct position inside the sheath. Nevertheless, care must be taken to ensure that the bronchoscope remains in a neutral position when the sheath is inserted and advanced outside of the working channel. In addition to the proper use of the needle, carrying out the leakage test correctly and careful inspection of the water-resistant caps are all suggestions provided by the manufacturer to help prevent damage. It is possible that repetitive use coupled with the age of the scopes put them at risk for moisture invasion and repair. It does not seem that increased experience and familiarity of the operators with the equipment had any effect in reducing damage or repair costs, as these were constant over time and in fact lowest during the first year of use. As such, general wear and tear may play a larger role. It is unclear at which time point replacement of a scope becomes more economically desirable in comparison with ongoing repair.
Several factors may impact the generalizability of our results. All of our procedures are carried out through an oral airway (Tudor-Williams) under conscious sedation. This may increase the risk of damaging the equipment by patients biting the endoscopes. Unfortunately, we found early on in our experience that a nasal approach was almost always unsuccessful given the large dimension of the EBUS scope and have abandoned attempts at nasal intubation. Some centers also carry out EBUS procedure through laryngeal mask airway or endotracheal tube under general anesthesia,13 which may reduce the risk of bite damage to endoscope, although bronchoscopes can also be damaged if advanced through an undersized endotracheal tube. Nevertheless, it is unlikely that the substantial increase in costs associated with carrying out EBUS under general anesthesia would be overcome by a reduction in repair costs. Given equivalent diagnostic yield reported with these 2 approaches,14 costs may still favor the conscious sedation approach. Finally, this is a single-center experience. However, it is the largest volume EBUS center in Canada. Given that nearly 1000 EBUS procedures have been carried out at this center, it is reasonable to conclude that a great degree of expertise in EBUS exists at this institution. It is conceivable that other institutions with similar experience could expect similar outcomes. Generalizability may be less robust with centers that carry out fewer procedures or who have staff less familiar with EBUS procedures.
The impact of limiting EBUS procedures to 2 or 3 physicians, each carrying out at least 100 procedures per year all in the same endoscopy suite, on repair costs is unknown. Similarly, our center uses a small number of dedicated bronchoscopy respiratory therapists who process the EBUS endoscope, which may limit damage both during procedures and during processing. Procedure volumes and various staffing models for both physicians and assistants may influence these costs. IPM fellows and pulmonary fellows also carry out the majority of EBUS procedures in our center, which may also have effects on these costs, although this has not been found with standard equipment.11
Three articles have recently investigated cost issues surrounding EBUS procedures. One article compared costs for 100 hypothetical patients with lung cancer and mediastinal lymph nodes greater than 1 cm and found that a standard TBNA followed by EBUS was the least expensive approach, with mediastinoscopy costing €1170 ($1600 USD) more per patient.15 In another hypothetical analysis, a group from Leeds Teaching Hospitals NHS Trust in the United Kingdom published a projected cost analysis for the implementation of EBUS in lung cancer staging.16 A projected cost savings of £32 631 (45,000 USD) per year, including capital costs, was calculated for the implementation of EBUS for staging of 47 patients, with savings resulting for the most part from a reduction in the number of surgical mediastinoscopies.16 A more detailed cost-minimization model comparing various diagnostic approaches in the evaluation of patients with non–small-cell lung cancer reported that esophageal ultrasound (EUS) was most cost effective, with EBUS slightly more expensive, but this was based on US Medicare reimbursement fees 3.5 times higher for EBUS than for EUS that does not represent the true costs of these procedures, which intuitively should be relatively equivalent.17 In addition, the study with the lowest published diagnostic yield for EBUS (69%) was used in the modeling, far from the 93% reported in a recent metaanalysis.1 None of the aforementioned analyses incorporated repair and maintenance costs of EBUS or other modalities in their calculations. This could be an important factor between various techniques, as EUS scope repair has been reported to be lower ($41USD/procedure) in a survey analysis,18 and standard mediastinoscopes are perhaps less likely to require ongoing maintenance.
This study is the first to delineate the repair costs associated with the use of linear EBUS bronchoscopes in a large-volume EBUS center. Our flexible bronchoscopy repair costs are comparable with those published earlier, suggesting that in general our center maintains and cares for its bronchoscopes in an appropriate manner. The cost of EBUS repairs per procedure in our study was $116.00 ($102.08 USD). This significant cost illustrates the importance of understanding the ongoing maintenance issues inherent in these delicate pieces of medical equipment.
The authors thank Chris Edgerton RRT, Cris Santillo RRT, Evelyn Davis RRT, and Maria Civitarese RRT for their help in collation of the data.
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