Keywords
Cholangioscopy - Pancreatoscopy - Quality and logistical aspects - Hygiene - Pancreatobiliary
(ERCP/PTCD) - Quality and logistical aspects
Introduction
In France, each year, about 90,000 endoscopic retrograde cholangiopancreatographies
(ERCPs) are performed with duodenoscopes [1]. Despite strict adherence to both manufacturer-issued reprocessing protocols and
international guidelines on the high-level disinfection reprocessing workflow [2]
[3]
[4], bacterial colonization of duodenoscopes leading to infections still occurs [5]
[6]
[7]. In France, the risk of duodenoscope-related infection was estimated to be one to
three cases per million endoscopic procedures [8] or 25 infections in 6 years [9]—lower than in other countries [10]
[11]. Because the introduction of single-use duodenoscopes has been presented as a solution
to avoid infections, assessing the costs of device purchase, maintenance, microbiological
control, and reprocessing per ERCP with a reusable duodenoscope is timely.
The cost of reusable endoscope reprocessing has been evaluated in France and abroad
[7]
[12]
[13]
[14]
[15]
[16]
[17], yet external validity of the results remains challenging. Differences stem from
the guidelines used, hospital internal organization, number of duodenoscopes, type
and volume of activity, team composition, and reprocessing techniques [18].
The aim of this study was to assess the costs of purchase, maintenance, microbiological
control, and reprocessing (including storage) of a reusable duodenoscope, per ERCP.
On the one hand, survey-based costs reflect real-world practices and some costs may
be omitted or underestimated if, for instance, reprocessing guidelines are not strictly
followed. On the other hand, guideline-based costs may be overestimated compared to
real-world practices because guidelines aim to maximize security. Therefore, it appeared
essential to have a dual approach: implementing a survey in hospitals to collect data
on the real-world costs and estimating the costs using a theoretical approach partially
based on the 2016 and 2018 national guidelines for duodenoscope reprocessing [8]
[19].
Methods
The following costs were considered: purchase, maintenance, and reprocessing (including
storage) (Supplementary Table 1). The costs of infection, downtime due to breakdown or maintenance, reprocessing
single-use material disposal, and device disposal were beyond the scope of this study.
Survey-based approach
Study centers and study period
Four French hospital centers were selected to ensure diversity of ownership: two university
hospitals (a large one with 2,543 beds and a smaller one with 1,051 beds), one private
hospital, and one private nonprofit hospital. Between December 1, 2019 and December
1, 2020, they completed a survey (Supplement Methods 1) to report the costs of duodenoscope
reprocessing, microbiological controls, and associated costs of used equipment.
Survey
The survey questionnaire was based upon the 2016 and 2018 national guidelines [19,8]
(with particular attention paid to the products used) and guidelines for hospital
environmental control and videos directed by the Center for the Prevention of Healthcare-related
Infections (CPIAS) of Nouvelle Aquitaine [20]
[21]
[22]. Data on the number of duodenoscopes and annual number of ERCPs and the duration
of duodenoscope life cycles were collected.
Costs of purchase, maintenance, and microbiological control of the washing equipment
(automated endoscope reprocessing machine, [AER]) and the storage equipment (endoscope
drying cabinet, [EDC]) were excluded from the survey. Costs related to that "ancillary
equipment" are difficult to compare from one hospital to another. Moreover, washing
and storage equipment are not restricted to duodenoscopes and corresponding costs
are small compared to the other costs involved in the cost of an ERCP. Neither were
considered costs incurred by complying with procedures (training time, quality insurance,
internal audits, time spent handling documentation for repair), structural costs,
and costs incurred for biomedical operations. In all, 35% were added as overhead costs
(15% and 20% for the facility [12] and quality assurance [7], respectively).
Theoretical approach
This approach was based on national recommendations, guidelines released by the Ministry
of Health [8]
[19], associated Frequently Asked Questions, and CPIAS guidelines [20]
[21]
[22].
[Fig. 1] presents the reprocessing steps and allows for the identification of corresponding
needs and related costs. Consumables and operation time for duodenoscope reprocessing
considered for the modeling cost assessment are shown in Supplementary Table 2. The microbiological controls (with consumables and human resources) included controls
of the duodenoscope, the water, the EDC, and the room environment. The number of microbiological
controls per year are shown in Supplementary Table 3. Absent EDC, if the duodenoscope is used ≥ 6 hours after reprocessing, a short reprocessing
cycle is needed prior to use. Thus, one short reprocessing cycle per day was added
to the reprocessing cost for reprocessing without EDC.
Fig. 1 Reusable duodenoscope reprocessing steps. AER, automated endoscope reprocessing machine;
HC, healthcare; microbiological control, controls (with consumables and human resources)
of the duodenoscope, the water, the endoscope drying cabinet, and the room environment.
To account for hidden and structural costs, 35% overhead costs were added [7]
[12].
Data sources
Mean consumables and equipment costs were estimated based on tariff data from three
university hospitals (no fixed tariffs). The human resources costs were based on 2021
data provided by the University Hospital of Toulouse, the annual gross salary of a
nurse, a laboratory technician, and a caregiver were €70,744.28, €55,365.46, and €47,553.97,
respectively. According to the Ministry of Health, the gross annual salary of hospital
doctors was €118,012 [23]. Computations were based on 1,575 annual working hours.
Assumptions
The number, methods, and frequency of microbiological controls were based on the 2018
Good Practices for Microbiological Surveillance of the Environment in Health Care
Institutions [24]. Based on 88,440 ERCP performed in 346 facilities (min-max 179–266 ERCP per facility)
[1], the mean annual number of ERCP per duodenoscope was 223 (corresponding to using
a duodenoscope once per business day). This number was used as the denominator to
compute the theoretical cost per ERCP. We assumed that the duodenoscope would undergo
a short reprocessing cycle prior to use (except when stored in an EDC or sealed in
a vacuum-dried envelope) and added the corresponding cost. Of note, additional microbiological
controls may be needed after repair or maintenance but were not considered.
We followed the number of maintenance procedures recommended by the manufacturer and
added one repair. The depreciation periods for the equipment were set at 4 years for
duodenoscopes (although it is more than 4 years in public hospitals), 6 years for
AERs and 8 years for EDCs. The costs of maintenance, purchase, and the product life
cycle for a duodenoscope, an AER, and an EDC are presented in Supplementary Table 4.
Outcome
The outcome was the mean cost of purchase, maintenance, and reprocessing (including
storage) per ERCP with a reusable duodenoscope, in a real-world setting (survey-based
approach) and from a theoretical viewpoint (guidelines-based model). Of note, the
number of ERCP per duodenoscope was different in the survey-based and the guidelines-based
approaches.
Statistical methods
Continuous data were summarized by their mean and standard deviation (SD) for the
survey results. Costs are expressed in EUR2020.
Ethics
This study did not involve patient data and, therefore, approval from an ethics committee
was not required.
Results
Survey-based approach
The four hospitals performed between 250 and 580 duodenoscopies per year and owned
three or four duodenoscopes ([Table 1]). Consequently, the annual number of ERCPs per duodenoscope varied from 62 to 193
between hospitals.
Table 1 Number of reusable duodenoscopes, annual number of ERCPs, and annual number of ERCPs
per duodenoscope in each surveyed hospital.
|
Hospital
|
Number of reusable duodenoscopes
|
Annual number of ERCPs
|
Annual number of ERCPs per duodenoscope
|
|
ERCP, endoscopic retrograde cholangiopancreatography.
|
|
A
|
4
|
410
|
102.5
|
|
B
|
3
|
530
|
176.7
|
|
C
|
3
|
580
|
193.3
|
|
D
|
4
|
250
|
62.5
|
The average purchasing cost of a duodenoscope was around €30,000. Device life cycle
and depreciation period varied between 4 and 6 years. In addition, the annual cost
of maintenance was around €4,000 (identical in all hospitals). Consequently, the cost
of purchase and maintenance per ERCP varied between €18.55 and €29.53 per hospital
([Table 2]). Assuming five microbiological controls per year (four compulsory + one after maintenance),
the mean cost of the microbiological control per duodenoscope use was €2.96. As for
reprocessing, the cost of consumables was similar in all hospitals (mean €14.76),
but the cost of human resources varied from one hospital to the other (from €13.50
to €20.88).
Table 2 Cost of duodenoscope purchase, maintenance, microbiological controls, and reprocessing,
per ERCP, using the survey-based approach.
|
Hospital
|
Duodenoscope purchase and maintenance (€) (1)
|
Microbiological controls (€) (2)
|
Reprocessing (3)
|
Overhead 35% of (1) + (2) + (3)
|
Total (€)
|
|
Consumables (€)
|
Human resources (€)
|
|
SD, standard deviation.
*The cost of duodenoscope purchase and maintenance for Hospital D was not communicated;
the mean cost at the other hospitals was used.
†The cost of microbiological controls for Hospitals B and D was not communicated; the
mean costs at the other hospitals were used.
|
|
A
|
24.40
|
3.95
|
14.48
|
19.20
|
21.71
|
83.74
|
|
B
|
18.55
|
2.96
|
17.18
|
20.88
|
20.85
|
80.42
|
|
C
|
29.53
|
1.97
|
13.17
|
16.60
|
21.44
|
82.71
|
|
D
|
24.16
|
2.96
|
14.22
|
13.50
|
19.19
|
74.03
|
|
Mean (±SD)
|
24.16 (±4.49)
|
2.96 (±0.99)
|
14.76 (±1.48)
|
17.55 (±2.79)
|
20.80 (±0.98)
|
80.23 (±3.77)
|
In all, the average observed cost of purchase, maintenance, microbiological control,
reprocessing, and overhead was €80.23 (±3.77, 95% confidence interval [76.54–83.92])
per ERCP.
Theoretical approach
For each ERCP, the purchase and maintenance costs were €60.54 for the duodenoscope,
€49.33 for the AER, and €5.32 for the EDC ([Table 3]). The cost of using an EDC was €6.80. The costs of the microbiological controls
were €2.99 for the duodenoscope, €2.81 for the water, €1.59 for the EDC, and €1.25
for the room environment. The cost of all microbiological controls was small (from
€4.24 to €8.64) compared to the cost of purchase and maintenance, and reprocessing.
The total cost of one reprocessing (consumables and human resources), considering
whether the hospital performed it manually or with AER, with or without EDC, ranged
from €57.34 (AER processing without EDC) to €78.33 (manual reprocessing without EDC).
Table 3 Cost of duodenoscope purchase, maintenance, microbiological controls, and reprocessing,
per ERCP, using the theoretical approach.
|
Procedure
|
Duodenoscope, EDC, and AER purchase and maintenance (€) (1)
|
Microbiological controls (€) (2)
|
Reprocessing (3)
|
Overhead 35% of (1) + (2) + (3)
|
Total (€)
|
|
Consumables (€)
|
Human resources (€)
|
|
EDC, endoscope drying cabinet; AER, automated endoscope reprocessing. Overhead was
defined as 15% for facility + 20% for quality assurance.
*Includes additional reprocessing per day to take into consideration duodenoscope
use for more than 6 hours after reprocessing.
|
|
Manual reprocessing without EDC*
|
60.54
|
4.24
|
49.76
|
28.57
|
47.37
|
182.71
|
|
Manual reprocessing with EDC
|
65.86
|
5.83
|
45.89
|
24.17
|
49.61
|
191.36
|
|
AER without EDC*
|
109.87
|
7.05
|
42.14
|
15.20
|
60.99
|
235.25
|
|
AER with EDC
|
115.19
|
8.64
|
47.83
|
19.05
|
65.75
|
253.62
|
In all, the average theoretical cost of purchase, maintenance, microbiological control,
reprocessing, and overheads per ERCP was €182.71 for manual reprocessing without EDC,
€191.36 for manual reprocessing with EDC, €235.25 for AER reprocessing without EDC,
and €253.62 for AER reprocessing with EDC.
Discussion
Based on direct observations in four hospitals, the mean cost of purchase, maintenance,
microbiological control, reprocessing, and overhead per ERCP with a reusable duodenoscope
was €80.23 and fairly consistent across hospitals. Based on a theoretical, guidelines-based
approach, this mean cost was estimated to vary between €182.71 and €253.62, depending
on whether an EDC and an AER were used or not.
Comparison of survey results in four hospitals
Even if hospitals follow guidelines, their processes may not coincide because of differences
in their internal organizations. While the cost of one ERCP was fairly homogeneous
among the four hospitals, differences were noted in some items. For instance, Hospital
B had a lower purchasing cost for the duodenoscope. Hospital D hired less qualified
staff for the multiple tasks, hence the cost of human resources in the duodenoscope
reprocessing was lower than in the other hospitals. Other factors impact duodenoscope
reprocessing costs, including volume of activity, number of devices, and equipment.
Comparison of survey-based and theoretical approaches
The average theoretical costs were two to three times higher than the average survey-based
costs, showing that the theoretical approach in itself is not sufficient. On the face
of it, the higher theoretical costs were explained by the higher costs of purchase
and maintenance, microbiological controls, and consumables for the reprocessing considered
in the model. The average theoretical costs per ERCP were higher despite assuming
a higher annual number of ERCPs per duodenoscope compared to the numbers found with
the survey. In any case, the optimal duodenoscope reprocessing modality remains to
be determined [25]. For example, maximum time between device reprocessing and use is 6 hours in France
but 4 hours in Belgium [26]. In addition, recommendations are sometimes contradictory and difficult to implement
[27]. For all these reasons, it is therefore difficult to ascertain, even theoretically,
the cost of an ERCP. The difference between the theoretical and the observed costs
also implies that not all costs can be captured in a survey (some costs were estimated
and not measured, costs were reported by staff and not collected by an external independent
worker), even based on guidelines.
Finally, the difference in the results of the two approaches could mean that, despite
laudable efforts from the hospitals, guidelines were not fully implemented.
Comparison of our results with other studies
Previous French studies have examined the cost of reprocessing reusable select endoscopes
(including bronchoscopes [12], fiberscopes [13]
[14], soft endoscopes [15], and choledochoscopes [16]) but not duodenoscopes. The cost of reprocessing flexible endoscopes has been investigated
in 14 healthcare institutions in the United States to explore the real-world impact
of strengthened guidelines on reprocessing time and cost [17]. Although the study did not account for every aspect of reprocessing, the minimum
and maximum costs were $114.07 and $280.71 per reprocessing, which is higher than
the survey-based and theoretical costs of reprocessing we found. In a second US study,
assuming 200 ERCPs per year, the per-procedure cost with a reusable duodenoscope was
$232 without considering infections [11]. The per-procedure cost rose to $732 and $2,107 when factoring in infection rates
of 0.4% to 1.5%, respectively (with the cost of treating cholangitis of $125,000).
In a third US study, assuming 650 ERCPs per year performed with three duodenoscopes
(or 217 ERCPs per duodenoscope), the per-procedure cost (including purchase, repair
and maintenance, reprocessing, 20% overhead, and a 1% infection risk) was $960.24
[7]. The estimated cost for treating a duodenoscope-related infection was $47,181, leading
to a per-procedure infection cost ranging from $471.81 to $566.17 for 1% and 1.2%
infection risks, respectively. A difference in the costs between the United States
and France is to be expected and can be explained by differences between guidelines,
labor costs, and device costs. At any rate, our study confirms that cost studies should
be conducted on a national basis before making national decisions on payment of procedures,
reimbursement for devices, and the types of devices to be preferred (single-use versus
reusable).
Future of duodenoscope reprocessing
Despite the best possible reprocessing, patient cross-contamination is still possible
with reusable duodenoscopes [28]. Enhanced reprocessing protocols may further reduce patient risk of exposure to
contaminated duodenoscopes, yet they significantly increase the cost of performing
ERCPs. Future innovation should focus on approaches that can ensure patient safety
while maintaining the ability to perform ERCP in a cost-effective manner [29]. Acknowledging the challenges of eliminating all contamination during reprocessing
and maintaining the duodenoscope contaminant-free during storage, the US Food and
Drug Administration issued a safety communiqué recommending transitioning to duodenoscopes
with innovative designs that allow more effective reprocessing, including single-use
sterile parts [30]. In select cases deemed at high risk of cross-contamination or when the quality
of high-level disinfection cannot be enforced with the highest level of confidence,
SUU present an alternative which is already available and may deserve consideration.
However, our study—especially the survey findings—demonstrated a relatively low cost
for duodenoscope reprocessing and, if microbiological and environmental concerns are
added, the debate is not over. So far, single-use duodenoscopes might be more appropriate
in limited cases, such as highly-infectious or immunocompromised patients, and when
duodenoscopes are unavailable due to maintenance, repair, or bacteriological surveillance
and after hours when trained staff is unavailable for reprocessing.
Strengths and limitations
This study’s strengths are its double approach (survey-based and theoretical) and
that multiple costs have been considered and detailed.
This study also has some limitations. First, the survey was completed by the hospital
staff, which could have an impact on the answers. Second, it failed to consider the
cost of infections, which would increase the cost of ERCP— because it is difficult
to distinguish infection related to preexisting contamination of the duodenoscope
and infection related to the act itself (bacteremia, for example) [11]. The cost of infections is extremely variable from one case to another and should
include the direct expenditures (treatments, extended hospital stay) and indirect
costs (crisis management, degradation of the institution's image). Then, some costs
were covered by the overhead (facility and quality insurance), but other costs were
beyond the scope of this study but merit attention and should be integrated into the
cost of ERCP (disposal of trash generated by the reprocessing and the duodenoscope
[17], environmental impact of reprocessing, downtime due to breakdown or maintenance
and its consequence, device end-of-life disposal). The findings may not be representative
on a national level, because the types of duodenoscope used, staff employed, and reprocessing
materials and methods vary greatly. Participation of other hospitals might have yielded
different results (in one direction or the other), given that some perform fewer than
250 ERCPs per year and others more than 580. The model should have been replicated
for varied mean number of ERCPs per duodenoscope. Some data could not be obtained
from two hospitals.
Conclusions
The estimated costs of purchase, maintenance, microbiological control, and reprocessing
of a reusable duodenoscope per ERCP were significantly different with the theoretical
and observational approaches. The costs found with the theoretical approach were much
higher. The costs found with the observational approach were consistent between hospitals
and fairly low. This shows that using several approaches (each having its own limitations)
is necessary to assess costs associated with duodenoscopes. These findings can feed
the discussion on the positioning of single-use duodenoscopes.
