Review for 10.1186/1471-230X-11-105 (2011)

Reviewer's report
Title:Comparative cost-efficiency of the EVOTECH Endoscope Cleaner and
Reprocessor versus manual cleaning plus automated endoscope reprocessing in
a real-world Canadian hospital endoscopy setting.
Version: 3Date:23 May 2011
Reviewer: Lawrence Muscarella
Reviewer's report:
Discretionary revisions:
1. The authors have adequately addressed the reviewer’s comment #1.
2. The authors stated in reply to my original comment that: “The reviewer is
correct in that the time required to reprocess colonoscopes is longer because of
the complexity of the colonoscopes where there are three channels to manually
brush in the colonoscope and only a single channel in the bronchoscope. No
change was made to the manuscript to explain this. It is assumed that readers of
the paper would be aware of the physical differences between the endoscope
types.”
The review agrees that the time to reprocess a colonoscope manually, compared
to a bronchoscope, would be longer, due to the former endoscope’s physical
complexity. But the reviewer does not concur with the authors that readers of the
manuscript would know why, for example, the Medivators DSD-201, an
automated and presumably standardized process, would require more time to
reprocess colonoscopes (49.88 minutes) than bronchoscopes (42.43 minutes).
Specifically, it is unclear to this reviewer why the Medivators DSD-201’s
automated process would cause its time to reprocess a bronchoscope to be
approximately 7 minutes less.
The authors note in the revised manuscript that: “the longer processing time for
colonoscopes compared with the other scope types reflected the time required
for an additional tap water rinse.” Please clarify that this is a change to the
manuscript and why the Medivators DSD-201’s number of water rinses would
depend on the type of endoscope being reprocessed.
3. The authors have adequately addressed the reviewer’s comment #3.
4. The authors are requested to clarify in their manuscript that the Evotech ECR
is no longer the only reprocessor device in the U.S. to be cleared by the FDA to
eliminate manual pre-cleaning of the endoscope prior to its automated
processing. Another of Medivators’s endoscope-reprocessing models (the
Advantage Plus) was recently cleared with the same claim as the Evotech
ECR’s.
While such a clearance may not be as important to a device’s legal use in
Canada as in the U.S., it is reasonable to ask the authors to discuss and clarify
for the reader whenever an implication or consequence of this manuscript’s
results and conclusions may not be the same in the two countries.
5. The authors have noted in their reply to the reviewer’s original comment that:
“We agree with the reviewer’s statement and we have referred readers to an
actual practice clinical effectiveness evaluation of EVOTECH ECR conducted by
Alfa et al. (Alfa MJ, Degagne P, Olson N, Fatima I. EVOTECH® endoscope
cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of
cleaning efficacy. BMC Infectious Diseases 2010;10:200
(doi:10.1186/1471-2334-10-200).)”
This article by Alfa et al. (2010) is incomplete, however, and it has been
corrected. The authors are asked to reference in their manuscript, in addition to
this article, the following reference/correction:
Alfa MJ, Degagne P, Olson N, Fatima I. Correction: EVOTECH® endoscope
cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of
cleaning efficacy. BMC Infectious Diseases 2010;10:291
(doi:10.1186/1471-2334-10-291).)
6. The authors have adequately addressed the reviewer’s comment #6.
Minor essential revisions:
1. The authors have adequately addressed the reviewer’s comment #1.
2. Based on their reply, the authors are respectfully requested to clarify for the
reader that its revised manuscript’s calculations, cost analysis and conclusions
are based on labor costs in Canada and, therefore, may not be applicable to the
Evotech ECR’s use in the U.S. or another country.
Alternatively, the authors would include in their revised manuscript their reply to
this reviewer’s original comment – namely, “Information on the cost implications
for the U.S. was not included in this study. The authors concluded that a
discussion of the cost implications for the U.S. would be out of place in a study
reporting on actual practice and costs in Canada. If U.S. reviewers would like to
understand the cost implication of the labour savings in the U.S., they could
estimate the U.S. labour cost savings by multiplying the hours saved with
EVOTECH ECR by their own institutional technician per hour labour cost.”
3. The authors have adequately addressed the reviewer’s comment #3.
4. The authors appear to have adequately addressed the reviewer’s comment
#4, although they are asked to mention briefly in the manuscript why, if the
immersion time of the Cidex OPA disinfectant was 5 minutes, its immersion
temperature was not 25° C as indicated on its labeling (in the U.S.), but rather
“28-29°C.” The reason for this elevated temperature is unclear.
Major compulsory revisions:
1. The authors’ comments are appreciated, but their manuscript’s focus and
conclusion that the annual costs of using the EvoTech ECR are less than the
Medivators DSD-201’s, as well as their statement that “the purpose of this
economic evaluation was to determine the cost-efficiency of using the EVOTECH
ECR versus another disinfection system, Medivators DSD-201, by comparing the
total costs, including labour and consumable supplies, involved in using each
reprocessor in an actual clinical practice setting in Canada,” would seemingly
require including as a footnote in Table 7 the authors’ estimate of the initial
purchase price of both the Evotech ECR and Medivators DSD-201 models.
Alternatively, the authors would include as a footnote in Table 7 a statement, like
this table’s other footnote, to the effect that: “ *Does not include the initial
purchase price of either device.”
If it were not to include in its calculations an estimate of the initial purchase price
of both compared models, then the manuscript would be arguably incomplete,
and the validity of its comparison of the total costs of the Evotech reprocessing
device, compared to the Medivators DSD-201, or its conclusion that “the Evotech
was … less costly to use for the reprocessing of endoscopes than the Medivators
DSD-201” might be in doubt. It is important that such a comparative cost analysis
as this manuscript’s include all germane costs – including both devices’
respective initial purchase cost.
The authors note in their reply that: “We agree with the reviewer that the study
did not include the reprocessor purchase price and the annual cost of
maintenance contracts. We have removed reference in the manuscript to the
capital costs.”
Rather than removing this reference – in fact, it is requested that this be reinsert
in the manuscript, – the authors are asked to discuss differences in the estimated
initial purchase price between the Evotech ECR and the MediVators DSD-201
and how these differences might impact the revised manuscript’s conclusions, in
general, and the following two, in particular: first, The EVOTECH ECR was more
efficient and less costly to use for the reprocessing of endoscopes than manual
cleaning followed by (disinfection using the Medivators DSD-201)”; and, second,
“the increased efficiency with EVOTECH ECR could lead to even further
cost-savings by shifting endoscopy laboratory personnel responsibilities but
further study is required.” If the authors cannot estimate the initial purchase price
of either device in Canada, then a comparison of their respective costs in the
U.S. or another country of choice is recommended.
Although less suitable, the authors could alternatively discuss in the manuscript
the following text, along with its implications: “the study did not include the
reprocessor purchase price and the annual cost of maintenance contracts, the
primary reason for which is that, in Canadian hospitals, the operating budgets do
not cover capital costs and vice versa. The target audience for this paper is
hospital decision makers interested in operating costs. A secondary reason for
excluding the capital purchase price of the reprocessors was the fact that,
although prices appear to be publicly available in the U.S., comparative pricing
was not available for Canada.” This text is important to this manuscript’s
discussion.
2. The authors provide an important footnote in the revised Table 5 stating that:
“**Although a less costly disinfectant (such as glutaraldehyde) may be in use in
other centres, they were not in use at this site and are no longer commonly used
because of their association with occupational disease among cleaning
personnel [23].”
This rationale presents a slippery slope. The authors are asked to clarify that
their statement that they “are no longer commonly used” is referring specifically
to glutaraldehyde-based disinfectants (or instead to “a less costly disinfectant”) in
Canada. (That glutaraldehyde-based disinfectants remain in use in the U.S. is
noted.)
Moreover, if such a statement about occupational disease is to be included in the
revised manuscript vis-à-vis, for example, glutaraldehyde, then, for balance, the
authors are asked to clarify whether the Evotech ECR is contraindicated for
reprocessing urological instrumentation (e.g., cystoscopes) used to treat patients
with a history of bladder cancer. Reports have linked anaphylaxis-like reactions
among this subclass of patients to the use of Cidex OPA (which is the active
ingredient of the Evotech ECR’s single-use disinfectant) to reprocess urological
equipment used repeatedly on these patients.
3. The authors wrote: “We agree with the reviewer’s comment that manual
cleaning is required in cases of emergency procedures (i.e., patients were not
properly prepped prior to the procedure) and where soiled endoscopes are not
reprocessed within one hour after their clinical use. Information was available in
the introduction section of the manuscript to describe this; however, we have also
repeated this information in the discussion section to ensure that readers
understand the impact that the manual cleaning requirement in these two
scenarios would have on the overall costs.”
In reply, the authors are requested to include in the manuscript not just an
acknowledgement of these two limitations of the Evotech ECR’s, but also an
estimation of the potential financial impact of both on the manuscript’s
calculations and conclusions. Inclusion in the manuscript of this
acknowledgement and estimation are important to ensure that its results do not
feature a measurement bias that might skew its conclusions favoring the Evotech
ECR’s device (one of the manuscript’s authors is employed by Johnson and
Johnson Medical Companies, a division of which manufactures and markets this
Evotech device).
The manuscript would lack objectivity if it were to have omitted factors (e.g., the
financial costs associated with manual cleaning of those types of flexible
endoscopes that the Medivators DSD-201 can reprocess, but that the Evotech
ECR cannot; or, the initial purchase price of the Medivators DSD-201, which
reportedly is significantly less than the Evotech ECR) that would reduce the
financial benefits and enhanced efficiency of the Evotech ECR, compared to the
Medivators DSD-201.
The authors also state that: “With respect to the types of scopes that can and
cannot be reprocessed with EVOTECH ECR, EVOTECH ECR can reprocess
most scope types including ERCP scopes, enteroscopes and videoscopesh;
however, double biopsy channel scopes and ultrasound scopes must be
reprocessed in another manner. A sentence was added to the discussion to state
that the EVOTECH ECR cannot reprocess all scope types.”
The authors are asked to note in the manuscript, not just that “the EVOTECH
ECR cannot reprocess all scope types,” but that, if true, it cannot reprocess
double biopsy channel scopes and ultrasound scopes, which appear to be the
only two.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I have previously declared that I am employed by a manufacturer whose
products may be in competition with the two discussed in this manuscript. This
association does not bias me in favor of either one over the other.