Review for 10.1186/1471-230X-10-76 (2010)

Reviewer's report
Title:Computer-aided recording of automatic endoscope washing and
disinfection processes as an integral part of medical documentation for quality
assurance purposes
Version: 1Date:4 March 2010
Reviewer: Lawrence Muscarella
Reviewer's report:
Lawrence F. Muscarella Ph.D.
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland, PA 18974 Tele: 215.364.8577
Fax: 215.364.7674
E-Mail: LFM@myendosite.com
March 2, 2010
Re: My review of the manuscript “Computer-aided recording of automatic
endoscope washing and disinfection processes as an integral part of medical
documentation for quality assurance purposes” (by: B. Krakamp, D. Emmerich,
T. Saers, A. Scheding, O.Kirschberg, S. Klein).
Initial comments:
1. The importance of quality assurance to thorough endoscope reprocessing,
patient safety, and the prevention of healthcare-acquired infections - a topic on
which this manuscript focuses - cannot be overstated.
2. This manuscript’s discussion about the type of data that can be communicated
from the automated endoscope reprocessor and archived into a secure database
is of general interest.
Discretionary revisions:
1. The authors are asked to note that endoscope reprocessing may be performed
manually, too, though admittedly it is very often performed using an automated
endoscope reprocessor. The authors are also asked to comment on whether the
discussed software program can be used as part of a complete quality assurance
program by an endoscopy unit that manually reprocesses endoscopes.
2. Though they state it meets international standards, the authors are asked to
comment on whether this software/computer program has been validated as
required by the FDA for use in the U.S. For example, would the authors’
computer program require a 510(k) clearance to be used on an automated
device currently used in the U.S. to reprocess endoscopes? And, if so, has this
computer program received a 510(k) clearance as an accessory to a device
(automated endoscope reprocessors) that themselves require 510(k) clearances
as class 2 devices?
3. The authors are asked to consider using the word “properly” instead of
“perfectly” to describe the goal of endoscope reprocessing – for example, instead
of stating “only perfect (sic) disinfected endoscopes are released for
examination,” consider stating instead “only properly disinfected endoscopes are
released for examination.”
4. The authors are also asked to comment on whether the discussed software
program is validated for use on any type of “PC” or Mac, or instead requires
some type of a computer server.
5. The authors might consider a title that better clarifies for the reader that the
manuscript focuses on the validation of a specific computer program designed by
the authors to monitor and document the automated reprocessing of endoscopes
using a washer-disinfector (or automated endoscope reprocessor).
Minor essential revisions:
1. The authors discuss that, for reasons of hygiene, “it is sensible to reprocess
medical products” – namely flexible endoscopes – once again if the instrument
has been stored for at least 8 days. The authors are asked to review an article I
published last month that provides important references that justify 5 to 7 days
(instead of 8 days) as the more appropriate number of “storage” days for
endoscopes. My article is available at:
www.myendosite.com/htmlsite/2009/endostore.pdf Please consider adding one
or more of the references listed at this link to support any claims provided in the
manuscript.
2. The authors are asked to consider adding to Table 1, under the heading of
“Device manager,” that this program also records, as discussed in the
manuscript’s text, the maintenance history and intervals, failures, and error
messages associated with the automated endoscope reprocessor.
3. The authors are asked to comment briefly on this software program’s use and
stored data as each may apply in the U.S. to: (1) patient privacy laws; and (2)
protection from computer or software viruses.
4. The authors are asked to better clarify for the reader any known limitations of
the software program.
Major compulsory revisions:
1. The authors are asked to place more focus on relevant design controls and to
discuss the protocols and the collected data used to ensure the validation and
verification of the computer program’s software and its compatibility with different
hardware interfaces (e.g., parallel port, serial port, Bluetooth, network interfaces)
used by marketed automated endoscope reprocessors. Are there any interfaces
that are not compatible with this computer program’s device manager? Are there
any types of computers on which this program cannot operate? Further, are there
any specific automated endoscope reprocessors on the U.S. or international
markets that are not compatible with (and have not been verified to work with)
this computer program?
2. The authors are asked to provide more clarity in the text to differentiate for the
reader the differences between the terms: “documentation system,” “computer
program,” “the reporting system,” and “quality system program” (see Table 1),
among other terms. Are these interchangeable terms or distinct entities? At times
I am confused by the meaning and use in the manuscript of each of these terms.
For example, is the “device manager” a component of the “reporting system”? Is
the “reporting system” the same as the “computer program”?
What’s next?
Based on my assessment of the validity of this manuscript, I advise the following:
> Accept after minor essential revisions (which the authors can be trusted to
make).
Level of interest?
> This is an article whose findings are important to those with closely related
research interests.
Quality of written English:
> I conclude that it needs some language corrections and/or clarifications before
being published.
Statistical review:
> No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I am employed by Custom Ultrasonics, Inc., a manufacturer of automated
endoscope reprocessors (e.g., washer-disinfectors). I am not associated in any
way (financial or otherwise) with the product discussed in this reviewed
manuscript, however, and I certainly would not expect to benefit or gain a
competitive edge in any way whatsoever (financial or otherwise) by this
manuscript’s publication, or by its rejection. Other than those disclosed herein, I
have no financial (or otherwise) competing interests.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
Declaration of competing interests:
I am employed by Custom Ultrasonics, Inc., a manufacturer of automated
endoscope reprocessors (e.g., washer-disinfectors). I am not associated in any
way (financial or otherwise) with the product discussed in this reviewed
manuscript, however, and I certainly would not expect to benefit or gain a
competitive edge in any way whatsoever (financial or otherwise) by this
manuscript’s publication, or by its rejection. Other than those disclosed herein, I
have no financial (or otherwise) competing interests.