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:25 March 2010
Reviewer: Ottmar Leiss
Reviewer's report:
Computer-aided recording of automatic endoscope washing and disinfection
processes
as an integral part of medical documentation for quality assurance purposes.
B. Krakamp, D. Emmerich, T. Saers, A. Scheding, O. Kirschberg, S. Klein
Major Compulsory Revisions:
1.
The meaning of the statement in the abstract ‘The program implements
international standards
for the monitoring of hygiene in endoscopes and the guidelines for the
reprocessing of
medical products.’ is not clear and is not discussed in the paper.
2.
Since the objective of the report is to monitor and document the automatic
reprocessing of
endoscopes and accessories in fully automatic washer-disinfectors it would be of
interest
whether this computer program can be connected with a sterilizer for
reprocessing biopsy
forceps or polypectomy loops.
3.
The results are obtained in four washer-disinfectors (two different machine
types). However,
the conclusion stressed that the documentation system can be used on any
washer-disinfector.
More details of the washer-disinfectors used should be given (Manufacturer ?
Date of release
on the market ? Washer-disinfectors designed for different disinfectants or only
for a special
disinfectant i.g. EAW? Single channel disinfection ? Are changes in reprocessing
cycles or
cleaning or disinfectant solutions automatically documented in the internal
documentation
system ? Which types of disinfectants are used in the tests?)
4.
Testing this documentation system in 6000 examinations ‘no apparent
deficiencies have been
reported’. That’s not sufficient !!! What is the benefit ? How many different
endoscopes are
tested ? Was the failure rate different for new endoscopes compared to
endoscopes 3-4 years
old ? How often an endoscope was not released because of prolonged storage ?
More details
of the results (examples of the documentation) would be helpful for
understanding the value
of this tool.
Minor Essential Revisions:
5.
The computer-aided documentations program only supports documentation of
the steps in the
washer-disinfector, not all the steps involved in cleaning and disinfection. The
preliminary
manual cleaning step is not automatically documented. However, this step is
essential
especially for reprocessing endoscopes in a washer-disinfector using
electrolyzed acidic water
(EAW).
6.
The meaning of ‘regular checking of successful hygiene’ (page 2) is not clear. In
reprocessing
flexible endoscopes a more careful discussion whether we should focus on
process quality (of
washer-disinfectors) or on outcome quality (regular microbiological surveillance
cultures) is
desirable.
7.
In the discussion on page 8 literature citations on the storage time of
reprocessed endoscopes
should be given.
Comments:
The authors described a new tool called device administrator for management of
reprocessing
medical devices, especially flexible endoscopes. In which situations is this tool
helpful ?
Firstly, for leaders of a large interdisciplinary endoscopy unit. Coordinating
reprocessing of
20 – 40 flexible endoscopes of gastroenterological, pulmonary, urological or
other units no
doubt, this computer program is very helpful to overview the reprocessing status
of the
different devices. Secondary, for quality managers in hospitals. A central
documentation for
reprocessing medical devices, not only flexible endoscopes, is essential in the
working-up of
outbreaks of nosocomial infections and / or in the defense of medicolegal claims.
Thirtly, for
hygienists involved in basic investigation addressing biofilm formation in flexible
endoscopes
under different conditions (different cleaning or disinfection solutions, different
temperatures,
..) (see Alfa MJ, Howie R, BMC Infectious Diseases 2009; 9:56). In this situation,
the tool is
helpful for statistical analysis of the different simulations. Fourtly, for hospital
managers
involved in equipment investigations. A manager responsible for investigations in
endoscopes
and washer-disinfectors for many hospitals is interested on data whether device
x1 from
manufacturer y1 using the reprocessing cycle z1 has a longer lifetime, lower
failure rate and
lower repair costs compared to device x2 from manufacturer y2 using the same
or an other
reprocessing cycle z2. Using the presented computer-aided device administrator
over 5 – 10
years and comparing the results of different hospitals a lot of economic data
become available
for investment decisions.
However, as a gastroenterologist working together with 4 colleagues in a small
gastrointestinal
endoscopy unit it is questionable whether this computer tool is really helpful in
practice.
In a small unit there is no problem to overview how many instruments are in the
cabinet, how
many are in use and how many are in the washer-disinfector for reprocessing.
The pool size of
flexible endoscopes or the overview over the device status (storage, in use,
reprocessing) is
not the problem; the problem is rather the manpower in the unit. For small
endoscopy unit it is
important whether the documentation of the sterilization of biopsy forceps or
polypectomy
loops could be integrated in the computer-aided documentation system.
However, the electronic
connection of the documentation of different types of washer-disinfectors with
different
types of office sterilizers to a central reprocessing documentation is not
addressed in the
presented paper. Without that the computer-aided device administrator is a tool
nice to have in
large endoscopy units but for the mass of smaller endoscopy units it is of rather
limited value.
To my knowledge no such computer-aided documentation system has been
published or is
available on the market. Accept after minor essential revisions.
Level of interest:
An article whose findings are important to those with closely related research
interests.
Quality of written English: Acceptable (however, I’m not a native speaker).
Statistical review: The manuscript does not need to be seen by a statistician.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
Declaration of competing interests:
I’m physician in internal medicine and gastroenterology (with additional
certification for
quality management in medicine) working in a small gastroenterology office. I’m
member of
the commission for hospital hygiene and infection prevention (KRINKO) at the
Robert Koch
institute, Berlin, leading the working group preparing the guidelines for
reprocessing flexible
endoscopes (published in 2002). I declare that I have no competing interests.
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:25 March 2010
Reviewer: Ottmar Leiss
Reviewer's report:
Computer-aided recording of automatic endoscope washing and disinfection
processes
as an integral part of medical documentation for quality assurance purposes.
B. Krakamp, D. Emmerich, T. Saers, A. Scheding, O. Kirschberg, S. Klein
Major Compulsory Revisions:
1.
The meaning of the statement in the abstract ‘The program implements
international standards
for the monitoring of hygiene in endoscopes and the guidelines for the
reprocessing of
medical products.’ is not clear and is not discussed in the paper.
2.
Since the objective of the report is to monitor and document the automatic
reprocessing of
endoscopes and accessories in fully automatic washer-disinfectors it would be of
interest
whether this computer program can be connected with a sterilizer for
reprocessing biopsy
forceps or polypectomy loops.
3.
The results are obtained in four washer-disinfectors (two different machine
types). However,
the conclusion stressed that the documentation system can be used on any
washer-disinfector.
More details of the washer-disinfectors used should be given (Manufacturer ?
Date of release
on the market ? Washer-disinfectors designed for different disinfectants or only
for a special
disinfectant i.g. EAW? Single channel disinfection ? Are changes in reprocessing
cycles or
cleaning or disinfectant solutions automatically documented in the internal
documentation
system ? Which types of disinfectants are used in the tests?)
4.
Testing this documentation system in 6000 examinations ‘no apparent
deficiencies have been
reported’. That’s not sufficient !!! What is the benefit ? How many different
endoscopes are
tested ? Was the failure rate different for new endoscopes compared to
endoscopes 3-4 years
old ? How often an endoscope was not released because of prolonged storage ?
More details
of the results (examples of the documentation) would be helpful for
understanding the value
of this tool.
Minor Essential Revisions:
5.
The computer-aided documentations program only supports documentation of
the steps in the
washer-disinfector, not all the steps involved in cleaning and disinfection. The
preliminary
manual cleaning step is not automatically documented. However, this step is
essential
especially for reprocessing endoscopes in a washer-disinfector using
electrolyzed acidic water
(EAW).
6.
The meaning of ‘regular checking of successful hygiene’ (page 2) is not clear. In
reprocessing
flexible endoscopes a more careful discussion whether we should focus on
process quality (of
washer-disinfectors) or on outcome quality (regular microbiological surveillance
cultures) is
desirable.
7.
In the discussion on page 8 literature citations on the storage time of
reprocessed endoscopes
should be given.
Comments:
The authors described a new tool called device administrator for management of
reprocessing
medical devices, especially flexible endoscopes. In which situations is this tool
helpful ?
Firstly, for leaders of a large interdisciplinary endoscopy unit. Coordinating
reprocessing of
20 – 40 flexible endoscopes of gastroenterological, pulmonary, urological or
other units no
doubt, this computer program is very helpful to overview the reprocessing status
of the
different devices. Secondary, for quality managers in hospitals. A central
documentation for
reprocessing medical devices, not only flexible endoscopes, is essential in the
working-up of
outbreaks of nosocomial infections and / or in the defense of medicolegal claims.
Thirtly, for
hygienists involved in basic investigation addressing biofilm formation in flexible
endoscopes
under different conditions (different cleaning or disinfection solutions, different
temperatures,
..) (see Alfa MJ, Howie R, BMC Infectious Diseases 2009; 9:56). In this situation,
the tool is
helpful for statistical analysis of the different simulations. Fourtly, for hospital
managers
involved in equipment investigations. A manager responsible for investigations in
endoscopes
and washer-disinfectors for many hospitals is interested on data whether device
x1 from
manufacturer y1 using the reprocessing cycle z1 has a longer lifetime, lower
failure rate and
lower repair costs compared to device x2 from manufacturer y2 using the same
or an other
reprocessing cycle z2. Using the presented computer-aided device administrator
over 5 – 10
years and comparing the results of different hospitals a lot of economic data
become available
for investment decisions.
However, as a gastroenterologist working together with 4 colleagues in a small
gastrointestinal
endoscopy unit it is questionable whether this computer tool is really helpful in
practice.
In a small unit there is no problem to overview how many instruments are in the
cabinet, how
many are in use and how many are in the washer-disinfector for reprocessing.
The pool size of
flexible endoscopes or the overview over the device status (storage, in use,
reprocessing) is
not the problem; the problem is rather the manpower in the unit. For small
endoscopy unit it is
important whether the documentation of the sterilization of biopsy forceps or
polypectomy
loops could be integrated in the computer-aided documentation system.
However, the electronic
connection of the documentation of different types of washer-disinfectors with
different
types of office sterilizers to a central reprocessing documentation is not
addressed in the
presented paper. Without that the computer-aided device administrator is a tool
nice to have in
large endoscopy units but for the mass of smaller endoscopy units it is of rather
limited value.
To my knowledge no such computer-aided documentation system has been
published or is
available on the market. Accept after minor essential revisions.
Level of interest:
An article whose findings are important to those with closely related research
interests.
Quality of written English: Acceptable (however, I’m not a native speaker).
Statistical review: The manuscript does not need to be seen by a statistician.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
Declaration of competing interests:
I’m physician in internal medicine and gastroenterology (with additional
certification for
quality management in medicine) working in a small gastroenterology office. I’m
member of
the commission for hospital hygiene and infection prevention (KRINKO) at the
Robert Koch
institute, Berlin, leading the working group preparing the guidelines for
reprocessing flexible
endoscopes (published in 2002). I declare that I have no competing interests.
Please review this paper.
user
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:25 March 2010
Reviewer: Ottmar Leiss
Reviewer's report:
Computer-aided recording of automatic endoscope washing and disinfection
processes
as an integral part of medical documentation for quality assurance purposes.
B. Krakamp, D. Emmerich, T. Saers, A. Scheding, O. Kirschberg, S. Klein
Major Compulsory Revisions:
1.
The meaning of the statement in the abstract ‘The program implements
international standards
for the monitoring of hygiene in endoscopes and the guidelines for the
reprocessing of
medical products.’ is not clear and is not discussed in the paper.
2.
Since the objective of the report is to monitor and document the automatic
reprocessing of
endoscopes and accessories in fully automatic washer-disinfectors it would be of
interest
whether this computer program can be connected with a sterilizer for
reprocessing biopsy
forceps or polypectomy loops.
3.
The results are obtained in four washer-disinfectors (two different machine
types). However,
the conclusion stressed that the documentation system can be used on any
washer-disinfector.
More details of the washer-disinfectors used should be given (Manufacturer ?
Date of release
on the market ? Washer-disinfectors designed for different disinfectants or only
for a special
disinfectant i.g. EAW? Single channel disinfection ? Are changes in reprocessing
cycles or
cleaning or disinfectant solutions automatically documented in the internal
documentation
system ? Which types of disinfectants are used in the tests?)
4.
Testing this documentation system in 6000 examinations ‘no apparent
deficiencies have been
reported’. That’s not sufficient !!! What is the benefit ? How many different
endoscopes are
tested ? Was the failure rate different for new endoscopes compared to
endoscopes 3-4 years
old ? How often an endoscope was not released because of prolonged storage ?
More details
of the results (examples of the documentation) would be helpful for
understanding the value
of this tool.
Minor Essential Revisions:
5.
The computer-aided documentations program only supports documentation of
the steps in the
washer-disinfector, not all the steps involved in cleaning and disinfection. The
preliminary
manual cleaning step is not automatically documented. However, this step is
essential
especially for reprocessing endoscopes in a washer-disinfector using
electrolyzed acidic water
(EAW).
6.
The meaning of ‘regular checking of successful hygiene’ (page 2) is not clear. In
reprocessing
flexible endoscopes a more careful discussion whether we should focus on
process quality (of
washer-disinfectors) or on outcome quality (regular microbiological surveillance
cultures) is
desirable.
7.
In the discussion on page 8 literature citations on the storage time of
reprocessed endoscopes
should be given.
Comments:
The authors described a new tool called device administrator for management of
reprocessing
medical devices, especially flexible endoscopes. In which situations is this tool
helpful ?
Firstly, for leaders of a large interdisciplinary endoscopy unit. Coordinating
reprocessing of
20 – 40 flexible endoscopes of gastroenterological, pulmonary, urological or
other units no
doubt, this computer program is very helpful to overview the reprocessing status
of the
different devices. Secondary, for quality managers in hospitals. A central
documentation for
reprocessing medical devices, not only flexible endoscopes, is essential in the
working-up of
outbreaks of nosocomial infections and / or in the defense of medicolegal claims.
Thirtly, for
hygienists involved in basic investigation addressing biofilm formation in flexible
endoscopes
under different conditions (different cleaning or disinfection solutions, different
temperatures,
..) (see Alfa MJ, Howie R, BMC Infectious Diseases 2009; 9:56). In this situation,
the tool is
helpful for statistical analysis of the different simulations. Fourtly, for hospital
managers
involved in equipment investigations. A manager responsible for investigations in
endoscopes
and washer-disinfectors for many hospitals is interested on data whether device
x1 from
manufacturer y1 using the reprocessing cycle z1 has a longer lifetime, lower
failure rate and
lower repair costs compared to device x2 from manufacturer y2 using the same
or an other
reprocessing cycle z2. Using the presented computer-aided device administrator
over 5 – 10
years and comparing the results of different hospitals a lot of economic data
become available
for investment decisions.
However, as a gastroenterologist working together with 4 colleagues in a small
gastrointestinal
endoscopy unit it is questionable whether this computer tool is really helpful in
practice.
In a small unit there is no problem to overview how many instruments are in the
cabinet, how
many are in use and how many are in the washer-disinfector for reprocessing.
The pool size of
flexible endoscopes or the overview over the device status (storage, in use,
reprocessing) is
not the problem; the problem is rather the manpower in the unit. For small
endoscopy unit it is
important whether the documentation of the sterilization of biopsy forceps or
polypectomy
loops could be integrated in the computer-aided documentation system.
However, the electronic
connection of the documentation of different types of washer-disinfectors with
different
types of office sterilizers to a central reprocessing documentation is not
addressed in the
presented paper. Without that the computer-aided device administrator is a tool
nice to have in
large endoscopy units but for the mass of smaller endoscopy units it is of rather
limited value.
To my knowledge no such computer-aided documentation system has been
published or is
available on the market. Accept after minor essential revisions.
Level of interest:
An article whose findings are important to those with closely related research
interests.
Quality of written English: Acceptable (however, I’m not a native speaker).
Statistical review: The manuscript does not need to be seen by a statistician.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
Declaration of competing interests:
I’m physician in internal medicine and gastroenterology (with additional
certification for
quality management in medicine) working in a small gastroenterology office. I’m
member of
the commission for hospital hygiene and infection prevention (KRINKO) at the
Robert Koch
institute, Berlin, leading the working group preparing the guidelines for
reprocessing flexible
endoscopes (published in 2002). I declare that I have no competing interests.
assistant