Cleaning and Disinfection - Flexible Endoscopes

Professional Standard Handbook
Cleaning and Disinfection
Flexible Endoscopes
Version 3.1, 2014
Published on behalf of:
Federation for Medical Technology
The Dutch Nurse Association: division Gastroenterology and Hepatology
Sterilization Association of the Netherlands
Dutch Society of Experts on Sterile Medical Devices
Dutch Society for Infection Prevention and Control in the Health Care Setting
PROFESSIONAL STANDARD
HANDBOOK
FLEXIBLE ENDOSCOPES
Cleaning and Disinfection
Published on behalf of:
SVN
V&VN-MDL
VDSMH
VHIG
NVKF
VZI
WIBAZ
by: the steering group for flexible endoscope cleaning and disinfection (SFERD)
version 3.1, 17 September 2014
The SFERD welcomes your comments on this document; please mail the response
form (appendix 20) to the SFERD secretary:
J.C. van Bergen Henegouw, j.vbergenhenegouw@hagaziekenhuis.nl
This document may be freely duplicated and distributed as long as the SFERD
is credited as author.
INTRODUCTION
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
INTRODUCTION
INTRODUCTION
version 3.1, 17 September 2014
The steering group for flexible endoscope cleaning and disinfection (SFERD) was set
up in 2006 as a collaboration between four professional bodies:
Sterilization Association of the Netherlands, SVN
Dutch Nurse Association; division Gastroenterology and Hepatology, V&VN-MDL
Dutch Society of Experts on Sterile Medical Devices, VDSMH
Dutch Society for Infection Prevention and Control in the Health Care setting,
VHIG
In 2009 this steering group published the first version of the flexible endoscope
cleaning and disinfection quality manual, in which existing legislation concerning the
cleaning and disinfection of flexible endoscopes was interpreted as a practical
standard.
The publication of this first version in 2009 led to more and stronger contacts with
other professional groups. This in turn has led to a positive contribution from various
scientific professional associations, the health care inspectorate, the infection
prevention working group, the NEN cleaning & disinfection working group and
particularly the technical professional bodies for healthcare:
Dutch Society for Medical Physics, NVKF
Dutch Society of Clinical Engineers, VZI
Taskgroup Instrumentation Management University Hospitals, WIBAZ
These technical professional bodies have come together in the Federation for Medical
Technology (Koepel MT) and have worked together as a member of the SFERD on
the quality manual version 2.0, 2010. When this version appeared it was widely
adopted as a standard for the field, as the following quotations bear out:
“The quality manual for cleaning and disinfection of endoscopes of the flexible
endoscope cleaning and disinfection steering group (SFERD) has been incorporated
into the NIAZ’s basic document collection.”
Ms
Beaard, NIAZ director
“The quality manual for cleaning and disinfection of endoscopes of the flexible
endoscope cleaning and disinfection steering group (SFERD) has been incorporated
into the HKZ standard for endoscopy.”
Ms K. vd
Haar, HKZ policy officer
“The quality manual for cleaning and disinfection of endoscopes of the flexible
endoscope cleaning and disinfection steering group (SFERD). I am very happy to see
that there is now a standard for the field which the Inspectorate is using as a
supervisory standard.”
Prof.dr. G. van der Wal, Inspector-general for healthcare, IGZ
In 2011 the SFERD was awarded the VHIG Infection Prevention Prize; this made it
possible to have the manual translated into English (version 2.1, 2011).
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3
INTRODUCTION
The SFERD hopes that with this update of the quality manual to version 3.0, 2013 that
the manual will lay more emphasis on day to day practice. The revision of section 10
(process control) will certainly make a contribution to this.
In 2014, the Foundation for Training in Infection Prevention (STIP,
www.STIPopleidingen.nl) sponsored SFERD with STIP’s annual charity fee. This fee
made it possible to publish this English version.
You are welcome to cast a critical eye and to carry on letting the SFERD know about
your remarks and observations, additions and new developments.
On behalf of all the members of SFERD,
Federation for Medical Technology
Martijn Franken, clinical physicist, Franciscus hospital, Roosendaal and Lievensberg
hospital, Bergen op Zoom
Sterilization Association of the Netherlands
Peter van Alphen, head of CSA Flevoziekenhuis, Almere
Angelique Fluitman, DSRD Scheper Bethesda Hospital, Hoogeveen and Emmen
Dutch Nurse Association; division Gastroenterology and Hepatology
Nel Blom, endoscopy specialist at St. Lucas Andreas hospital, Amsterdam
Dutch Society of Experts on Sterile Medical Devices
Carol te Beest, DSMH/DSRD Maasstad hospital, Rotterdam
John van Bergen Henegouw (secretary), DSMH/DSRD HagaZiekenhuis, Den Haag
Dutch Society for Infection Preventoeen and Control in the Health Care setting
Paul Steegh, DSRD Jeroen Bosch hospital, ’s-Hertogenbosch
Kees Ballemans (chair), DSRD University Medical Center, Utrecht
As well as the professional associations listed above involved in the SFERD, we
would like to thank the following associations and organisations for their critical review
of the draft version 3.0 of the manual:
• Dutch anaesthesiology association (NVA)
• Netherlands Society of Cardiology (NVvC)
• Dutch association for Internal Medicine (NIV)
• Dutch association for ear, nose and throat medicine and head and neck medicine
(KNO)
• Dutch association for pulmonary medicine and tuberculosis (NVALT)
• Dutch society for gastrointestinal and liver medicine (MDL)
• Radiological Society of the Netherlands (NVvR)
• Dutch association for radiotherapy and oncology (NVRO)
• Dutch urology association (NVU)
• Dutch association for medical microbiology (NVMM)
• Dutch association for technical facility management in health care (NVTG)
• National Institute for Public Health and the Environment (RIVM)
• Health care inspectorate (IGZ)
• Working party on Infection Prevention (WIP)
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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INTRODUCTION ............................................................................................................ 3
TABLE OF CONTENTS ................................................................................................. 5
DEFINITIONS ................................................................................................................. 7
ABBREVIATIONS .......................................................................................................... 9
DOCUMENT STRUCTURE.......................................................................................... 11
1.
LEADERSHIP: VISION AND ORGANISATION ................................................. 13
1.1
Introduction.................................................................................................. 13
1.2
Starting points ............................................................................................. 13
1.3
SFERD organisation and vision .................................................................. 14
2.
STRATEGY AND POLICY .................................................................................. 16
2.1
Organisation of cleaning & disinfection ....................................................... 16
2.2
Central versus decentralised organisation .................................................. 17
2.3
Quality system ............................................................................................. 18
3.
STAFF MANAGEMENT ...................................................................................... 19
3.1
Responsibilities and authority ..................................................................... 19
3.2
Training and education................................................................................ 21
4.
RESOURCE MANAGEMENT ............................................................................. 23
4.1
Construction and design requirements ....................................................... 23
4.2
Acquisition of endoscopes, endoscope disinfectors and accessories ........ 24
4.3
Package of requirements for endoscopes, endoscope disinfectors and
drying cabinets ............................................................................................................. 25
5.
PROCESS MANAGEMENT ................................................................................ 27
5.1
Primary process: cleaning, disinfecting and drying flexible endoscopes .... 27
5.2
Cleaning, disinfection and sterilisation of accessories ................................ 37
5.3
The installation of a endoscope disinfector ................................................. 38
5.4
Risk inventory and assessment .................................................................. 39
5.5
The traceability of endoscopes and patients............................................... 42
6.
ASSESSMENT BY CUSTOMERS ...................................................................... 44
6.1
Patient safety .............................................................................................. 44
6.2
Throughput/availability of endoscopes ........................................................ 44
7.
ASSESSMENT BY STAFF ................................................................................. 45
8.
ASSESSMENT BY SOCIETY ............................................................................. 46
8.1
Incident management.................................................................................. 46
8.2
Criteria for the start of an incident management procedure ....................... 47
8.3
Incident procedure stages ........................................................................... 48
8.4
Incident procedure stages: process description.......................................... 49
8.5
Damage to the image of the institution ....................................................... 51
9.
FINAL RESULTS................................................................................................. 52
10. PROCESS VERIFICATION ................................................................................. 53
10.1
Technical verification ................................................................................... 55
10.2
Functional tests and checks ........................................................................ 63
10.3
Microbial testing .......................................................................................... 65
10.4
Audit & Control ............................................................................................ 67
10.5
Release of the primary process .................................................................. 68
Appendix 1- Bibliography.............................................................................................. 71
Appendix 2 – Form for transport of a damaged or leaking endoscope ........................ 73
Appendix 3 – Sample decontamination declaration ..................................................... 74
Appendix 4 – Users maintenance of the endoscope WD............................................. 75
Appendix 5 – Release form for flexible endoscopy after maintenance ........................ 76
Appendix 6 – System specifications of the endoscope WD ......................................... 77
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TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS
Appendix 7 – Microbial quality ......................................................................................81
Appendix 8 – Flowchart flexible endoscope culture ...................................................84
Appendix 9 – Flowchart Final rinse water culture .......................................................85
Appendix 10 – Checklist positive cultures form endoscopes and/or WDs ...................86
Appendix 11 - Ninhydrin swab test ...............................................................................87
Appendix 12 – Hemoglobin swab test ..........................................................................88
Appendix 13 – Release form for flexible endoscopes ..................................................90
Appendix 14 – Schedule of requirements for washer-disinfector .................................91
Appendix 15 - Schedule of requirements for flexible endoscopes ...............................94
Appendix 16 - Schedule of requirements for drying cabinet .........................................96
Appendix 17 – Endoscope Cleaning & Disinfection Audit Form ...................................98
Appendix 18 – Endoscopy Department Audit Form ...................................................103
Appendix 19 - Endoscope technology & maintenance Audit Form ............................106
Appendix 20 – Response form SFERD handbook 3.1, 2014 .....................................109
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Adverse event
An adverse event is an unforeseen occurrence, or in other words a deviation from
protocols or operating instructions.
Compatibility
A combination of declarations concerning a medical resource to be reused, cleaning
materials and disinfectants and an automatic cleaning and disinfection device,
showing that the resources used in the cleaning and disinfection process can be used
effectively.
Contact
Person in the department in which the endoscope disinfector is in service with
authority to have repairs, maintenance, measurements, tests and checks conducted
and responsible for daily and weekly inspections, or head of department.
Drying cabinet
A drying cabinet is a cabinet in which a disinfected flexible endoscope can be hung up
wet and in which the endoscope’s channels can be connected so that HEPA filtered
air can be blown through. A drying cabinet dries the entire endoscope; the channels
and the exterior.
Endoscope disinfector
Machine designed to clean and disinfect flexible endoscopes using an automatic
process.
Flexible endoscope
Medical device (with flexible shaft) used to view the interiors of body cavities for
diagnostic purposes and/or to carry out therapeutic treatment.
Incident
A incident is any adverse event which leads to (possible) injury to a patient or staff.
Log
Digital (or written) document in which all relevant data on inspections, maintenance,
breakdowns and use is to be entered and retained.
Maintenance
All measures and preventive replacement of components specified by the
manufacturer in the maintenance schedule to enable the endoscope disinfector to be
used safely.
Manufacturer
The person or corporate body or the agent thereof, who:
1°. is responsible for the design, the manufacturing, the packaging and the labelling of
a medical device with the intention of marketing it under their own name, regardless of
whether these activities are carried out by the same party or under its responsible by a
third party; or
2°. which assembles, packages, handles, renovates or labels one or more
prefabricated products, or repurposes such products as medical devices with the
intention of marketing them under their own name.
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DEFINITIONS
DEFINITIONS
DEFINITIONS
Owner
Board of directors or body responsible for the management of the institution, its
representative(s), agent(s) and successor(s) that hold or own the endoscope
disinfector.
Release, functional
A device is functionally released for use when following technical release the party
responsible for it, in this manual the DSRD, considers it also to be functional for
working in a safe and appropriate manner.
Release, technical
A device is technically released when the responsible department, in this manual
assumed to be medical technology/clinical physics, has given a technical release for
the device to be used. In many cases a functional release is still required after this
step.
Release, microbiological
A device (a flexible endoscope, endoscope disinfector or drying cabinet) is
microbiologically released for use when the party responsible for it, in this manual the
doctor/microbiologist, considers it to be in a condition for working in a safe and
appropriate manner. In many cases the microbiological release forms part of the
functional release.
Repair
Any work carried out to rectify a fault storing in the endoscope disinfector.
Storage cabinet
A storage cabinet is an enclosed dust-free cabinet, with or without overpressure at
room temperature, inside which a dried flexible endoscope is stored. The difference
between a drying cabinet and a storage cabinet is that in a storage cabinet the
cannels of the endoscope cannot be connected.
Supplier
Any natural person or corporate body authorised by the manufacturer to supply, install
and maintain endoscope disinfectors.
User
Trained member of staff authorised to use an endoscope disinfector.
Verification
Verification is the evaluation of the results of measurements, tests and checks carried
out over a given period in order to ensure that the endoscope disinfector still complies
with the specifications drawn up by the manufacturer. On the basis of the
specifications the manufacturer has certified that the endoscope disinfector meets the
basic requirements of the Medical Devices Decree. These specifications are the
starting point for all subsequent measurements, tests and checks.
The results of the measurements and the procedures followed are tested/evaluated
using the standards and instructions in this manual and set out in a report together
with the underlying data (test reports, measurements, declarations, etc.).
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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ARBO
CSA
CSD
DSMH
DSRD
IGZ
INK
MT/KF
NIAZ
PDCA
SFERD
disinfection
THT
VMS
VWS
WIP
ABBREVIATIONS
ABBREVIATIONS
Working conditions (health and safety)
Central Sterilisation Section
Central Disinfection Section
Expert in sterile medical devices
Expert in cleaning and disinfection of scopes
Health care inspectorate
Dutch quality institute
Medical technology/clinical physics
Dutch institute for accreditation in healthcare institutions
Plan-Do-Check-Act
Steering group for flexible endoscope cleaning and
Usable at least until
Safety management system
Ministry for public health, welfare and sport
Workingparty on infection prevention
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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1
The INK model is a useful tool for healthcare institutions and professionals and is
enjoying increasing popularity in healthcare. The model offers a structure within which
to combine the interests of the patient with organisational goals in a balanced manner.
The model also appears to work very well as a means of communication between
management board, care professionals, managers, heads of department and staff
because of the simple methodology and division into 9 fields and the improvement
cycle; see the figure below:
It distinguishes between five interconnected “organisational fields”:
PLAN:
Leadership
Strategy and policy
DO:
Staff
Resources
Processes
Connection to these are five
defined result fields:
CHECK:
Assessment by customers
Assessment by staff
Assessment by society
End results
Figure 1 – the INK model with the Plan-Do-Check-Act cycle,
as applied in this SFERD manual
Testing and improving processes
is shown in the final field:
ACT:
Learning and improving
The SFERD is grateful to have been able to make use of this model in its attempts to
develop a guaranteed quality system. The PDCA cycle from the INK management
model is expressed in full across the sections as follows:
PLAN:
section 1
Leadership : Vision and organisation
section 2
Strategy and policy
DO:
section 3
Management of Staff
section 4
Management of resources
section 5
Management of processes
CHECK:
section 6
Assessment by customers
section 7
Assessment by staff
section 8
Assessment by society
section 9
End results
ACT:
section 10
Process control
1
The INK is an independent foundation established in 1991 at the initiative of the Ministry of economic
affairs under the name Instituut Nederlandse Kwaliteit
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DOCUMENT
STRUCTURE
DOCUMENT STRUCTURE
DOCUMENT
STRUCTURE
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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LEADERSHIP: VISION AND
ORGANISATION
1.1
Introduction
Flexible endoscopes are used for diagnostic and therapeutic purposes. Because the
same endoscopes are used to treat different patients, it is important that cleaning,
disinfection and sterilisation take place appropriately. Inadequate cleaning and
disinfection has adverse consequences such as:
Transmission of micro-organisms between patients
Endoscopy-related transmission of Gram-negative bacteria, mycobacteria,
and fungi have frequently been described in the literature. Nor can the
transmission of hepatitis B and C and HIV be excluded in the event of
deficient cleaning and disinfection of endoscopes [ref 31-35].
Incorrect diagnosis
As well as the infection risk for patients, there is also a danger of incorrect
diagnosis, with an inappropriate (antibiotic) treatment as a result. Patient
material, in the form of fibres, can remain behind if endoscopes are
inadequately cleaned and disinfected. This patient material can lead to a
mistaken diagnosis during the diagnostic investigation of a subsequent
patient. Alongside incorrect diagnosis with respect to mycobacteria for
example, this could also concern malignant cells [ref 7-9, 36-38].
In several Dutch hospitals in recent years, adverse events have occurred involving
flexible endoscopes which have caused hundreds of patients to be recalled to be
tested for HBV, HCV and HIV. The Healthcare Inspectorate (IGZ) has repeatedly
made the hospitals aware of their responsibilities [ref 6].
The goal of the Flexible Endoscope Cleaning and Disinfection Steering Group
(SFERD) includes the development of this flexible endoscope quality manual in which
the existing regulations for the cleaning and disinfection of flexible endoscopes is
translated into a practical standard text. It includes a verification and release
procedure, a complaints and recall procedure, and an audit and control system.
1.2
Starting points
Primum non nocere (first do no harm): with this memorable statement the medical
world declares that we wish to cause our patients no harm. This means that we
must avoid the occurrence of any exogenous contamination by micro-organisms
during diagnosis or treatment using a flexible endoscope.
In its reports the IGZ has already drawn attention to omissions in the cleaning and
disinfection of flexible endoscopes [ref 3,4,47]. The IGZ here refers to compliance
with the directive ‘Reiniging en desinfectie van endoscopen’ issued by the
infection prevention working party (WIP), the first version of which dates from
1992 and the current version from 2009 [ref 5].
In 2007 the inspector-general for health care Gerrit van der Wal presented the
safety programme ‘Prevent harm, work safely’ [ref 16] to the minister for public
health, welfare and sport (VWS) Ab Klink. This safety programme proposed the
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LEADERSHIP: VISION
AND ORGANISATION
1.
LEADERSHIP: VISION
AND ORGANISATION
introduction of a Safety Management System (SMS) from 1 January 2008 and
began with the reduction of hospital infections. The core of an SMS consists in a
risk analysis, a system for the (safe) reporting of adverse events, a method for
incident analysis and a system for managing the resulting recommendations and
measures for improvement. The introduction of this system within the cleaning
and disinfection of flexible endoscopes will have a positive impact on patient
safety.
In 2012 the IGZ published its assessment framework for the oversight of safety in
the cleaning and disinfection of flexible scopes, using the SFERD quality manual
as a reference [ref 45]. In the same year the NVZ and the NFU published an
‘agreement on the safe use of medical technology in the hospital’ which explicitly
stated that the hospital must have a procedure for the efficient cleaning,
disinfection, sterilisation and storage of medical equipment [ref 48].
In a European context, attention was paid to ensuring the quality of endoscope
disinfectors in the form of the directive EN-ISO-15883 [ref 10]. This directive
establishes verification tests to obtain assurance as to the technical specifications.
Parts 1, 4 and 5 of EN 15883 summarise the test programme for endoscope
disinfectors.
1.3
SFERD organisation and vision
The SFERD is a steering group with representatives from the following professional
associations: SVN, V&VN-MDL, VDSMH, VHIG and Koepel MT (NVKF,VZI and
WIBAZ).
The SFERD seeks to issue an updated version of the SFERD quality manual which
will be valid for three years. In the future the SFERD will ensure that relevant
developments in the cleaning and disinfection of flexible endoscopes will be
incorporated into new versions of this manual.
The SFERD has focused on current legislation and regulation. The starting point,
therefore, has been that the content of this quality manual must not conflict with the
existing guidelines. Nonetheless, there are areas where the vision of the SFERD does
not entirely correspond with that of the guidelines mentioned above.
In the view of the SFERD, mechanical cleaning and disinfection should be the first if
not the only choice for all flexible endoscopes. Mechanical disinfection is a
reproducible method of disinfection that ensures tracking and tracing. Manual
disinfection should only be seen as an emergency procedure for endoscopes without
channels.
The SFERD emphasises that endoscope disinfectors should not be used for other
medical instruments for which the supplier of the endoscope disinfector has provided
no compatibility declaration. This means that rigid endoscopes that are used in
naturally-non-sterile body cavities can be disinfected in the endoscope disinfector only
if the supplier so indicates. If single-use instruments become available for endoscopes
or probes, these should be preferred.
The SFERD fully concurs with the IGZ’s assumption that the cleaning and disinfection
of endoscopes should be carried out by qualified personnel. This is a matter of patient
safety in line with the Healthcare Facilities Quality Act [ref 40]. The feasibility of this
goal will be enhanced if cleaning and disinfection is centralised as much as possible,
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Despite the reliance on evidence-based guidelines, the SFERD concludes that the
advice in this manual is mainly based on best practice and common sense. The
SFERD also notes that the process of cleaning and disinfecting flexible endoscopes
still offers many challenges for research and publications.
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LEADERSHIP: VISION
AND ORGANISATION
so that these activities are carried out by as restricted a group as possible. In order to
train this group adequately, the SFERD calls upon professional associations to
develop appropriate training courses.
STRATEGY AND
POLICY
2.
STRATEGY AND POLICY
2.1
Organisation of cleaning & disinfection
Safety management is only successful if responsibilities are clearly allocated. Both the
VMS report and the IGZ reports mentioned above state as a condition that
responsibilities must be clearly defined, explicitly mentioning the commitment of
executive committees or boards. The involvement of all healthcare providers and
medical specialists is also crucial to the successful implementation of the SMS. The
IGZ recommends the appointment of an expert on endoscope cleaning and
disinfection to ensure a successful management plan [ref 4]. In practice, this
responsibility is assumed by infection prevention experts, experts in sterile medical
equipment, or the heads of the central sterilization department, the endoscopy
department or the medical technology/clinical physics department.
The Dutch Care Institutions Quality Act states that the executive committee or board is
at all times responsible for the quality and continuity of operational management.
Operational responsibility is delegated at a managerial level to the organisational
managers or management teams appointed for the purpose. These might be
management teams from decentralised endoscope disinfecting and/or using
departments. If an organisation has opted for centralised endoscope disinfection, the
management may be part of the central sterilisation department or of a service
company (support services). Hybrid approaches with precleaning at an outpatient
department, followed by the appropriate logistics and central mechanical disinfection
with the input of expert CSA employees, provide a safe structure for the cleaning and
disinfection of endoscopes. As a result of outsourcing, responsibility for the
disinfection of endoscopes can even be carried out entirely outside the organisation.
However the process is organised, measures for documentation, process quality,
tracking and tracing should be appropriately set up and periodically audited.
In the interest of the patient, organisational managers and professionals in
departments which use or disinfect endoscopes must ensure the quality of care at
their respective operational and medical levels when using medical equipment and
must prevent inexpert use.
The medical technology/clinical physics department monitors the life cycle of medical
equipment. The department also provides support and advice regarding the quality
and safety of medical equipment from a technical point of view.
The hygiene and infection prevention department contributes to good-quality patient
care with its expertise in on cleaning and disinfecting, providing advice spntaneously
and on request.
The cleaning and disinfection expert monitors operational conditions and procedures
for the use of endoscopes, based on laws and guidelines. He also highlights
possibilities for the improvement of patient care on behalf of the executive committee
or board of the institution or its delegate. On acquisition of endoscopes, cleaning and
disinfection equipment and process chemicals, the cleaning and disinfection expert
checks the compatibility declarations with suppliers on behalf of the organization in
compliance with EN-ISO 15883.
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2.2
Central versus decentralised organisation
SCENARIO 1 - Central treatment areas and cleaning/disinfection
Endoscopy treatment areas of various specialisms adjacent to (or in the vicinity of) the
cleaning and disinfection unit.
Advantage
Spatial facilities and expertise are better used
as the activities are carried out by a smaller
group
Personnel and equipment can be used more
efficiently. Stocks of materials can be reduced
Disadvantage
Difficult to set up in existing buildings
Depending on the location in the hospital,
additional transport costs and logistics
problems
More uniformity
Quality assurance is more easily controlled, so
there are fewer patient risks
N.B. Consultations regarding facilities are necessary between the various user
specialisms.
SCENARIO 2 - Central cleaning/disinfection
Endoscopy treatment areas at a distance from the cleaning and disinfection unit.
Advantage
Spatial facilities and expertise are better used
as the activities are carried out by a smaller
group
Personnel and equipment can be used more
efficiently. Stocks of materials can be reduced
More uniformity
Disadvantage
Additional logistics require transport and
staff
More flexible endoscopes may be
necessary
Quality assurance is more easily controlled, so
there are fewer patient risks
Version 3.1, 2014
17
STRATEGY AND POLICY
For the proper cleaning and disinfection of flexible endoscopes, the appropriate spatial
facilities and equipment must be provided, and staff must have expertise in the
cleaning and disinfection of endoscopes. The scope and design of the cleaning and
disinfecting area should maintain a clear physical separation between the clean and
contaminated areas. This being the case, a central cleaning and disinfection area is
preferred to a decentralised area.
STRATEGY AND
POLICY
SCENARIO 3 - Decentralised cleaning/disinfection
A cleaning/disinfection unit per one or several endoscopy treatment areas
Advantage
Disadvantage
Risk of limited staff knowledge and
experience
Very short logistics chain, fast throughput and
little transport required
Inefficient use of endoscopes
Inefficient use of endoscope disinfector and
staff.
Absence of hospital-wide uniformity
Quality assurance and documentation
management are more difficult
Recommendations
From the point of view of patient safety, quality assurance, the better use of spatial
facilities and the expertise of cleaning and disinfection staff, preference is for the
central (organisation of) endoscope cleaning and disinfection. This ensures better
allocation of responsibilities, clearer logistics and processes that can be planned.
In its 2004 report the IGZ stated that the hospitals it visited where disinfection took
place centrally saw clear benefits in centralisation, including
• better spatial facilities;
• activities carried out by a smaller group, so that better use is made of expertise.
2.3
Quality system
The process of cleaning & disinfecting flexible endoscopes should be embedded in the
hospital or departmental quality system. Guaranteeing the quality of this process
should be based on a quality philosophy and quality circles (Plan-Do-Check-Actcycles). The performance of controls, both during the acquisition and installation of
equipment and during the cleaning and disinfection process itself, should be tested by
frequent checks and audits. Documents recorded in a document management system
should carry the usual management data such as creation date, validity, author,
authoriser, etc. It is essential that roles are properly allocated between the staff
responsible. Documents for procedures with the same equipment used in different
departments must carry identical instructions (standardisation).
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STAFF MANAGEMENT
3.1
Responsibilities and authority
In an organisation where staff work with flexible endoscopes, responsibilities and
authority must be established in respect of the cleaning and disinfection process.
Every organisation will do this in a way which reflects its own management model.
Final responsibility for policy on flexible endoscopes rests with the management
committee or the board, which, according to the advice of the IGZ, should ensure a
clear allocation of responsibilities for the cleaning and disinfection process. The IGZ
recommends that a flexible endoscope disinfection expert should be appointed. For
the proper performance of his tasks, this officer needs the appropriate authority, for
example the powers to halt processes. This expert is not a part of the management
hierarchy but has an independent position vis-à-vis the departments working with
flexible endoscopes. The expert’s responsibilities can be further described as follows.
The expert in the cleaning and disinfection of endoscopes
• is responsible for testing, guaranteeing and assessing process quality via internal
audits;
• is responsible for the quality of the suggestions for improvement that arise from
the audit;
• ensures that changes in policy are reflected in the procedures and operating
instructions;
• is responsible for reporting and convening the policy team in the event of any
adverse events involving endoscopes where patient safety is under threat;
• has shared responsibility for the acquisition of flexible endoscopes and
equipment;
• establishes the verification plan in consultation with the medical technology /
clinical physics department and the supplier;
• has final responsibility for the functional release of the endoscope disinfector, the
drying cabinet and flexible endoscope after acquisition, installation and
maintenance;
• is empowered to halt the cleaning and disinfection in the event of any doubt
regarding the effectiveness and reproducibility of the processes.
Cleaning and disinfection department manager
• is responsible for the quality of processes for the cleaning, disinfection and
storage of flexible endoscopes;
• is responsible for the introduction of new equipment;
• is responsible for providing training or retraining, and for keeping the knowledge of
staff up to date;
• is responsible for reporting and documenting faults;
• manages the quality documents;
• is responsible for the induction and support of new staff;
• is responsible for ensuring that he or she is appropriately informed regarding
current procedures for the cleaning and disinfection of endoscopes and acts
accordingly;
• reports adverse events/faults to the cleaning and disinfection expert;
• is responsible for the exclusive use of approved equipment; in the event of any
doubt as to the technical or functional status of equipment it must not be used.
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3.
STAFF MANAGEMENT
Medical specialist / endoscopist
• is responsible for ensuring that he or she is appropriately informed regarding
current procedures for endoscopy and acts accordingly;
• should report suspected abnormalities or failure of current procedures to the
department manager;
• is responsible for the exclusive use of functioning equipment; in the event of any
doubt as to the technical or functional status of equipment it must not be used and
must be reported to the department manager;
• is jointly responsible for the risk assessment of disorders as a consequence of
adverse events.
Medical practitioner - microbiologist
• is responsible for the proper processing of microbiological cultures of rinse water
and the endoscope;
• is responsible for interpreting the results of microbiological tests;
• is jointly responsible for the risk assessment of disorders as a consequence of
adverse events.
2
Disinfection or Endoscopy assistant
• is responsible for conducting current procedures for the cleaning and disinfection
of flexible endoscopes, the endoscope disinfector, drying cabinet and associated
equipment;
• is responsible for maintaining logbooks and checklists regarding the use of flexible
endoscopes and associated equipment;
• is aware of the procedure in the event of faults or failure of current procedures;
• is responsible for the registration of patient, endoscope and endoscope disinfector
data (patient tracking system).
Medical technology/clinical physics department staff member
• is responsible for ensuring the quality and safety of medical equipment;
• is responsible for conducting current procedures for the maintenance and repair of
flexible endoscopes and associated equipment including carrying out the
verification plan;
• is responsible for recording malfunctions, repairs and maintenance of flexible
endoscopes, loaned equipment and related items;
• has shared responsibility for the acquisition of new equipment for the cleaning and
disinfection of flexible endoscopes;
• reports adverse events/faults to the cleaning and disinfection expert;
• is responsible for the release of the endoscope disinfector and drying cabinet after
maintenance and technical verification (technical release);
• is responsible for the installation, transfer and acceptance of the equipment.
Infection prevention expert
• takes part in audits of the cleaning and disinfection of endoscopes;
• provides advice and support in the development of hygiene procedures;
• provides advice in the event of adverse events;
• advises on the acquisition of cleaning substances and disinfectants for the
cleaning & disinfection of flexible endoscopes.
2
By endoscopy assistant we mean any assistant working in departments using endoscopes: GE, Urology,
Lungs, and ENT It is recommended that a specially qualified expert be appointed for disinfection.
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3.2
Training and education
Because the same endoscopes are used to treat different patients, it is important that
cleaning and disinfection are carried out in a responsible manner. The quality of this
cleaning and disinfection is largely determined by people. Staff should therefore be
able to perform all these tasks appropriately. The aim of the training given to these
employees is provide them with sufficient knowledge for the appropriate performance
of their duties. Managers should be aware which staff members have had sufficient
training. In the absence of relevant training courses offered by third parties, the
organisation itself should provide training for staff.
Starting point
The training required by staff involved in cleaning and disinfection should be at least at
intermediate vocational training level 3.
Subsequent training
To familiarise employees with the knowledge and skills required for cleaning and
disinfection, and to maintain this level of knowledge, the minimum requirements are as
follows:
New staff induction programme
Every new employee follows an induction programme which includes reading through
all the procedures, studying the instructions for the use of the equipment used,
cleaning and disinfecting endoscopes, handling equipment, reporting defects and
working safely with materials. During this period, the employee is supported by a
mentor who will monitor progress by means of part-qualification lists. After all aspects
of the induction programme have been approved by the department head, the new
employee may work independently.
Maintaining employee skills
Staff must maintain their skills and expertise in the field of cleaning and disinfection.
To do so they should have regular practice in carrying out these processes, and
should attend internal or external courses in the event of developments in areas such
as:
• relevant legislation
• cleaning methods and machines;
• cleaning and disinfection materials;
• health and safety and environmental legislation.
A copy of the attendance certificate is kept on the employee’s HR file.
Brief skills description
• vocational training certificate or equivalent level (level 3 apprenticeship training)
• fluent written and spoken Dutch, able to read and interpret instructions;
• knowledge of the contents of protocols and instructions;
• applied knowledge of and insight into the activities and practices of other
departments and knowledge of the function of the flexible endoscopes used there;
• affinity with hygiene, technology and protocol-based approaches to work;
• applied knowledge of computerisation and automation.
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STAFF MANAGEMENT
Purchaser
• coordinates commercial activities related to the acquisition of flexible endoscopes,
endoscope disinfectors, chemicals, drying cabinets and associated flexible
endoscope equipment.
STAFF MANAGEMENT
Educational requirements of the cleaning and disinfection expert.
• can work and think at at least university level + appropriate training
Brief skills description
• an affinity with technology;
• knowledge of process management;
• knowledge of medical microbiology;
• knowledge of quality systems and the ability to apply them;
• able to transfer knowledge;
• alert to risks to patient safety;
• able to conduct risk assessments and act decisively;
• prepared follow internal and external courses in:
o cleaning methods and machines;
o cleaning and disinfection materials;
o relevant legislation;
o quality systems;
o safety, working conditions & environment;
• prepared to enter into peer learning and review with other cleaning and
disinfection experts.
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RESOURCE MANAGEMENT
4.1
Construction and design requirements
A prerequisite for satisfactory cleaning and disinfection of endoscopes is that the used
endoscope must be routed so as to prevent any possibility of soiling of the cleaned
and disinfected endoscope with microbiologically contaminated material (used
endoscopes and accessories). This goal should be preferably be achieved by the
physical separation of work activities. If circumstances do not permit this, then work
carried out in the same space should be performed in a logical sequence to avoid
contact between clean and soiled material. The size and design of the
cleaning/disinfection space should be appropriate for this principle to be applied. To
achieve this, the following construction and design requirements must be met.
Construction aspect
Requirements/standards
Waste
In accordance with hospital environment plan, enough space for
separated waste
Disposal of disinfectants
In accordance with hazardous materials management
plan/environmental permit. See also the safety data sheet for the
chemicals
Automatic sliding doors preferred. Alternatively, foot operated
opening/closing. Windows compliant with labour law.
Compliant with NEN 1010, class 0 (technical quality requirements) [ref
14] of IEC 61010-2-040 [ref 46]
Air conditioning can be installed in accordance with the “Central
sterilisation section building standards” [ref 12]
Washer-disinfector extraction system, as per manufacturer’s
recommendations.
Splashing from preliminary hand cleaning must not contaminate clean
endoscopes.
Doors and windows
Electricity
Air conditioning
Receiving area for soiled
endoscopes
Enough space to take in and temporarily store soiled endoscopes
including their means of transport
Supplies storage for the
chemicals section
Liquids in drip tray, cleaning and disinfecting materias as required under
labour law and by environmental permit, see also the safety data sheets
for the materials
Ceiling
Ceiling in dust-free, moisture resistant material with adequate technical
space above ceiling
Floor area large enough to allow separate spaces for clean and soiled
goods flows
Spatial separation
Future
Take account of future developments in technology, data processing,
equipment required and possible expansion
Distribution area for clean
endoscopes
Lighting
Enough space to store and distribute clean endoscopes including their
means of transport (option: pass-through cabinet in the wall)
In line with standards, no areas in shadow
Wall and floor covering
Smooth finished, shock-resistant and easy to clean, resistant against
cleaning agents and disinfectants. Floor must not become slippery when
wet
Water from the used equipment must not be able to return into the water
supply. The water quality required depends on the type of disinfector
and the cleaning and disinfection agent and will be be specified by the
supplier. Take account of space for any water filters required.
Water
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Spatial design aspect
Requirements/standards
General
Facility to install emergency alarm.
Administrative workstations
If a PC is used, washable keyboard. Network connection and good lighting.
Equipment
Should be marked clearly (e.g. a printed sticker) with information for users
and technicians stating the time limits within which the equipment can be
used in view of its maintenance and verification status.
Health and safety
Construction and design is consistent with health and safety policy. As a
minimum there must be an eyebath and provision to protect staff from
splashing.
Drying and storage cabinets
Space separated from work on soiled material. Pass-through cabinets
should be considered. Utliities: HEPA filtered air, electricity, data
processing.
Endoscope disinfector
Enough space for number required, installation, loading/unloading,
operation, maintenance and repairs. Pass-through equipment should be
considered. Utliities: compressed air, water, electricity, suction, data, sewer
connection
On “dirty” work side:
- washstand with foot/elbow operated tap
- elbow-operated soap and hand cleanser dispensers
- hand towel dispenser
On “clean” work side:
-elbow-operated hand cleanser dispenser.
Close to sink but located such that no there can be no contact between
moisture and the internals of the (electric) leakage tester
Requirement depending on centralised or decentralised working.
Preferably mechanised Utliities for mechanised cleaning and disinfection:
compressed air, water, electricity, suction, data and sewer connection
Hand hygiene
Leakage tester
Carrying bins and means of
transport for cleaning and
disinfection products
Clean/dirty transport
Requirement depending on centralised or decentralised working.
Make a clear spatial separation between clean and dirty transport
Sinks and worktops
Sink (in easily cleaned material) with rounded corners, fitted with spray
head. Size consistent with endoscope length. For the sake of
reproduceability, automatic dosaging is recommended.
Dirty worktop, adequate size for the work to be carried out. Smooth
waterproof finish without seams. Rear wall of worktop smooth and easily
cleaned, seamlessly attached to worktop.
Storage space for materials required for cleaning by hand
Clean worktop, spatially separated from dirty worktop, including compressed
air pistol or other provision for cleaning out canals.
Storage space for clean endoscope accessories.
Consider high-low worktops (health and safety)
4.2
Acquisition of endoscopes, endoscope
disinfectors and accessories
The flow chart for the acquisition and replacement of equipment (figure 2) broadly
outlines the cycle of acquisition and/or replacement for endoscopes, endoscope
disinfectors and drying cabinets. The flow chart can used be as a guide to involve the
relevant disciplines within the hospital in the final choice of equipment. The structure
depends on the organisation.
Within a particular institution, when a given type of endoscope disinfector is used for
3
scope cleaning and disinfection, it is preferable that the same cleaning agents and
disinfectants are used for the different phases of cleaning (by hand and/or
mechanised) and disinfection (standardisation).
3
Where all endoscopes are suitably compatible with the same chemicals.
24
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4.3
The package of requirements is a verification tool for market research for purchasing
and is set out as a checklist, split into the following main groups of requirements:
-
Legal
Verification
Health, safety and environment
Technical and technological
Process
Cleaning and disinfection
-
User-friendliness
Traceability and recording
Installation conditions
Maintenance and service
Support/training
These primary groups are made up of subgroups for which the supplier should
indicate yes or no to show whether the specified criterion is met. It is also possible to
add remarks and reference can be made to attached documents.
The package of requirements covers both statutory requirements and points for
attention drawn up by the SFERD. It is the responsibility of hospital’s working party to
set a value for the points for attention or to seek clarification or other information.
A preliminary risk assessment, as recommended by bodies including the NVKF [ref
29], is necessary in order to be able to determine what points will require for attention
in the follow-up to the acquisition and what specific input is required from officials.
The appendices give examples for programmes of requirements. Programmes of
requirements cannot be copied and must be rewritten to suit the situation and the
preferences of the hospital. The documents in the appendices can be used as a
starting point.
See appendix 14
See appendix 15
See appendix 16
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for flexible endoscope package of requirements
for drying cabinet package of requirements
25
RESOURCE
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Package of requirements for endoscopes,
endoscope disinfectors and drying cabinets
RESOURCE
MANAGEMENT
Figure 2 - Flow chart for acquisition/replacement of endoscope, endoscope disinfector
and/or drying cabinet (and any other equipment)
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PROCESS MANAGEMENT
5.1
Primary process: cleaning, disinfecting and
drying flexible endoscopes
Processes are the basis of every organisation. A process sets out the sequence and
interactions of a series of activities which have to be carried out during a process.
Having a clear overview of risks allows them to be minimised and processes can be
organised efficiently and improved.
Risk management is used to optimise patient safety. This means that the risks which
stem from human, technical and/or organisational inadequacies in the process of
providing a service are as far as possible eliminated.
The different stages of the process are described in the primary process flow chart
(figure 3). The risks are shown in a risk table (paragraphs 5.4 and 8.2). This provides
a clear overview for all those involved. The management measures for the most
serious risks are described.
This section describes the following stages of the process:
STEP 1
STEP 2
STEP 3
STEP 4
STEP 5
STEP 6
STEP 7
STEP 8
STEP 9
STEP 10
STEP 11
STEP 12
STEP 13
STEP 14
STEP 15
STEP 16
STEP 17
Making the endoscope ready for use
Transport of disinfected (dry) endoscope
Initial cleaning by user in the treatment room
Transport of used endoscope
Preparation, cleaning and disinfection of the endoscope
Testing the endoscope for leaks
Operating a defective endoscope
Preliminary hand cleaning of the endoscope
Mechanised cleaning and disinfection of the endoscope
Release of the flexible endoscope following disinfection
Flexible endoscope drying process
Cleaning and disinfecting outside normal working hours
Loaning out flexible endoscopes and/or accessories
Variations to primary process for endoscopes without channels
Replacing cleaning materials and disinfectants
Self-disinfection of endoscope disinfector
User maintenance of endoscope disinfector
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5.
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STEP 1
Get released endoscope from drying cabinet
STEP 2
Transport of disinfected (dry) endoscope
Registration of specialist,
patient and endoscope ID
Performing endoscopy
STEP 3
After use, flush the channels of the endoscope and wipe off
the exterior
STEP 4
Transport of used endoscope, delivery of the used
endoscope en information in disinfection room
STEP 5
Preparations for cleaning and disinfecting endoscope.
Disassemble and perform ultrasound cleaning on removable
parts (e.g. valves)
STEP 6
Manual leak testing of endoscope
Release return to department
Repair peformed
STEP 13
loan endoscope
Repair performed
Transfer form
yes
Send endoscope in for repair and arrange loan
endoscope (if possible)
no
Repair by MT
possible?
STEP 7 Endoscope to Medical Technology (MT)
yes
Leakage of
endoscope?
no
yes
STEP 8
Manual brush channels
STEP 8
Aspirate and/or flush channels
STEP 8
Disconnect leak tester
STEP 8
Wipe off endoscope exterior
STEP 9
Place in disinfector and enter registration information
STEP 9
Start automated leak testing, cleaning and disinfection
Registration
of patient
specialist
endoscope ID
no
Repair by MT
possible?
STEP 7
Endoscope to MT
yes
Leakage of
endoscope?
yes
Transfer form
no
STEP 10
Check tubing, etc, after process
STEP 10
Remove endoscope.
no
yes
Solvable by
employee?
Known cause?
no
STEP 10 Release?
yes
< 4 hours reuse: mark as disinfected
STEP 11
Dry endoscope in drying cabinet
Figure 3 – Primary process for cleaning and disinfection of flexible endoscopes
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4 hours limit exceeded
without drying
STEP 2 - Transport of disinfected endoscope
- Lay the endoscope on a new cellulose pad (or otherwise protected from damage
while being moved) in a clean dust-free container which is enclosed (with a lid,
dust cover/plastic sleeve or similar);
- The container must be clearly marked or sealed to show that the endoscope has
been disinfected;
- The container should show the use-by time, taking account of whether the
endoscope has been properly dried and transported to the treatment/endoscopy
room.
While the endoscope is in use on the patient gloves must be worn. During endoscopy
the general precautionary measures recommended by the WIP should be applied.
Materials and liquids used should be applied in accordance with the Spaulding
5
principle .
STEP 3 - Initial cleaning by user in the treatment room
Direct after the endoscopy the following steps should be taken while wearing gloves:
6
- draw cleaning agent (acqueous solution) through the suction and biopsy channel;
- continue to draw fluid through until the used fluid is clear;
- flush and blow through he water/air channel (using valve);
- wipe the outer shell with an non-sterile gauze;
- set the endoscope friction controls to a neutral (free) position;
- disconnect the endoscope and take it to the disinfection space; if the disinfection
space is not immediately adjacent to the treatment room, then the endoscope must
be transported in a closed container (marked as dirty);
- immediately on concluding the examination, put on the protective cap;
- Deal with the (digital) recording of patient, medical specialist and endoscope.
4
The WIP gives a “use-by period” of a year if the endoscope has been dried correctly. The SFERD
considers that this may lead to risks which arise during the storage slipping through, with the opening and
closing of doors to remove and replace endoscopes; the SFERD recommends a period of one month, in
conjunction with the recommendation that the cabinet should be cleaned and disinfected monthly.
5
In 1968 is Spaulding drew up a cleaning, disinfection and sterilisation scheme for medical appliances,
based on the risk of infection for the patient. Spaulding operated on the basis of 3 categories: critical,
semicritical and non-critical. Critical means that a there is substantial risk of infection for the patient when
the medical appliance is contaminated with microorganisms. In these cases sterilisation is necessary.
Semicritical means that the risk of infection for the patient is lower and disinfection of the medical appliance
is enough, while for non-critical cases cleaning is sufficient.
6
The cleaning fluid should be transparent in order that the clarity of the used fluid can be assessed.
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STEP 1 - Making the endoscope ready for use
- All activities involving a disinfected endoscope must be carried out with disinfected
hands and using gloves;
- Take the endoscope from the drying/storage cabinet or endoscope disinfector (if
endoscope to be used within 4 hours). Release WARNING:
o for a endoscope taken from the endoscope disinfector, the disinfector display
must show that the endoscope was correctly disinfected;
o when using an endoscope from the drying cabinet, the “use-by period” must not
4
have expired.
- Install appropriate covers and valves.
PROCESS
MANAGEMENT
STEP 4 - Transport of used endoscope
- Lay the used endoscope back in the container on the cellulose pad (or otherwise
protected against damage in transit);
- Clearly mark on the container that the endoscope has been used and could be
contaminated, for example: the breakiong of the seal on the container marks the
endoscope as contaminated;
- Take the container to the disinfection room;
- Offer the container up immediately for preliminary cleaning by hand and
mechanised disinfection.
STEP 5 - Preparation for cleaning and disinfection of the endoscope
Requirements
for personal protection:
waterproof smock;
gloves;
mouth/nose mask;
protective goggles or splash guard.
for the cleaning process:
• A suitable cleaning agent for preliminary cleaning by hand, compatible with the
cleaning materials and disinfectants used in the endoscope disinfector. Activation
time, concentration and temperature are applied in accordance with manufacturer’s
instructions;
• Gauzes or cellulose cloths;
• Various brushes (compatible with working channel diameter; preferably single7
use) ;
• Tools to flush out or blow through channels, such as:
• air/water spraygun or suction system;
• Luer Lock connectors;
• waterjet channel tube (depending on type and make of endoscope);
• elevation channel tube (depending on type and make of endoscope);
• Leakage tester;
• Transport containers clearly marked for clean and dirty;
• Cleaning materials and disinfectants for transport containers or a container
washing machine.
Execution:
- Fill a large clean sink with cleaning fluid (concentration and temperature in
accordance with manufacturer’s instructions);
- Lay the cellulose mat on the worktop;
- Remove valves and distal caps, unless valves are required for endoscopes which
channels have to be flushed through rather than brushed (e.g. EUS/EBUS).
7
The SFERD strongly recommends the use of single-use brushes selected to match the appropriate
channel diameter; the brushes can be used for a shift for multiple channels of the same diameter. The
SFERD offers this advise with the intention of ensuring adequate preliminary cleaning, with better reach
through he use of good quality brushes, rather than the sterility of the brushes used.
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STEP 6 - Testing the endoscope for leaks
- The endoscope is laid on a cellulose pad, with the controls uppermost;
- Turn on the leakage tester;
- Connect the leak test cable to the connector on the light guide plug of the
endoscope (check the pressure);
- The shaft swells up slowly;
- Immerse the endoscope completely in the sink with cleaning fluid in which the
endoscope can lie;
- Wait at least 1 minute, until full pressure has been reached;
- Check the endoscope for leakage, being sure to agitate the tip thoroughly;
- if the endoscope leaks: see step 7;
- If the endoscope does not leak, carry out preliminary cleaning: see step 8;
- The endoscope should always be removed from the fluid with the leak testing
pump still active and laid on a cellulose pad;
- Turn off the leak tester and pull the connector slightly clear of the device to
depressurise the endoscope;
- Wait at least 1 minute, until the pressure is fully released;
- Disconnect the leak tester.
STEP 7 - Operating a defective endoscope
If an endoscope does not function to requirements, but is not leaking, it can be
disinfected and dried normally. Thereafter the fault should be reported to Medical
technology/clinical physics A leaking endoscope cannot be disinfected and may be
contaminated with pathogenic microorganisms. The endoscope should be handled as
follows before it is sent for repair:
- Clean the outside of the non-disinfected endoscope and wipe it off with alcohol
70%;
- Dry the channels (by hand using air and adequate personal protection). If the
endoscope is transported “wet” this can cause major damage to it;
- Label the endoscope “contaminated”;
- The user completes the transfer form (see example: appendix 2);
- The technician handles the endoscope with gloves on, and if necessary with
goggles and mouth and nose mask;
- The technician covers the endoscope in film and takes it away in a transport case.
The case is clearly labelled to show that the endoscope is contaminated;
- Following repair and before use the endoscope must always be mechanically
cleaned and disinfected.
9
STEP 8 - Preliminary hand cleaning of the endoscope
- Before brushing ensure that the channels are full of cleaning solution;
- Brush the biopsy/suction channel (there are endoscopes where other channels
must also be brushed):
o from suction channel valve housing to connector;
o from suction channel valve housing to distal;
o from biopsy valve to distal;
- Flush all channels through with cleaning solution;
- Flush the jet channel through with cleaning solution;
- Flush the CO2 channel, if any, through with cleaning solution;
8
Procedure depends on the type of leakage tester.
The manufacturer may recommend specific proecdures for the endoscope; the manufacturer’s
specifications are always to be taken as a guide
9
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Flush the elevation channel, if any, through with a 2 ml spray of cleaning solution;
Wipe off the outside with a gauze;
Brush the knobs on the control housing and the distal end;
Brush out the valves (see paragraph 5.2);
Take the endoscope out of the sink;
Lay the endoscope on the cellulose pad;
-
10
STEP 9 - Mechanised cleaning and disinfection of the endoscope
- Open the endoscope disinfector preferably using the foot or knee switch;
- Using gloves, place the endoscope inside the endoscope disinfector;
- Connect the leakage tester;
- Connect the inlet hoses onto the channels of the endoscope (follow the endoscope
disinfector supplier’s instructions). Use the correct hose set for the endoscope;
- Check the extra channels and connect them;
- Check that there are no cuts in the hoses;
- If necessary, remove the unused hoses, see the supplier’s instructions;
- If the valves, distal caps and suchlike are not single-use, they should preferably be
cleaned and disinfected by the CSA (see paragraph 5.2);
- Take gloves off and disinfect hands;
- Close the door of the endoscope disinfector;
- Choose the correct program. Follow the supplier’s instructions;
- Record (automatically or manually) the data required:
o date + time;
o identification number of the endoscope disinfector;
o patient data;
o identification number of the endoscope;
o medical specialist;
o R&D staff member responsible.
- Start the program;
- If the endoscope disinfector interrupts the program because of an error message,
follow the manufacturer’s instructions;
- In the event of repeated error messages, call in medical technology/clinical
physics.
STEP 10 - Release of the flexible endoscope following disinfection
- Check that the disinfection process has been completed without faults;
- Open the endoscope disinfector with disinfected hands (optionally with gloves) or
using a foot switch;
- Check that all hoses, caps and channel separators are still connected;
- If all conditions are met, then the endoscope can be released be and the release
recorded on the form ‘flexible endoscopes user release’ (see appendix 13) or
automatically;
- If not all conditions are met, then the problem must be resolved and the disinfection
procedure carried out anew;
- In cases of use within 4 hours of disinfection the transport container will be marked
with a label indicating the maximum time of use. If the endoscope is not used
within the period set, it must be returned for disinfection again. Before transport the
endoscope can be dried both inside and out using compressed air.
10
The procedures described depend on the type of endoscope disinfector
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Remarks:
• Where the endoscope has not undergone a complete drying process, if it is not
used within four hours it should be returned for disinfection again.
• If the drying cabinet is not working well or is faulty, contact should be made with
medical technology/clinical physics and the (insufficiently dried) endoscope should
not be kept for more than four hours before use.
• The drying cabinet should be validated as specified in the Verification section.
STEP 12 - clean and disinfect outside normal working hours
- Immediately after use initial preliminary cleaning is carried out in the treatment
room as described in step 3;
- this is followed by preliminary cleaning as described in step 8;
- Preliminary cleaning is followed by as soon as possible by mechanised cleaning
and disinfection.
Suggestion
If qualified staff are present, the endoscope can be mechanically disinfected. The
endoscope remains in the endoscope disinfector until the following working day.
Before the endoscope is removed from the endoscope disinfector the following
day, it is disinfected once again.
WARNING: this is not possible if there is a preset for thermal disinfection using a
timeswitch!
11
The supplier can advise on any variations in frequency (e.g daily maintenance)
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STEP 11 - Flexible endoscope drying process
- If it is not for immediate use, close the endoscope in the drying cabinet;
- Close all channels of the endoscope in accordance with the supplier’s instructions.
Depending on the type of drying cabinet, drying takes between 30 and 120
minutes: (in accordance with information from supplier);
- Put the valves and other loose components in a wire basket in the drying cabinet;
- Set the drying time in in accordance with the supplier’s instructions;
- When the drying process has finished and the process has been checked and
agreement reached, the endoscope can be released;
- After the complete drying procedure the endoscope (and the valves and other
loose components) can be stored for an indeterminate time in the drying cabinet or
dust-free storage cabinet, in accordance with the WIP. Because the frequent
opening of the drying or storage cabinet is linked to an increased risk of
contamination, a maximum storage time of one month for the endoscopes is
recommended; it is also recommended that the cabinet should be cleaned
11
monthly.
STEP 13 - Loaning flexible endoscopes and/or accessories
12
PROCESS
MANAGEMENT
13
Principal places a loan order with the appropriate department of the institution;
When making the order, the supplier’s conditions and documentation on technical
data and cleaning and disinfection are required;
The principal informs the departments in question (e.g: CSA, DSRD and MT/KF)
about the endoscopes and equipment ordered and the dates and time period on
which they will be supplied, used and returned;
The endoscopist can only plan the intervention if the conditions for adequate
14
cleaning and disinfection are met;
Reception and checking of endoscopes and/or equipment within the institution at
15
the medical technology/clinical physics department and then into the department
for cleaning and disinfection;
Loaned endoscopes should be “learned” in the endoscope disinfector, so that their
correct specifications can be stored in the endoscope disinfector;
Cleaning, disinfection and where necessary sterilisation by the relevant
department;
Delivery of the endoscopes and/or equipment to the user;
16
After use, return as quickly as possible for decontamination.
•
•
•
•
•
•
•
•
•
Explanation
Documentation by the supplier:
Offering an endoscope or equipment should always start on the presumption that it is
being offered for the first time. If it is a repeat order it should be indicated that all
documentation is already in the hands of the department in question.
Documentation to be supplied by the company:
• identification for for the endoscope;
• decontamination declaration;
and in accordance with EN 17664 [ref 39]:
• cleaning, disinfection and where necessary sterilisation protocol for loan supplies;
• maintenance instructions and instructions for functional operating test.
Reception of endoscopes/equipment, routing and checks.
The endoscope and/or equipment should be supplied to the medical
technology/clinical physics department at least one working day before the planned
intervention in a closed package for transport;
The endoscope is recorded by medical technology/clinical physics in the institution’s
recording system;
Medical technology/clinical physics is then responsible for transport to the relevant
department;
12
The same measures applie for a loaned disinfector as for a new disinfector
13
Loan/rental: for use with patients for a given period, via an order number submitted to organisation. For
assessment: only for testing, not in combination with use on patients/trial placement, etc.
14
Compatibility is determined.
15
Records should be kept of endoscopes with serial number and period in service in the institution.
16
Decontaminatie: adequate cleaning and disinfection with a validated process that results in a medical tool
which can continue to be used safely. If it is not possible to meet these conditions, a meeting with the
supplier will be necessary.
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Return via medical technology/clinical physics
if the endoscope was cleaned and disinfected immediately after the intervention, this
takes place within one working day, including issuing the decontamination declaration
(see example: appendix 3), ready for dispatch to the supplier;
At medical technology/clinical physics a record should be made of the loaned
endoscope on return to the supplier.
STEP 14 - Variations to primary process for endoscopes without channels
The risk of transfer of microorganisms during the use of endoscopes with channels is
considerably greater than with channel-less endoscopes. This does not mean that
channel-less endoscopes can be reused without adequate cleaning and disinfection.
For channel-less endoscopes the WIP has expressed a preference for a mechanical
cleaning and disinfection process. IN the evnet of aseptic use of a CE-marked sheath
there is no indication for cleaning and after the sheath has been removed the
endoscope can be disinfected with alcohol 70% or another disinfectant permitted for
this purpose. Without the use of a sheath there is therefore always an indication for
cleaning which is always carried out mechanically. A major exception for cleaning by
hand is the failure of equipment because of a power cut.
In short, this means that channel-less endoscopes, which are used with an intact
sheath, can be disinfected after use with alcohol 70% with a contact time of at least 30
seconds. At the end of the program the channel-less endoscopes are transported to
the (main) establishment for mechanised disinfection. This means that after each
endoscopy the endoscopes are automatically tested for any leaks using the leak test
in the endoscope disinfector. Endoscopes should be transported in closed transport
containers, which must be cleaned and disinfected. Since the chance of a look-back
procedure is so slight and an endoscope leak will only affect one endoscopy
programme, a track & trace recording is not necessarily required.
After disinfection the endoscope is stored dry in a storage cabinet or other dust-free
storage facility. If, following mechanised disinfection the endoscope does not come dry
out of the endoscope disinfector, the endoscope is dried in a drying cabinet or wiped
off on removal from the disinfector using a gauze with alcohol 70%, so that air-drying
is promoted.
STEP 15 - Replacing cleaning materials and disinfectants
Required materials (if indicated on the safety data sheet):
cleaning agent and/or disinfectant, CE-marked, permitted on the Netherlands
market and compatible with endoscopes and endoscope disinfectors;
gloves;
mouth/nose mask;
smock;
safety goggles.
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The supplier must keep a log for the endoscope in which the decontamination
declarations are kept and the history of the tool can be made available to the user on
request;
The supplier declares to the institution on delivery of the endoscopes that the
materials have been decontaminated. In this it cannot invoke a declaration made by
an earlier user.
PROCESS
MANAGEMENT
Method:
- Take account of specified safety measures; see endoscope guide and chemicals
safety data sheet;
- When the message is received from the endoscope disinfector the cleaning
agent/disinfectant is replaced;
- Take a new container out of the supplies cabinet. The types of containers used
should be identifiable in such a way that only a single type of cleaning agent or
disinfectant is contained in a specific shaped or coloured container. This will
prevent confusion of chemicals from suppliers with a major delivery program using
the same containers;
- Replace the container; check for the correct colour coding on the connector. Read
the Dutch labelling closely;
- Second person checks that the containers are fully connected, in the case of
automatical control;
- Record in the log: date, time, name of the agent being replaced, name of
endoscope disinfector, if not computerised then to be initialled by two people.
Remarks:
• Changing containers results in the endoscopes being inadequately cleaned and
disinfected.
• Using incompatible chemicals can lead to damage to endoscopes and endoscope
disinfector.
• The cleaning agents and disinfectants for hand and mechanised cleaning and
disinfecting of endoscopes should be standardised across the entire organisation.
• Do not pass residues on for reuse.
• Containers with residual disinfectants should be closed and processed in
accordance with current hospital guidelines.
STEP 16 - Self-disinfection of endoscope disinfector
Most endoscope disinfectors are provided with a self-disinfection program. This
program is executed to prevent a biofilm from forming.
The self-disinfection procedure reaches internal parts of the machine which are not
touched by disinfectant during the standard process.
Method:
Check that the endoscope disinfector does not contain an endoscope and start
the self-disinfection program. The endoscope disinfector’s self-disinfection
program should be used in accordance with the supplier’s instructions. At least
weekly, preferably after the weekend (if consultation hours start on Monday);
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STEP 17 - User maintenance of endoscope disinfector
in accordance with the instructions, Medical technology/clinical physics will decide
jointly with the DSRD what maintenance is needed. Thereafter responsibilities for
maintenance can be split between the DSRD and medical technology/clinical physics
and possibly others. The supplier recommends that the owner carry out frequent
checks and routine maintenance to the endoscope disinfector. Checks and
maintenance carried out should be signed off; the template for a routine endoscope
disinfector maintenance form (appendix 4) could be used for this purpose. The form is
stored in the log for each endoscope disinfector. Checks and maintenance should be
considered to include:
- running the endoscope disinfector’s self-disinfection program;
- checking that cleaning agent and disinfectant are correctly connected;
- checks on (defective) connecting hoses;
- checks on (defective) O-rings; (also on channel separator)
- cleaning the control panel and handles;
- cleaning the outside of the endoscope disinfector.
- remove and clean strainer (depends on brand);
- soften water for the endoscope disinfector in accordance with supplier’s
instructions (when the endoscope disinfector indicates this; the frequency depends
on the hardness of the water used).
These check-items are also considered as an element of verification; see para 10.2.
5.2
Cleaning, disinfection and sterilisation of
accessories
Accessories used in endoscopy may be divided into four groups:
1. Accessories used in endotherapy;
2. Rinsing systems;
3. Endoscope accessories;
4. Accessories used during cleaning process.
If during endoscopy the accessories come into direct with sterile tissue, they too must
be sterile. The prescribed method for these four groups is described below.
Group 1: Accessories used in endotherapy
These instruments come into direct contact with sterile tissue during
endoscopy;
Single-use accessories are preferred;
Reusable accessories must be sterilised. When using an irrigation system,
sterile water should be used.
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NB:
The SFERD recommends that the disinfector manufacturer’s advice should be
followed. Variations to this procedure should only be made after due consideration
with sufficient grounds. Changes to the recommended procedures will probably result
in the manufacturer’s no longer being liable for any issues arising.
Following a thermal self-disinfection program the endoscope disinfector remains hot
for long enough that a cooling period is necessary. No endoscope disinfection may
take place in the interim. Account should be taken of this when scheduling thermal
self-disinfection.
PROCESS
MANAGEMENT
Group 2: Rinsing systems
The sterile water bottle is filled with sterile water and must be replaced daily;
Single-use bottles are preferred;
Reusable bottles must be sterilised.
Group 3: Endoscope accessories
These accessories do not come into direct contact with sterile tissue, but the
likelihood of contamination with tissue and bodily fluids is high;
Single-use accessories are preferred;
Reusable accessories should preferably be sterilised;
Reusable valves should be brushed both in open and closed position. This
removes as much contamination as possible. The valves are then transferred
to the central sterilisation department for further treatment.
Group 4: Accessories used during the cleaning process
These instruments do not come into direct contact with the patient during
endoscopy;
Single-use accessories are preferred;
Table1 – Accessories and their respective methods of disinfection or sterilisation
Group
Accessory type*
1
Mechanical
thermal
disinfection
Sterilisation
17
Single
Use
Biopsy forceps, loops, ERCP
materials and irrigation equipment
X
X
Rinsing water bottle and hose
X
X
Valves, caps and mouth pieces
X
X
X
Water jet channel hoses
X
X**
X
Brushes
X
NB: - single-use are always preferred to reusable equipment.
* = accessories which cannot withstand disinfection or sterilisation may be used once
and then discarded.
** = if material withstands sterilisation
5.3
The installation of a endoscope disinfector
Before the endoscope disinfector is taken into use, the supplier checks the following
aspects of the installation in consultation with the medical technology/clinical physics
department.
General utilities
The room must contain at least a water supply (including filters), an outlet to the
sewage system, electricity, air extraction and a network connection.
17
Sterilisation is always preceded by cleaning and mechanical disinfection
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Instruments
Testing and if necessary calibration of:
o
temperature, pressure and flow sensors;
o
disinfectant dosing system;
o
detergent dosing system.
technical verification (see paragraph 10.1);
provide a logbook for each endoscope disinfector; record with mention of
process counter status:
o
machine inventory data;
o
preventive and corrective maintenance;
o
faults;
o
replacement of components;
o
interrupted processes;
o
replacement of detergent and disinfectant containers;
o
verification (refer to verification report);
o
release declaration.
Microbiological aspects
Microbiological verification (see paragraph 10.3);
These items are reported to the cleaning and disinfection expert by the department
responsible;
The cleaning and disinfection expert is responsible for the assessment and functional
release of the endoscope disinfector (see Appendix 5 for release form);
He is also responsible for archiving the technical and microbiological installation
reports.
5.4
Risk inventory and assessment
The cleaning and disinfection of endoscopes is carried out in order to prevent patient
risks. However, these procedures may bring other risks with them. Both the supplier of
the cleaning and disinfection equipment and the heads of the departments concerned
must take this into account. Risks can be divided into categories:
risks to staff;
risks to endoscopes and endoscope disinfectors;
environmental risks;
chemical risks;
microbiological risks
Risks can be minimised by using general precautionary measures or by circumstancespecific measures. The potential risks in each category and the measures required to
minimise them are described below.
The hospital itself should conduct a risk assessment tailored to the location.
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Risks to staff
PROCESS
MANAGEMENT
Tasks
Transport of contaminated
endoscopes
Risk
Risk-minimising measures
Injury, contamination, physical Clear working instructions,
symptoms
protective clothing, vaccinations in
accordance with hospital policy,
appropriate attitude to work
Manual preliminary
cleaning of contaminated
endoscopes
Injury, microbiological and
chemical contamination (via
the skin, mucous membranes
or inhalation; or caused by
aerosols),
physical symptoms
Injury, contamination, contact
with chemical fluids (via the
skin, mucous membranes or
inhalation)
physical symptoms
Loading and unloading the
endoscope disinfector
Replacement of cleaning
and disinfection materials
Contact with chemical fluids
(via the skin or inhalation)
Storage of clean
endoscopes
Injuries, physical
symptoms
Clear working instructions,
protective clothing, extractor
system, vaccinations in accordance
with hospital policy, appropriate
attitude to work
Clear operating instructions,
protective clothing, vaccinations in
accordance with hospital policy,
well ventilated work place,
endoscope disinfector extractor,
regular maintenance and
appropriate attitude to work
Clear operating instructions,
protective clothing, mask, well
ventilated work place, appropriate
attitude to work
Storage in accordance with
instructions
Gloves, appropriate attitude to
work
Risks to endoscopes and endoscope disinfectors
Tasks
Transport of
(contaminated)
endoscopes
Manual preliminary
cleaning of contaminated
endoscopes
Risk
Damage
Risk-minimising measures
Clear operating instructions,
protective transport containers
Damage, leakage, corrosion,
biofilm
Clear operating instructions, the
right cleaning materials/equipment,
mechanical cleaning
Loading, mechanical
disinfection and unloading
of the endoscope
disinfector
Damage, defects and leaks,
corrosion and biofilm to
endoscopes and endoscope
disinfectors
Storage of clean
endoscopes
Damage
Compatibility checks, clear
operating instructions, the right
cleaning and disinfection materials,
thermal self-disinfection, preventive
maintenance
Protective transport containers,
appropriate drying and storage
cabinets
Environmental risks
Tasks
Storage of chemicals
Disposal of chemical waste
Discharge to the sewer
40
Environmental risks
Leaks
Explosive
Improper disposal or leakage
of chemical waste
Risk-minimising measures
Storage in accordance with
supplier’s instructions
Clear operating instructions, special
containers and disposal procedures
Improper discharge of
chemical waste
Clear operating instructions,
discharge permit
Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Chemical risks
Risk-minimising measures
Clear operating instructions, special
containers and disposal procedures
Replacement of cleaning
and disinfection materials
in the endoscope
disinfector
Ventilation of the area in
which the endoscope
disinfectors are set up
Clear operating instructions,
appropriate storage of cleaning and
disinfection materials, special
containers and disposal procedures
Thorough ventilation, use and
maintenance of appropriate filters
Unintentional spillage and
leakage of detergents and
disinfectants, improper
disposal
Unintentional leakage of
harmful vapours
Microbiological risks
Tasks
Transport of
contaminated
endoscopes
Risk
Contamination of staff,
cross-contamination with
other equipment
Disposal of contaminated Contamination of staff,
material
cross-contamination with
other equipment
Risk-minimising measures
Clear operating instructions,
closed transport containers,
sufficient working space,
vaccination in accordance with
hospital policy, good logistics
organisation**
Vaccination in accordance with
hospital policy, clear operating
instructions, appropriate use of
waste containers, good logistics
organisation
**including the separation of clean and contaminated equipment
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Tasks
Risk
Disposal of chemical waste Improper disposal or leakage
of chemical waste
PROCESS
MANAGEMENT
5.5
The traceability of endoscopes and patients
The IGZ requires hospitals to use a traceability system which records which
endoscope is used on which patient by whom, and in which endoscope disinfector the
endoscope is cleaned and disinfected.
Tracking & Tracing
Tracking and tracing is the recording of successive data that safeguard the
effectiveness of the disinfection process. Endoscopy and disinfection processes are
preferably recorded automatically.
Required measurement data and records
Record the process number together with the date and time of the disinfection
process;
Record the serial number of the endoscope disinfector and the section (left or right
container, position 1,2,3 or 4, etc.);
Record the endoscope series number per section or position;
Record the patient identification number for the used endoscope awaiting
disinfection, per section or position;
Treating medical specialist for the endoscopy, per section or position;
Persons carrying out the cleaning & disinfection process, per section or position;
the person who places the endoscope in the endoscope disinfector and person
who removes the endoscope from the endoscope disinfector after the cleaning
and disinfection process (= person who releases the endoscope for safe reuse);
Record the effective or interrupted cleaning & disinfection process, per section or
position, along with measurement data including:
o pressure measurement (including leak test and continuous pressure
monitoring for connection controls and flow);
o temperature measurements;
o duration of the cleaning, disinfection and drying phases;
o starting time, finishing time and duration of the process; if necessary, the
duration of other phases of the process.
The data to be recorded per work process / work space is as follows:
endoscopy:
o
patient data;
o
treating medical specialist;
o
endoscope identification/charge number.
loading and connecting the endoscope in the endoscope disinfector:
o
patient data;
o
endoscope identification number;
o
endoscope disinfector identification number, including connection position
(left/right, top/bottom);
o
name of operator.
release of the endoscope:
o
endoscope identification number;
o
endoscope disinfector identification number;
o
name of operator.
Record storage period
There are no statutory storage periods for technical data on cleaning and disinfection.
The decree on sterilised medical devices [ref 43] states that the records for a batch of
sterilised medical equipment “shall be stored for at least six months”. In the case of
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It is recommended that all the available data is periodically backed up. Data should
not only be stored locally on a work station; it must be managed centrally (on the
network).
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sterilisation carried out for third parties, the storage period for sterilisation records is
five years [ref 44].
In this profession, a storage period of six months is on the short side, since it is
possible for the symptoms of infection resulting from patient treatment to become
apparent after this time.
The SFERD recommends a storage period of five years for technical data on cleaning
and disinfection. This enables an organisation to demonstrate with a probability
bordering on certainty that any infections manifested in a patient could not have been
caused by inadequate endoscope disinfection. This storage period includes the
periods subject to lookback investigation in the event of incidents relating to
inadequate cleaning and disinfection endoscope procedures.
ASSESSMENT BY
CUSTOMERS
6.
ASSESSMENT BY CUSTOMERS
6.1
Patient safety
Within the EFQM model, assessment by the partners, customers, and suppliers with
which an organisation works is of great importance to its successful performance.
Partners are external organisations with which there is a long-term or close working
relationship. These may be suppliers or buyers, sometimes in changing roles. It is
necessary to know how they assess products, services and cooperation. What is their
opinion about these things? Does the organisation know why people decide whether
or not to use its services? And what can the organisation expect from them in the
future?
Patient satisfaction can be investigated. Research methods are available, including
the use of questionnaires. To match the service to patient expectations, organisationwide creative initiatives can lead to a rise in patient numbers. This can result in an
increasing demand for investigations in which flexible endoscopes are used.
An attractive setting with an eye for colour and function, in combination with discreet
and friendly treatment, gives patients the confidence that they are in good hands.
Features indicating that the guidelines and standards are met can contribute to an
understandable sense of patient safety.
Transparency in the form of information about the tests which patient must undergo
reassures the patient and helps create a relaxed atmosphere for treatment.
Written and verbal means should be available to allow the expression of complaints,
or suggestions about the patient experience. Patients should be confident that when
they report complaints or suggestions their points are at least considered in the
discussion of how to improve future patient care, audits or incident drills.
6.2
Throughput/availability of endoscopes
Within the endoscopy department team, the medical specialist should be regarded as
the customer, with requirements, rights, and obligations. When treating a patient the
medical specialist must be able to assume that the right endoscopes will be available
at the right time. The decontamination cycle should be so designed that the
endoscope is quickly available again for patient use. The number of endoscopes
required should be determined on the basis of the number of patients awaiting
treatment and the speed of cleaning and disinfection.
It is for the specialist to satisfy himself that the endoscope presented to him has been
properly cleaned and disinfected so that patient safety is not at put at risk, as set out in
the Order of Medical Specialists’ guidelines for medical equipment [ref 30.].
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ASSESSMENT BY STAFF
The EFQM model addresses the question of the extent to which the organisation
delivers additional value to its staff. The staff assessment should be evaluated through
staff satisfaction surveys. The results of such surveys can help an organisation to
keep staff interested and committed to the institution.
New developments can lead to the expansion of tasks and to remuneration at a
different rate after assessment using the heath care job evaluation system.
Organisation and department managers must create a balance between work, pay,
development and giving staff sufficient challenges. Good motivation leads to effective
efforts and performance.
It is important for staff working with flexible endoscopes to feel satisfied and safe, both
on their own behalf and on behalf of patients. Therefore, the tasks to be performed in
the organisation should be described in an endoscopy quality manual.
When performing a task described in a quality manual, staff can be confident that they
will carry out the procedures correctly and safely. Procedures are derived from
guidelines and drawn up in protocols based on local circumstances These protocols
are established with the support of the team and provide instructions for day to day
operations. This enables procedures to be standardised, audited and improved. The
protocols should also ensure a safe working environment (Quality, Working conditions
and the Environment.) They should ensure the statutory registration of dangerous
substances, and establish a safe working environment, for example taking account of
activities that involve noise and climatic conditions. To maintain the quality of working
and labour conditions, an organisation must have access to a medical technology /
clinical physics department, an infection protection department, an occupational health
service and a cleaning and disinfection expert.
State-of-the-art equipment should be used, and staff should be suitably trained or
retrained. This demands the preparedness of the board to invest appropriately.
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ASSESSMENT BY
STAFF
7.
ASSESSMENT BY
SOCIETY
8.
ASSESSMENT BY SOCIETY
Assessment by society is a significant factor in the quality of care in Dutch hospitals.
The development of performance indicators contributes to greater transparency of
care. Media attention to the quality of healthcare is an important incentive encouraging
hospitals to keep the quality of care high on the agenda. Incidents relating to the
cleaning and disinfection of endoscopes attract a good deal of attention in the media.
This can damage the reputation of the hospitals concerned. Transparent care leads to
increasing social pressure. This finds expression in official government targets, as set
out in the Safety Management system (SMS). Patient safety is a important issue in
contemporary hospital management.
Society requires hospitals to use endoscopes safely, and to be fully accountable
should safety be in any way at risk. This means that a hospital should have an
appropriate incident management procedure, focusing both on preventing the
recurrence of incidents and on providing clear explanations of such events and the
potential risks to patients.
8.1
Incident management
Despite every care in the proper cleaning and disinfection of flexible endoscopes, an
incident may still occur.
The steps to be followed in incident management are based on a risk assessment; in
other words, on an estimate of the likelihood that an incident can cause an
emergency. The aim of incident management is to take immediate measures in the
event of incidents involving flexible endoscopes to prevent any transmission of microorganisms through improperly cleaned and disinfected endoscopes or accessories. It
also aims to take steps to prevent a repetition of the incident and to investigate
whether patients or staff have been put at any risk of the transmission of microorganisms.
The hospital’s current procedure will be used in the event of an incident. The chairman
of the incident committee will if necessary advise the board to appoint an expert team
consisting of the cleaning and disinfection expert, a medical microbiologist or virologist
and representatives of the infection prevention department, the management
committee or board, the medical technology/clinical physics department and the
endoscopy department(s) involved. The expert team is responsible for:
conducting a further analysis of the nature and extent of the incident and an
assessment of the risks to patients and staff;
informing management of the findings;
advising the management about the steps and measures to be taken to
ensure patient and staff safety;
drafting an evaluation report and if necessary establishing a prevention
strategy to prevent recurrence;
delivering internal – and if necessary external – reports (including a report to
the IGZ);
identifying and analysing all necessary information;
determining whether an incident has actually occurred on the basis of all the
available information;
advising the management about the (temporary) measures that should be
taken to guarantee patient safety, including the suspension of endoscopic
examinations.
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8.2
The incident procedure comes into action when a fault is reported in the endoscope
cleaning and disinfection process. The table below gives examples of possible
incidents; however, this table is not complete. The cleaning and disinfection expert
carries out a risk assessment of the incident, and if necessary a risk assessment for
the patient risk in consultation with a medical specialist and a medical microbiologist.
The procedure below can be started on the basis of these assessments.
Table 2 - Examples of incidents
Inadequate cleaning & disinfection of endoscopes or accessories
inadequate pre-cleaning (e.g. failure to brush channels)
use of incorrect or expired chemicals
use of incorrect concentrations, processing times or temperatures
contamination of the last rinsing water or endoscope culture medium
observation of organic material in endoscope or endoscope disinfector
use of non-sterile accessories for invasive diagnosis/treatment
inadequate transport and/or storage of endoscopes
insufficient drying of endoscopes
improper storage of endoscopes (e.g. in transport containers)
contaminated or defective endoscope disinfector
contamination of tubes, containers, etc.
contamination of the last rinsing water
biofilm in pipes, containers, etc.
incorrect use of endoscope disinfector (e.g. incorrect programmes)
technical faults (found on verification or maintenance).
design limitations or damage to the endoscope
lumens too small or inaccessible channels (not accessible to brushes)
damage to endoscopes (with possible build-up of organic material)
incomplete implementation of the cleaning & disinfection process
omissions due to inexpert staff
incomplete process due to excessive throughput/pressure of work
inappropriate use of loan endoscope
loan endoscope taken into use with notification and testing
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ASSESSMENT BY
SOCIETY
Criteria for the start of an incident
management procedure
ASSESSMENT BY
SOCIETY
8.3
Incident procedure stages
The following flow chart describes the different steps in the procedure. Some steps
may be started and carried out in parallel.
Figure4 – Incident procedure action plan
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8.4
ASSESSMENT BY
SOCIETY
Incident procedure stages: process
description
STEP 1:
- Notification
The cleaning and disinfection expert receives a notification based on:
signals from staff, medical specialist;
findings of regular controls (maintenance, verification, cultures);
anomalous process parameters in the automated cleaning and disinfection
process;
production registration findings via tracking & tracing.
STEP 2 - Inventory and analysis
The cleaning and disinfection expert identifies and analyses the notifications. The
table in paragraph 8.2 (Incident examples) can be used as a guide. If the notification
appears to be ‘only’ a deviation from daily practice, the procedure will not be
continued, unless there is a structural divergence from day to day procedures.
STEP 3 Risk inventory
Based on the inventory and analysis, the cleaning and disinfection expert estimates
whether there is or has been:
SCENARIO 1 : Process risk
Any omissions in the work process can lead to a long-term risk to patients and staff.
These omissions should be included and safeguarded in protocols or work
instructions. If patients or staff have run no increased risks due to these omissions, a
recall is unnecessary.
SCENARIO 2: Patient or staff risk
In the event of a suspected or demonstrated risk to patients or staff, the cleaning and
disinfection expert contacts the medical microbiologist directly to further assess the
risk (see step 4). Note that the risk does not always have to be microbiological; for
example, there may be chemical risks. In this event a pharmacist / toxicologist or
safety expert can be involved.
SCENARIO 3: No patient or staff risk
On analysis, it appears that the notification carries no risk to the process, patients or
staff. The procedure is terminated, though the notification is still reported.
STEP 4 - Risk assessment
The medical microbiologist, pharmacist / toxicologist and safety expert assess the risk
together with the cleaning and disinfection expert. This assessment may have three
possible outcomes:
a. There is an incidental risk for one patient/employee. The anomaly may have
been present for longer, but on the basis of the inventory and analysis, the
risk assessment can be limited to one individual. In this event the procedure
will continue.
b. There is a structural risk whereby several patients or staff have been at risk. In
this event the procedure will continue.
c. Mutual consultations show that there is or was no risk to patients or staff. The
procedure is terminated, though the notification is still reported.
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STEP 5 - Notifying the board
The cleaning and disinfection expert reports the findings to the board and advises the
chairman of the board to appoint an expert team.
STEP 6 - Board appoints expert team
The representative of the board appoints an expert term, the members of which are
selected in consultation with the cleaning and disinfection expert and the medical
microbiologist. The size of the team will reflect whether the risk is individual (step 4a)
or affects a group (step 4b). If staff have been put at risk, the occupational physician
will join the team.
STEP 7 - Policy decision
The expert team decides on the policy to be conducted and advises the board. The
following aspects must be addressed:
can endoscopic examinations proceed without increased to patients or staff;
must patients be recalled for examination, if the risk of hepatitis B, hepatitis C
or HIV cannot be excluded;
must the incident be reported to the IGZ;
must there be a press release.
If the incident is caused by malfunctioning equipment, the supplier will be contacted so
that it can be involved in determining further investigation and strategy.
STEP 8 - Implementing the decision
A. Corrective measures
Establish measures to ensure that there is no further risk and to prevent incidents
in the future.
B. Determining the recall population and strategy
the risk period and risk population are determined on the basis of the
inventorised data;
which investigations will be conducted and when is determined on the basis of
the risk assessment;
the strategy for communication to patients, staff and media is determined on
the basis of the decision.
C. No recall
If the expert team decides a recall is not necessary, the procedure is terminated
here; however, the notification, assessment and decision should all be reported.
STEP 9 - Implementing policy
A. Interventions
The corrective measures identified are put into action. The manager of the
department is responsible for carrying them out.
B.
Recall
The recall is carried as determined. In conjunction with the assessment of the risk
of blood-borne diseases, the medical microbiologist is responsible for the recall
process. The medical specialist concerned is responsible for contacting patients.
The occupational physician is responsible for contacting staff (if they have been
exposed to risk).
C.
Communications
The board and/or the PR & information department is responsible for
communication with the media.
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STEP 11 - Conclusion of the process: reporting
The cleaning and disinfection expert draws up a final report of the procedure. This
report is sent to the board, the infection prevention committee and members of the
expert team. It is also sent to the IGZ if relevant.
8.5
Damage to the image of the institution
An organisation does not just deliver services to society; it is also a part of that
society. An organisation can demonstrate that it has learned lessons from an incident,
and in this way can distance itself from the from the problems existing before the
incident. In the interests of healthcare, treatment should be resumed in accordance
with the new quality standard. This new standard comes about after the demonstrable
implementation of adapted or even new equipment, increased expertise among
practitioners, improved support within the organisation or from the supplier of the
equipment concerned, or changed procedures. Unreasonable social expectations
should be avoided: explain what you do and how you do it.
The cleaning and disinfection of flexible endoscopes involves a high standard of
disinfection in line with the type of instruments and their applications. The casually
use of the term “sterility” should be avoided.
Tell both the internal and external media that you can explain the necessary changes.
Mention the marginal likelihood the risk now compared with the time before the
incident and explain that this has been reduced to a level accepted by the authorities
(IGZ / infection prevention working party). Point out the effect of your quality
assurance system and the role of audits in the short and longer term.
When managing patient reactions, the involvement of a confidential patient counsellor
or contact person may be helpful. Patients may enter a claim against the organisation
because of suffering in the form of uncertainty or indeed certainty about an infection
caused by the incident. Any such claims should be handled in accordance with
arrangements with the institution’s insurers.
The management or board can at least partially delegate media dealings to the PT or
communication department.
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STEP 10 - Evaluating and determining prevention strategy
The progress of the procedure is evaluated and reported to all the parties concerned.
Any improvements to prevent a future recurrence of the incident are identified on the
basis of this assessment. These improvements may be included in the endoscope
management plan. If necessary, procedures will be adapted.
FINAL RESULTS
9.
FINAL RESULTS
Guaranteed safety for both the patient and staff. The patient must be justifiably
confident of responsible care (IGZ principle). Such care comes about through:
• the existence of an operational quality system for the management of the
process of cleaning and disinfecting endoscopes;
• the existence of a structural process of quality assurance that means that
points for improvement noted will be acted upon;
• taking account of the following starting points: applicable legislation and
regulation covering quality assurance for cleaning and disinfecting
endoscopes, such as the healthcare institutions quality law [ref 40], the BIG
law[ref 41], the law on medical resources.
To assess the testing of the state of quality assurance for cleaning and disinfecting
endoscopes, the IGZ uses the guidelines of the infection prevention working group.
monitoring and implementing new technological developments. These should be
considered as guidelines in a path of continuous improvement, particularly where new
construction or rebuilding is concerned.
The staff should have the skills required and be able to meet these requirements in
safe and healthy working conditions, a stimulating working atmosphere with due
professional concern for the environment.
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In this quality manual process verification is defined as the evaluation of the results of
measurements, tests and checks that have been performed in a particular time period
to ensure that the cleaning and disinfection process meets the current standards and
regulations.
The department manager is responsible for the cleaning and disinfection of the flexible
endoscopes and accessories. The procedures for cleaning and disinfection as well as
the results from measurements, tests and checks are periodically evaluated under the
responsibility of the DSRD. The steps and actions that are part of this system of
process verification are given in table 3. As a whole these steps and action
encompass the ‘validation’ of the endoscope WD and the related procedures.
The four parts of process verification are:
Part 1
Part 2
Part 3
Part 4
Technical verification
Functional tests and checks
Microbial test
Audit & Control
Detailed guidance on the each part is given in the clauses below. The sum of all
actions gives the assurance that the cleaning and disinfection process is effective and
reproducible. The hospital bears the final responsibility for ensuring that all the actions
are properly performed. The actual work however, may be outsourced to various third
parties.
The verification of the specifications of the WD and the processes is performed
annually. A range of functional tests and checks is performed on a daily, monthly or
quarterly bases. Part of the functional tests and checks are the verification of the
channel non-connection and channel blockage alarms, channel cleaning tests and
micro biological testing of the final rinse water.
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10. PROCESS VERIFICATION
10.1
10.1.1
10.1.2
10.1.3
Technical verification
Verification of the system specification of
the endoscope WD
Verification of the system specification of
the drying cabinet
Inspection of endoscopes
X
X
X*
X*
X
X
X*
X*
X
X
Facultative
After maintenance
At incidents
Yearly
Quarterly
Monthly
Daily
At purchase
Clause
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Action
After process altering repairs
Table 3 – System of process verification
X
10.2.1
Compatibility establishment
Functional test and checks
Check of channel separators
X
X
10.2.2
Check of connectors
X
X
10.2.3
Check of the connection tubes
X
X
10.2.4
Channel obstruction test
X
X
10.2.5
Channel non-connection test
X
X
10.2.6
X
X
X
X
10.3
Cleaning test
Testing the efficacy of the selfdisinfection cycle
Testing the cleanliness of the external
surfaces of the endoscope
Microbial tests
10.3.1
Microbial quality of the final rinse water
X
10.3.2
Microbial status of endoscopes
X
X*
10.3.3
Microbial status of loan endoscopes
X
X*
10.4
Audit & Control
Audit primary process
10.1.4
10.2
10.2.7
10.2.8
10.4.1
10.4.2
10.4.3
10.4.4
10.4.5
Audit technology and maintenance
Audit incident handling procedure
Audit expertise of the reprocessing
persons
Audit records of exchange of process
chemicals containers
10.4.6
Audit logs
10.4.7
10.4.8
Audit track-and-trace
Audit omissions in SOPs
10.4.9
Audit endoscope management plan
X
X
X
X
X
X
X*
X
X
X
X
X
X
X
X
X
X
X
X
* To be decided by the DSRD
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Periodic technical verification of the WD is necessary to ensure reproducible cleaning
and disinfection of the endoscopes. The technical verification as described in this
quality manual is not intended to demonstrate that the WD meets the requirements of
the international standard ISO 15883 or the Medical Devices Directive. This has
already been established by the manufacturer and the CE-mark on the WD shows that
the requirements are met.
This quality manual provides guidance for organisation of the technical verification of
endoscope WDs, endoscope storage and drying cabinets and the periodic checks of
flexible endoscopes that are used in the hospital.
The technical specifications of the WD and its processes are designed by the
manufacturer to fulfil the essential requirements of the Medical Devices Directive.
These technical specifications form the criteria for all measurements, tests and
checks. This quality manual gives guidance for the periodic verification of the
measurements, test and checks and the evaluation of the procedures, the results of
which are collated into a report and completed with the available test reports,
measurement data, manufacturer statements, etc.
SFERD has the opinion patient safety is served by meticulously documenting all
checks and maintenance of medical equipment. Apart from the technical
measurements and micro biological tests, the machine safety aspects of the WD
should also be periodically verified.
To the question ‘who should perform the measurements to verify that the WD works
within its technical specifications’, SFERD is of the opinion that the DSRD has the
responsibility to perform (or outsource), in collaboration with the supplier of the WD,
periodically all necessary measurements, tests and checks and to verify that the
technical specifications as provided by the WD manufacturer are met.
The DSRD, as the responsible person decided who will perform the measurements,
tests and checks. Where possible the measurements, test and checks could coincide
with period preventive maintenance. This will safe time, thus increasing the availability
of the WD. It is unnecessary and uneconomical to repeat measurements, tests and
checks by another party, where these have already been performed during
maintenance. It is the task of the DSRD to make detailed agreements with the
involved parties about the work that is outsourced. Possible partners are the supplier
of the WD, the Medical Technology department / Clinical Physics of the hospital and
validation companies.
10.1.1 Verification of technical specifications of the WD
The endoscope WDs shall meet the requirements of the Medical Devices Directive [ref
27] and shall be CE-marked.
The efficacy of the cleaning and disinfection process is determined by the use of the
process chemicals that have been validated by the WD manufacture, the washing
principle, the manner of channel connection and irrigation and the process
parameters. Technical verification of the WD is performed by measuring the process
parameters. Establishment of the efficacy of the cleaning, disinfection and final rinse
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10.1 Technical verification
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to remove the residues of the disinfectant, is part of the type testing and has not to be
repeated by hospital. At least annually the technical system parameters (see 10.1) are
verified. Where necessary corrections to the automatic controller are made (e.g.
calibration of sensors) during maintenance. The DSRD ensures that the verification of
the system parameters is performed according a protocol that is suitable for the
particular WD. Before commencement of the system verification the logs of the WD
are checked for any particulars that should be taken into account when doing the
system verification.
18
Verification of the system parameters may be performed by any competent party
(supplier of the WD, the Medical Technology department / Clinical Physics of the
hospital, validation company), but could be, for the sake of efficiency be combined
with routine maintenance. Many of the process parameters are already verified during
maintenance. The parameters that are verified, the procedures that are used and the
necessary accuracy should be agreed upon with the party that performs the
verification. For those system specifications that are not verified by the maintenance
party, the DSD will contract another party. The DSRD verifies that the parties involved
have the necessary expertise and that the procedures that are used are endorsed by
the WD manufacturer.
WARNING: No (temporary) modification of the WD shall be made for the
performance of the verification. E.g. disconnection of internal tubing the in WD to
connect sensors, disconnection of WD sensors to test alarm systems or modification
of process parameters. There is a risk that the modifications are not fully restored
after the measurements. In that case the WD may not perform as designed by the
manufacturer, resulting in ineffective processes. Thus the verification measurements
become a patient hazard!
Modifications to the WD are only allowed by the WD supplier, if only to maintain the
validity of the CE-mark and the product liability of the manufacturer. Where the
manufacturer prescribes that temporal modifications to the WD shall be made to
facilitate particular measurements, he shall provide a clear protocol.
The results of measurements, tests and checks are recorded. Whenever corrections
to sensors or measuring systems are made, the condition of these before the
corrections are also recorded. E.g. when a temperature sensor indicates a value that
is lower than the real temperature, the sensor should be adjusted. In this case also the
deviation before the adjustment shall be recorded. The DSRD shall establish whether
the deviation had a negative impact on process efficacy to an extend that patient
safety was at risk. Where necessary patient ‘look back’ shall be considered.
When there is doubt about the efficacy of the disinfection phase of the process, one
should verify whether the disinfectant that is used is prescribed by the WD
manufacturer and the process parameters that influence the disinfection efficacy shall
be verified. In addition the concentration of the active ingredients(s) of the disinfectant
could be verified. Possibly the concentration of the active ingredients are not as
manifested on the label.
18
A party is competent when it is acquainted with all the technical details of the WD and how it operates. A
competent party shall use a maintain a quality assurance management system, e.g. ISO 9000.
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Where in this document reference is made to ‘the standard’ the conjunction of the
standards is meant.
Requirements and responsibilities
In this clause the persons are mentioned that have a role in the verification of
endoscope WDs. These persons have responsibilities and need particular expertise.
Contact person
Ensures that the endoscope WD is used in accordance with the users manual, the
endoscopes are correctly prepared for automated reprocessing as prescribed in the
standard operating procedure, the daily and weekly inspections are actually done and
that the WD’s log is kept. Whenever the contact person has doubts about the
performance of the WD, they shall contact the DSRD.
Owner
The owner ensures that sufficient means are available for the cleaning and
disinfection of flexible endoscopes. The owner also ensure timely maintenance of the
equipment and education of personal.
Manufacturer/supplier
The manufacturer/supplier delivers a WD that fulfils the requirements of the sales
agreement. This includes the requirements of the Medical Devices Directive and the
international standard ISO 15883, parts 1, 4 and 5.
The manufacture shall clearly identify the endoscopes (brands, types, series) that can
be reprocessed in the WD, the necessary connectors for each endoscope and the
preparations that are necessary before the endoscope can be placed in the WD.
Before the endoscope is put into service it shall be established that this information is
incorporated in the SOPs. Where needed the SOP shall be updated and the
reprocessing technicians instructed. The manufacture specifies all process
parameters and how to verify these, as well as instruction for user maintenance.
User
The user shall use the endoscope WD as instructed by the manufacturer and
prescribed in the SOPs, for the purpose identified by the manufacturer. The user shall
have up to date expertise and shall be instructed in the operation of the WD. This
should be instruction by the manufacturer/supplier including the technical functioning
of the WD with emphasis on the limitations of the WD and its processes.
The user shall be capable to recognise fault conditions and malfunctions and able to
correct these. Malfunctions that cannot be corrected by the user shall be reported to
the Medical Technology / Clinical Physics Department. The Medical Technology /
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Normative references
The performance requirements and test methods for endoscopes WDs are given the
international standards. [ref 10.] :
NEN-EN-ISO 15883-1:2009
Washer-disinfectors - Part 1: General requirements,
terms and definitions and tests
NEN-EN-ISO 15883-4:2009
Washer-disinfectors - Part 4: Requirements and tests
for washer-disinfectors employing chemical
disinfection for thermo labile endoscopes
NPR-CEN-ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods
for demonstrating cleaning efficacy
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Clinical Physics Department records the report and the subsequent actions in the
WD’s log and informs the DSRD about the event.
Performer of measurements, tests and checks
The persons that conducts measurements, checks and test shall be specifically
trained and shall be familiar with design, use and maintenance of the endoscope WD.
The system specifications provided by the manufacturer are the reference to which the
results from measurements, checks and tests are judged.
Third parties that conduct maintenance, measurements, tests and checks shall work
within a quality assurance system, e.g. ISO 9000. To assure the professional integrity
of the personnel all work shall be performed and reported as prescribed in SOPs. The
DSRD monitors the work and reporting.
Planning of technical verification of the endoscope WD
In the following clauses give the steps of the verification procedure. The DSRD
ensures that all steps are performed according to plan. Verification of the WD is
performed at least annually. Maintenance and repair, depending on the nature of it,
shall be followed by verification measurements, tests and checks. At least a release
test shall be done. The manufacturer/supplier shall explain whether maintenance or
repair has a possible detrimental effect on the performance of the WD, the Medical
Technology / Clinical Physics Department together with the DSRD evaluate the
explanation of the manufacturer/supplier and establish the nature and extent of the
release tests.
Logs
In the log all data about the endoscope WD shall be recorded. Every WD has its own
log that kept with the WD. Electronic logs shall be accessible by the user, DSRD and
hospital technicians from their respective work places. The records shall contain at
least:
name, site and address of the owner/contact person;
brand name, type/model, serial number, year of manufacturing of the WD.
The following information shall be recorded in the log:
date of the exchange of process chemical containers, the lot numbers of the
containers and the names of the persons that conducted and verified the
exchange;
overview and results (by reference to SOPs, reports and other documents) of
measurements, tests and checks, including the name of the person that
conducted these;
overview of daily, weekly and quarterly inspections including the name of the
person that conducted these;
overview of the routine cleaning of the WD, including the name of the person that
conducted these
overview of maintenance and the results from the release tests, including the
name of the person that conducted these;
overview of malfunctions and corrections/repairs and the results from the release
tests, including the name of the person that conducted these;
overview of maintenance of water treatment systems and the results from the
release tests, including the name of the person that conducted these;
overview of a the compatible endoscopes and accessories;
date of the exchange of water filters (pre filters and bacterial grade filters) the lot
numbers of the filters and the name of the person that conducted the exchange.
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System specifications
The values for the process parameters (including upper and lower limits) for the
endoscope WD shall be stated, to allow verification, through measurements, that the
machine is still operating within the manufacturer’s specifications. The values of the
process parameters shall be specified by manufacturer of the endoscopes WD,
including the detergent and disinfectant to be used and the concentrations and
temperatures to be used for these process chemicals. All specifications have to be
stated in measurable units, allowing verification of the attainment of these parameters
through measurements.
The parameters for the different process stages are listed in Appendix 6. Depending
on the age, the manufacturer and the type of endoscope WD, additional process
parameters can be applicable or not all process parameter are applicable. For all
process parameters, the values and allowed tolerances shall be specified. The reason
for a process parameter not being applicable, shall be provided.
Changes made by the manufacturer/distributor
As a consequence of a corrective action of the manufacturer, changes can be made to
the endoscope WD. The DSRD shall, in cooperation with the manufacturer, assess
these changes. This shall include the arguments given of the manufacturer and an
evaluation by the DSRD of:
The changes are entered into the log (by the manufacturer);
The influence on the efficacy of the cleaning and disinfection for every type of
endoscopes that can be processed in the endoscope WD;
The influence on the reproducibility of the processes.
The influence on the quality of the final rinse water;
The influence on the efficacy of the self-disinfection process.
The results of these evaluations are documented by the DSRD. If the DSRD
concludes that the efficacy and reproducibility of the endoscope WD are no longer
guaranteed following the changes, he can decide to suspend the use of the
endoscope WD. In the latter case, it is likely that the changes to the endoscope WD
are such, that the type tests as once performed by the manufacturer are no longer
valid. The manufacturer shall redo part of the type tests and hand the results over to
the DSRD.
10.1.2 Verification of the system specification of the drying cabinet
Reliable storage of disinfected flexible endoscopes in drying cabinets is of utmost
importance to guarantee the quality of the endoscope following storage periods longer
than 4 hours.
The verification of drying cabinets is derived from CEN/TC102 N784 NWIP
STORAGE CABINETS-heat-sensitive endoscopes (version January 2008) and is
focused on the Dutch market. This document is only the first draft of a European
standard. The publication of the final version will take considerable time. With this,
SFERD tries to get the verification of drying cabinets moving in the right directions.
Due to the large variety in drying cabinets, the current drying cabinets will be unable to
partially or fully comply with these requirements. For the purchase or replacement of
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Note: The exchange of process chemical containers may be recorded in the log,
however this is often recorded on separate sheet, outside the log.
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drying cabinets it is advised to include the feasibility of performing verification for the
drying cabinets in the purchasing requirements.
Difference between drying cabinet and storage cabinet
A drying cabinet is a cabinet in which a wet disinfected flexible endoscope can be
placed and in which the channels of the endoscope can be connected to blow HEPAfiltered air, warm and/or dry, through these channels. A drying cabinet dries the entire
endoscope,; the channels and the outside. The drying cabinet can be connected to a
track/registration system, allowing to check how long every endoscope has been in
the cabinet.
A storage cabinet is a closed dust free cabinet, with or without overpressure at room
temperature, in which a dried flexible endoscope can be stored. The difference
between a drying and storage cabinet is that the endoscope channels are dried using
HEPA-filtered air in the drying cabinet. For endoscopes without channels, a drying
cabinet is not required.
Documentation
As part of the purchase process for a drying/storage cabinet, a (digital) log shall be
made available. In this log, the following data and documents need to be included:
date of installation on site
product specifications as stated in the schedule of requirements
process specifications as stated by the manufacturer
safety equipment
type test declaration
connection drawings/information for pipework, computer networks etc.
compatibility declaration for endoscopes that can be dried in the cabinet
channel connection protocol for each type of endoscope
loading and unloading protocol
user’s manual
maintenance protocol
cleaning protocol
technical manual
The following needs to specified as well:
• environmental conditions:
o temperature, humidity and rate of air changes in the room where the
cabinet is installed
• power supply:
o voltage and current
• pressurized air:
o capacity, static and dynamic pressures
o quality, particulate matter, humidity, oil content.
System verification of the drying/storage cabinet
Are all documents present?
Is the responsibility set for release of the drying/storage cabinet after installation,
routine maintenance and repairs?
Are all channel connectors and connecting tubes in good order?
Are all channels of every endoscope actually flushed with air?
Are the endoscope hangers in good working order?
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Is all routine maintenance performed as required by the manufacturer?
Is the drying/storage cabinet cleaned as required by the manufacturer?
19
Does the drying/storage cabinet work within its specifications, are the (critical)
parameters within the limits specified by the manufacturer?
Does the drying cabinet indicate an alarm when faults occur in the drying
process?
Does the drying cabinet indicate an alarm when the maximum storage time is
exceeded?
Does the drying cabinet indicate an alarm when a door is not closed?
Does the drying cabinet indicate an alarm when the power fails?
Are the environmental conditions changed?
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Track records
It should be possible to connect the drying cabinet to the endoscope tracking system
that is used in the hospital.
10.1.3 Endoscope inspection
When the endoscope is damaged (e.g. crack in the biopsy channel, torn distal end
rubber), it is possible that a cleaned and disinfected endoscope is still contaminated
despite the flawless cleaning and disinfection process. These type of defects are not
always detected with the air leakage test.
To enable an effective cleaning and disinfection process and subsequent drying in the
drying cabinet, the channel connectors, connecting tubes and the channel separators
shall be in good working order. SFERD proposes to inspect these items annually.
Annual inspection of endoscopes and accessories
The endoscope shall be inspected at least annually. This may be done by the medical
devices technician of the hospital, the endoscope supplier or a third party. The (visual)
inspections should focus on the following hygiene related items:
visual defects;
corrosion and other deposits;
cleanliness of the outside of the endoscope, including the control section and light
source connector;
wear of coatings, readability of insertion depth indicator marks, type and series
number or other identifier;
condition of the connectors to the light source, water bottle, air source and suction
bottle;
function of the RFID chip;
correlation of the RFID chip data and the logs of the endoscope;
manual leakage test of the endoscope, while the distal end is wagging.
10.1.4 Compatibility establishment
The manufacturer of the WD shall declare which endoscopes the WD is able to clean
20
21
and disinfect (declaration of compatibility, see EN-ISO 15883-4 §4.1.3. en §8.a. )
19
Where applicable, e.g. temperature, relative humidity, flow through the channels, flow in the cabinet,
status of HEPA filter.
20
After the complete process in the WD the endoscope shall be free from vegetative bacteria (but not
necessarily spores) and other contamination. The combination of the cleaning process and the disinfection
process shall be designed to achieve this condition, recognising the high level of bacterial contamination
that may exist. It shall be necessary to take into account other factors such as the design of connectors. The
WD manufacturer shall demonstrate this capability during type testing for all the types of endoscope that the
WD is designed to process.
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By adding an endoscope to the list of compatible endoscopes the manufacturer
actually states that the endoscope can be effectively cleaned and disinfected in the
WD, under the condition that the correct channel connectors and channel separators
as well as the prescribed cleaning and disinfection agents are used, and that the
endoscope is prepared for automated processing as prescribed by the manufacturer
22
of the WD; see EN-ISO 15883-4 §4.1.4. .
Most manufacturers of endoscope WDs have a list available of the endoscopes that
can be cleaned and disinfected in the WD. Owners are advised to check whether their
endoscopes are on the list of compatible endoscopes of the WD manufacturer before
purchase of the WD. This check should also be done when a new endoscope is
purchased or a loan endoscope is going to be used.
When the endoscope is on the list of compatible endoscopes there is no need for the
hospital to test whether the endoscope can be effectively reprocessed in the WD. This
has already been established by the WD manufacturer.
Where the WD manufacturer is no able to give a declaration of compatibility, the
hospital should not purchase the particular endoscope, unless the hospital performs
the necessary tests themselves.
Task to perform at initial verification is to check whether:
the endoscopes that are in use, are on the list of compatible endoscopes of the
WD manufacturer;
the correct channel connectors, channel separators and port closures are
available;
the necessary preparations as prescribed by the WD manufacturer (e.g. the
brushing of channels) are incorporated into the operator’s SOP.
Task to perform at re-verification is to check whether:
new endoscopes or loan endoscopes are on the list of compatible endoscopes of
the WD manufacturer. If necessary the WD manufacturer or the endoscope
manufacturer shall establish whether the endoscope can be effectively cleaned
and disinfected in the WD;
the correct channel connectors, channel separators and port closures are
available for the new or loaned endoscope;
de juiste connectoren voor de nieuwe endoscoop aanwezig zijn;
any new or special preparations as prescribed by the WD or endoscope
manufacturer (e.g. the brushing of channels) are incorporated into the operator’s
SOP.
21
In addition to the information specified in ISO 15883-1:2006, Clause 8 the WD manufacturer shall provide
the following information: the devices and/or device families for which the WD manufacturer has evidence
that they can be processed satisfactorily and any precautions necessary for particular devices or operational
conditions
22
The WD manufacturer’s instructions shall recommend that any requirements, e.g. for manual cleaning
and or disassembly of the endoscope, prior to processing in the WD, provided by the device manufacturer
should be followed.
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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10.2 Functional tests and checks
23
Daily checks
User maintenance on the endoscope WD, like the replacement of filters, cleaning and
disinfection agents and the self disinfection of the endoscope WD, shall be carried out
by the department responsible for the decontamination of the endoscopes. The
activities shall be part of the procedures of the department and have to be entered in
the log (see appendix 4 for an example).
On every working day, the endoscope WD shall be visually inspected before it is used.
The visual inspection consists of:
• sufficient amount of chemicals in the containers;
• the containers are in the correct location and are correctly connected,;
• control of the expiry date of the solutions;
• inspection of defects, faults and other inadequacies that can be visibly
detected;
• inspection for leaks;
• inspection for corrosions and other deposits that can be indications of leaks;
• check that the use period/maintenance interval mentioned on the equipment
has not expired.
The manufacturer of the endoscope WD can require additional checks.
10.2.1 Check of the channel separators
The channel separator shall not impair the operation of the machine caused by leaks,
flow restrictions or other limitations.
The check of the channel separators consists of inspection of:
the mechanical operation of movable parts: do parts move smoothly;
attachment of fixed parts; are parts that need to be attached indeed attached
completeness of the channel separator; are parts missing;
state of O-rings and interface with the endoscope;
damage, scratches, bending of parts.
10.2.2 Check of the connectors
The connection between the machine and the endoscope shall not impair the
operation of the machine as a consequence of leaks, flow restrictions or other
limitations
The check of the connectors as a consequence of leaks, flow restrictions of other
limitations:
state of O-rings and interface with the endoscope;
damage of the connector and the tubes attached to it.
23
These daily checks have to be considered as a routine alertness that has to be performed for each
process.
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The following inspections and checks are usually conducted according to the yearly
schedule as described in table 3. When an incident occurs, it is required to investigate
the cause of the incident. Following the correction of the problem, it shall be verified in
the endoscope WD is again operating within specifications.
The nature and extent of the activities required to be performed will depend on the
nature of the incident and the problem that caused the incident. The DSRD shall (let)
draw up a dedicated program of inspections, verifications and checks , and have this
program carried out.
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10.2.3 Check of the connection tubes
The connection tubes shall not be damaged and shall not be blocked by bending or
twisting.
Quarterly inspection
Using a surrogate endoscope, the performance of the channel irrigation control
system (channel obstruction test), the channel connection control system and the
cleaning shall be checked. The tests are performed using a commercially available
surrogate endoscope and/or a comparable test endoscope (as specified in NEN EN
ISO 15883).
10.2.4 Channel obstruction test
The surrogate endoscope has the option to restrict the flow in every channel. The
endoscope WD shall give an alarm for every obstructed channel.
10.2.5 Channel non-connection test
The channels of the endoscope are connected. One of the channels is disconnected
and the process is started. The WD shall indicate a fault. The test is repeated for each
channel. The WD shall give an alarm for every disconnected channel.
10.2.6 Cleaning test
The cleaning test is performed using a (commercially available) indicator. Such a test
provides a quick insight into the performance of the endoscope WD. By comparing the
test results over a period of time, insight can be gained into the reproducibility of the
endoscope WD. Following the post-washing rinse between the cleaning stage and the
disinfection stage, the process is interrupted and the surrogate endoscope is taken
from the WD, unless the manufacturer of the indicator states that the process can be
completed, including the disinfection stage.
The result of the test is recorded and compared to the results of the previous tests.
Attention shall be paid to a negative trend in the results. This can indicate wear of
parts of the WD, that could eventually lead to break down of the machine or to an
unacceptable deterioration of the efficacy of the cleaning and disinfection process.
The cleaning test is also used as a release test following installation, maintenance and
repair.
10.2.7 Testing the efficacy of the self-disinfection cycle
The self-disinfection of the endoscope WD is intended to prevent contamination of the
endoscope WD itself. The self-disinfection is performed according to the instructions
of the manufacturer. During the self-disinfection process, most of the parts of the
system of the endoscope WD, that are not disinfected during routine processes, are
disinfected. For example, these can be parts of the water supply or water treatment
systems (filters).
The microbiological quality of the final rinse water is actually also an indication of the
absence of bacteria in the machine. When a machine is contaminated with a biofilm,
bacteria can be found when the final rinse water is tested. If bacteria are found when
the final rinse water is tested, a water sample shall be taken after the self-disinfection.
This sample shall be test for the presence of bacteria. To do this, the procedure as
presented in appendix 7 can be used.
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10.2.8 Testing the cleanliness of the external surfaces of the
endoscope
Test the cleanliness of the external surfaces of the endoscope, including the control
section and the light source connector. The test is performed visually. Residual
contamination can be made clearly visibly by swabbing the surface with a moist swab.
Using ninhydrin, (see Appendix 11) residual protein on the swab can be stained and
using TMB (see Appendix 12), residual hemoglobin is detected.
NB. ATP measurements are used in the food industry to get a quick and rough
indication of the bacterial contamination on the surfaces. ATP measurements are not
sufficiently developed as a control method for endoscopes. Information on research
and acceptance criteria, to effectively use this method, are lacking.
10.3 Microbial testing
Processes and systems are guaranteed through technical verification. Microbiological
controls can be considered as additional control to this. Microbiological controls can
be considered as valuable trend analysis and to a lesser degree as a critical value,
since no growth from microbiological tests is no guarantee for a successful process.
10.3.1 Microbial quality of the final rinse water
Following installation of the endoscope WD and/or a water treatment system, the
microbial quality of rinse water shall be tested. It is recommended to repeat this test
twice with a week between measurements. Afterwards, a final test shall be performed
a month after the last measurement.
If all results are acceptable (see acceptance criteria of Willes), it is sufficient to test the
microbiological quality of the water quarterly. The protocol for these tests is given in
Appendix 7.
An acceptable result is not only achieved when there are no microorganisms detected
in the final rinse water. The following table specified how the results of the
microbiological tests shall be interpreted and which actions have to be taken, if
necessary. The type of microorganism (pathogenicity) determines the interpretation
and acceptability see Appendix 10.
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NB: The self-disinfection is often a thermal process. The temperature of the final rinse
water can be high, or was high shortly before a sample was taken. As a consequence,
it is highly likely that thermally disinfected water is not contaminated. For some
systems, chemical self-disinfection is performed using a higher concentration of
chemicals, which could lead to a higher level of residue in the rinse water. When a
sample still contains disinfectant, a possible contamination risk might not be detected.
To identify a contaminated endoscope WD or water supply system, it is necessary to
run a routine process following the self-disinfection process and then determine if the
final rinse water of this routine process is free of bacteria.
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Tabel 4 – Acceptance criteria of Willes for a microbiological test of the final rinse water
[ref 28.]
Aerobe colonies Interpretation and possibile action
per 100ml
0
Acceptable.
1-9
Acceptable. Consistent low number of bacteria indicates that a
water treatment system is under control.
10-100
Questionable.
Find the cause of the problem, see Appendix 9 and 10.
>100
Unacceptable. Decommission the endoscope WD until the
water quality has improved.
10.3.2 Microbial testing of endoscopes
Microbial testing of flexible endoscopes, as described in this paragraph, is not
intended to demonstrate adequate performance of the endoscope WD. Therefore,
there is no point in periodically testing endoscopes. However, the SFERD has decided
to include these tests in the handbook, as there can be occasions where it is useful to
verify if the endoscopes could be the source of infections. Endoscopes are only
microbiologically tested following a specific defect of the endoscope, endoscope WD,
water treatment system or drying cabinet and a possible outbreak of endoscope
related infections.
The procedures described are general, which means that for each (type of)
endoscope it has to be assessed which channels and other risk items have to be
tested. The channels of the endoscope can be microbiologically tested by flushing the
channels with sterile saline solution, the method is described in Appendix 7.
Loboratory method
See Appendix 7.
Interpretation of positive cultures
See flow chart and assessment list in Appendix 8 and 10.
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10.4 Audit & Control
10.4.1 Audit of the primary process
Apart from the regular organization-focused audits (eg NIAZ), every department where
scopes are cleaned and disinfected shall be audited by the DSRD, together with the
department for infection prevention. These audits, as recommended by the Dutch
Healthcare Inspectorate, shall focus on rooms, facilities, equipment, logs and
procedures. These audits can have a general of thematic approach. An example of a
general audit is included in Appendices 17 and 18. The results and any proposals for
improvement are reported to the responsible manager.
10.4.2 Audit of Department of medical technology/Clinical Physics
and maintenance
In accordance with the advice of the Dutch Healthcare Inspectorate, a yearly audit is
performed by the DSRD to verify the maintenance, verification and registration of the
endoscope WD’s, endoscopes and drying cabinets, which is done by the Department
of medical technology/Clinical Physics. An example of such an audit is included in
Appendix 19. The results and possible proposals for improvement are reported to the
responsible manager.
10.4.3 Audit of incident procedure
Apart from the requirement to perform yearly audit on the activities done according to
general procedures related to endoscope disinfection, the Healthcare Inspectorate
promotes the yearly evaluation of the effectiveness of the incident handling, together
with tracking and tracing. To do this, the DSRD has to think up a possible incident and
assess if all patients involved can be traced using the look back procedure. The
effectiveness of the agreements within the institution on this for the available expertise
at infection prevention, technical and management level have to be visibly evaluated.
The actions taken, findings related to handling the practice incident and the points for
improvement need to be documented.
In particular, this means:
thinking up the incident;
analyzing the risk on equipment level/procedure/microbiological risk;
acting on deviations, preventing the occurrence of subsequent risks;
analyzing the patients involved that were exposed to the risky agent;
involving the required expertise to identify the risk for patients;
evaluating the risk for the current group of patients (track and trace);
Involving the relevant practitioners and formulating the strategy, formulating an
approach for at least patient information/patient treatment and communications.
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10.3.3 Microbiological testing of loan endoscopes
Apart from the compatibility declaration, as described in paragraph 10.1.4, loan
endoscopes can be tested microbiologically as described in 10.3.2. However, in
practice, loan endoscopes are to be used immediately, which does not allow waiting
for the results of the culturing of microbiological samples taken.
Apart from the compatibility declaration of the distributor of the endoscope stating that
the endoscope can be safely cleaned and disinfected in the endoscope WD used, it is
advised to ask for a declaration that the endoscope has only been used on human
subjects.
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Following all these activities, the incident has to be evaluated to be able to improve
this type of procedures or evaluations. Possibly, new ideas for a practice incident can
be generated.
10.4.4 Audit of the reprocessing persons’ expertise
The workers that operate the endoscope WD, shall be qualified and competent. For
every worker, there has to be a portfolio, demonstrating the education, in-service
training and refresher courses. Check that the portfolios are available.
10.4.5 Audit of the registration of the replacement of cans of
chemicals
In cast the process of replacing the chemical is not guaranteed by automation (e.g.
using RFID) or incorrect replacement isn’t prevented by technical means (e.g. using
guards), the replacement of a can shall be verified by another worker shall be
documented. It shall be checked that this list is correctly and completely filled in.
10.4.6 Audit of logs
Several aspects shall be recorded in logs (see 10.1.1 en 10.1.2). It shall be checked
that logs are correctly and completely filled in.
10.4.7 Audit of registration for traceability
Check if the relation between patient, medical practitioner, endoscope, cleaning
process and drying cabinet is being recorded. Verify that the incident procedure has
been assessed in accordance with 10.4.3.
10.4.8 Audit omission of protocols
All protocols shall be available, clear and up-to-date. Test at random if this is the
case.
10.4.9 Audit of management plan
The management plan shall be present and up-to-date and every relevant officer
within the organization shall be aware of it. Check if this is the case by asking relevant
officers.
10.5 Release of the primary process
Every year, all results of the management measures (10.1-10.4) are verified by the
DSRD. Is one or more aspects are not sufficient, the DSRD assesses the severity of
the deviation and the DSRD shall decide which improvement measures are
necessary. If the deviation could result in risks for patient safety, the DSRD can decide
to (temporarily) stop the process.
When a WD it put into operation following purchase, maintenance or verification
activities, the user shall be attentive to possible deviation in the functioning of the
endoscope WD. The department of Medical Technology /Clinical Physics or the DSRD
shall always be involved in case of unexpected results.
Attention of workers involved in disinfection can reveal possible failures and reduce
risks.
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Approval marking
If the verification indicates that het endoscope WD is safe to use, this shall be clearly
marked on the endoscope WD using an approval sticker issued by the department of
Medical Technology /Clinical Physics. The validity until the next scheduled date of
maintenance is to be mentioned on the sticker.
Disapproval marking
If the verification indicates that het endoscope WD is not safe to use, the endoscope
WD shall be decommissioned. This shall be clearly marked on the endoscope WD
using a decommissioned sticker. This sticker shall be red and include the
decommissioning date. Decommissioning occurs when e.g. damage to the endoscope
WD prevents it to be used safely, maintenance/repair is no longer possible or when
this is a clear conclusion from the verification.
The data shall be recorded in the log, including het conclusion “not to be used”. The
decommissioning has to be done in manner that prevents the endoscope WD from
being used.
10.5.2 Functional release of endoscope WD
Following technical release by the department of Medical Technology /Clinical Physics
, the endoscope WD is functionally released by the DSRD. On the basis of functional
requirements, the DSRD can decide not to release the system functionally and/or to
have additional technical, microbiological or functional tests performed.
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10.5.1 Technical release of endoscope WD
Technical approval/release of equipment is performed by the department of Medical
Technology/Clinical Physics if all requirement form paragraph 10.1 are fulfilled.
Rejection occurs when one or more requirements are not fulfilled. The DSRD
assesses the severity of the deviation and decides, in consultation with the
department of Medical Technology /Clinical Physics if the endoscope WD is to be
decommissioned.
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
Appendix 1- Bibliography
[2.] State Supervision Public Health, Letter to
Pulmonologists, directors of hospitals,
medical microbiologists, hospital hygienist,
Hospital Pharmacists and Experts sterilised
medical accessories, GHI/INFZ/93647;
Rijswijk, November 1993
[3.] State Supervision Public Health, Health
Care Inspectorate report "Scope Disinfection
in Dutch hospitals", The Hague, April 2000
[4.] State Supervision Public Health, Health
Care Inspectorate report 'Follow-up research
scope Disinfection ", The Hague, June 2004
[5.] Workgroup Infection Prevention, directive
"Cleaning and disinfection of endoscopes",
Leiden, April 2009 (www.wip.nl)
[6.] State Supervision Public Health, Letter to
Hospital managements or Board of Directors
of hospitals, medical microbiologists and
hospital hygienist, 1997-1905 IGZ, Rijswijk,
March 1997
[7.] Bronchoscopy related Infections and
Pseudoinfections in New York, 1996 and
1998, MMWR Weekly, July 9, 1999 / 48(26);
557-560
[8.] Agerton et al., Transmission of a highly
Drug Resistant Strain (Strain W1) of
Mycobacterium tuberculosis, JAMA, October
1, 1997 – vol 278, No. 13
[9. ] Michele et al., Transmission of
Mycobacterium tuberculosis by a fiberoptic
brochoscope, JAMA, October 1, 1997 – vol
278, No. 13
[10.] NEN-EN-ISO 15883, Disinfecting
wasing machines.
[11.] Workgroup Infection Prevention,
directive "Storage and transportation of used
instruments for sterilisation", Leiden,
December 2007 (www.wip.nl)
Version 3.1, 2014
[12.] Construction standards, central
sterilisation department, Board for
Healthcare Institutions, November 18, 2002
[13.] Construction atandards consultation
department, outpatient therapy and general
examination organfunction; Board for
Healthcare Institutions, 2004
[14.] NEN 1010 Safety requirements for low
voltage installations
[15.] NEN-EN-7396-1 Medical gas pipeline
systems - Part 1: Pipeline systems for
medical gases under pressure and vacuum
[16.] Safety program prevent damage, work
safely in Dutch hospitals, Health, Welfare
and Sport (VWS), June 2007
[17.] ESGE/ESGENA guideline for process
validation and routine testing for
reprocessing endoscopes in washerdisinfectors. Endoscopy 2007; 39: 85-94
[18.] ESGE/ESGENA guideline for quality
assurance in reprocessing: Microbiological
surveillance testing in endoscopy.
Endoscopy 2007; 39: 175-181
[19.] Standards for Endoscopic Facilities and
Services, 3th Edition 2006.
Gastroenterological Society of
Australia/Gastroenterological Nurses Society
of Australia
[20.] ESGE Guideline for Quality Control of
Endoscope Service and Repair (2004).
Endoscopy 2004;36(10):921-3
[21.] ESGE/ESGENA Technical Note on
Cleaning and Disinfection (2003) Endoscopy
2003; 35: 869 – 877
[22.] ESGE-ESGENA guideline: Cleaning
and disinfection in gastrointestinal
endoscopy, update 2008;Endoscopy 2008;
40: 939-957
[23.] "Clean" is not clean enough,
microbiological safety around endoscopy can
be improved J. Kovaleva et al, Medisch
Contact 64 No. 23, June 4, 2009: 10411043.
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[1. ] State Supervision Public Health, Letter
to Hospital Managements, Hygienists /
departments hospital hygiene,
pulmonologists, medical microbiologists and
hospital pharmacists about brochoscopes,
GHI/JK/DV/93557; Rijswijk, February 1993
PROCESS
VERIFICATION
[24.] Letter Report 360050013/2008 quality
of cleaning and disinfection of flexible
endoscopes Reprise Adrie de Bruijn, Arjan
van Drongelen RIVM, July 2008
[25.] State Supervision Public Health, Health
Care Inspectorate report 'Risks of medical
technology underestimated ", The Hague,
October 2008
[26.] CEN/TC102 N784 NWIP STORAGE
CABINETS-heat-sensitive endoscopes,
Version 1, september 2004
[27.] Directive 93/42/EEC European Council
of 14 June 1993 concerning medical
accessories
[28.] Willis, C., Bacteria-free endoscopy rinse
water - A realistic aim? Epidemiology and
Infection, 2005. 134(2): p. 279-284
bronchoscope. JAMA 1997 Oct 1;
278(13):1073-7
[35.] Chauffour X, Deva AK, et al. Evaluation
of disinfection and sterilization of reusable
angioscopes with the duck hepatitis B model.
J.Vasc Surg. 1999 Aug ; 30(2) :277-82
[36.] Cox R, deBorja K, et al. A pseudooutbreak of Mycobacterium chelonae
infections related to bronchoscopy. Inf.
Control Hosp. Epid. 1997 Feb; 18(2):136-7
[37.] Kressel AB, Kidd F. Pseudo-outbreak of
Mycobacterium chelonae and
Methylobacterium mesophilicum caused by
contamination of an automated endoscopy
washer. Inf. Control Hosp. Epid. 2001 Jul;
22(7):414-8
[29.] Performance Indicators Quality
Assurance Medical Systems, Dutch Society
of Clinical Physics, May 2007
[38.] Silva CV, Magalhaes VD, et al. Pseudooutbreak of Pseudomonas aeruginosa and
Serratia marcescens related to
bronchoscopes. Inf. Control Hosp. Epid.
2003 Mar; 24(3):195-7
[30.] Guideline Responsibility medical
specialist in maintenance and management
of medical equipment, Order of Medical
Specialists, October 17, 2008
[39.] EN-ISO 17664 (2004) Sterilization of
medical devices - Information to be provided
by the manufacturer for the processing of
resterilizable medical devices
[31.] Pidduck D. Cross infection and the
laryngoscope. Br. J. Perioper. Nurs. 2002
May; 12(5):170-5.
[40.] Quality Act Healthcare Institutions,
2010
[32.] Lo Passo C, Pernice I, et al.
Transmission of Trichosporon asahii
oesophagitis by a contaminated endoscope.
Mycoses. 2001; 44(1-2):13-21
[33.] Wenzel RP, Edmond MB. Tuberculosis
infection after bronchoscopy. JAMA 1997
Oct 1; 278(13):1111
[41.] Act on professions in individual
healthcare, 1993
[42.] A. J. Buss, M. H. Been et al.
Endoscope disinfection and its pitfalls ±
requirement for retrograde surveillance
cultures. Endoscopy 2008; 40: 327-332
[43.] Decree sterilised medical
[34.] Agerton T, Valway S, et al.
Transmission of a highly drug-resistant strain
(strain W1) of Mycobacterium tuberculosis.
Community outbreak and nosocomial
transmission via a contaminated
72
accessories in hospitals, Article 7
paragraph 3 (1983)
[44.] Decree sterilisation companies
medical accessories, Article 6
paragraph 3 (1989)
Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
Appendix 2 – Form for transport of a damaged or leaking
endoscope
Checklist for user
The exterior of the endoscope has been wiped off with alcohol
The channels have been dried
Note: If an endoscope is sent in “wet”, this can lead to major damage to it.
Label indicating "disinfected yes/no" attached to the endoscope
Failure reported to department of Medical Technology/Clinical Physics
To be completed by the user
Inventory code for the endoscope
Description of the problem
The endoscope has been …. by the user:
wiped off with alcohol
manually cleaned
mechanically disinfected
Inventory code for the
washer-disinfector
Checklist for the technician
Handle the endoscope while wearing gloves. If necessary wear safety goggles and a
mouth mask.
Wrap the endoscope in foil and take it to the transportation case.
Indicate both on the inside and outside of the case whether manual pre-cleaning
and/or disinfection has been performed.
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Appendix 3 – Sample decontamination declaration
I the undersigned hereby declare that the flexible endoscope:
Number……………………………………
Type…………………………………
Institution name: …………………………
Department……………………………
has been decontaminated (completely cleaned and disinfected) and not used on
animals, cadavers and/or in a pathological anatomy laboratory.
The flexible endoscope was last processed for cleaning and disinfection in:
[WD brand]
Machine number 1
Machine number 2
Machine number 3
WD no
Sent for repair to company: ...................................................................
Checking and assessment of complaint handled by (MID) :
Name: .............................................................................................................................
Date sent: ............................................................................................................
Place: …………………………………………………………………………………………
Signature:
……………………………………………………………………………………………..
* fill form in completely.
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Appendix 4 – Users maintenance of the endoscope WD
Form: Start en check of the endoscope WD
Malfunctions
Weekly
Cleaning of the drain + WD
Weekly
Descaling
Exchange of disinfectant container
2x autograph
Exchange of detergent container
2x autograph
Daily
Cleaning of control panel and handles
Daily
Check channel connecting tubes
Daily
Check O-seals of channel connectors
and separators
ontrole O-ringen
Daily
Check amount of detergent and
disinfectant
Every 1st day of the week
Self-disinfection
Date
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Year 20……
Month …………………
Endoscope WD identification number …………………..
Appendix 5 – Release form for flexible endoscopy after
maintenance
Release Washer-disinfector
specification: ……………………………..
Technical validation correct
dated ……………….
by: ……………
Microbiological validation correct
dated……………….
by: ……………
Release Flexible Endoscope
specification: ……………………………..
Technical validation correct
dated ………………
by: ……………
Microbiological validation correct
dated ………………
by: ……………
Release Drying Cabinet
specification: ……………………………..
Technical validation correct
dated……………
by ………….
The aforementioned instrument is hereby released for responsible use for up to one
year after the date of signature. The release is no longer valid if the instrument /
equipment has been repaired/subjected to radical maintenance during that period.
Date of release: …………………….
Signature of Expert on Endoscope Cleaning & Disinfection (DSRD):
……………………………………………
This release statement is filed by the DSRD and a copy of this statement will be sent
to the head of Medical Technology/Clinical Physics and the head of the endoscopy
department.
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Appendix 6 – System specifications of the endoscope WD
Parameter
Manufacturer
specified value
and tolerances
Measured
value
Conforming:
Yes/No/
Remarks
I Pre-rinse
Number of rinses
Amount of water taken in
Quality of the water that is taken in (see VI)
Temperature of the water that is supplied to the WD
The time required for the WD to heat the water to rinse
temperature
The temperature of the water during rinsing
The duration of the rinse (the time interval after the rinse
temperature is attained)
II Cleaning
Amount of water taken in
Quality of the water that is taken in (see VI)
Dosing of detergent
The time required for the WD to heat the detergent solution to
cleaning temperature
The temperature of the detergent solution during the cleaning
phase
The temperature of the chamber walls during the cleaning
phase
The duration of the cleaning phase (the time interval after the
cleaning temperature is attained)
The pressure delivered by the circulation pump
The flow of cleaning solution through the channels of a worst
case endoscope as identified by the WD manufacturer or the
pressure at the connection to the endoscope channels:
•
Suction
•
Biopsy
•
Biopsy 2
•
Water
•
Air
•
Jet
•
CO2
•
Elevator
•
Balloon filling
•
Balloon emptying
Rotation speed of washing arms
III Intermediate rinse (between cleaning and disinfection)
Number of rinses
Amount of water taken in
Quality of the water that is taken in (see VI)
Temperature of the water that is supplied to the WD
The time required for the WD to heat the water to rinse
temperature
The temperature of the water during rinsing
The duration of the rinse (the time interval after the rinse
temperature is attained)
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Parameter
Manufacturer
specified value
and tolerances
Measured
value
Conforming:
Yes/No/
Remarks
The pressure delivered by the circulation pump
IV Disinfection
Amount of water taken in
Quality of the water that is taken in (see VI)
Dosing of disinfectant
The time required for the WD to heat the disinfectant solution
to disinfection temperature
The temperature of the disinfectant solution during the
disinfection phase
The temperature of the chamber walls during the disinfection
phase
The duration of the disinfection phase (the time interval after
the disinfection temperature is attained)
The pressure delivered by the circulation pump
The flow of disinfectant solution through the channels of a
worst case endoscope as identified by the WD manufacturer
or the pressure at the connection to the endoscope channels:
•
Suction
•
Biopsy
•
Biopsy 2
•
Water
•
Air
•
Jet
•
CO2
•
Elevator
•
Balloon filling
•
Balloon emptying
V Post-rinse
Number of rinses
Amount of water taken in
Quality of the water that is taken in (see VI)
Temperature of the water that is supplied to the WD
The time required for the WD to heat the water to rinse
temperature
The temperature of the water during rinsing
The duration of the rinse (the time interval after the rinse
temperature is attained)
VI Quality of the water used in the WD
Temperature
Hardness
Mineral content, other than water hardness
Number and type of micro organisms
Details of built in water softeners, ion exchangers, ROmembranes, etc.:
•
Maintained as required
•
Disinfected as required
Built in filters
•
Prescribed filter type installed
•
Maintained as required
•
Disinfected as required
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Parameter
Manufacturer
specified value
and tolerances
Measured
value
Conforming:
Yes/No/
Remarks
Note: The specified water qualities may be different for the
process phases.
VII Self-disinfection
Amount of water taken in
Quality of the water that is taken in (see VI)
Temperature of the water that is supplied to the WD
Where applicable; dosing of disinfectant
The time required for the WD to heat the water solution to selfdisinfection temperature
The temperature of the water solution during the selfdisinfection phase
The temperature of the chamber walls during the selfdisinfection phase
The duration of the disinfection phase (the time interval after
the disinfection temperature is attained)
The pressure delivered by the circulation pump
VIII Purging of the channels at the end of the cycle
Quality of the air that is used for the purging of the channels
Air pressure
Air temperature
Settings of the pressure limiter (to prevent damage to the
endoscope)
Duration of the purging
IX Leak test
Note: The parameters of the leak test have no direct influence
on the effectivity of the cleaning and disinfection of the
endoscopes. However, the leak test is an important part of the
cycle and the parameters are easily verified.
Pressure (at which the test is conducted)
Settings of the pressure limiter (to prevent damage to the
endoscope)
Setting of the pressure decline during the test that should raise
an alarm.
Maximum allowed temperature change of the endoscope
during the test.
X Monitoring, recording and fault indication systems, set
limits and allowed tolerances
Limits of the flow reduction or pressure increase (or the
change of any other relevant parameter) during the channel
non obstruction test, that will cause the indication of a fault.
Limits of the flow increase or pressure reduction (or the
change of any other relevant parameter) during the channel
non connection test, that will cause the indication of a fault.
The limit of the maximum pressure that may occur in the
endoscope channels before a fault is indicated.
Limits of the min/max temperature that will cause the
indication of a fault.
Limits to the min/max dose of detergent and disinfectant that
will cause the indication of a fault.
Maximum duration or maximum number of cycles for which a
Version 3.1, 2014
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Parameter
Manufacturer
specified value
and tolerances
Measured
value
Conforming:
Yes/No/
Remarks
disinfectant may be reused.
For monitoring systems that check the nature of the detergent
and/or disinfectant (e.g. viscosity, refraction index, colour, pH)
in order to detect whether the correct product is placed in the
WD, the limits of the measured parameter, that will cause the
indication of a fault. .
The parameters that are recorded during the cycle.
The accuracy of every system that records a parameter.
The specifications of any safety devices for the particular WD.
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Appendix 7 – Microbial quality
Final rinse water
Test for aerobic mesophilic bacteria
Frequency
Quarterly, at verification and after repairs that may influence the
water quality
Sample size
100cc
Method
0,22 – 0,45 µm filter
Growth medium
Filter on R2A ager plate
o
Incubation temperature
28-32 C
Incubation time
5 days
Acceptance criterion
<10 CFU/100ml. See annex 10 Checklist positive cultures from
endoscopes or WD
Test for environmental Mycobacteria
Frequency
Per event, e.g. proven inadequate cleaning phase or increasing
number of patients with (atypical) Mycobacteria
Sample size
Method
Refer to the sampling method and culture method prescribed by
Growth medium
the laboratory that performs the test.
Incubation temperature
Incubation time
Acceptance criterion
No Mycobacteria
Test for Legionella
Frequency
Method
The (drinking)water supply in the hospital is monitored in line
with the Legionella-control measures
No further tests are indicate for the quality assurance of
endoscope reprocessing.
The water treatment system shall be maintained and disinfected as instructed by the
manufacturer. Check whether this is done before doing any microbial tests.
- Carry out a normal operating cycle, especially when samples are taken after selfdisinfection of the WD;
- Where the manufacturer prescribes a specific sampling method this method shall
be used. The protocol should be based on a real-time process and fulfil the
requirements of EN-ISO 15883-4;
- Aseptically take a sample from the final rinse water. Use the sampling procedure
24
provided by the WD manufacturer . The sample should be at least 100 ml and be
collected in a sterile container;
- Where the final rinse water is disinfected by the addition of disinfectant in the final
rinse water, a neutralizing agent shall be added to the sample immediately after
collection. The WD manufacturer shall identify suitable neutralizing agents.
24
NEN EN ISO15883-4:2008 §8 Information to be supplied by the manufacturer
Version 3.1, 2014
81
Procedure for the microbial study:
- Filtrate the water sample through a 0,22-0,45 µm membrane and transfer the
25
membrane to a R2A-agarplate .
Warning: The technique of ‘sample plating’ using an ‘inoculation eye’ is unsuitable
to detect small amounts of bacteria.
- Incubate for at least 5 days, at 28 to 32 ºC
- Check for growth and count CFUs.
- There shall be less than 10 CFU/100 ml (see annex 9).
- In case of growth (> 10 KVE/100 ml) determinate the bacteria species.
- Where the WD is used for the cleaning and disinfection of bronchoscopes, the test
shall be repeated for Mycobacteria and/or Legionellae whenever there growth.
26
This requires specific culture media and incubation periods . The water shall be
free from these species.
Acceptance criteria:
- See acceptance criteria Willes, clause 10.3.1
- See annex 9 Flowchart Culture of final rinse water
- See annex 10 Checklist positive cultures from endoscopes or WD
Endoscope channels
Materials for sampling
gloves
sterile luer syringes 25 ml
if necessary sterile needles
100 ml sterile physiological saline
solution
sterile tubes
sterile containers
sterile brush or sponge
sterile channel separator
laboratory form for tests
25
NEN EN ISO 15883-1:2006 §6.4.2.4
26
NEN EN ISO 15883-4 Annex B3 en B4
82
Remark
number needed depends on the number of
channels
20 ml per channel
(elevator channel to be rinsed twice with 10ml if
necessary)
number needed depends on the number of
channels
number needed depends on the number of
channels
to mobilize biofilm
to ensure that the correct channel is sampled
Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
27
Sample collection
- It takes two persons to aseptically sample an endoscope
- Both persons disinfected their hands and don gloves
- After the operating cycle disconnect the endoscope from the WD (see
manufacturer’s instructions
- Where possible leave the endoscope in the WD, or position the endoscope on a
sterile workbench
- Position a channel separator
- Ensure that all of the endoscope’s channels are sampled: suction/biopsy channel,
water/air channel, elevator channel (ERCP endoscope), jet channel, etc.
- Where necessary use a sterile tube to connect the syringe to the endoscope
channel.
- Close/cap the biopsy port. Flush the suction channel with 20 ml sterile
physiological saline solution and collect the fluid from the distal end into a sterile
container. While keeping the distal end submerged in the collected fluid, suck and
press the fluid strongly through the channel for three times. Use the syringe to
purge the channel with air, until all liquid is expelled and collected.
- Close/cap the suction channel. Flush the biopsy channel from the biopsy port
down to the distal end, with 20 ml sterile physiological saline solution and collect
the fluid from the distal end into a sterile container. While keeping the distal end
submerged in the collected fluid, suck and press the fluid strongly through the
channel for three times. Use the syringe to purge the channel with air, until all
liquid is expelled and collected.
- Using a well-fitting sterile brush or sponge brush the suction and biopsy channel.
Shake the brush in the container with rinsing liquid or when using a single use
brush, cut it off.
- Flush the air/water channels with 20 ml sterile physiological saline solution and
collect the fluid from the distal end into a sterile container.
- Flush the elevator channel with 20 ml sterile physiological saline solution, if
necessary in two portions of 10 ml each, and collect the fluid from the distal end
into a sterile container.
- Flush any other channels with 20 ml sterile physiological saline solution and
collect the fluid from the distal end into a sterile container.
- Mark and date all samples.
- Complete the lab form with all required information and the reason of sampling
(periodic monitoring / post repair / post purchase / repeated sampling after positive
culture).
- Transfer all samples to the lab as soon as possible. Where it takes more than 4
hours to get the samples to the laboratory additional precautions may be
necessary as indicated by the laboratory.
27
A retrograde sampling technique can also be used; see [ref 42]
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Appendix 8 – Flowchart flexible endoscope culture
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Appendix 9 – Flowchart Final rinse water culture
Microbiological control final
rinse water washer-disinfector
Determination
laboratory according
to ISO 15883
Assessment list
positive cultures
Protocol sample
collection
Determination
laboratory according
to ISO 15883
Assessment list
positive cultures
Filter sample
Culture
> 10 cfu/100 ml
no
End procedure
yes
Perform self-desinfection
and recollect sample after
replacing new water filters
Culture
> 10 cfu/100 ml
no
End procedure
yes
Take washer-disinfector out
of service and contact the
manufacturer / supplier
ja
no
Defect or possible
cause identified?
Discard washerdisinfector
yes
Perform self-disinfection and
recollect sample after
replacing new water filters
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Appendix 10 – Checklist positive cultures form
endoscopes and/or WDs
MICROORGANISMS
Escherichia coli,
other
Enterobacteriaceae
Enterococcus
Pseudomonas
and other nonfermenting Gramnegative rods
POSSIBLE CAUSES
inadequate cleaning and/or
disinfection procedure
(especially in case of manual
cleaning)
−
−
verify the reprocessing cycle, with special
attention for the manual cleaning
re-culture the endoscope that tested positive
−
mechanical or electronic
malfunctions of the WD or
defective endoscope
−
−
−
complete maintenance of the WD
culture the final rinse water
re-culture the endoscope that tested positive
−
−
−
insufficient rinsing
contamination of rinsing water
contamination of the WD due o
mechanical or electronic
malfunctions
contamination of filters
defective endoscope
−
−
−
verify water supply and audit the procedures
for manual and/or automated rinsing
complete maintenance of the WD and the
filters
re-culture the endoscope that tested positive
culture the rinse water
insufficient drying of the
endoscope during storage
defective endoscope
−
−
verify the performance of the drying cabinet
re-culture the endoscope that tested positive
−
−
audit the procedures for storage and transport
re-culture the endoscope that tested positive
−
−
−
−
−
Staphylococcus
aureus,
Coagulase Neg
Staphylococci
Micrococcus
Bacillus species
ACTION
−
re-contamination of the
endoscope as the result of:
• inadequate storage and
transport
• inadequate hand hygiene
−
−
contamination of the sample as
the result of faulty sampling
technique or faults during
culturing
−
−
audit the procedures for sampling and culturing
re-culture the endoscope that tested positive
−
in-effective drying cycle
−
audit the drying procedure and verify the
ventilation in storage
re-culture the endoscope that tested positive
−
Atypical
Mycobacteria
Legionella
(special culture
technique)
−
−
contamination of the
contamination of the water
supply
−
−
−
−
86
verify the (drinking)water supply system and
audit the procedures for manual and/or
automated rinsing
complete maintenance of the WD and the
filters
re-culture the endoscope that tested positive
culture the rinse water
Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
Appendix 11 - Ninhydrin swab test
Note: This provides the basic procedure, the amounts of liquids and the incubation
28
time need to be quantified for the particular swabs that are used.
Materials
• Swabs; simple cotton swabs with a plastic handle.
• Incubator set to 220 °C
• If necessary injection needles (0.9 x 70) inserted into the hollow plastic
handles of the swabs, to prevent them from bending during incubation.
• Water for injection.
• Ninhydrin (ordernr. N4876, Sigma, Netherlands) 2 % in 70 % isopropanol
(ordernr. 1.09634.1000, Merck, Netherlands) in water, used within 3 weeks
after preparation.
• 2 pipets to dispense 50 µl liquid.
Method
• Select an endoscope that is clearly visibly contaminated with blood and/or
other debri after use.
• Label the endoscope.
• Clean the endoscope as usual.
Assessment of the cleaned endoscope
• Assess the cleanliness of the endoscope by visual observation. Observe the
presence of stains, colour deviations, foreign materials, water marks, etc.
Note the observations.
• Apply 50µl of water on a swab and strongly rub the surface of the endoscope.
• Check the cleanliness of the swab and observe whether the surface has given
off any visible material to the swab. Note the observation.
• Apply additional 50µl ninhydrin solution to the swab and incubate the swab for
3,5 minutes.
• Observe the swab and check for the presence of purple colorations that
indicate the presence of protein was present.
28
See A.C.P. de Bruijn, T.H.J. Orzechowski, C. Wassenaar “Validation of the ninhydrin swab test to monitor
cleaning of medical instruments”. Zentralsterilisation 4/2001.
Version 3.1, 2014
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Appendix 12 – Hemoglobin swab test
By using the pseudo-peroxidases activity of van hemoglobin, traces of blood residues
can be detected. An amount of blood as small as 0,1 µg will give a colour reaction that
the clearly visible even when the blood is dried or denatured. The peroxidases activity
of hemoglobin works in the presence of hydrogen peroxide as a catalyst in the
oxidation of chromogen, resulting in a clearly visible colour reaction. Blood residues
turn into an intense blue colour within seconds.
This peroxidases activity in blood will even render a positive result after treatment with
heat, alkaline or aldehydes. Oxidizing process chemicals such as hydrogen peroxide,
can influence the test negatively. This test method is therefore not suitable to
demonstrate the presence of blood on items that have been treated with such
chemicals.
Materials
TMB-test, consisting of:
0,1 % tetramethyl benzidine (TMB) in 5 % acetic acid;
3 % hydrogen peroxide solution;
1 % SDS solution, for the sampling of lumen.
Activate 1 ml of TMB solution by adding four drops of the 3 % hydrogen peroxide
solution. The activated solution is now ready for use.
Note: TMB may be purchased ready for use from the laboratory suppliers.
Equipment
• Glass tubes;
• Cottons swabs, free form peroxidases (verify!);
• 1 ml pipets;
• Syringes, 10 ml, for the flushing of lumen.
Selection of the endoscope to be sampled
• Select an endoscope that is visibly contaminated with blood.
• Label the endoscope.
• Clean the endoscope as usual.
Sampling method
Direct method
The activated TMB solution may be applied to the surface of the endoscope using a
pipet or a saturated swab, to visualise blood residues in situ.
Swab method
Verify that the swab itself does not give a colour reaction by performing a negative
control.
Fill a glass tube with 1 ml of activated TMB solution. Use a swab to sample the outer
surfaces of the endoscope. When the surfaces are dry, moisten the swab with a drop
of water of 1% SDS solution.
Insert the swab into the activated TMB solution.
Flushing method for hollow instruments
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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Blood residues in lumen can be detected by flushing the lumen with several millilitres
of 1 % SDS solution. The presence of hemoglobin can be demonstrated with microhaematuria dipsticks.
Acceptance criteria
The result of the cleaning process is acceptable when none of the samples show
presence of blood residues. When the use of micro-haematuria dipsticks
demonstrates the presence of more than 10 molecules hemoglobin per microliter
eluent, this indicates the presence of blood residues.
Safety
Handling reagents
The information that is provided by the manufacturer of the reagents, e.g. safety data
sheets, shall be followed. Where necessary protective clothing, gloves and goggles
shall be worn.
Waste removal
All reagent wastes need to discarded in conformance with the in-house rules. Medical
devices that have been in contact with activated TMB solution or SDS solution shall be
reprocessed before further use.
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Appendix 13 – Release form for flexible endoscopes
Release form for flexible endoscopes
Washer-disinfector:
Date:
Time
Endoscope
number
Tubes
connected
Channel separator
present
End caps
present
Entire
programme
completed
Control by
Appendix 14 – Schedule of requirements for washer-disinfector
I
Purpose of the washer-disinfector
Cleaning and disinfection of flexible endoscopes and their accessories.
II
Interaction with endoscopes and their accessories
It must be possible to clean all types of flexible endoscope and accessories in accordance with the required procedure
III Patient categories
N/A
IV Users
Staff in CSA, inpatient or outpatient examination departments.
Requirement/ Demand
1. Legal requirements
M edical Devices Directive
EN standard
EN 60601
NEN-EN-IEC 61010-2-040:2005
EN 1717
WIP directives
Occupational health, safety
and environment
2. Validation
Explanation
Yes No
1.1 The washer-disinfector has a CE label under the Medical Devices Directive 93/42/EC.
1.2 The washer-disinfector complies with EN ISO 15883-1 and EN ISO 15883-4
1.3 The washer-disinfector meets the electrical safety standard (EN 60601).
1.4 The washer-disinfector meets the safety requirements for electronic equipment - Part 2040: Special requirements for sterilisers and washer-disinfectors used to treat medical
supplies.
1.5 The connections of the washer-disinfector meet the requirements of the water supply
company (EN 1717)
1.6 The washer-disinfector complies with the WIP directive "Cleaning and disinfection of
endoscopes", (www.wip.nl).
1.7 The washer-disinfector complies with the occupational health and safety law
(www.arbo.nl).
Yes No
2.1 The cleaning and disinfection processes have been validated and a validation report is
present (supply copy).
2.2 There is an installation qualification program/protocol (provide programme/protocol ).
2.3 There is a qualification programme/protocol for the release for the process (provide
programme/protocol ).
2.4 The supplier has a list of critical process parameters (including criteria) that can/should
be validated (enclose list)
2.5 The supplier provides training for external validators (certificate is issued).
2.6 Supplier indicates how the training is structured and which validators have attended it
(enclose list of validators).
2.7 The supplier makes a dummy endoscope available for validation
2,8 The supplier provides documentation showiing how validation should be carried out and
what form the validation should take.
2,9 The supplier indicates how the last rinse water from the machine can be sampled for microbiological investigation.
Yes No
3. Occupational health and safety and environment
3.1 Supplier indicates the water consumption (specify consumption).
3.2 Supplier indicates energy consumption (specify consumption).
3.3 The supplier/ manufacturer accepts returns of washer-disinfectors which need to be
replaced
3.4 The substances contained in the cleaning agent and disinfectant are permitted under the
disposal permit
3.5 The detergent and disinfectant are deliverer in an appropriate UN approved package.
3.6 A safety sheet for the detergent and disinfectant is present.
3.7 Indicate the average quantity of residual liquid in the storage tank
3.8 The washer-disinfector is equipped with facilities to prevent
- substances from being released into the environment;
- substances remaining in the user-accessible areas of the units;
- substances remaining on the treated endoscopes?
3.9 The working height complies with occupational health standards (state specified
working height)
3.10 There is an extraction system on the washer-disinfector (specify size).
3.11 During the entire process the noise level remains at or below 65dB (A) (provide test
report).
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91
4. Technical requirements
Technical aspects
Yes No
4.1 The washer-disinfector should be suitable for all types of flexible endoscope used in the
hospital (provide declaration).
4.2 Malfunctions or incomplete processes are indicated by both a visible and an audible
signal.
4.3 The endoscope is monitored for leak tightness throughout the whole process.
4.4 The washer-disinfector is equipped with an automatic mechanism to identify blockages
during the process.
4.5 The washer-disinfector features a continuous channel connection check for each
connected channel (enter maximum number of channels that are monitored).
4.6
4.7
The washer-disinfector indicates in good time when preventive maintenance is required
It is not possible to switch or interconnect the detergent and disinfectant.
4.8 There is leak tray for the detergent and disinfectant.
4.9
All parts are easily accessible for maintenance and repair.
4.10
All parts are resistant to the chemicals and water type to be used (eg RO water).
4.11 A"no-break" facility is provided for data storage.
4.12 The washer-disinfector is resistant to power failures. (Specify).
4.13 There is a facility to prevent water from flowing back from the water compartment into the
water supply system.
4.14 Can the following processes be halted independently by authorized staff?-cleaning;
- flushing
- disinfection;
- discharge-disinfectant;
- flushing microbiologically safe water;
- production microbiologically safe water;
- drying.
4.15 The washer-disinfrector should be constructed such that the contact surface with the
endoscope is minimal.
4,16 The machine has an outlet for water for testing.
4.17 The manchine has a monitor for the bacteria filter
4.18 The manufacturer has drawn up a filtration plan for the water supply and provides advice
on installing filters.
4.19 The washer-disinfector can communicate with data management systems in place at the
time of purchase. Indicate the forms of communication which are possible and the
4.20 The supplier of the washer-disinfector undertakes to provide declarations of compatibility
for endoscopes to be acquired by the purchaser throughout the service life of the
Process requirements
Yes No
5.1 The washer-disinfector operates in accordance with the pass-through principle
(clean/contaminated materials separated).
5.2
The program cannot be continued after interruption of the process.
5.3
The endoscope is not released if the process has not been entirely completed.
5.4 The process consists of at least the following phases: pre-cleaning, cleaning, flushing,
disinfecting, rinsing.
5.5
The current phase of the process is shown on the display
5.6
Process parameters can be changed only by authorised staff
6. Cleaning and disinfection
Yes No
6.1 Detergent and disinfectant should be CE marked
6.2 The washer-disinfector is suitable for generic detergents and disinfectants.
6.3 State the consumption of detergents and disinfectants used for each process (process
cost)
6.4 The product information for the machine states the temperatures used for cleaning and
disinfecting.
6.5 A product information sheet showing usable materials, concetration, contact time and
temperature is present
6.6 The machine has a self-disinfection procedure.
6.7 The washer-disinfector displays a warning if the disinfectant container is empty.
6.8 The washer-disinfector displays a warning if the detergent container is empty.
6.9 There is a check on the dosage of:
-disinfectant;
-detergent
6.10 Dosage, exposure time and temperature of the detergent and disinfectant should be
established in the programs.
6,11 The equipment runs a rinse cycle with bacteria-free water to eliminate residues of
detergent and disinfectant.
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7. Support/training requirements
7.1 An English instruction manual is available.
7.2 English operating and loading instructions are available.
Yes No
7.3 There is a protocol for corrective, preventive and inspective maintenance available to
technicians (certificate issued).
7.4 The technicians are trained for both corrective and preventative maintenance and
inspections.
7.5 A technical manual is supplied with the machine
7.6 The supplier has access to an English speaking technical helpdesk.
7.7 The supplier provides user training (certificate issued).
7.8 The supplier provides connection diagrams for all types of flexible endoscope used in the
hospital.
8. Usability requirements
Yes No
8.1
Washer-disinfector operation is ergonomic.
8.2 In the event of an alarm or warning, the machine gives a clear description of the problem
and gives instructions for resolving it suitable for users.
8.3 The loading and unloading doors can be opened hygienically.
8.4 The machine assists users with clear on-screen instructions during operation.
8,5
Detergents and disinfectants can be topped up ergonomically
9. Traceability and recording requirements
9.1 Functionality is available to record data on the endoscope, load, process, date and time,
patient and operator.
Yes No
9.2 Data (eg on machine, patient, endoscope, specialist and process flow) is recorded
digitally and stored locally and remotely for each disinfection cycle
9.3
The washer-disinfector can communicate with management systems (specify).
9,4 The washer-disinfector offers the option to generate management data (specify).
10. Installation requirements
Yes No
10.1 Drawings and measurements of the facilities required for installation (drainage, ventilation,
extraction, water) are supplied
10.2 Specific requirements for water quality are supplied.
11. Requirements regarding maintenance
11.1 The supplier offers maintenance contracts, .
Yes No
11.2 The supplier provides a price list for the most commonly used parts.
11.3 The company accepts the Standard Service Agreement (SSO) of the FHI.
11.4 All required components can be supplied within 24 hours.
11.5 The supplier provides passwords and codes for repair and maintenance of hardware and
software or mechanical components
11.6 A supplier's technician can attend within 24 hours.
11.7 A loan washer-disinfector can be made available within 2 days
11.8 The maximum downtime for software and hardware problems is 24 hours.
11.9 Software licenses should be valid for the service life of the machine.
11.10 Software and hardware updates and features for software and hardware updates can be
provided for at least 10 year for procedural and control purposes.
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Appendix 15 - Schedule of requirements for flexible endoscopes
I
Purpose of the flexible endoscopes.
For non-invasive diagnostic and therapeutic examinations
II
Interaction with washer-disinfector, drying cabinet, and medical supplies.
All types of flexible endoscope and accessories must be disinfected in accordance with the prescribed
procedure
III Patient categories
Various
IV Users
Staff in CSA, inpatient or outpatient examination departments.
Explanation
Requirement/ Demand
1. Legal requirements
Medical Directive
NEN 10601
Yes No
1.1 The endoscope has a CE mark as per the Medical Devices Directive
93/42/EC.
1.2 The endoscope meets the electrical safety standard (NEN 10601).
2. Technical requirements
Technical aspects
Yes No
2.1 The endoscope can be cleaned and disinfected automatically in all
washer-disinfectors present in the hospital. (compatibility with
detergents and disinfectants).
2.2 All parts are resistant to the chemicals to be used.
2.3 The endoscope should be designed in such a way that it can be
properly cleaned, both manually and automatically, and disinfected.
2.4 The endoscope can communicate with the data management
systems in use at the time of purchase.
2.5 The manual provides a list of compatible devices and accessories (for
research and cleaning / disinfection).
2.6 The endoscope is resistant to medications, bodily fluids and agents
used during the examination.
2.7 The endoscope can be positioned and connected in the currently used
drying cabinets
2.8 Specifications for maximum pressure and pressure differences in the
channels are given
3. Cleaning, disinfection, and sterilisation
Yes no
3.1 The temperatures for cleaning, disinfection, and sterilisation are given
in the product information for the endoscope
3.2 The product information states to which detergents, disinfectants, and
sterilisation agents the endoscope is resistant.
3.3 The manual describes the preliminary cleaning required as preparation
for machine cleaning and disinfection.
3.4 Connecting equipment for leakage testers, washer-disinfectors and
drying cabinets are supplied. Specify what connecting equipment
3.5 The endoscope is steam sterilisable (121gr.).
3.6 The endoscope is steam sterilisable (134gr.).
3.7 The endoscope is formaldehyde sterilisable.
3.8 The endoscope is ethylene oxide sterilisable.
3.9 The endoscope is plasma sterilisable.
4. Support/training requirements
Yes no
4.1 An English instruction manual is available.
4.2 English operating instructions are available.
4.3 There is a protocol for corrective and preventive maintenance and
inspection available for technicians
4.4 Technicans are trained in corrective and preventive maintenance and
inspections
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5. Usability requirements
Yes no
5.1 Assessment following trial installations
6. Traceability and recording requirements
Yes no
6.1 The endoscope includes an identifier which can be read by the
recording software in use at the hospital.
7. Installation requirements
Yes no
7.1 The endoscope is compatible with the processor and light source
present.
8. Maintenance requirements
Yes no
8.1 The supplier offers maintenance contracts, .
8.2 The supplier provides a price list for the most commonly used parts.
8.3 The company accepts the Standard Service Agreement (SSO) of the FHI.
8.4 All required components can be supplied within 24 hours.
8.5
Defective endoscopes can be repaired within an agreed time. A loan
endoscope will be available during that time.
8.6 Parts are available for at least 10 years.
8.7 A supplier's technician can attend within 24 hours.
Maintenance and repairs can be carried out by medical technicians
8.8 (special tools can be supplied)
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Appendix 16 - Schedule of requirements for drying cabinet
I
Purpose of drying cabinet
Drying and storage of flexible endoscopes and their accessories (both exterior and channels).
II Interaction with endoscopes and their accessories
All types of flexible endoscopes and accessories must be able to be dried in accordance with the prescribed
procedure.
III Patient categories
Various
IV Users
Staff in CSA, inpatient or outpatient examination departments
Requirement/ Demand
1. Legal requirements
Explanation
yes no
Medical Directive
1.1
The drying cabinet has a CE label under the Medical Devices Directive
93/42/EC.
EN standard
1.2
Not yet available
EN 60601
1.3
The drying cabinet complies with electrical safety standard (EN 60601).
WIP guidelines
1.4
Occupational health,
safety and environment
1.5
The drying cabinet complies with the WIP directive "Cleaning and disinfection of
endoscopes " (www.wip.nl).
The drying cabinet complies with the occupational health and safety law
(www.arbo.nl).
2. Validation
yes no
2.1
2.2
2.3
2.4
2.5
2.6
The drying process has been validated and the validation report is available
(provide copy).
The supplier provides training on the required validation procedure and
what the validation should comprise
The supplier provides training to external validators (certificate
awarded)
The supplier invidates how the training is supervised and which validators have
taken it.
There is an installation qualification programme/protocol (provide
programme/protocol ).
There is a qualification programme/protocol for the release for the process
(provide programme/protocol ).
3. Occupational health and safety and environment
3.1
3.2
3.3
3.4
3.5
The working height is appropriate in accordance with occupational health and
safety standards (state specified working heights).
The noise level remains below 65dB(A) throughout the process (provide test
report).
4. Technical requirements
Technical aspects
yes no
Supplier indicates compressed air consumption (specify consumption).
Supplier indicates energy consumption (specify consumption).
The supplier/manufacturer accepts returns of drying cabinets which need to be
yes no
4.1
The drying cabinet should be suitable for all types of flexible endoscope used in
the hospital (provide declaration).
4.2
The supplier has issued a written declaration that the drying cabinet is
compatible with the endoscopes in use.
4.3
Malfunctions or incomplete processes are indicated by both a visible and an
audible signal.
4.4
The drying cabinet features a continuous channel connection check.
4.5
The drying cabinet features a continuous flow monitor for each connected
channel.
4.6
The drying cabinet gives a signal when preventive maintenance is required.
4.7
All components for maintenance and repair are readily accessible.
4.8 A no-break facility is provided for data storage.
4.9 The drying cabinet is resistant to power failures (specify)
4.10 The drying cabinet should be constructed in such a way that the contact
surface with the endoscope is minimal.
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5. Drying process
yes no
5.1
The process parameters (time/temperature/pressure) are shown in the product
information for the drying cabinet.
5.2
The drying cabinet features continuous temperature monitoring.
5.3
Drying times must be determined by the programs.
5.4
The device uses an appropriate drying cycle with bacteria-free compressed air
to prevent contamination of the endoscope.
5.5
An overpressure is maintained in the cabinet.
6 Support/training requirements
6.1
6.2
An English instruction manual is available.
6.3
A protocol for corrective and preventive maintenance and inspection is available
for technicians.
The technicians are trained in both corrective and preventive maintenance.
6.4
6.5
yes no
English operating and loading instructions are available.
A technical manual is supplied
6.6
6.7
The supplier has access to an English speaking technical helpdesk.
The supplier provides user training
7.1
The drying cabinet is easy to use (describe)
7.2
In the event of an alarm or warning, the machine gives a clear description of the
problem and gives instructions for resolving it suitable for users.
7.3
The loading and unloading doors can be opened hygienically.
7 Usability requirements
yes no
The drying cabinet assists users with clear on-screen instructions during
operation.
7.5 The drying cabinet has a maximum storage time setting and an alarm is
triggered if the storage time is exceeded.
8 Traceability and recording requirements
7.4
8.1
Functionality is available to record data on the endoscope, load, process, date
and time, patient and operator.
8.2
Data (eg on cabinet, patient, endoscope, specialist and process flow) is
recorded digitally and stored locally and remotely for each disinfection cycle
8.3
9 Installation requirements
yes no
The drying cabinet can communicate with the management system.
yes no
9.1
Drawings and measurements of the facilities required for installation (drainage,
ventilation, extraction, water) are supplied
9.2
Specific requirements for water quality are supplied
10 Maintenance requirements
yes no
10.1 The supplier offers maintenance contracts, .
10.2 The company accepts the Standard Service Agreement (SSO) of the FHI.
10.3 All required components can be supplied within 24 hours.
10.4 The supplier provides passwords and codes for repair and maintenance of
hardware and software or mechanical components
10.5 A supplier's technician can attend within 24 hours.
10.6 A loan drying cabinet can be made available within 2 days
10.7 The maximum downtime for software and hardware problems is 24 hours.
10.8 Software licenses should be valid for the service life of the machine.
10.9 Software and hardware updates and features for software and hardware updates
can be provided for at least 10 year for procedural and control purposes.
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Appendix 17 – Endoscope Cleaning & Disinfection Audit Form
Questionnaire on behalf of endoscope cleaning & disinfection dept.
Department/location:
Audited:
Auditor (s):
Date:
Definition for prioritisation of criteria for the recommendations or points for improvement in the audit report for each department:
1. A non-permissible occurrence concerning cleaning or disinfection which should be tackled directly.
2. An occurrence which has policy-level impact on the effectiveness of endoscope cleaning and disinfection processes, to be carried out within three months.
3. Lowest priority: should be implemented within six months.
n.a. = not assessed
answ er the questions by entering 'yes', 'no' or 'partly' in the appropriate column
1
Policy rules for cleaning and disinfecting endoscopes
1.1
Endoscopes and accessories used in non-sterile body cavities
are cleaned and disinfected by machine
Endoscopes and accessories used in sterile body cavities are
sterilised
1.2
1.3
Used forceps, snares, etc. are sterilised or disposables are used
Work follows the correct principles:
1.4
1.5
leak test
pre-cleaning
yes no
partly notes / comments / advice
process steps in disinfector:
1.6
1.7
leak test
cleaning
rinsing (if required)
1.8
disinfection
1.9
final rinse
1.10
drying
priority
recommendation / point for improvement
1
2
2
Execution of manual endoscope cleaning
2.1
The cleaning procedure is set out in the protocol
2.2
The protocol is accessible near the sink and readily understood
by anyone.
Non-sterile gloves are worn during manual cleaning.
2.3
2.4
yes no
Date protocol:
A solution of a compatible cleaning agent in lukewarm water is
used for cleaning.
The concentration of the solution is as specified in the
instructions
This solution is refreshed every shift or in the event that
contamination is observed
A leak test is carried out before immersion.
2.5
2.6
2.7
2.8
partly notes / comments / advice
used product:
used concentration:
The endoscope is placed on the worktop immediately after the
examination.
The exterior of the endoscope is wiped off using a gauze or
washcloth.
2.9
2.10
The suction head is disassembled, sprayed with water, brushed,
soaked in cleaning solution and then rinsed with water
2.11
Ring, caps and any other removable parts (non-disposable) are
brushed, soaked in cleaning solution and then rinsed with water.
priority
recommendation / point for improvement
1
2
3
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Ultrasonic Bath
yes no
partly notes / comments / advice
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
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4
Loading the washer-disinfector
4.1
Loading instructions are present
disinfector type:
4.2
They are kept close to the machine and readily accessible to
anyone.
The loading instructions include the following steps:
date of instructions:
4.3
Ring, caps and any other removable parts are put into a basket
in the machine.
The endoscope is placed into the machine in such a way that the
entire distal section is "free" (e.g. disappears into the aperture of
There is a system to prevent connection errors.
4.4
4.5
4.6
yes no
partly notes / comments / advice
The loading instructions describe which tubes should be
connected to which channels
priority
recommendation / point for improvement
1
2
5
Operating the machine
5.1
The general way in which the machine operates, including the
technical aspects, is clear to staff.
Operating instructions are located close to the machine and
readily accessible to everyone
A written procedure has been drawn up showing the steps to
take in the event of malfunctions; kept within reach and
The process parameters and process programs can only be
altered by authorised staff
The endoscope compartment is locked during the process. If a
process is interrupted, that process cannot then be restarted.
The washer has an automatic leak tester.
5.2
5.3
5.4
5.5
5.6
5.7
yes no
partly notes / comments / advice
date regulation:
date procedure:
authorised persons
5.9
The washer monitors the pressure in the channels to identify
obstructions
The washer is disinfected weekly and any time that it is to be out
of service for more than 24 hours using a self-disinfection
The washer is frequently descaled
5.10
Descaling is logged
last date recorded:
5.11
The washer has a system for preventing recontamination during
the final rinse (bacteria-free water).
The washer has a process counter to determine periodic
maintenance requirements.
The washer has a facility to allow patient tracking data to be
entered.
The washer undergoes preventive maintenance by an external or
internal technical expert once a year.
Checks and release after regular major maintenance and major
repairs are recorded in a protocol for validation and release of
endoscope washers.
means:
5.8
5.12
5.13
5.14
5.15
Carried out by:
Protocol date:
Validated by:
Released by:
priority
recommendation / point for improvement
1
2
6
Cleaning and disinfecting the endoscope washer
6.1
The washer has a system for monitoring the dosage of detergent
and disinfectant.
The washer is fitted with connectors which prevent detergent and
disinfectant from being wrongly attached.
Detergent and disinfectant are kept in a locked cabinet using a
FIFO principle
The method for replacing the detergent and disinfectant
containers is described in a protocol.
This protocol is kept close to the machine and is readily
accessible to everyone.
The containers of detergent and disinfectant are replaced in
accordance with this protocol.
6.2
6.3
6.4
6.5
6.6
yes no
partly notes / comments / advice
which system:
storage quantity:
priority
recommendation / point for improvement
1
2
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7
Drying an endoscope in a drying cabinet
7.1
The procedure for drying the endoscope is described in a
protocol.
The protocol is kept close to the drying cabinet and readily
accessible to everyone.
Endoscopes which are not used within 4 hours of disinfection are
dried in the drying cabinet for at least 30 minutes.
7.2
7.3
7.4
yes no
protocol date:
set drying time:
Endoscopes which are not used for a period of over 4 hours
without being dried are disinfected again before use.
There is written guidance on how long endoscopes may be hung
in the drying cabinet.
The drying cabinet is given general cleaning once a month. The
cleaning schedule is present and signed.
A protocol covers periodic maintenance and filter change
frequency.
7.5
7.6
7.7
partly notes / comments / advice
applied storage life
protocol date:
frequency of replacement:
recommendation / point for improvement
priority
1
2
8
Transporting endoscopes
8.1
The procedure for transporting contaminated and clean
endoscopes is described in a protocol
The protocol is kept close to the drying cabinet and readily
accessible to everyone.
Endoscopes are only transported from the disinfection area to
adjoining examination or storage areas
If the answer to 8.3 is not "yes", answer the remaining
questions.
Endoscopes are transported using an enclosed transport system
8.2
8.3
8.4
8.5
yes no
partly notes / comments / advice
protocol date:
specify transport:
system:
When endoscopes are transported, it is clear whether the
endoscope is clean or contaminated.
For clean endoscopes, the transport system is sealed.
8.6
8.7
The transport system is cleaned and disinfected after
contaminated endoscopes have been carried.
Method:
recommendation / point for improvement
priority
1
2
9
Registration of data
9.1
A logbook is k ept for each disinfector (whether automated or
not) in which the following items are recorded.
-Date
9.2
-Patient number
9.3
-Number of the endoscope
9.4
-Name / code of staff member responsible for loading
9.5
-Name / code of operating endoscopy specialist
9.6
yes no
partly notes / comments / advice
system:
-Name / code of staff member responsible for unloading
When replacing detergent and disinfectant, the following
information is recorded:
9.7
-Date of replacement
9.8
Batch number detergent / disinfectant
9.9
Machine number
9.10
Signature of the staff member who replaced the container
9.11
Signature for check by colleague
system:
recommendation / point for improvement
priority
1
2
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10
Hygiene and prevention of infection
yes no
partly notes / comments / advice
Hygienic endoscopy working methods
10.1
Clean and contaminated materials follow separate paths
10.2
No rings, watches, or bracelets worn
10.3
After every endoscopy the endoscopist washes or disinfects
his/her hands before touching anything else.
After every endoscopy the assistant washes or disinfects his/her
hands before touching anything else.
After every endoscopy hands are washed and disinfected after
taking off the gloves.
disinfector hygiene
10.4
10.5
10.6
The top of the lid, its seat, and the control panel are routinely
cleaned and then disinfected
The endoscopist wears:
10.7
Gloves
10.8
Protective jacket
10.9
Mask (if pulmonary tuberculosis is suspected)
10.10
Protective glasses or splash goggles
10.11
Gloves
10.12
Protective jacket
10.13
Mask (if pulmonary tuberculosis is suspected)
10.14
Protective glasses or splash goggles
10.15
Adequate hand washing facilities available.
10.16
The tap can be operated with elbows or feet.
10.17
Alcohol dispenser available.
10.18
Soap dispenser available
10.19
Towel dispensers with paper towels available.
10.20
Pedal bin (or other hands-free bin) available
disinfectant:
checklist present:
The assistant wears:
Facilities
recommendation / point for improvement
priority
1
2
11
Staff expertise
yes no
11.1
Which staff members carry out the disinfection?
11.2
At least vocational secondary level (medical nurse)
11.3
Complete settling-in programme
11.4
Training from disinfector supplier
11.5
Training from endoscope supplier
11.6
Endoscopy training
partly notes / comments / advice
function:
Employees have specialist training?
More information
Employees have frequent in-service training
11.7
annual endoscopy conference
11.8
annual training internally or from supplier
recommendation / point for improvement
priority
1
2
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12
yes no
Quality assurance
Protocols are updated at predetermined regular intervals
12.1
12.2
partly
notes / comments / advice
It is clear who is responsible for authorisation
12.3
technical
external/ internal:
who:
frequency:
12.4
functional validation
frequency:
12.5
microbiological
frequency:
12.6
use (audit)
frequency:
The endoscopes are validated at predetermined regular intervals
The machine is validated at predetermined regular intervals
12.7
technical
external/ internal:
who:
frequency:
12.8
functional validation
frequency:
12.9
microbiological
frequency:
12.10
use (audit)
frequency:
12.11
the endoscope management plan is evaluated annually
recommendation / point for improvement
priority
1
2
13
Area
13.1
There is a separate area for cleaning and disinfecting
endoscopes
The work surface is large enough for spatial separation of clean
and contaminated endoscopes
Is there adequate technical provision for occupational health and
safety: splash screens, air treatment, extraction, etc.
Is there enough working space for the preliminary cleaning of
contaminated endoscopes and assembly of clean endoscopes
Is there a separate administrative workplace
13.2
13.3
13.4
13.5
13.6
yes no
partly notes / comments / advice
ventilation / extraction:
splash screen:
enlarged sink:
separate worktops:
Is there a separate area for drying and storing endoscopes
(with pass-through system where appropriate)
Floors, walls, edges and ceiling are finished to building standards
for healthcare institutions (smooth, shock-resistant, resistant to
chemicals, etc.)
13.7
recommendation / point for improvement
priority
1
2
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Appendix 18 – Endoscopy Department Audit Form
Checklist for use in endoscopy departments
Department:
Audited:
Date:
Auditors:
Definition for prioritisation of criteria for the recommendations or points for improvement in the audit report for each department:
1. A non-permissible occurrence concerning cleaning or disinfection which should be tackled directly.
2. An occurrence which has policy-level impact on the effectiveness of endoscope cleaning and disinfection processes, to be carried out within three months.
3. Lowest priority: should be implemented within six months.
n.a. = not assessed
answ er the questions by entering 'yes', 'no' or 'partly' in the appropriate column
1 Endoscope cleaning and disinfection policy
yes no
1.1 Staff are familiar with the endoscope management plan
Endoscope policy is established at departmental level and known
1.2
to the staff (protocols, operating instructions)
1.3 Endoscopes are disinfected mechanically
1.4 All equipment (used in sterile body cavities) is sterilised
It is clear where responsibilities for cleaning and disinfecting
1.5
endoscopes lie.
Is the role and function of DMSH and H&I in these processes
1.6
known?
1.7 These are set out in writing
There is a separate routing for articles which have to be cleaned
1.8
and disinfected via the CSA or CSD
Are the numbers and assortment of endoscopes adequate for
1.9
existing CSD and transport procedures?
1.1 Is equipment cleaned (or disinfected) in the department
partly notes / comments / advice
recommendation / point for improvement
priority
1
2
2 Handling flexible endoscopes
Disinfected flexible endoscopes are handled with disinfected
hands
2.2 Endoscope is used immediately in prepared room
2.3 Attention is paid to what is happening with the tip
yes no
partly notes / comments / advice
2.1
recommendation / point for improvement
priority
1
2
3 Preliminary cleaning of endoscopes by hand
The procedure for preliminary cleaning is set out in a protocol:
“returning soiled endoscope to CSD"
3.2 The protocol is present and easily accessible to everybody.
Endoscopes are rinsed through/aspirated by the using
3.3 department and taken elsewhere for the most serious
decontamination work
yes no
partly notes / comments / advice
3.1
recommendation / point for improvement
priority
1
2
4 Transport/Logistics
yes no
4.1 Are transport containers always locked.
Disinfected containers are stored in such a way that there is no
4.3
risk of contamination.
If applicable for wet transport: What is the longest time that a wet
4.4 endoscope remains in a container/ is en route between CSD and
place of use?
Transport containers with disinfected endoscopes: are supplied
4.6 at a fixed location. It is ensured that they are not left
unsupervised. In locked cabinet/space.
Transport containers with soiled endoscopes: Is it ensured that
4.7
they are not left unsupervised? In locked cabinet/space.
Cabinets and carts for endoscope storage have a clearly visible
4.8
separation between clean and dirty
4.9 The cabinets appear to be clean
4.1 Endoscopes are used on a FIFO basis
Endoscopes remain in storage until used (in locked container or
4.11
in drying cabinet)
Is it clear who needs to be approached if transport does not run
4.12
as it should?
partly notes / comments / advice
recommendation / point for improvement
priority
1
2
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5 Drying and storing endoscopes in drying cabinet
The procedure for drying an endoscope is described in a
protocol.
5.2 The protocol is easily accessible to everybody.
Endoscopes which are not used within four hours of disinfection
5.3
are dried for at least 2 hours in the drying cabinet*.
Endoscopes which are not used for longer than four hours
5.4
without drying are disinfected again before use.
yes no
partly notes / comments / advice
5.1
5.5 It is clear how long endoscopes can be left in the drying cabinet.
5.6
5.7
5.8
5.9
5.1
The bottom of the drying cabinet (drip tray) is cleaned daily and
disinfected in accordance with protocol.
The drying cabinet is routinely cleaned and disinfected once a
month. Cleaning schedule is present and signed.
Protocol for cleaning and disinfection for the drying cabinet is
present and is being followed
How is the endoscope operated? With disinfected hands?
A logbook is kept for each drying cabinet.
* 2 hours or 30 minutes, depending on drying cabinet
recommendation / point for improvement
priority
1
2
6 Record keeping
yes no
Use is made of an automatic track and trace system for both the
6.1 cleaning, disinfection and drying process, and for the linking of
patient data with the endoscope used
Use: overruling does not occur. Explain how messages are
6.2
handled
partly notes / comments / advice
recommendation / point for improvement
priority
1
2
7 Hygiene and prevention of infection
Staff are aware of the way they operate (as regards hand
disinfection, operating (disinfected) endoscopes, etc.)
7.2 Separate routings are maintained for clean and dirty
7.3 Work is carried out aseptically
7.4 Clothing instuctions are complied with
7.5 No rings, wrist watches or armbands are worn
7.6 Hands are disinfected after removing gloves.
7.7 the endoscope is only hung on the hook in a clean state
is the equipment and furniture cleaned and where necessary
7.8
disinfected between operations.
yes no
partly notes / comments / advice
7.1
Facilities in surgery/consulting room?
7.9 Adequate hand washing facilities present.
7.1 The tap can be operated with elbow or foot.
7.11 Hand alcohol dispenser present.
7.12 Soap dispenser present.
7.13 Hand towel dispenser with paper towels present.
7.14 Foot-operated waste bin present
7.15 Glove dispensers with gloves present (various sizes)
recommendation / point for improvement
priority
1
2
8 Staff expertise
yes no
8.1 Are staff trained in dealing with flexible endoscopes?
8.2 Do staff have free access to protocols, manuals, procedures, etc.
partly notes / comments / advice
8.3 Staff receive further and continuing training
8.4 Are staff given individual assessments?
recommendation / point for improvement
priority
1
2
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9 Quality assurance
9.1 Staff knowledge of protocols is up to date.
The procedure for handing a defective endoscope should be
9.2
described in a protocol
9.3 The protocol is easily accessible to everybody.
9.4
yes no
partly notes / comments / advice
Agreements have been reached on duties and responsibilities
concerning maintenance of equipment, resources and materials.
Agreements have been reached on procedures for requesting
maintenance (corrective/preventive)
9.6 Is the incident procedure known?
Agreements have been reached on the cleaning of endoscopes
9.7
outside regular working hours
Is it known how a request should be made to hire/loan an
9.8
endoscope?
9.5
recommendation / point for improvement
priority
1
2
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Appendix 19 - Endoscope technology & maintenance Audit Form
Department / Location:
Audited:
Auditor (s):
Date:
Type of disinfector(s):
Type of endoscopes:
Definition for prioritisation of criteria for the recommendations or points for improvement in the audit report for each department:
1. A non-permissible occurrence concerning cleaning or disinfection which should be tackled directly.
2. An occurrence which has policy-level impact on the effectiveness of endoscope cleaning and disinfection processes, to be carried out within three months.
3. Lowest priority: should be implemented within six months.
n.a. = not assessed
answ er the questions by entering 'yes', 'no' or 'partly' in the appropriate column
T.1
Technical verification
yes no
partly notes / comments / advice
Washer-disinfectors are technically checked:
1.1
1.2.1
* before entry into service/on acquisition
1.2.2
* after repairs
1.2.3
* after maintenance
1.2.4
* If the washer-disinfector is used for a new type of endoscope?
There is a release procedure before a washer-disinfector is taken
into service
There is an up-to-date technical logbook available for each
washer-disinfector
There is a procedure for planning and executing preventive
maintenance on the washer-disinfector
1.3
1.4
1.5
recommendation / point for improvement
priority
1
2
T.2
Using the washer-disinfector
yes no
2.1
The process parameters and process programs can only be
changed by appropriately authorised persons
2.2
The endoscope compartment is locked during the process. If a
process is interrupted that process cannot then be restarted.
partly notes / comments / advice
The washer-disinfector monitors the pressure in the channels in
order to detect obstructions
The washer-disinfector is designed to prevent recontamination
during the final rinse (bacteria-free water)
The washer-disinfector has a process counter to determine
periodic maintenance requirements
The washer-disinfector has a facility for entering data for patient
tracking
The washer-disinfector is preventively maintained by an external
or internal technical specialist at least once a year
2.3
2.4
2.5
2.6
2.7
The procedure for checking and releasing the machine after
routine major maintenance and major repairs is set out in a
validation and release protocol for washer-disinfectors
The washer-disinfector has a system for checking dosages of
detergent and disinfectant
The washer-disinfector uses connectors which prevent switching
of detergent and disinfectant.
2.8
2.9
2.10
recommendation / point for improvement
priority
1
2
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
T.3
User maintenance of the washer-disinfector
yes no
partly notes / comments / advice
The water softener is frequently regenerated
3.1
the coarse filter of the drying unit is replaced every xxx operating
hours
The fine filter (sterile filter) is replaced every xxx operating hours
3.2
3.3
The washer-disinfector monitors the pressure in the channels in
order to detect obstructions
The UV unit is maintained at predetermined intervals
3.4
3.5
The filters in the rinsing space are cleaned frequently
3.6
The filters in the water supply are regularly checked
3.7
The nozzles on the spray arm are regularly checked to ensure
they are not blocked
3.8
The sealing rings of the leak detector are regularly checked and
replaced if necessary
The nozzles and tubes of the inset trolley are examined and
cleaned frequently
3.9
3.10
recommendation / point for improvement
priority
1
2
T.4
Other
yes no
partly notes / comments / advice
The drying cabinets are maintained regularly
4.1
The drying cabinet filters are replaced regularly
4.2
The drying cabinets use filtered dust-free air
4.3
The drying cabinets have a preset minimum drying time
4.4
The extraction channel from the drying cabinet vents outside
4.5
An up-to-date technical logbook is present for each drying
cabinet
This technical logbook is up to date and contains useful data
4.6
4.7
priority
recommendation / point for improvement
1
2
T.5
Ultrasound
T.6
Endoscopes
6.1
Technical checks on endoscopes are carried out at the following
times
* on acquisition
6.1.1
6.1.2
6.1.3
yes no
partly notes / comments / advice
* after repairs (external)
* after maintenance (annual major)
There is a release procedure before an endoscope is put into
service?
An up to date technical logbook is present for each endoscope
6.2
6.3
The endoscope has a unique code for automatic tracking and
tracing
Preventive maintenance is performed on the endoscope by an
internal or external technical specialist at least twice a year
6.4
6.5
recommendation / point for improvement
priority
1
2
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T.7
Quality assurance
yes no
7.1
Protocols are updated regularly at predetrermined intervals
7.2
It is clear who is responsible for authorisations
7.3
Staff are familiar with the protocols. They are signed for.
7.4
The procedure for dealing with a defective endoscope is
described in a protocol
7.5
The protocol is familiar to MT staff.
7.6
Agreements have been reached on duties and responsibilities for
maintenance of equipment, resources and materials.
7.7
This is set out in a protocol.
7.8
Agreements have been reached on the procedure for requesting
maintenance (corrective/preventive)
7.9
This is set out in a protocol.
7.10
Contacts concerning defective equipment/endoscopes are
always made via AT/MT - in other words, there is no direct
contact between CSD staff and the company
7.11
There are no omissions in the existing procedures/no additional
procedures are required
partly notes / comments / advice
recommendation / point for improvement
priority
1
2
yes no
T8
Hygiene
8.1
MT staff know how to proceed with a contaminated endoscope
8.2
This is set out in a protocol
8.3
It is clear when an endoscope is contaminated
8.4
A transport case is available to transport a contaminated
endoscope
partly notes / comments / advice
recommendation / point for improvement
priority
1
2
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
Appendix 20 – Response form SFERD handbook 3.1, 2014
Feedback Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection:
Page
Paragraph
/ Line
Remark
Request or suggestion for alteration /
modification
Date:
Contributor:
Institution:
E-mail:
You can send your response to the secretary of the SFERD:
J.vbergenhenegouw@hagaziekenhuis.nl
Version 3.1, 2014
109
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Professional Standard Handbook Flexible Endoscope Cleaning and Disinfection
freely provided the SFERD is listed as the author
Version 3.1, 2014
111
The translation of this standard handbook was made possible through:
Stichting Trainingen Infectie Preventie
Lwww.stipopleidingen.nl