Reprocessing and Preparation of Devices Guide Dec 2016.pdf
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D-8994-2011
D-91140-2013
for Use
Instructions
The current
lid and are
va
ly
al
ndition
remain unco
book.
nd
by this ha
not replaced
Reprocessing and preparation
of devices V 1.0
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Reprocessing and Preparation of Devices V 1.0
Issued by:
Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23558 Lübeck, Germany
www.draeger.com
Important note
Due to research and clinical experiences, medical expersise is subject
to constant change. The author of this book took care to assure that
views, opinions and assumptions expressed herein correspond to the
current state of knowledge, especially those with regard to application
and effect. This, however, does not absolve the reader from the responsibility for clinical measures. (08/2016)
All rights for this book, especially the copyright, are reserved to
Drägerwerk AG & Co. KGaA. It is prohibited to reproduce or store
the book or parts of it mechanically, electronicaly or photographically,
without prior written approval by Drägerwerk AG & Co. KGaA.
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Table of contents
1 Laws, standards and guidelines
8
2 Preparation methods for reusable medical products
2.1 Spaulding Classification for Medical Devices
and Levels of Disinfection
2.2 Surface disinfection
2.3 Manual disinfection
2.4 Mechanical cleaning and thermal disinfection
2.5 Sterilisation using validated sterilisation methods
10
3 Anaesthesia Workstations
3.1 Fabius family (Fabius Plus, plus XL, Tiro,
GS Premium, MRI)
3.2 Primus family (Primus, Primus IE, Apollo)
3.3 Perseus A500
3.4 Zeus IE
15
15
23
29
35
4 Intensive care ventilators and lung monitoring
4.1 Evita family / Savina 300
4.2 Carina
4.3 PulmoVista
41
41
47
51
10
12
13
13
13
5 Neonatal workplace
55
6 Oxylog family
63
7 Patient monitoring
67
8 Workplace infrastructure
73
9 Further ward equipment
79
10 Accessories list
84
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Reprocessing and Preparation of Devices V 1.0
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Introduction
The importance of hygiene in the hospital has continuously grown
within the past years. Dräger as a manufacturer of medical technology,
contributes to this infection protection development.
To prevent nosocomial infections, it is essential to break the chain of
infection which can be realised, amongst other measures, through the
correct preparation of medical products.
All over the world the meaning of infection prevention standards has
tightened the guidelines regarding nosocomial infections.
Studies as “Microbial contamination of manually reprocessed, ready to
use ECG lead wire in intensive care units” by Lestari, Ryll und Kramer
(GMS Hygiene and Infection Control 2013, Vol. 8 (1) have proven
that even allegedly clean medical products can be contaminated with
germs.
This handbook serves as orientation for the respective preparation of
medical products by Dräger. It provides the user with an overview on
the preparation of individual components for each workstation.
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Reprocessing and Preparation of Devices V 1.0
Table of examples
The following table provides information whether a device/device
component/accessory can be (green check) surface disinfected,
manually prepared, prepared in the washer-disinfector (WD) or
sterilised or not (red cross).
The current Instructions for Use remain unconditionally valid and are
not replaced by this handbook.
Devices
Surface disinfection
Zeus IE
Explanations
✓
Device can be surface
disinfected
Manual disinfection
×
Device cannot be
prepared manually
Devices components
Surface disinfection
Breathing system (APL valve)
Explanations
Breathing system
Explanations
✓
APL valve can be surface
disinfected
Manual disinfection
✓
APL valve can be
prepared manually
✓
×
Breathing system can be
surface disinfected
Breathing system cannot
be manually prepared
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This overview can be used to validate and/or define intrahospital
hygiene guidelines and standards. Intrahospital hygiene guidelines
and standards remain valid and have priority.
Washer disinfector
Sterilisation
×
×
Device cannot be
prepared in the washerdisinfector (WD)
Device cannot
be sterilised
Washer disinfector
Sterilisation
✓
✓
APL valve can be
prepared in the washerdisinfector
✓
Breathing system can be
prepared in the washer-
disinfector
APL valve can
be sterilised
Disposable accessories
If available, disposable
accessories are listed
Disposable accessories
If available, disposable
accessories are listed
✓
Breathing system can
be sterilised
If available, disposable
accessories are listed
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Reprocessing and Preparation of Devices V 1.0 |
Laws, standards and guidelines
1 Laws, standards and guidelines
The following laws, standards and guidelines must be orbserved for
the preparation of medical products:
– Medical Device Directive 93/42 EEC (06/1993)
– FDA Guidance, March 2015
Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling
Guidance for Industry and Food and Drug Administration Staff
– RKI Empfehlung
Anforderungen an die Hygiene bei der Reinigung und Desinfektion
von Flächen
Empfehlung der Kommission für Krankenhaushygiene und
Infektionsprävention beim Robert Koch-Institut (RKI),
Gesundheitsschutz 2004 47:51–61
– Anforderungen an die Hygiene bei der Aufbereitung von
Medizinprodukten:
Empfehlung der Kommission für Krankenhaushygiene und
Infektionsprävention (KRINKO) beim Robert Koch-Institut (RKI) und
des Bundesinstitutes für Arzneimittel und Medizinprodukte (BfArM),
Bundesgesundheitsbl 2012 55:1244–1310
– VDI 5700 Blatt 1:2015-05
Risikomanagement der Aufbereitung von Medizinprodukten
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– DIN EN ISO 17664:2004-07
Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
(ISO 17664:2004); German version EN ISO 17664:2004
– DIN EN ISO 15883-1:2014-10
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014); German version
EN ISO 15883-1:2009 + A1:2014
– DIN EN 285:2014-09 DRAFT sterilization, steam sterilization
– DIN EN ISO 17665-1:2006-11
Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine control
of a sterilization process for medical devices (ISO 17665-1:2006);
German version EN ISO 17665-1:2006
– DIN EN 556-1:2002-03
Sterilization of medical devices - Requirements for medical devices
to be designated “STERILE” - Part 1: Requirements for terminally
sterilized medical devices; German version EN 556-1:2001
– Recommendations by other relevant, local institutions
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Reprocessing and Preparation of Devices V 1.0 |
Preparation methods for reusable medical products
2 Preparation methods for resusable medical
products
Information on cleaning, disinfection and sterilisation of
reusable medical products and accessories.
2.1 Spaulding Classification for Medical Devices and
Levels of Disinfection:
The Spaulding classification categorizes medical devices due to related
risk of infection during their use. This classification is widely accepted
and used by authorities, like e.g. the Food and Drug Administration
(FDA) and the Centers for Disease Control and Prevention (CDC),
specialists and other organizations to support adequate reprocessing
that is required for the devices. Each classification category encompasses recommendations for reprocessing of the medical devices.
Following the Spaulding classification, medical devices and their
components are classified according to the way they are used and the
resulting risk:
Noncritical:
Devices or items that get in contact only with intact skin and not with
mucous membrane.
For further information regarding Spaulding classification please also
refer to the CDC website: www.cdc.gov
Semicritical:
Devices or items that get in contact with mucous membranes or non
intact skin are regarded as semicritical. This includes devices for
ventilation like e.g. respiratory therapy and anaesthesia equipment.
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Critical:
Devices that directly bear a high risk of infection when contaminated
are regarded as critical. Any device or item that will be in contact to the
vascular system or human sterile tissue therefore is classified as critical
and has to be sterilized.
Notice
National legal regulations, national and international standards,
guidelines and applicable hygiene guidelines must be observed during
preparation.
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Reprocessing and Preparation of Devices V 1.0 |
Preparation methods for reusable medical products
2.2 Surface disinfection
Manual cleaning with simultaneous surface disinfection.
The compatibility of disinfectants on surfaces depends on the
composition of the agent including active substances and substitutes.
All the ingredients, even substitutes like stabilizers or tensides can
have an influence on the material compatibility. Therefore material
compatibility of disinfectants cannot be classified by the active
substance groups like peroxides, chlorides, quarternary ammonium
compounds, alcohols or aldehydes, only. Therefore disinfectants are
tested as a specific composition of different chemicals by our certified
Test Center to give a recommendation regarding material compatibility.
The independent and ISO 17025 accredited Dräger TestCenter has
performed over 20,000 tests on the compatibility of all common
disinfectant groups with regard to material groups of medical
technology used worldwide.
For further information on Dräger tested disinfectants please contact
your local Dräger representative.
Using tested agents which are suitable for the entire workstation for
your Dräger products improves the safety of your patient and
workstation and also protects your investment in medical technology.
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2.3 Manual disinfection
Perform the manual disinfection according to the respective
Instructions of Use of the individual product.
2.4 Mechanical cleaning and thermal disinfection
Perform the mechanical cleaning and thermal disinfection in
a washer-disinfector according to the respective Instructions for Use
until the required A0 (definition A0, please see DIN EN ISO 15883-1)
value is reached.
Dwell time
minutes
Temperature
°C
A0 value
seconds
100
6.000
70
600
10
600
80
600
1
60
90
600
50
3.000
80
3.000
5
300
90
3.000
Example for dwell times in relation to temperature
2.5 Sterilisation using validated sterilisation methods
Perform the sterilisation according to the respective Instructions for
Use.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, FABIUS FAMILY
Notes
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Anaesthesia workstations
D-75695-2013
3.1 Fabius Family (Fabius Plus, plus XL, Tiro, GS Premium, MRI)
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, FABIUS FAMILY
Devices
Fabius Family
Infinity C500/C700
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
Infinity M540/M500/PS250
Vamos Gas monitor and
Scio Gas module
Surface disinfection
✓
✓
✓
✓
✓
Manual disinfection
×
×
×
×
×
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
×
×
×
×
×
×
×
×
×
×
Disposable accessories
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, FABIUS FAMILY
Device components
Compact breathing system
COSY
APL Valve, Compact breathing
system COSY
Ventilator diaphragm
(Rolling diaphragm)
Surface disinfection
Manual disinfection
✓
✓
✓
✓
×
✓
Ventilator lid
×
D-Vapor, Vapor 2000
✓
×
✓
✓
✓
✓
✓
✓
×
×
×
✓
Anaesthetic gas
scavenging AGS
(Flow tube)
Anaesthetic gas
scavenging AGS
incl. transfer hoses
Endotracheal suction
regulator
Flow sensor: Spirolife
Flow sensor: Spirolog
Flow sensor: Infinity ID
✓
✓
✓
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
✓
✓
✓
✓
✓
✓
✓
✓
×
×
×
×
✓
×
×
×
×
×
×
✓
Disposable accessories
Particle filter AGS
See Chapter 10, Accessories
List (9066485)
Particle filter AGS
See Chapter 10, Accessories
List (9066485)
Filter for suction
See Chapter 10, Accessories
List (9066485)
×
×
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, FABIUS FAMILY
Device options
Clic Sodalime
(Contact surface)
Click adapter
Absorber
(Contact surface)
Hose systems with
breathing bag and connectors
(Contact surface)
Water trap WaterLock 2
(Contact surface)
Flowmeter O2
Surface disinfection
Manual disinfection
✓
×
✓
×
✓
✓
✓
×
✓
×
×
✓
Further information on accessories can be found within accessories catalogue,
corresponding “and more” catalogues or IFUs.
Please see also chapter 10: Accessories Lists.
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
✓
✓
✓
✓
✓
✓
✓
×
×
×
×
×
Disposable accessories
See Chapter 10, Accessories
List (9066485)
See Chapter 10, Accessories
List (9066485)
See Chapter 10, Accessories
List (9066485)
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, Primus FAMILY
Notes
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D-18862-2010
3.2 Primus family (Primus, Primus IE, Apollo)
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Reprocessing and Preparation of Devices V 1.0 |
Anaesthesia workstations, PRIMUS FAMILY
Devices
Surface disinfection
Manual disinfection
Primus family
✓
Infinity C500/C700
Infinity Delta/Delta XL/
Kappa/Gamma/GammaXL
✓
×
×
✓
×
Infinity M540/M500/PS250
✓
×
Device components
Surface disinfection
Manual disinfection
Breathing system
✓
✓
APL valve, Breathing system
✓
✓
Ventilator unit
(Rolling diaphragm)
×
✓
✓
×
✓
✓
✓
✓
✓
✓
D-Vapor/3000,
Vapor 2000/3000
Anaesthetic gas
scavenging AGS
including Flow Tube
Anaesthetic gas
scavenging AGS
incl. transfer hoses
Endotracheal suction
regulator
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.
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Washer disinfector
Sterilisation
×
×
×
×
×
×
×
×
Washer disinfector
Sterilisation
✓
✓
✓
✓
✓
✓
×
×
×
×
×
×
×
×
Disposable accessories
Disposable accessories
Particle filter AGS
See Chapter 10, Accessories
List (9066485)
Particle filter AGS
See Chapter 10, Accessories
List (9066485)
Filter for suction
See Chapter 10, Accessories
List (9066485)
This handbook does not replace the currently valid Instructions for Use
which remain valid, without restriction.