Isolette
Babylog and Neonatal Ventilator Series
Reprocessing and Preparation of Devices Guide Dec 2016
Guide
86 Pages
Preview
Page 1
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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
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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
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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
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
10 12 13 13 13
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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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– 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.