Dräger Medical
Reprocessing and Preparation of Devices Guide Aug 2015
Guide
80 Pages
Preview
Page 1
D-8994-2011
D-91140-2013
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Reprocessing and preparation of devices
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REPROCESSING AND PREPARATION OF DEVICES
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. (08/2015) 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 Classification of medical products 2.2 Surface disinfection (for uncritical medical products) 2.3 Manual disinfection 2.4 Mechanical cleaning and thermal disinfection 2.5 Sterilisation using validated sterilisation methods
9 9 10 11 11 11
3 Anaesthesia Workstations 3.1 Fabius family 3.2 Perseus A500 3.3 Primus family 3.4 Zeus IE
13 13 21 27 33
4 Intensive care ventilators 4.1 Evita family / Savina 300 4.2 Carina
39 39 45
5 Neonatal workplace
49
6 Oxylog family
57
7 Patient monitoring
61
8 Workplace infrastructure
67
9 Further ward equipment
73
10 Accessories list
78
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REPROCESSING AND PREPARATION OF DEVICES
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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 act. 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
Table of examples DEVICES
Surface disinfection Zeus range
✓
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
The 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 line). The current Instructions for Use remain unconditionally valid and are not replaced by this handbook.
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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
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.
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REPROCESSING AND PREPARATION OF DEVICES | 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) – DIN EN ISO 17664 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (07/2004) – DIN EN ISO 15883 Washer-disinfectors (04/2014) – DIN EN 285 Sterilisation (08/2009) – Recommandations by other relevant, local institutions
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2 Preparation methods for resusable medical products Information on cleaning, disinfection and sterilisation of reusable medical products and accessories. 2.1 CLASSIFICATION OF MEDICAL PRODUCTS
To define the preparation method, the medical products and their components are classified according to their application and the resulting risk: 1. Uncritical medical products: Surfaces (e.g. device surface, cables) accessible by user and patient 2. Semicritical medical products: Breathing gas bearing parts, e.g. breathing hoses, masks 3. Critical medical products: penetrating skin or mucous membranes Notice National legal regulations, national and international standards, guidelines and applicable hygiene guidelines (see Point 1) must be observed during preparation.
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REPROCESSING AND PREPARATION OF DEVICES | PREPARATION METHODS FOR REUSABLE MEDICAL PRODUCTS
2.2 S URFACE DISINFECTION (FOR UNCRITICAL MEDICAL PRODUCTS)
Manual cleaning with simultaneous surface disinfection. 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. Based on these studies, in Instructions for Use dated before April 2015 for medical products which are maufactured by Dräger, the specifications on surface disinfectants as well as general recommendations on substance groups are replaced by the following: – Descogen liquid, Descogen liquid r.f.u. by Antiseptica – Dismozon pur/Dismozon plus by Bode Chemie – Mikrozid sensitive by Schülke – Perform by Schülke – Virkon by DuPont – Actichlor plus by Ecolab – Klorsept 17 by Medentech – Oxycide by Ecolab USA – BruTab 6S by Brulin – Buraton by Schülke These surface disinfectants have been material compatible at the moment of validation (July 2015). Their manufacturer-tested effectiveness covers bacteria (bactericidal), candida (yeasticidal) and viruses (virucidal or limited virucidal). When using these products to its intended use on surfaces of Dräger devices, the material compatibility as well as the required germ spectrum are covered.
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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. 2.3 MANUAL DISINFECTION
Cleaning/disinfection of reusable semicritical medical products. 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 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
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 | ANAESTHESIA WORKSTATIONS
NOTES
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3 Anaesthesia workstations
D-75695-2013
3.1 FABIUS FAMILY
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 | ANAESTHESIA WORKSTATIONS
DEVICES
Surface disinfection
Manual disinfection
Fabius Family
✓
/
Infinity C500/C700
✓
/
✓
/
✓
/
✓
/
Infinity Delta/Delta XL/ Kappa/Gamma/GammaXL Infinity M540/M500/PS250 Vamos Gas monitor and Scio Gas module
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 | ANAESTHESIA WORKSTATIONS
DEVICE COMPONENTS
Compact breathing system COSY (APL valve) Compact breathing system COSY Ventilator diaphragm (Rolling diaphragm)
Surface disinfection
Manual disinfection
✓
✓
✓
✓
/
✓
Ventilator lid
/
✓
Vapor 2000/3000
✓
/
Anaesthetic gas suction AGS (Flow tube)
✓
✓
Anaesthetic gas suction AGS incl. transfer hoses
✓
✓
Bronchial suction vacuum regulator/suction ejector
✓
✓
✓
✓
Suction container, lid and silicone connecting hose (lid omitted when using VacuSmart/VacuSmart GEL) Flow senor: Spirolife
/
✓
Flow sensor: Spirolog
/
✓
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 current Accessories list on page 78 Particle filter AGS See current Accessories list on page 78 Filter for suction See current Accessories list on page 78 VacuSmart/VacuSmart GEL; Suction hose with Fingertip See current Accessories list on page 78
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 | ANAESTHESIA WORKSTATIONS
DEVICE OPTIONS
Clic Sodalime (Contact surface) Absorber (Contact surface) Silicone masks Hose systems with breathing bag and connectors (Contact surface) Water trap, Waterlock2/ Waterlock ID (Contact surface) Blood pressure cuffs and blood pressure hose ECG cable /MultiMed core cable Temperature sensor SpO2 sensor Connection cable, sensors
Surface disinfection
Manual disinfection
✓
/
✓
✓
/
✓
✓
/
✓
/
✓
/
✓
/
✓
✓
✓
/
✓
/
Self Test lung (MP02400) (blue plastic cover)
✓
/
Self Test lung (MP02400)
✓
✓
Flowmeter O2
✓
/
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 current Accessories list on page 78 No. 9052629
✓
✓
✓
✓
✓
✓
✓
/
See current Accessories list on page 78 No. 9052629 See current Accessories list on page 78 No. 9052629
/
/
See current Accessories list on page 78 No. 9052629
/
/
/
/
/
/
/
/
/
/
/
/
✓
✓
/
/
See current Accessories list on page 78 See current Accessories list on page 78 See current Accessories list on page 78 See current Accessories list on page 78 See current Accessories list on page 78
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 | ANAESTHESIA WORKSTATIONS
NOTES