Reprocessing and Preparation of Devices Guide Dec 2016

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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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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.