HYDROGEN PEROXIDE STERILISATION IN A ISO EN 13485

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HYDROGEN PEROXIDE STERILISATION IN A ISO EN 13485 ENVIRONMENT Wouter Meert, manager CSSD, UZ

HYDROGEN PEROXIDE STERILISATION IN A ISO EN 13485 ENVIRONMENT Wouter Meert, manager CSSD, UZ Leuven

UZ Leuven

UZ Leuven

UZ Leuven Healthcare campus

UZ Leuven Healthcare campus

UZ Leuven • • • 1900 beds 9 038 employees 56 658 hospitalizations 684

UZ Leuven • • • 1900 beds 9 038 employees 56 658 hospitalizations 684 199 consults (2 748/day) 100 005 one day hospitalizations 53 544 surgical procedures (215/day – 45 operating rooms)

CSSD UZ Leuven

CSSD UZ Leuven

CSSD UZ Leuven • ISO EN 13485 (since 2012, successfull recertification 2015) • 54,

CSSD UZ Leuven • ISO EN 13485 (since 2012, successfull recertification 2015) • 54, 90 FTE • 1900 m 2 • 3 batch and 3 tunnel WD • 5 floor load autoclaves • 2 Sterrad 100 NX

ISO EN 13485 • • • Organisational structure Infrastructure Structure QMS Process controle Customer

ISO EN 13485 • • • Organisational structure Infrastructure Structure QMS Process controle Customer feedback Staf training

ISO EN 13485

ISO EN 13485

Hydrogen peroxide sterilizers

Hydrogen peroxide sterilizers

Hydrogen peroxide UZ Leuven • First Sterrad 100 S bought in 1998 • Second

Hydrogen peroxide UZ Leuven • First Sterrad 100 S bought in 1998 • Second in 2000 • Half december 2013, 2 new Sterrad 100 NX • Spring 2015, installation double door • Current use 10 – 15 cycle/day/machine • 221 different items

Infrastructure Before double door installation

Infrastructure Before double door installation

Building plans

Building plans

Current setting

Current setting

Medical instruments • • • Optics HD camera’s Light cables endoscopes Da Vinci instruments

Medical instruments • • • Optics HD camera’s Light cables endoscopes Da Vinci instruments • Foetal surgery • Brachytherapie • Echoprobes 80 % • • Hipec Sentinel probe Diamant drills Electrodes/kirschner

Temperature probe Hipec

Temperature probe Hipec

Echo probe

Echo probe

Utrecht applicator brachy

Utrecht applicator brachy

Da Vinci XI

Da Vinci XI

Foetal surgery

Foetal surgery

Process switch 1 proces • • Standaard Duo Flex Express

Process switch 1 proces • • Standaard Duo Flex Express

Defining process compatibility • Registration conform ISO EN 13485 • Listing instruments • Sterilisation

Defining process compatibility • Registration conform ISO EN 13485 • Listing instruments • Sterilisation Program selection: – ASP Sterrad Sterility guide – User manual instrument manufacturer – Sterility experts ASP • Registration within traceability system and inventory • Training employees

NBN EN ISO 14937 • IQ, OQ, PQ • Routine controle: – Chemical indicators/

NBN EN ISO 14937 • IQ, OQ, PQ • Routine controle: – Chemical indicators/ biological indicators • Periodically maintenance • Parametric release

Parametric release

Parametric release

Conclusion • Need for hydrogen peroxide LTS within our setting because of specific surgical

Conclusion • Need for hydrogen peroxide LTS within our setting because of specific surgical instruments • Important for ISO EN 13485 : – Sterrad Sterility Guide – Support by sterility advisors – Process control en parametric release • More research is needed on effects of hydrogen peroxide on instruments

Thank you Wouter Meert Manager CSSD UZ Leuven wouter. meert@uzleuven. be Tel 0032 16

Thank you Wouter Meert Manager CSSD UZ Leuven wouter. meert@uzleuven. be Tel 0032 16 34 40 07

WELCOME ISO 13485 2016 MDR ISO 13485 2016WELCOME ISO 13485 2016 MDR ISO 13485 2016
ISO 9001 a ISO 13485 aplikace na pracovitchISO 9001 a ISO 13485 aplikace na pracovitch
1 Qualittsmanagement nach ISO 13485 2003 und ISO1 Qualittsmanagement nach ISO 13485 2003 und ISO
HYDROGEN ENERGY Hydrogen storage Hydrogen Uses of hydrogenHYDROGEN ENERGY Hydrogen storage Hydrogen Uses of hydrogen
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ISO 9001 ISO 9001 ISO 9001 19942008 ISOISO 9001 ISO 9001 ISO 9001 19942008 ISO
O TO NHN THC CHUNG V ISO 13485O TO NHN THC CHUNG V ISO 13485
Stand 102009 DIN EN ISO 13485 SoftwareValidierung DirkStand 102009 DIN EN ISO 13485 SoftwareValidierung Dirk
An Overview of ISO 13485 2016 Medical DevicesQualityAn Overview of ISO 13485 2016 Medical DevicesQuality
ISO 13485 2016 Norm for regulatory compliance AliceISO 13485 2016 Norm for regulatory compliance Alice
QAD Medical Devices ISO 13485 2003 7 1QAD Medical Devices ISO 13485 2003 7 1
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ISO 13485 Training Series Formaes especficas para oISO 13485 Training Series Formaes especficas para o
Material Hydrogen Production of hydrogen properties of hydrogenMaterial Hydrogen Production of hydrogen properties of hydrogen
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THNK hydrogen THNK hydrogen project description THNK hydrogenTHNK hydrogen THNK hydrogen project description THNK hydrogen
Hydrogen bond Hydrogen bond When hydrogen atom liesHydrogen bond Hydrogen bond When hydrogen atom lies
Material Hydrogen Production of hydrogen properties of hydrogenMaterial Hydrogen Production of hydrogen properties of hydrogen
Impact of Oxygen and Hydrogen Peroxide Treatments onImpact of Oxygen and Hydrogen Peroxide Treatments on
Polyamine Oxidase is the Source of Hydrogen PeroxidePolyamine Oxidase is the Source of Hydrogen Peroxide
Effectiveness of Hydrogen Peroxide on Aspergillus Niger GrowthEffectiveness of Hydrogen Peroxide on Aspergillus Niger Growth