Monitoring of Cleaning and
Sterilization Processes in Healthcare Facilities
Micro-biological, technical and legal Aspects,European Medical Device Directive
(MDD)
Aika
Tiistai 8.9.2015, kello 8.45 – 16.00
Paikka
Labo Line Oy:n koulutustilat:
Karjalankatu 2 (6.krs), 00520 HELSINKI
Reittiopas ja aikataulut www.hsl.fi
Kustannukset
Koulutuksen osallistujakohtainen hinta on
HUS:n työntekijöille 49 € (alv 0 %), muille hinta on 49 € (+ alv 24%)
Hintaan sisältyvät koulutusmateriaali, kahvi- ja lounastarjoilu
Järjestäjät
HUS-Servis Koulutuspalvelut, Labo Line Oy ja
gke-GmbH, Waldems-Esch, Germany
Ilmoittautuminen
HUS:n henkilöstö HUS Plus -järjestelmän kautta
1.9.2015 mennessä,
muut ilmoittautumiset 1.9.2015 mennessä: www.hus.fi/koulutus
Huomioithan, että viimeisen ilmoittautumispäivän jälkeen tehdyistä peruutuksista veloitamme osallistujamaksun kokonaisuudessaan
Tiedustelut
Koulutuspäivän sisältöä koskeviin tiedusteluihin vastaa Labo Line Oy:n
tuotepäällikkö Mikko Kajovaara [email protected]
Target of the seminar
The technology of the steam sterilization pro-cess has dramatically changed during the
past 20 years.
Fractionated pre-vacuum-cycles have dramati-cally reduced the process time of steam
sterilization processes. After the introduction of minimal invasive surgery technologies
surgical instruments became more complex and therefore cleaning and sterilization are
more difficult. Those developments increase the risks of malfunctions in cleaning and
steam sterilization processes.
Consequences for organization and monitoring methods according to International
standards are offered.
Since January 1st, 1995 the Medical Device Directive (MDD) is published from the EU
commission and later on implemented in all European associated member countries.
International and European standards for cleaning processes, steam sterilizers, biological and chemical indicators and validation procedures are revised adopting to modern
sterilization technologies.
The seminar is tailored to persons of the following departments in hospitals and outpatient and dental clinics:
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Sterilization department (CSSD)
Operation room
Hygienic department
Servicing and medical technology
Monitoring of Cleaning and
Sterilization Processes in Healthcare Facilities
Micro-biological, technical and legal Aspects,
European Medical Device Directive (MDD)
Tuesday 8.9.2015
Technical aspects of cleaning and steam sterili-zation processes and resulting consequences
for validation and monitoring
Speaker: Dr. U. Kaiser, Manager R+D, gke-GmbH, Germany
Member of national and international working groups for sterilization monitoring of
DIN, CEN and ISO
8.45
Coffee and registration
9.00
Introduction
9.45
Critical variables influencing cleaning processes
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10.45
Instrument design
Contaminants of instruments
Pre-treatment of instruments before cleaning
Cleaning agents
Cleaning mechanisms
Washing methods
Typical WD cleaning procedures
Definition of the A0-value in thermal disinfection in a WD
Discussion
Coffee break
11.00
gke Test method for cleaning indicators
 Construction of the gke spray test rig
 Tests comparing standard test soils according ISO 15883-5 and
gke Clean-Record® Test Systems
in the spray test rig
Discussion
Cleaning Monitoring
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Definition “Clean” and “Disinfected”
Complexity of monitoring
Contamination on surfaces and flushing canals
Current situation in the standards
Protein test methods
Tests with cleaning indicators
gke Cleaning indicators
Test of ultrasonic cleaning basins and lubricating agents
Discussion
12.00
Lunch break (Restaurant Ilma)
13.00
Physical basics of the sterilization processes
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Heat transfer into packs with goods
Air removal process and steam penetration
Modification of EN 285
Discussion
Potential problems in the sterilization process
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Insufficient air removal
Leakages
Non condensable gases (NCG) in steam
Discussion
Specific problems during sterilization of minimal invasive surgical (MIS-) instruments
and tubes with small lumens
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Dependence on length, diameter and material
Sterilization of assembled or dissembled instruments?
Sterilization of narrow splits
Use of protecting and lubricating agents
Discussion
14.30
Coffee break
14.45
Routine monitoring
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Bowie-Dick-Test
Process indicators
Monitoring with package indicators
Batch monitoring system
Discussion
Use of medical device simulators (MDS) and batch monitoring systems (BMS)
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16.00
Definition: MDS, BMS
Application of
MDS to prove sterility of MDs
BMS for batch monitoring
Final Discussion
End of the meeting