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5th congress of sterilizationand disinfection

4 – 8 april 2007WOW Kremlin Palace hotel, Antalya, Turkey

Topics in sterilization

Wim Renders

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Congresses have to provide

information and practical guidelines,a look into the future.

Topics in Sterilization

1. Globalisation

Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials,sterile barrier systems and packaging systems(ISO 11607-1:2006)

“This international standard is applicable to industry, health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.”

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BS EN 867-4: 2001

Class B

Solidarity =

to put knowledge and expertise at the disposal of others!At a national level much more opportunities should be created.The drive in an organisation to learn is influenced by its contacts with domestic and foreign organizations.

Solidarity:

increases mutual coherence,contributes to a gradual harmonisation of all sterilization departments.

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Topics in Sterilization

1. Globalisation2. Cleaning and disinfection

Galileo

A product is sterile when the chance ofa micro-organism being present equalsor is less than 1 out of 1 million.

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Thyroiedectomy:Farabeuf: 2 cfuNeedle holder: 6 cfu

Thrombectomy:Suction tube: 14 cfuWound spreader: 3 cfuForceps: 40 cfu

Rinsing

Ultrasonic unit

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Ultrason bath is:

emptied in the evening and dried out. The sides and the lid are sprayed with alcohol 70°, and some alcohol is poured down the drain.

RKI recommendations:

Detergents pH > 10Sterilisation: 5’ 134°C

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Disinfection parameters:Ao = 600 (80°C , Z = 10°C): uncritical:

80°/10 min or 90°/1 min Ao = 3000: semi-critical & critical

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Suction tubes are:

first rinsed with cold water and than treated with hydrogen peroxide 3 %, next: normal procedure.

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Thyroiedectomy: Before AfterFarabeuf: 2 cfu 10 cfuNeedle holder: 6 cfu 6 cfu

Thrombectomy:Suction tube: 14 cfu 6 cfuWound spreader: 3 cfu 6 cfuForceps: 40 cfu 7 cfu

Topics in sterilization

1. Globalisation2. Cleaning and disinfection3. Industrialisation

Because one cannot support the ideathe patient may have different qualityof care if the instruments have beenprocessed by the industry or by thehospital.

B. Kouchner

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Topics in sterilization

1. Globalisation2. Cleaning and disinfection3. Industrialisation4. Outsourcing

WHY?

Rising operating costs of CSSD,Lack of space,Bad quality, too expensive to upgrade.

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Economic management models in CSSD:objective analysis of practises lead toappropriate measures and better quality.

Cooperation with an external partner is abetter option than providing bad quality!

Crucial in a decision is the answer on:can a company offer:

Same quality at the same or lower price?Better quality for a lower price?Same quality for the same price?

Topics in sterilization

1. Globalisation2. Cleaning and disinfection3. Industrialisation4. Outsourcing5. Quality system

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Prevention is better than cure!Managing and checking the processes make it possible to predict the outcome.Remedial measures reduced.Higher costumer satisfaction.Better patient care.Higher status for the CSSD.Job satisfaction of the collaborator!

EN – ISO 13485 (2003)« Quality systems – Medical devices -

Particular requirements for the application of EN – ISO 9001 »

EN – ISO 14971 (2000)“Application of Risk Management to

Medical Devices “

Tracebility

It is not so much about delivering the proof of good work but about delivering good work.Added value for the staff.

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Topics in sterilization

1. Globalisation2. Cleaning and disinfection3. Industrialisation4. Outsourcing5. Quality system6. Bowie-Dick vs Helix

Bowie Dick test

DPCD

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Topics in sterilization

1. Globalisation2. Cleaning and disinfection3. Industrialisation4. Outsourcing5. Quality system6. Bowie-Dick vs Helix7. Education

To deliver continuous quality demands a large degree of professionalism of all involved!

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THANK YOU