1. Building Partnerships Presentation to the Dental Decontamination Training Event organised by NHS Manchester on 30 th June 2010

2. Introduction Dave Wilson Service Manager Audere Medical Services Limited

3. What is Validation and why is it required? What is Validation and why is it required? What are the differences between servicing and testing? What are the differences between servicing and testing? Periodic testing requirements for HTM 01-05 Periodic testing requirements for HTM 01-05 Auditable evidence for testing and validation Auditable evidence for testing and validation Contents

4. Validation ‘Validation is the means by which your entire process is verified, tested and documented, with the ability to be consistently reproducible. Ensure ultrasonic, washer disinfector and sterilization equipment used in practices are validated. This is to demonstrate that all instruments and equipment cleaned and sterilized by these methods are reliably and consistently cleaned using pre-determined and reproducible conditions.’ Department of Health HTM 01-05

5. Validation Use and testing of small sterilizers ‘Validation is necessary to demonstrate that the physical conditions required for sterilization (temperature, pressure and time) are achieved. Consultation with appropriately qualified engineers through a PCT or commercial arrangements will be necessary in this area. The engineer will be able to ensure that validation is achieved and that the instrumentation used for parametric release is functioning and calibrated appropriately.’ Department of Health HTM 01-05

6. Typical decontamination equipment

7. Differences between Servicing and Validation Service As per Manufacturer recommendations Equipment warranty conditions Provides continued machine reliability Ensures correct operation No specialist equipment required Validation Legislative requirement Safeguards users and patients Required periodically relevant to HTM 01-05 Section 3 Requires an Authorised Person (Decontamination) Records maintained for all validation results Enable parametric release of products

8. Periodic Testing Requirements Daily Performed by User Weekly Performed by Authorised Persons (Decontamination) Quarterly Performed by Authorised Persons (Decontamination) Annually Performed by Authorised Persons (Decontamination)

9. Auditable Evidence Maintain ALL service and validation records in compliance with your PCT audit policy. Records maintained for daily, weekly, quarterly and annual validation should be stored in log books situated locally to each unit. At a minimum, practices should audit their decontamination processes on an annual basis, within an appropriate review dependent on audit outcomes.

10. Thank you for your time If you would like to receive any further detailed information about HTM 01-05 or to discuss your specific requirements, please contact our Head Office. Audere Medical Services Limited Oak Suite Llancayo Court Usk South Wales NP15 1HY Tel: 01291 671271 Email: info@auderemedical.co.uk Website: www.auderemedical.co.uk