Compliance & Standards
The the new standard AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities​ has made significant changes to the old standard and as part of AHPRA registration it is expected that all standards and guidelines are met.
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How we meet AS 5369:2023
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​Facility lay out- including designated dirty and clean sink- with seperate hand wash facilities. Including airflow considerations ( Needing to be from clean to dirty to reduce chance of contamination)
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Use of TGA Approved Class 1 instruments- Reusable Instruments. ARTG No: 445771
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Pre treatment with ultrasonic cleaner- using reverse osmosis water and approved agent ( new standard on water quality and water quality testing)
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Cleaning and rinsing of instruments in reverse osmosis water (new standard with water quality testing required)
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Water quality testing both of distilled water and water used for pre treatment and washing/ rinsing.
We are also equiped with constant monitoring of water quality for TDS, EC, Humidity, Temperature values and PH.
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Standard requires 3 positive indicators of successful sterilisation cycle- we utilise compliant pouches with indicator, class 6 emulating indictor (this is for temperature and time at temperature), Printex process indicator and Melag display of successful cycle.
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​Complaint labelling of instruments with tracking/batch numbers
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Complaint tracking information and sterilisation information supplied
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​Packing and transport of instruments following recommendations by standard
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Compliant policies and procedures ( updated in the new standard are strict written policies and procedures including for testing of water quality, agent register, cleaning log, maintenance log, recall procedures, occupational health and safety policy, complaints and non compliance.)
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Use of Melag Autoclave- steam sterilisation (as recommended by RACGP guidelines) with compliance testing by authorised bodies- see below
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NSW Government Clinical Excellence Commission Assessment of Reprocessing Competencies
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​Audit completed by using SA Health Southern Adelaide Local Health Network audit tool
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​Membership of Sterilization Research Advisory Council of Australia
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Adhesive Label on each packet with sterilsation date, batch, expiry date and our business name. This is all required for tracking compliance.
Lab test results for our reverse osmosis waster used for ultrasonic pre treatment, washing and final ri
Documentation delivered with each order. Clearly states items ordered with tracking numbers.
Returned instrument sheet to keep track of items.
Tracking sheet for clinics use and compliance.
