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COMPLIANCE & STANDARDS

COMPLIANCE & STANDARDS

AS 5369:2023 introduced significant changes to the reprocessing requirements for reusable medical devices within healthcare settings.

PodMed Supplies operates with systems and processes designed to work with these requirements.

Our Compliance Framework

Quality Systems

✓ ISO 9001 Audited & Certified
✓ Written policies and procedures
✓ Staff competency 

✓ On going auditing
 

Sterilisation Controls

✓ Class 6 emulating indicators
✓ Printex process indicators
✓ Batch traceability systems
✓ Cycle validation and monitoring

 

Water Quality Management

✓ Reverse osmosis water systems
✓ Water quality testing
✓ Continuous monitoring of TDS, EC, pH and temperature

 

Facility & Workflow Controls

✓ Dirty to clean workflow separation
✓ Dedicated hand wash facilities
✓ Airflow and contamination considerations

 

Regulatory Compliance

✓ TGA Class I reusable instruments
✓ AS 5369:2023 compliant instruments
 

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Sterilising 1
sterilising 2
SA
CEC
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Adhesive Label on each packet with sterilsation date, batch, expiry date and our business name. A printex indicator label is also attached for each packet This is all required for tracking compliance.
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Lab test results for our reverse osmosis waster used for ultrasonic pre treatment, washing and final rinse
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Documentation delivered with each order. Clearly states items ordered with tracking numbers.
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Returned instrument sheet to keep track of items.
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Tracking sheet for clinics use and compliance.
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Compliance information emailed
Contains Class 6 Emulating Indicator
Printex Label Indicator
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