top of page
sterilizing-in-autoclave_edited.jpg

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
 

Instrument Processing Workflow
Sterilising 1
sterilising 2
SA
CEC
Sterilisation Complaince Documentation
Full compliance documentation supplied with every sterilisation batch. This is email and uploaded onto your clinics portal.
Sterilisation Complaince Documentation
Each order includes batch documentation with item tracking and compliance records.
QR code linked to batch records on your clinics portal

Sterilisation Complaince Documentation

Patient instrument traceability log.
Easy to use return tracking sheet included with every collection box.
Used medical instrument return form.
Batch tracking log included to support clinics traceability requirements.
Biohazard warning for used medical instruments.
Sterile instrument pouch with traceability labels.
Each sterile pack includes complete traceability labelling, including sterilisation date, batch number, expiry date,  Printex process indicator label and QR code access to batch records via clinic portal
PodMed reusable podiatry kit TGA certificate.
Reverse osmosis water quality test report.
Lab test results for our reverse osmosis waster used for ultrasonic pre treatment, washing and final rinse
PodMed steriliser validation and calibration certificate.
bottom of page