Darren Martin1
1Bendigo Health, PO Box 126 Bendigo, Victoria, 3552, darren.martin@bendigohealth.org.au
Abstract:
Background
Reprocessing reusable medical devices (RMDs) is a specialised process that needs to be undertaken following strict procedures in line with National and International Standards. At the end of 2023, the new Australian Standard AS5369 was released and is applicable to all health and non-health related facilities responsible for reprocessing RMDs and other devices.
Method
This presentation aims to compare the superseded AS/NZS4187 and AS/NZS4815 standards with the newly released AS5369 standard and analyse the changes, impacts and risks to those facilities required to adhere to the reprocessing requirements of the new standard.
Results
The AS5369 standard has considerable changes in comparison to the previous AS/NZS4187 standard with updated information, additional guidance and the inclusion of a new appendix with an emphasis on a risk-based approach. There are significant differences when comparing AS5369 to the previous AS/NZS4815 standard with many additional requirements now applicable including product families, water quality and facility design.
Conclusion
Health and non-health related facilities responsible for reprocessing RMDs are required to adhere to the requirements of AS5369. The standard provides facilities with a framework to safely reprocess RMDs and ensures there are quality processes to prevent infections. Meeting the requirements of AS5369 will be challenging, particularly for those facilities that previously followed AS/NZS4815.