The Australian Commission on Safety and Quality in Health Care (ACSQHC) has a developed a gap analysis tool to help health service organisations (HSO) in assessing compliance with the Australian Standard AS 5369:2023 Reprocessing of Reusable Medical Devices and Other Devices in Health and Non-Health Related Facilities.

This tool should be used by stakeholders within a health service organisation that use, reprocess or have oversight of reusable medical devices. The tool is not suitable for risk assessing the reprocessing of devices labelled as single use.

HSOs are required to complete a gap analysis of compliance with AS 5369 by 30 June 2025 in accordance with the relevant advisories published. Refer https://www.safetyandquality.gov.au/newsroom/national-standards-updates/as2401-national-safety-and-quality-health-service-standards-requirements-reprocessing-reusable-medical-devices-health-service-organisations and https://www.safetyandquality.gov.au/newsroom/national-standards-updates/pchs2401-national-safety-and-quality-primary-and-community-healthcare-standards-requirements-reprocessing-reusable-medical-devices-practices

For more information and to download the tool, click https://www.safetyandquality.gov.au/publications-and-resources/resource-library/reprocessing-reusable-medical-equipment-gap-analysis-tool