If your Health Service Organisation (e.g. office-based practices, day hospitals, hospitals) is accredited to the National Safety and Quality Health Service Standards or Primary and Community Healthcare Standards, the Commission recently published AS24/01 and PCH24/01 (11 November 2024). This Advisory describes the minimum compliance requirements within Action 3.17 or Action 3.13 for health service organisations that reprocess reusable medical devices (RMDs). It is mandatory for approved accrediting agencies to implement this Advisory. This advisory replaces advisory AS18/07 which has been rescinded and provides advice regarding the released AS/NZS 5369:2023, which supersedes both AS/NZS 4187:2014 and AS/NZS 4815:2006.
There are a number of Advisory requirements, namely:
- Performing a gap analysis by 30 June 2025 if using semi-critical and critical RMDs;
- Implementing risk mitigation strategies where risks are identified;
- Compliance with national or international standards;
- Replacement of inoperable or obsolete equipment, devices and water filtration equipment;
- Conduct a water quality risk assessment and monitor water quality.
Where timelines for implementation of project plans exceed 3 years, health service organisations may apply to the Commission for an extension.
For details refer to 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 or 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 .
To assist with transitioning from AS/NZS 4187:2014 and AS/NZS 4815:2006, the Commission has resources to assist available from:
