Australian Commission on Safety and Quality in Health Care
This resource will assist health service organisations to implement the new requirements of AS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.
Overview
Action 3.17a of the National Safety and Quality Health Service (NSQHS) Standards requires health service organisations to have processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines. In December 2023, AS 5369:2023 superseded AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations and AS/NZS 4815:2006 Office-based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment.
AS 5369:2023 specifies the requirements for the effective and safe reprocessing, storage, handling, and transportation of reusable medical devices (RMDs) and other devices used in human health care and other treatments. Implementation of AS 5369:2023 is required in all healthcare settings as well as other non-healthcare settings where RMDs and other devices are in use.
Key changes
The transition from AS/NZS 4187:2014 to AS 5369:2023 involves the following key changes, several of which are significantly different to AS/NZS 4187:2014 and have resource implications for health service organisations:
An expanded scope to include office-based and non-health related facilities that use RMDs and other devices for diagnosis, treatment, and other procedures
No recommendation on the timeframe for health service organisations to implement the requirements of AS 5369:2023, while AS/NZS 4187:2014 recommended a two-year timeframe
An emphasis on a risk-based approach
A recommendation for annual training of staff in infection prevention and control and occupational exposure procedures
An emphasis on management responsibilities, and the establishment of systems such as business continuity planning to ensure compliance with the standard under all conditions
Requirements about evidence of accreditation and quality management activities in contracts with third parties for reprocessing services
The involvement of competent persons to oversee document and record controls and product selection processes
An emphasis on Therapeutic Goods Administration (TGA) requirements for RMDs, RMDs accessories, reprocessing equipment, and reprocessing agents
Additional guidelines for maintaining traceable and legible records
Guidance for grouping devices into product families, which determine the methods for reprocessing
Facility design that supports dedicated reprocessing areas and adherence to unidirectional workflows to mitigate cross-contamination risks
Stipulations for cleaning sinks, hand hygiene facilities and ventilation systems
Enhanced risk assessment and performance qualifications for handling, storage, and transport of RMDs and other devices to prevent contamination and ensure safety throughout the reprocessing cycle.
Table 1 maps AS 4187:2014 to the detailed updates and new requirements of AS 5369:2023 and includes suggestions for implementation strategies for health service organisations. In general, a staged implementation process, informed by risk assessment, is recommended.
Implementation considerations
Health service organisations should conduct a gap analysis using a risk-based approach to determine changes that are necessary to align with the new requirements in AS 5369:2023. Health service organisations should update or develop an asset management plan, including timelines for future redevelopment or upgrade to their reprocessing service to meet the requirements of the new standard.
For the full guidelines please download the document below.
More information
For more information on the NSQHS Standards, please visit: https://www.safetyandquality.gov.au/standards/nsqhs-standards
For further enquiries contact AdviceCentre@safetyandquality.gov.au
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