To ensure appropriate risk management of the reprocessing of reusable medical devices, all staff involved must adhere to relevant local health network, state, national and international standards and guidelines, and the National Safety and Quality Health Service Standards. AS5369 Reprocessing of reusable medical devices and other devices in health and non-health related facilities describes requirements across all healthcare settings as well as non-health settings in which devices with infection control risks are reprocessed between clients.
Prior to the adoption of AS5369 in December 2023, two separate standards applied;
Please note that guidelines, audit tools and recommendations published by national and international organisations may be under revision as AS5369 is implemented.
Items marked "single-use only" (PDF 81KB) or with this symbol must not be reprocessed.
Items labelled "single-patient use", can be re-used on the same patient only, after reprocessing according to the manufacturer’s instructions.
Currently the regulatory requirements for the reprocessing of medical devices labelled as "single use" are covered by:
Cleaning is the essential first step for any form of reprocessing:
The item and its intended use determine the level of reprocessing required. The manufacturer’s instructions, health service policy, applicable guidelines and standards should all be taken into consideration when determining the most appropriate process. The "Spaulding classification" is often used to assess reprocessing requirements1 and is summarised as follows:
Application: Entry or penetration into sterile tissue, body cavity or bloodstream
Process: Sterilisation
Application: Contact with intact mucous membranes or non-intact skin
Process: Sterilisation where possible. If sterilisation is not possible then high-level thermal or chemical disinfection is required
Application: Contact with intact skin only
Process: Clean as necessary with detergent and water (low or intermediate level disinfection after cleaning as required)
Semi-critical items such as endoscopes, laryngoscope blades and ultrasound probes/transducers that are used in body cavities or during surgery should ideally be sterilised, but many of these devices are incompatible with both steam and low temperature sterilisation, and therefore require high-level disinfection as the next most comprehensive process to render them safe to use on another patient. There are several automated high-level disinfection systems, including automated flexible endoscope reprocessors (AFERs), and specific standalone equipment for high-level disinfection of ultrasound probes.
Examples of effective high-level disinfectants include:
There are disadvantages with the use of any chemical disinfectant, such as occupational exposure and material compatibility. Chemical high level disinfectants must be monitored at each use for ongoing efficacy, and expiry dates must be strictly followed. For a summary of these issues see the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (Table 5).
Ortho-phthalaldehyde (OPA) has largely replaced the use of glutaraldehyde in most healthcare facilities due to its superior microbicidal properties, shorter immersion time and safer risk profile.
For detailed information on training and reprocessing of endoscopic devices, see the Gastroenterological Society of Australia Infection Control in Endoscopy Guidelines.
For detailed information on the quality assurance of endoscope reprocessing, see the SA Health Microbiological Testing of Endoscopes Clinical Guideline (PDF 420KB).
Compliance with AS/NZ 5369:2023 can be assessed by using an audit tool (PDF 699KB) developed by Southern Adelaide Local Health Network (SALHN). A word version of the audit tool is available on request by contacting SA Health's Infection Control Service.
The NSW Clinical Excellence Commission has developed a suite of audit tools and quality management resources for monitoring compliance with reprocessing standards.
All healthcare providers who reprocess reusable medical devices are responsible for meeting appropriate national standards of safety and quality in infection control. To support compliance with accreditation requirements the Australian Commission on Safety and Quality in Health Care provide standards and audit tools for health facilities.
This includes office-based and smaller medical practices where the comprehensive SALHN tool may not be suitable.
Ultrasound transducers are used in a variety of healthcare settings, and their Spaulding Classification may vary according to the internal or external tissues contacted during each use. Advice on the method of reprocessing required in each scenario including the use of sterile probe covers or sheaths, has been developed bu the Australian Society for Ultrasound in Medicine (ASUM) and the Australasian College for Infeciotn Prevention and Control (ACIPC). Resources are as follows:
The SA Health Reprocessing of Reusable Medical Devices Governance Group is a group of health professionals from metropolitan and country hospitals who work collaboratively to advocate for the best practice in sterilisation and reprocessing of reusable medical devices, giving oversight of the implementation of AS/NZ AS5369 across SA Health facilities.
The Reference Group is also a forum for health professionals to network, raise issues and seek advice from other members' knowledge and experience. To share ideas or seek reprocessing advice, contact the Sterilising and Reprocessing Medical Device Reprocessing State Coordinator.
For further information on reprocessing of medical devices, contact SA Health's Infection Control Service.
1 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, page 10.
