Reprocessing of medical devices
The SA Health Reprocessing Policy Directive aims to ensure appropriate governance systems are in place; regular audits occur, and all staff involved in the use and reprocessing of reusable medical devices consistently adhere to the recommendations in the relevant local health network, state, national and international standards and guidelines, in particular AS/NZS 4187:2014 – Reprocessing of reusable of medical devices in health service organisations, and the National Safety and Quality Health Service Standards.
Single-use and single-patient use devices
Items marked "single-use only" (PDF 81KB) or with the symbol must not be reprocessed.
Items labelled "single-patient use", can be re-used on the same patient 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:
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- Therapeutic Goods (Medical Devices) Regulations 2002
- Section 19 of the Australian regulatory guidelines for medical devices (ARGMD).
SA Health also has a fact sheet on the Safe Use of Anaesthetic Equipment and Prevention of Cross Infection (PDF 108KB) which outlines the infection control requirements for reprocessing of these specific items, several of which may be labelled as "single use" or "single patient use".
The importance of cleaning
Cleaning is the essential first step for any form of reprocessing:
- thorough cleaning should commence as soon as practicable after use
- if an item cannot be thoroughly cleaned, it cannot be adequately reprocessed
- failure to achieve adequate cleaning may result in ineffective disinfection or sterilisation of instruments or equipment.
Level 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 in the following table:
|Level of risk||Application||Process|
|Critical||Entry or penetration into sterile tissue, body cavity or bloodstream||Sterilisation|
|Semi-critical||Contact with intact mucous membranes or non-intact skin||Sterilisation is preferred where possible.If sterilisation is not possible then high-level chemical disinfection is required|
|Non-critical||Contact with intact skin only||Clean as necessary with detergent and water (disinfect after cleaning as required)|
Semi-critical items, such as endoscopes, laryngoscopes and ultrasound probes/transducers that are used in body cavities or during surgery should ideally be sterilised, but many of these equipment items are heat sensitive and therefore require high-level disinfection to render them safe to use on another patient. There are many different automated systems available for high-level disinfection, including automated endoscope reprocessors, and specific systems for high-level disinfection of ultrasound probes.
Examples of effective high-level disinfectants include:
- glutaraldehyde at ≥2% (activated, pH 7.5 to 8.5)
- ortho-phthalaldehyde at 0.55%
- peracetic acid at 0.2%
- hydrogen peroxide at 7.5%
There are disadvantages with the use of each of these chemicals, such as occupational exposure concerns and materials compatibility issues. For a summary of these issues see the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (Table 5, page 110).
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. SA Health has developed a fact sheet on the safe use of OPA (PDF 52KB) which highlights some of the risks and procedures that need to be followed.
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 4187:2014 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.
All healthcare providers who reprocess reusable medical devices are responsible for meeting appropriate national standards of safety and quality in infection control. This includes office-based and smaller medical practices where the above tool may not be suitable.
- The Australian Dental Association (ADA) provides guidelines for infection control for dental facilities.
- The Podiatry Board of Australia provides an audit tool (PDF 127KB) for checking compliance with the Board’s infection control guidelines.
- The RACGP publishes standards in infection control to guide General Practitioners and office-based practices. Audit tools may be available from the practice’s accreditation provider.
- The Australian Commission on Safety and Quality in Health Care provide standards and audit tools for health facilities.
All healthcare providers that use ultrasound transducers, standard of practice for reprocessing ultrasound transducers can be sources from:
- Australian Society for Ultrasound in Medicine (ASUM)
- Guidelines for reprocessing ultrasound transducers
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.