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:
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:
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 is preferred where possible.If sterilisation is not possible then high-level chemical disinfection is required
Application: Clean as necessary with detergent and water (disinfect after cleaning as required)
Process: Contact with intact skin only
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:
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.
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.
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