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Elements and Performance Criteria

1. Elements define the essential outcomes
2. Prepare sterilisation equipment
   • Clean and check steriliser, and accessory equipment according to manufacturer’s recommendations
   • Conduct, interpret and record performance test cycles
   • Interpret and accurately document results from physical and chemical tests
3. Load steriliser
   • Select sterilisation method according to reusable medical devices (RMD) manufacturer requirements
   • Assign appropriate cycle and batch control number and complete documentation correctly
   • Check packaging, sealing and labelling for compatibility with organisation policies and procedures
   • Check load content and configuration for compliance with annual steriliser performance qualification
   • Load steriliser to ensure sterilant contact and according to manufacturer’s recommendations
   • Add additional test items such as biological indicator or process challenge device according to organisation protocol
4. Operate steriliser
   • Check steriliser function for sterilant availability
   • Check function of physical process recording accessories
   • Select appropriate cycle in accordance with organisation policies and procedures
   • Identify, report and action faults according to manufacturer’s recommendations and organisation policies and procedures
5. Unload and release sterilised loads
   • Check and interpret sterilisation cycle parameters and chemical monitors, and record results on completion of cycle
   • Remove sterilised load immediately on completion of cycle
   • Remove compromised items, dismantle for reprocessing and record details
   • Unload cooled load using appropriate handling techniques
   • Complete documentation of the sterilising cycle for parametric release
   • Check and document additional load release tests
   • If used, incubate and check results of biological indicators
6. Comply with quality management requirements
   • Adhere to operational monitoring and testing, performance qualification and maintenance of sterilisers and associated equipment
   • Comply with documentation requirements for sterilising cycles, batch control and load release control
   • Report and document all steriliser faults/malfunction and load non-conformance/non-compliance
   • Store and archive documentation in accordance with organisation policies and procedures

Performance Evidence

The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:

followed established procedures, work processes and national standards to prepare, operate, load and unload sterilisers and release the sterilised loads on at least three occasions, including:

correctly interpreting test results

accurately completing all documentation for cycles, tests and load content, including specialised items

addressing relevant work health and safety, infection control and manual handling requirements

identifying and responding to routine problems within delegated authority

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Knowledge Evidence

The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:

terminology used in sterilising and methods of sterilisation used in Australia

environmental conditions required for efficient functioning of a sterilisation area, including:

quarantine protocols

conditions and parameters for successful sterilisation

cleaning protocols and special requirements for sterilisers, trolleys and carriages

features of sterilisation process that influence sterilisation outcomes, including:

cycle stages and physical parameters that determine sterilisation outcomes

differences between methods of low temperature sterilisation processes including hydrogen peroxide and peracetic acid

the biocidal action of chemical sterilants and impact on sterilisation outcomes

monitoring equipment and procedures

features of steam sterilisation that influence sterilisation outcomes, including:

cycle stages and physical parameters that influence sterilisation outcomes

principles of steam generation and steam quality that impact on sterilisation outcomes

significant mechanical components of steam sterilisers

the biocidal action of steam under pressure and the impact on sterilisation outcomes

monitoring equipment and procedures

performance testing:

air removal test

process challenge device

leak rate test

physical, chemical and biological monitoring devices

requirements of quality assurance documentation, including release processes

safe work practices in the sterilisation work area:

manual task risk factors and how to control for them

infection control

personal hygiene

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