Application
This unit describes the skills and knowledge required to prepare, assemble and package cleaned reusable medical devices according to manufacturer’s instructions.
This unit applies to individuals working under general supervision and within established procedures in a range of health service organisations.
The skills in this unit must be applied in accordance with Commonwealth and State/Territory legislation, Australian/New Zealand standards and industry codes of practice.
Elements and Performance Criteria
ELEMENT | PERFORMANCE CRITERIA |
Elements define the essential outcomes | Performance criteria describe the performance required to demonstrate achievement of the element |
1. Prepare for inspection and packing | 1.1 Select and wear appropriate attire and ensure personal hygiene preparations are followed 1.2 Clean area prior to processing according to infection control guidelines 1.3 Test packing equipment in readiness for use and accurately document results |
2. Inspect reusable medical devices | 2.1 Sort items according to priority, specialties and packaging requirements and product families 2.2 Inspect items for cleanliness and dryness and reprocess where required 2.3 Inspect items for functionality and completeness according to organisation requirements 2.4 Follow safe procedures for insulation testing as required 2.5 Use illuminated magnifier appropriately 2.6 Identify loan items and implantable items 2.7 Identify, report, remove and/or replace damaged/faulty items and items due for preventative maintenance 2.8 Report missing items according to organisation policies and protocols |
3. Prepare and assemble reusable medical devices | 3.1 Select, inspect and prepare instrument trays or rigid sterilisation containers against checklists 3.2 Open and unlock items with hinges/ratchets 3.3 Disassemble/loosen multi-part instruments and re-assemble to ensure sterilant contact on all surfaces according to manufacturer’s instructions 3.4 Lubricate according to manufacturer instructions 3.5 Prepare hollow ware items with all openings facing the same direction 3.6 Protect delicate and sharp items in accordance with organisation policies and procedures 3.7 Use chemical indicators according to standards |
4. Package reusable medical devices | 4.1 Select packaging systems with reference to sterilisation method 4.2 Use safe manual handling techniques 4.3 Interpret operating instructions for packaging equipment and use equipment safely 4.4 Pack, secure and label sterile barrier systems to comply with aseptic removal principles 4.5 Assemble and package thermally disinfected reusable medical devices for transfer to appropriate location 4.6 Complete accurate quality assurance documentation |
Evidence of Performance
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 for the inspection, assembly, packaging and labelling of reusable medical devices on at least 3 occasions
operated and monitored equipment on at least 3 occasions, including illuminated magnifier
completed accurate quality assurance documentation
addressed relevant work health and safety, infection control and manual handling requirements
identified and responded to routine process and maintenance problems and variations
Evidence of Knowledge
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:
packaging in relation to client safety, and implications of negligence
existence and basic requirements of AS/NZS 4187, and its role in packaging
features of inspection and test equipment and processes, including:
air guns
lighted magnification
heat sealer
height adjustable work stations
insulation testing
labelling systems
instrument checklists
wrapping and packaging materials and techniques:
relationship of sterile barrier systems and wrapping material to sterilisation method used
sealing materials
single use and reusable sterile barrier systems
rigid reusable container systems
classes of chemical indicators
identification and traceability systems
performance qualification for packaging
features of quality assurance documentation
safe work practices in the sterilisation work area:
manual task risk factors and how to control for them
infection control
personal hygiene
Assessment Conditions
Skills must have been demonstrated in the workplace or in a simulated environment that reflects workplace conditions. The following conditions must be met for this unit:
use of suitable facilities, equipment and resources, including:
wrapping and packaging materials
heat sealing equipment
sterile barriers systems
reusable medical devices:
personal hygiene hair ware
quality assurance documentation
procedures to be followed by the candidate
modelling of industry operating conditions, including:
speed and timing requirements for the checking and packaging process
presence of situations requiring problem solving
Assessors must satisfy the Standards for Registered Training Organisations (RTOs) 2015/AQTF mandatory competency requirements for assessors
Foundation Skills
The Foundation Skills describe those required skills (language, literacy, numeracy and employment skills) that are essential to performance. |
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency. |