This course has been developed to provide healthcare workers responsible for the selection and validation of reprocessing equipment with an understanding of the related regulatory requirements. Note that this Module has been designed for those healthcare workers who are responsible for the selection and validation of reprocessing equipment and associated processes.
This course has been designed to educate healthcare workers (HCWs) responsible for the selection and validation of reprocessing equipment and associated processes in accordance with current standards, guidelines and manufacturers’ instructions for use (IFU).
This course includes:
- The requirements for the selection of reprocessing equipment – revised in accordance with current standards & guidelines, eg AS 5369, AS 2773 & AS 5330
- The Product Families for steam sterilisation- revised in accordance with current standards & guidelines, including AS 5369 & additional information provided in guidance appendix A.5.2
- The specific requirements for the validation of reprocessing equipment, and alternate activities involved in the reprocessing of an RMD - revised in accordance with current standards & guidelines. Inclusion of additional requirements in relation to Mechanical Dryer Validation as per AS 5330, Validation of Low Temperature Vaporized Hydrogen Peroxide sterilisation process as per ISO 22441
- Steam quality- revised in accordance with current standards & guidelines, including expanded requirements for Steam Quality & Purity
This module will provide you with an understanding of reprocessing equipment selection and validation, including:
- the requirements for the selection of reprocessing equipment
- the general requirements for validation
- the Product Families for steam sterilisation
- the specific requirements for the validation of reprocessing equipment, and alternate activities involved in the reprocessing of an RMD
- steam quality, and
- sterile stock shelf life.
AS/NZS 4187, Disinfection, Product Families, Reusable Medical Devices, RMDs, Reprocessing, Sterilisation, Steriliser, Sterile Barrier System, SBS, Sterile Stock Shelf Life, Validation, Washer Disinfector, Water Quality, Sterilising Services, Sterilising, HICMR
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