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KAYLENE STYLES

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    KAYLENE STYLES

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    Dear Glenys/Cath and Tim
    Thank you very much for your most helpful responses. The product proposed is the Antigermix AS1.
    The device that has been introduced without infection prevention knowledge has very limited HLD products approved by the company that are acceptable here.
    I have previously spoken with the company both here and USA and find there is no plan even to test these particular ultrasound transducers with Trophon use.
    We have been informed by the renal team that these devices are in use widely across renal dialysis.
    I would be interested if any other facilities use the transducers in their renal units and how they are managed.
    Regards

    [Barwon Health]

    Kaylene Styles
    Clinical Nurse Consultant | Infection Prevention Service | Barwon Health
    Direct. (03) 4215 2323 |kaylenes@barwonhealth.org.au
    Post. PO Box 281 Geelong 3220
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    Hi Kaylene/ Glenys

    In response to Glenys’s recent posting compared to my earlier posting please note the distinction between two products. In my reply the link provided is for ANTIGERMIX E1 (AE1) – Light, germicidal, ultraviolet. (now attached) In Glenys’s attachment the listed device is for ANTIGERMIX S1 (AS1) – Light, germicidal, ultraviolet Product Type Medical device system Effective.

    I cannot quickly determine if the devices are the same as their indications are different ie. one is indicated for TOE probes and the other seems for general. It’s a good example of not having a carte blanche approach but rather closely looking at device registration, device models, details and indications.

    In your original email you didn’t differentiate to which ANTIGeRMIX model you are referring. Hopefully our respective views and others will help you find a safe solution to your original query.

    Yours sincerely

    Cath

    Cathryn Murphy RN B. Photog MPH PhD CIC
    Chief Executive Officer & Creative Director
    Infection Control Plus Pty Ltd
    QLD, Australia

    E: Cath@infectioncontrolplus.com.au
    M: +61 428 154154
    W:http://www.infectioncontrolplus.com.au

    Hi Kaylene,

    The device you mention is regulated by TGA as a Class 11b “Medical Device” and is included in the TGA Australian Register of Therapeutic Goods (ARTG). See attached TGA “Summary for ARTG entry” and “TGA Summary of Disinfectant Regulations” at the following link https://www.tga.gov.au/summary-disinfectant-regulation

    As mentioned by Cath Murphy note the intended purpose in the “Summary for ARTG entry” which states the following:

    * “The ANTIGERMIX S1 (AS1) automaton is a dry disinfection process for ultrasound transducers. The AS1 device performs a High Level Disinfection on external or endocavitary ultrasound transducers. The process is based on UVC radiation as an alternative to a chemical disinfection process”.

    Before using you should establish with the supplier/manufacturer of the transducer/s and the supplier/manufacturer of the Class 11b “Medical Device” [ANTIGERMIX S1 (AS1)] that they are compatible for the purposes of use and your warranty.

    Regards

    Glenys

    Glenys Harrington
    Infection Control Consultancy (ICC)
    P.O. Box 6385
    Melbourne
    Australia, 3004
    M: +61 404816434
    E: infexion@ozemail.com.au
    [Description: ICC Diagram ICCversion]

    Good morning all
    I am looking for some assistance with managing the high level disinfection of ultrasound probes. We currently use Trophon (hydrogen peroxide) but have found a few new small ultrasound transducers for the renal patients that have been brought into the system without an consultation with infection prevention. These have not been tested with the Trophon system and we do not have any other method to disinfect appropriately at this point.
    Our biomedical team have distributed information to the teams that use ultrasounds suggesting they implement UV Antigermix system. Is there anyone using this?
    Our team would appreciate any information that might help our choices.
    Regards

    [Barwon Health]

    Kaylene Styles
    Clinical Nurse Consultant | Infection Prevention Service | Barwon Health
    Direct. (03) 4215 2323 |kaylenes@barwonhealth.org.au
    Post. PO Box 281 Geelong 3220
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    [Barwon Health Twitter]

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    [raditional Owners Flags]

    We, Barwon Health, acknowledge the Traditional Owners of the land, the Wadawurrung people of the Kulin Nation.
    We pay our respects to the Elders both past and present.

    [Barwon Health]

    [Barwon Health]

    E-MAIL IS CONFIDENTIAL. If you have received this e-mail in error, please notify us by return e-mail and delete the document. If you are not the intended recipient you are hereby notified that any disclosure, copying, distribution or taking any action in reliance on the contents of this information is strictly prohibited and may be unlawful. Barwon Health is not liable for the proper and complete transmission of the information contained in this communication or for any delay in its receipt.

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