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  • in reply to: ASUM guidelines and US probe cleaning #70019
    Scott Pabst
    Participant

    Author:
    Scott Pabst

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    Dear Phillipa,

    Please find links to:

    1) 2012 ASUM statement regarding the use of the wipes you refer to

    2) Current Policy position of Australian Sonographers Association on the use of the wipes you refer to

    3) WA Health operational directive regarding the re-processing of Ultrasound Transduces (including specific reference to the wipes you refer to).

    http://www.asum.com.au/newsite/Files/Documents/Policies/2012.05.28_SOP%20Press%20Release%20Tristel.pdf

    http://www.a-s-a.com.au/fileRepository/files/Website/Public%20site/Quality%20Practice/ASA%20Guidelines/0295_ASA-Guideline_ID_Update%20May2012.pdf

    http://www.health.wa.gov.au/circularsnew/pdfs/12913.pdf

    Yours Sincerely

    Scott Pabst
    National Sales Manager
    AshMed Pty Ltd
    Ph. 0435 843 950
    E. scott@ashmed.com.au

    Dear All,

    I am seeking some assistance with interpreting the ASUM guidelines and their requirements for US probe cleaning.

    We are using the Trophon for all intracavity probes and wiping over all other probes used for routine imaging, biopsy guidance etc with a disinfectant wipe. The current wipe in use is not one of the four recommended disinfection methods referred to in their guidelines.
    We use probes covers routinely for all interventional procedures or on mucous membranes, wounds etc.

    Am I correct in interpreting the ASUM guidelines – that all probes regardless of cover usage must be cleaned in one of the four ways stated by ASUM. Can anyone throw some more light on this issue for me please.

    We have received full Imaging reaccreditation and our current practise was not raised as an issue.

    Regards

    Phillipa Parsons
    Infection Prevention and Control Clinical Coordinator
    Cabrini Health
    183 Wattletree Rd
    Malvern Vic 3144
    03 9508 1577
    0400 369 741

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    in reply to: Chlorine Dioxide Wipes TGA Intended Use Statement #69048
    Scott Pabst
    Participant

    Author:
    Scott Pabst

    Position:

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    Dear all,

    AshMed has received approval from the Australian Sonographers Association for Tristel Wipes use with Intra Cavity Ultrasound transducers, and a press release indicating approval by the Australian Society of Ultrasound in Medicine (ASUM) group has just been posted to the ASUM website.

    Please find below links to both sites

    A.S.A Website

    http://www.a-s-a.com.au/fileRepository/files/Website/Public site/Quality Practice/ASA Guidelines/0295_ASA-Guideline_ID_Update May2012.pdf

    A.S.U.M Website

    http://www.asum.com.au/newsite/Files/Documents/Policies/2012.05.28_SOP%20Press%20Release%20Tristel.pdf

    I hope these are helpful in creating an informed understanding of the approved use of Tristel Wipes for the use with Intra Cavity Ultrasound Transducers

    Yours Sincerely

    Scott Pabst
    National Sales Manager
    AshMed Pty Ltd
    Ph. 0435 843 950
    E. scott@ashmed.com.au

    —–Original Message—–
    From: Scott Pabst [mailto:scott@ASHMED.COM.AU]
    Sent: Monday, 28 May 2012 3:37 PM
    To: AICALIST@AICALIST.ORG.AU
    Cc: Scott Pabst
    Subject: Chlorine Dioxide Wipes TGA Intended Use Statement

    Dear all,

    Please find attached a copy of the TGA Intended Use Statement for ARTG Number .
    This statement was reviewed and released by the TGA on 3rd May, 2012.

    The Tristel Wipes System is intended to decontaminate and disinfect non-lumened medical devices including those that cannot be fully immersed in liquid disinfectant or sterilants and cannot be sterilised by heat. The system provides high level disinfection in less than 2 minutes. The Tristel Wipes System is not intended for use on critical medical devices which must be sterilised prior to use on a patient.

    Further, TGA also undertook an independent review of the use of this product in March 2012 and returned the following findings- (these are on file at AshMed and I am happy to make them available upon request at: scott@ashmed.com.au)

    The Tristel Wipes System is a Medical Device Included Class 2B-ARTG #182843. Device is a semi critical device designed specifically for use with heat sensitive reusable ENT scopes and Ultrasound probes. The instructions for use has been reviewed along with GENCA and GENSA Infection Control Guidelines for Endoscopy and Australian Standards AS/ANZ 4187 and there appears to be no disagreement in principles. Information available to the TGA does not conflict with the manufacturers claim of Chlorine Dioxide as an oxidising agent nor the intended use of the device. TGA does not therefore intend to take any further action but will continue its monitoring of the product in the market place.

    Thank you for the opportunity to contribute to the current discussion around this product

    Scott Pabst
    National Sales Manager
    AshMed Pty Ltd
    (Local Agents for Tristel PLC, UK)
    0435 843 950

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