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Re: Update – Duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography – New Reprocessing Instructions for the Olympus TJF-Q180V duodenoscopes

Home Forums Infexion Connexion Re: Update – Duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography – New Reprocessing Instructions for the Olympus TJF-Q180V duodenoscopes

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    Cath Murphy
    Participant

    Author:
    Cath Murphy

    Email:
    cath@INFECTIONCONTROLPLUS.COM.AU

    Organisation:

    State:

    FYI – if anyone is interested in viewing a copy of a presentation I made last year in Sydney on endoscopic reprocessing here is a view-only link

    https://infectioncontrolplus-my.sharepoint.com/personal/cath_infectioncontrolplus_com_au/_layouts/15/guestaccess.aspx?guestaccesstokenjLj%2fmIO8yyYwOtz2NK7nZN9OE%2fbRRGQsaL825yQiwOY%3d&docid0f3026b5937cd4e41ac850ffb749513b0

    Regards
    Cath

    Dr Cathryn Murphy RN MPH PhD CIC
    Executive Director
    Infection Control Plus Pty Ltd
    http://www.infectioncontrolplus.com.au
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    Glenys et al

    Thank you for this really interesting commentary which again highlights the challenge of new technologies and our need for constant vigilance. As you are aware for many years Australia and I think parts of Canada have been outliers in terms of recommending regular sampling of scopes.

    APIC is currently writing an article for their Infection Preventionist magazine on duodenoscopes and have asked me to draft a few words on Australia’s approach to routine culturing as per GENCA Guidelines. APIC is particularly keen to share with their members the practical ways in which routine culturing is undertaken. I feel compelled to provide a broad overview and examples of different organisation’s practices and especially any difficulties w/ complying w/ sampling. I understand how 2 large SE QLD hospitals did it. I am familiar w/ the GENCA Guidelines and CHRISP protocols but I wondered if any on this list would be willing to offer insights. Dot points would be fine. I suspect that issues like:
    – time taken for results
    – lack of additional circulating scopes
    – access to micro labs
    – standardised procedure
    – action in the event of positive culture
    – clearance/ repeat reprocessing and culturing
    – ? need for Lookback, suspension of duodenoscopic services until clearanceetc
    may all be potentially problematic.

    Would list members who are willing to help me please post here ASAP as I am past the APIC deadline, or email me directly. Copies of local policy would be especially helpful .I am very happy to attribute anyone who provides insight (or have them remain anonymous as desired) and thank you in advance. I am also happy to share the final draft w/ any list members who may be interested.

    Regards
    Cath

    Dr Cathryn Murphy RN MPH PhD CIC
    Executive Director
    Infection Control Plus Pty Ltd
    Cath@infectioncontrolplus.com.au
    http://www.infectioncontrolplus.com.au
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    Dear all,

    Find below the FDA notification of the New Reprocessing Instructions for the Olympus TJF-Q180V duodenoscopes.

    Attached is the Olympus letter to customers which details the new reprocessing instructions including;

    * supplementary flushing instructions

    * additional recess flushing and forceps elevator raising /lowering steps during pre-cleaning

    * manual cleaning

    * manual disinfection and endoscope rinsing and alcohol flushing.

    Olympus advise that “these new reprocessing procedures should be implemented as soon as possible” and that “the new cleaning procedure requires the use of a small bristle cleaning brush (MAJ_1888) which Olympus anticipates shipping no later than May 8, 2015”

    The key differences include the following:

    Pre cleaning

    * During immersion, raise and lower the elevator 3 times
    Manual cleaning

    * Additional brushing of the forceps elevator recess area using an additional brush (MAJ-1888 brush)

    * Additional flushing of forceps elevator recess area

    * Additional raising and lowering the forceps elevator
    Manual high level disinfection

    * Additional manual flushing steps and increased flushing volume of the endoscope channel and forceps recess area

    * Additional raising and lowering of the forceps elevator

    Regards

    Glenys

    Glenys Harrington
    Consultant
    Infection Control Consultancy (ICC)
    PO Box 5202
    Middle Park
    Victoria, 3206
    Australia
    M: +61 404 816 434
    infexion@ozemail.com.au
    ABN 47533508426

    [MedWatch logo][MedWatch – The FDA Safety Information and Adverse Event Reporting Program]

    Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication – New Reprocessing Instructions Validated

    * Implement the new manual cleaning and high level disinfection procedures for the Olympus TJF-Q180V duodenoscope in accordance with the manufacturer’s reprocessing instructions.
    * Train appropriate staff on Olympus’ new reprocessing instructions and implement them as soon as possible.
    * Contact Olympus directly with specific questions and concerns or to schedule a site visit with their Endoscopy Support Specialists Technical Assistance Center (TAC), 1-800-848-9024, option 1 Monday – Friday between 7AM EST – 8 PM EST.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

    * Complete and submit the report Online: http://www.fda.gov/MedWatch/report
    * Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

    Read the MedWatch Safety Alert, inclusing links to the FDA Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm440098.htm

    ________________________________

    You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at http://www.fda.gov/medwatch/report.htm

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