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4187 standard and high level disinfection wipe systems

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  • #74101
    Pamela Ann Boon
    Participant

    Author:
    Pamela Ann Boon

    Position:

    Organisation:

    State:

    Good afternoon everyone,

    We use a 3 wipe high level disinfection process for non-channelled ENT scopes.

    We were wondering if the new 4187 standard will not permit wipe systems to be used for high level disinfection for reusable medical devices.

    Does anyone have any advice?

    Thanks so much in advance.

    Cheers from Pam (sweating +++ in Darwin!!)

    Pamela Boon | Clinical Nurse Manager
    Infection Prevention & Management Unit
    Royal Darwin Hospital |Top End Health and Hospital Services

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    #74103
    Anonymous
    Inactive

    Author:
    Anonymous

    Position:

    Organisation:

    State:

    Hi Pam,

    It is not within the scope of AS/NZS4187 to specifically allow or not allow
    any particular method / system for cleaning, disinfection or sterilisation.
    The requirements would be that the system is entered on the ARTG and the
    process can be validated.

    In this case I would make reference to Clause 5.1.2 in AS/NZS4187:2014.

    It provides what I refer to as a reprocessing hierarchy – in brief the
    Clause says that critical RMDs must be sterilised by steam unless they are
    not compatible with steam. If not compatible with steam then a low
    temperature sterilisation system can be used.

    Semi-critical RMDs must be sterilised with either steam or a low temperature
    sterilisation system unless they not compatible with these processes. If
    not compatible the next process to be applied is a thermal disinfection
    process. If not compatible with that then the next process to be applied is
    a chemical disinfection process.

    So the fundamental question is – What level in this reprocessing hierarchy
    does the non-channelled ENT scope fall into? Once you have determined that
    then you know what process should be applied.

    I hope this helps?

    Kind Regards

    Terry McAuley

    Sterilisation & Infection Prevention and Control Consultant

    STEAM Consulting Pty Ltd ACN 604 439 698

    E: terry@steamconsulting.com.au

    W: http://www.steamconsulting.com.au

    A: PO BOX 779

    Endeavour Hills

    VIC Australia 3802

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    Of Pamela Ann Boon

    Good afternoon everyone,

    We use a 3 wipe high level disinfection process for non-channelled ENT
    scopes.

    We were wondering if the new 4187 standard will not permit wipe systems to
    be used for high level disinfection for reusable medical devices.

    Does anyone have any advice?

    Thanks so much in advance.

    Cheers from Pam (sweating +++ in Darwin!!)

    Pamela Boon | Clinical Nurse Manager

    Infection Prevention & Management Unit

    Royal Darwin Hospital |Top End Health and Hospital Services
    Casuarina, NT 0811
    pamela.boon@nt.gov.au

    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO
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    #74105
    Michael Wishart
    Participant

    Author:
    Michael Wishart

    Position:

    Organisation:

    State:
    NSW

    Hi Pam

    Some points for you to ponder, from myself and my CSSD Manager

    * The TGA licensing (ARTG entry) will outline the basis for the use of the product. Deviation from the licensed use is deemed non-0compliance.

    * The Information For Use (IFU) for any product is to be the basis for use.

    * Note where a product requires specific timings for contact and specific sequence of a cleaning / disinfection / neutralisation process for the product to be effective than this process needs to be followed, and documented.

    * Non completion of the supplier recommended process will mean noncompliance with the approved use of the product, and the product will not have achieved the High Level Disinfection required. The operator then must accept they are using a contaminated reusable medical device (RMD)!

    * NSW Health requires where these types of product are used, a formal education and annual competency on using these wipes for all staff who are involved in areas such as ENT clinics where this product is known to be used.

    * If you do not have a documented training process and competency then I believe the organisation must accept they are potentially supplying contaminated RMD (ie no evidence the manufacturer’s process has been followed), and wear any subsequent legal action for cross contamination. Be warned!

    * Be aware that there are specific transmittable viruses that are not inactivated by these wipes if not used correctly.

    Good luck! We have been lucky (!) enough here to steer clear of use of this type of product thus far.

    Cheers
    Michael

    Michael Wishart
    Infection Control Coordinator

    A 627 Rode Road, Chermside QLD 4032
    P (07) 3326 3068 | F (07) 3607 2226 | E michael.wishart@svha.org.au | W http://www.hsnph.org.au
    [cid:image001.png@01D01926.61F1C2B0]
    P Please consider the environment before printing this email

    Good afternoon everyone,

    We use a 3 wipe high level disinfection process for non-channelled ENT scopes.

    We were wondering if the new 4187 standard will not permit wipe systems to be used for high level disinfection for reusable medical devices.

    Does anyone have any advice?

    Thanks so much in advance.

    Cheers from Pam (sweating +++ in Darwin!!)

    Pamela Boon | Clinical Nurse Manager
    Infection Prevention & Management Unit
    Royal Darwin Hospital |Top End Health and Hospital Services

    ______________________________________________________________________
    This email and any attachments to it (the “Email”) is confidential and is for the use only of the intended recipient, and may not be duplicated or used by any other party without the express consent of the sender. If you are not the intended recipient of the Email, please notify the sender immediately by return email, delete the Email, and do not copy, print, retransmit, store or act in reliance on the Email. St Vincent’s Health Australia (“SVHA”) does not guarantee that the Email is free from errors, viruses or interference. Emails to and from SVHA or its related entities may be scanned and filtered in locations outside Australia.
    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

    The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

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    #74107
    Glenys Harrington
    Participant

    Author:
    Glenys Harrington

    Position:
    Consultant

    Organisation:
    Infection Control Consultancy (ICC)

    State:

    Interesting summary Michael.

    Do you have a link to the NSW Health requirement that you refer to below?

    Regards

    Glenys

    Glenys Harrington

    Infection Control Consultancy (ICC)

    P.O. Box 6385

    Melbourne

    Australia, 3004

    M: +61 404816434

    E: infexion@ozemail.com.au

    Of Michael Wishart
    disinfection wipe systems

    Hi Pam

    Some points for you to ponder, from myself and my CSSD Manager

    . The TGA licensing (ARTG entry) will outline the basis for the use
    of the product. Deviation from the licensed use is deemed non-0compliance.

    . The Information For Use (IFU) for any product is to be the basis
    for use.

    . Note where a product requires specific timings for contact and
    specific sequence of a cleaning / disinfection / neutralisation process for
    the product to be effective than this process needs to be followed, and
    documented.

    . Non completion of the supplier recommended process will mean
    noncompliance with the approved use of the product, and the product will not
    have achieved the High Level Disinfection required. The operator then must
    accept they are using a contaminated reusable medical device (RMD)!

    . NSW Health requires where these types of product are used, a
    formal education and annual competency on using these wipes for all staff
    who are involved in areas such as ENT clinics where this product is known to
    be used.

    . If you do not have a documented training process and competency
    then I believe the organisation must accept they are potentially supplying
    contaminated RMD (ie no evidence the manufacturer’s process has been
    followed), and wear any subsequent legal action for cross contamination. Be
    warned!

    . Be aware that there are specific transmittable viruses that are
    not inactivated by these wipes if not used correctly.

    Good luck! We have been lucky (!) enough here to steer clear of use of this
    type of product thus far.

    Cheers

    Michael

    Michael Wishart

    Infection Control Coordinator

    A 627 Rode Road, Chermside QLD 4032
    P (07) 3326 3068 | F (07) 3607 2226 | E
    michael.wishart@svha.org.au | W
    http://www.hsnph.org.au
    cid:image001.png@01D01926.61F1C2B0

    P Please consider the environment before printing this email

    Of Pamela Ann Boon

    Good afternoon everyone,

    We use a 3 wipe high level disinfection process for non-channelled ENT
    scopes.

    We were wondering if the new 4187 standard will not permit wipe systems to
    be used for high level disinfection for reusable medical devices.

    Does anyone have any advice?

    Thanks so much in advance.

    Cheers from Pam (sweating +++ in Darwin!!)

    Pamela Boon | Clinical Nurse Manager

    Infection Prevention & Management Unit

    Royal Darwin Hospital |Top End Health and Hospital Services
    Casuarina, NT 0811
    pamela.boon@nt.gov.au

    ______________________________________________________________________
    This email and any attachments to it (the “Email”) is confidential and is
    for the use only of the intended recipient, and may not be duplicated or
    used by any other party without the express consent of the sender. If you
    are not the intended recipient of the Email, please notify the sender
    immediately by return email, delete the Email, and do not copy, print,
    retransmit, store or act in reliance on the Email. St Vincent’s Health
    Australia (“SVHA”) does not guarantee that the Email is free from errors,
    viruses or interference. Emails to and from SVHA or its related entities may
    be scanned and filtered in locations outside Australia.

    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO
    NOT REPRESENT THE OPINION OF ACIPC.

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    ______________________________________________________________________
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    for the use only of the intended recipient, and may not be duplicated or
    used by any other party without the express consent of the sender. If you
    are not the intended recipient of the Email, please notify the sender
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    Australia (“SVHA”) does not guarantee that the Email is free from errors,
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    be scanned and filtered in locations outside Australia.

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    NOT REPRESENT THE OPINION OF ACIPC.

    The use of trade/product/commercial brand names through the list is
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    or services by brand or commercial names, please do this outside the list.

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    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

    The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

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    #74111
    Michael Wishart
    Participant

    Author:
    Michael Wishart

    Position:

    Organisation:

    State:
    NSW

    I need to clarify a point in my previous email.

    As far as I am aware, there is not a written requirement from NSW Health for annual competency education on high level disinfection wipe systems. (I would be happy to be proven wrong, but I do not have any such documentation available to me.)

    However, Queensland Health does definitely have this requirement (see ‘Reprocessing audit tool’ on this page: https://www.health.qld.gov.au/clinical-practice/guidelines-procedures/diseases-infection/reprocessing/intracavity-ultrasound-transducers)

    As a general rule, competencies that seek to validate a process should be undertaken regularly (eg annually), so you can demonstrate that the process is indeed being followed. This is most important when there are no physical parameters documented (like temperatures or chemical concentrations) to show proof of process.

    I hope this clarifies the previous comment I made.

    Thanks
    Michael

    Michael Wishart
    Infection Control Coordinator

    A 627 Rode Road, Chermside QLD 4032
    P (07) 3326 3068 | F (07) 3607 2226 | E michael.wishart@svha.org.au | W http://www.hsnph.org.au
    [cid:image001.png@01D01926.61F1C2B0]
    P Please consider the environment before printing this email

    Hi Pam

    Some points for you to ponder, from myself and my CSSD Manager

    * The TGA licensing (ARTG entry) will outline the basis for the use of the product. Deviation from the licensed use is deemed non-0compliance.

    * The Information For Use (IFU) for any product is to be the basis for use.

    * Note where a product requires specific timings for contact and specific sequence of a cleaning / disinfection / neutralisation process for the product to be effective than this process needs to be followed, and documented.

    * Non completion of the supplier recommended process will mean noncompliance with the approved use of the product, and the product will not have achieved the High Level Disinfection required. The operator then must accept they are using a contaminated reusable medical device (RMD)!

    * NSW Health requires where these types of product are used, a formal education and annual competency on using these wipes for all staff who are involved in areas such as ENT clinics where this product is known to be used.

    * If you do not have a documented training process and competency then I believe the organisation must accept they are potentially supplying contaminated RMD (ie no evidence the manufacturer’s process has been followed), and wear any subsequent legal action for cross contamination. Be warned!

    * Be aware that there are specific transmittable viruses that are not inactivated by these wipes if not used correctly.

    Good luck! We have been lucky (!) enough here to steer clear of use of this type of product thus far.

    Cheers
    Michael

    Michael Wishart
    Infection Control Coordinator

    A 627 Rode Road, Chermside QLD 4032
    P (07) 3326 3068 | F (07) 3607 2226 | E michael.wishart@svha.org.au | W http://www.hsnph.org.au
    [cid:image001.png@01D01926.61F1C2B0]
    P Please consider the environment before printing this email

    Good afternoon everyone,

    We use a 3 wipe high level disinfection process for non-channelled ENT scopes.

    We were wondering if the new 4187 standard will not permit wipe systems to be used for high level disinfection for reusable medical devices.

    Does anyone have any advice?

    Thanks so much in advance.

    Cheers from Pam (sweating +++ in Darwin!!)

    Pamela Boon | Clinical Nurse Manager
    Infection Prevention & Management Unit
    Royal Darwin Hospital |Top End Health and Hospital Services

    ______________________________________________________________________
    This email and any attachments to it (the “Email”) is confidential and is for the use only of the intended recipient, and may not be duplicated or used by any other party without the express consent of the sender. If you are not the intended recipient of the Email, please notify the sender immediately by return email, delete the Email, and do not copy, print, retransmit, store or act in reliance on the Email. St Vincent’s Health Australia (“SVHA”) does not guarantee that the Email is free from errors, viruses or interference. Emails to and from SVHA or its related entities may be scanned and filtered in locations outside Australia.
    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

    The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

    Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

    Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au

    To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.

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    ______________________________________________________________________
    This email and any attachments to it (the “Email”) is confidential and is for the use only of the intended recipient, and may not be duplicated or used by any other party without the express consent of the sender. If you are not the intended recipient of the Email, please notify the sender immediately by return email, delete the Email, and do not copy, print, retransmit, store or act in reliance on the Email. St Vincent’s Health Australia (“SVHA”) does not guarantee that the Email is free from errors, viruses or interference. Emails to and from SVHA or its related entities may be scanned and filtered in locations outside Australia.

    ______________________________________________________________________
    This email and any attachments to it (the “Email”) is confidential and is for the use only of the intended recipient, and may not be duplicated or used by any other party without the express consent of the sender. If you are not the intended recipient of the Email, please notify the sender immediately by return email, delete the Email, and do not copy, print, retransmit, store or act in reliance on the Email. St Vincent’s Health Australia (“SVHA”) does not guarantee that the Email is free from errors, viruses or interference. Emails to and from SVHA or its related entities may be scanned and filtered in locations outside Australia.
    MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

    The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

    Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

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