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Liberali, Sharon (Health)

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  • Liberali, Sharon (Health)
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    Liberali, Sharon (Health)

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    Hi Kavitha,

    I assume that you when you mention the ‘plastic perforated trays’ you are referring to the packaging system, which sits under Section5.5 as well as Guidance A5.5 within AS/NZS 4187.

    This states that the packaging system needs to conform to ISO 11607-1 and ISO 11607-2 and that it needs to be compatible with the sterilizing process. It needs to allow the removal of air, ingress and egress of the sterilizing agent and removal of water vapour.

    My background is in dentistry, and we commonly use ‘plastic packaging systems’ e.g. cassettes for reprocessing of our semi-critical instruments. We also use stainless steel packaging systems, and disposable packaging systems (steri bags). In addition, like you all of these different packaging systems are validated and re-validated as part of PQ.

    I sit on the HE-023 Standards committee which writes 4187, and to my knowledge there is nothing in the standard which necessitates the need for a specific type of packaging system.

    Sharon
    A/Prof. Sharon Liberali
    BDS(Adel); Grad.Dip.Clin.Dent; MScMed (OFP); D.Clin.Dent (SND);FRACDS (SND); FICD; FPFA.

    Specialist, Special Needs Dentistry
    Director, Special Needs Unit, Adelaide Dental Hospital, SA Dental Service.
    Program Convenor, Special Needs Dentistry, School of Dentistry, University of Adelaide.

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    OFFICIAL

    Hi Team,

    We use plastic perforated trays for instrument (RMD) reprocessing. Does this comply with AS/NZS 4187 standard? The AS/NZS 4187 standard is vague. We have been recommended to replace all plastic perforated trays with open wire mesh tray. This will be a very expensive option for us.

    We have validated the plastic perforated trays in ultrasonic, washer disinfectors and sterilisers during the performance qualification also each year during re- performance qualification.

    Regards, Kavitha
    Kavitha Kugathas | Director
    Food and Sterilising Services |Sterilising Services
    Canberra Health Services | ACT Government

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    Liberali, Sharon (Health)
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    Liberali, Sharon (Health)

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    Hi Kylie,

    There is detailed information within AS/NZS 4187 in section 7.4.5 related to the specificities of PPQ and MPQ for sterilisers, and referencing the relevant ISO 17665.1. It states that the PQ needs to include at least 3 consecutive successful exposures of the load to the process to demonstrate reproducibility of the process.

    It is important to understand that he intention of PQ is to ensure the performance is robustly demonstrated for real world load conditions so there is confidence the intended sterilisation will occur on each and every occasion the parameters are used.
    PQ is intended to protect patients from ultimate failure in the sterilisation processes, therefore it is important that the full assortment and range of RMD’s which are intended or likely to be sterilised are included in the PQ process.
    The PQ results contribute to ensuring robust evidence supports the normal operation of the steriliser.

    In the practices I take responsibility for the PQ of our sterilisers is only provided by a qualified instrument technician. Within the PQ process the steriliser is tested through 4 cycles with the instrument technician present for the whole process and monitoring each of the four cycles with their testing equipment (in addition to the three x Type 5 indicators). The requirement of the PQ validation report is also documented in AS/NZS 4187 and includes

    * diagrammatic depictions of probe placement

    * photographs of loaded chamber

    * biological and chemical indicator results of all cycles with cycle numbers provided

    * summary data of test results for all cycles

    * temperature and pressure charts for all cycles

    * validation certification in accordance with AS/NZS 4187 (2014).

    While on quick perusal of AS/NZS 4187 today I couldn’t find where it specifically states that the technician needs to be monitoring all 3 cycles with their equipment (it may in the ISO standard) under 7.5.2 (j) the validation report needs to report the parameters used for each cycle and a copy of the specification for each process.

    I would be extremely concerned if the technicians were not monitoring all cycles tested with their equipment. If there were differences between the cycle results, the reason would not be able to be answered without the information provided by the testing equipment.

    Sharon Liberali
    Chair, ADA Infection Control Committee
    Member of HE-023 Committee of Standards Australia

    A/Prof. Sharon Liberali
    BDS(Adel); Grad.Dip.Clin.Dent; MScMed (OFP); D.Clin.Dent (SND);FRACDS (SND); FICD; FPFA.

    Specialist, Special Needs Dentistry
    Director, Special Needs Unit, Adelaide Dental Hospital, SA Dental Service.
    Program Convenor, Special Needs Dentistry, School of Dentistry, University of Adelaide.

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    Hi everyone,

    Office based dental practices primarily utilise small benchtop sterilisers. Under 4815 these sterilisers are subject to an annual validation that requires successful performance qualification (PQ), this includes physical and microbiological qualifications run concurrently over three consecutive tests.

    Usually steriliser technicians will conduct this process for dental practices.

    I’m interested to know if anyone can provide guidance on whether the steriliser technician should be monitoring each of these three cycles with their testing equipment (in addition to the three x Type 5 indicators) rather than just the first cycle with the indicators and the testing equipment and the other two with just the indicators (and no technician testing equipment).

    Thanks everyone, I’d be interested to hear your thoughts.

    Kylie

    Kylie Robb MHSM (Clinical Leadership), CICP-P
    ADA NSW Practice Services Manager
    Infection Prevention and Control Professional (CICP-P)
    Conjoint Lecturer – University of Newcastle – Oral Health School of Health Sciences – Faculty of Health and Medicine
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    in reply to: Hand wash supply issue #77014
    Liberali, Sharon (Health)
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    Liberali, Sharon (Health)

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    Hi Emma,

    The NHMRC ICG, HHA and ACQSHC HHI all essentially provide the following recommendations pertaining to plain liquid soaps:

    * ensure alcohol-based handrub, soaps, and moisturising lotions used are chemically compatible to minimise skin reactions among staff.
    * use products that contain skin emollient to minimise skin irritation and drying
    * ensure regular use of skin moisturisers.

    I checked the ARTG re liquid soaps – here is the link:

    https://tga-search.clients.funnelback.com/s/search.html?queryliquid+soap&collectiontga-artg&start_rank1?

    QV products are produced by Ego pharmaceuticals, which is on the TGA list.
    I have access to QV gentle wash and moisturiser in both the public and private dental practices in which I work.

    Sharon Liberali
    Chair, Australian Dental Association, Infection Control Committee.

    ________________________________

    Hi All

    Regarding hand soap in the dental channel we are experiencing supply issues.

    Our Australian Dental Association guidelines for infection control reference only TGA ABHR products to be used but I can’t reference anything specific relating to soaps. Obviously clinicians cannot use domestic handwash but QV gentle wash has come up as a potential option.

    I believe this a non TGA listed hand wash as it has no specific claims but is apparently on contract to NSW Health and some NSW dental health clinics.

    My question is would QV gentle wash (or similar) be a suitable option for use in the dental channel?

    Thanks for all your help
    Emma

    Emma Jones
    Infection Control Category Manager

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    in reply to: Re: Pig cadaver #76987
    Liberali, Sharon (Health)
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Viewing 4 posts - 1 through 4 (of 4 total)