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Reprocessed Medical Devices and expiry dates

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  • #75416
    Anonymous
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    Hi everyone
    Looking for some advice on expiry date for reprocessed medical devices. I can’t seem to find anything on AS/NZ 4187 or ACORN.
    In our facility RMD’s are labelled with a sticker with the date reprocessed printed. If RMD is not used they are reprocessed in 12mths even if packaging not damaged , includes items in Steripeel or Kimguard .
    Is there information regarding timeframes for reprocessing unused RMD’s?
    Thanks
    Cate Coffey | Clinical Nurse Consultant
    Infection Prevention and Control Unit | Central Australia Health Service
    Northern Territory Government
    Alice Springs Hospital, Gap Rd, Alice Springs
    GPO Box 2234, Alice Springs, NT 0871
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    #75423
    Anonymous
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    Anonymous

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    Cate

    I have been researching this very thing, and the answer is interesting and complex!

    First of all, most facilities have adopted event related sterility – which means that the item is considered sterile unless exposed to an event (these can include but are not limited to; moisture; tears or holes in the package; temperatures outside the defined parameters of 18 to 25 degrees Celsius; relative humidity outside the ranges of 35 to70%; sources of microbial contamination including vermin & insect; and more!).

    Second, you need to find out what shelf life studies or limitations have been set by the manufacturer of the sterile barrier system (SBS) and its components (sterilisation tape). Most manufacturers have demonstrated sterility is maintained to at least 12 months. Due to costs etc, not many have gone past the 12 months. HOWEVER, we can do this provided we undertake this as part of our validation etc. So you could go longer, you just need to validate it!

    One of the limitations that I have found however, is that most SBS and sterilisation tape do have a shelf life. If for example, the wrap we use is due to expire in 12 months, chances are it may start to disintegrate after this time!. I note that with most tracking systems, the expiry of the products used for SBS are not included, maybe they should be? This may assist us to more accurately determine when items should be reprocessed if not used.

    So in answer to your question, you will have to go back to the manufacturer and ask them for the information. I hope this helps.

    Kind regards

    Mandy Davidson
    RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A
    Clinical Nurse Consultant – 4187 Implementation project
    Infection Prevention & Control

    [cid:image001.png@01D3A192.E1513890]
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    Mandy.Davidson@health.qld.gov.au
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    Townsville Hospital and Health Service
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    Hi everyone
    Looking for some advice on expiry date for reprocessed medical devices. I can’t seem to find anything on AS/NZ 4187 or ACORN.
    In our facility RMD’s are labelled with a sticker with the date reprocessed printed. If RMD is not used they are reprocessed in 12mths even if packaging not damaged , includes items in Steripeel or Kimguard .
    Is there information regarding timeframes for reprocessing unused RMD’s?
    Thanks
    Cate Coffey | Clinical Nurse Consultant
    Infection Prevention and Control Unit | Central Australia Health Service
    Northern Territory Government
    Alice Springs Hospital, Gap Rd, Alice Springs
    GPO Box 2234, Alice Springs, NT 0871
    p … 08 89517737
    e … cate.coffey@nt.gov.au http://www.nt.gov.au/health

    Our Vision: Better health outcomes for all Central Australians
    Our Values: Community at the Centre | Equity and Integrity | We are Accountable | We are Relevant Today and Ready for Tomorrow | We are Committed to High Quality Care | We Value our Partnerships

    Central Australia Health Service is a Smoke Free Workplace

    The information in this e-mail is intended solely for the addressee named. It may contain legally privileged or confidential information that is subject to copyright. If you are not the intended recipient you must not use, disclose copy or distribute this communication. If you have received this message in error, please delete the e-mail and notify the sender. No representation is made that this e-mail is free of viruses. Virus scanning is recommended and is the responsibility of the recipient.

    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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