Discussion: View Thread

  • 1.  Challenging MIFUs

    Posted 11-04-2025 15:24

    Hi 

    I remember there being an agency somewhere that one could reach out to if they had problematic IFUs. This agency would work to promote IFUs that were reasonable. Does that sound familiar to anyone?   I am trying to follow the GE ultrasound probes MIFU  (2023 rev) - have any of you been able to do this for your non-critical probes? 



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    Connie Jubitz BSN, RN, CIC
    Mid Columbia Medical Center
    The Dalles, Oregon 97058
    (541)296-7398
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  • 2.  RE: Challenging MIFUs

    Posted 11-05-2025 00:48

    Hi Connie!

    I would be happy to connect with you.  The national APIC Policy Committee is collecting these and pushing for change in the industry.  Free free to email me at ckroll@peacehealth.org.

    Catherine




  • 3.  RE: Challenging MIFUs

    Posted 11-05-2025 12:45

    thank you! 



    ------------------------------
    Connie Jubitz BSN, RN, CIC
    Mid Columbia Medical Center
    The Dalles, Oregon 97058
    (541)296-7398
    ------------------------------

    Original Message


  • 4.  RE: Challenging MIFUs

    Posted 11-05-2025 12:28

    Hi Connie, 

    APIC National has a dedicated webpage: Modernizing Medical Device Instructions for Use (IFUs) - APIC.

    It contains the published report, policy contact, press release, and a link to share IFU concerns: IFU@apic.org



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    Lori Graber
    Infection Preventionist
    La Grande, Oregon
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  • 5.  RE: Challenging MIFUs

    Posted 11-05-2025 12:46

    thanks!! Perfect!



    ------------------------------
    Connie Jubitz BSN, RN, CIC
    Mid Columbia Medical Center
    The Dalles, Oregon 97058
    (541)296-7398
    ------------------------------

    Original Message


  • 6.  RE: Challenging MIFUs

    Posted 11-05-2025 13:27
    Hi Connie!
    I know that we've struggled with this issue as well. I learned a lot from a presentation that was at APIC this year (MIFU Friend or Foe) and I've also had an opportunity to meet with a rep from GE who explained a lot about why the IFUs were written the way they are. I'd be happy to talk more about this with you.
    To file a complaint, it is through the FDA - this is mentioned in the APIC presentation. 

     

     

    Susan Diskin MSN, RN, CIC (she/her)

    Director Infection Prevention and Control | Special Pathogen Unit

    Quality & Patient Safety | Legacy Health

    1919 NW Lovejoy, Portland, OR 97209

    503-415-4881 - office |  sdiskin@lhs.org - email 


    CONFIDENTIAL AND PROTECTED: The entire contents of this communication (including any subsequent email communication attaching, responding to or discussing the subject email communication) are privileged and protected pursuant to ORS 41.675 & 41.685, RCW 4.24.240-260 & 70.41.200, the federal Health Care Quality Improvement Act of 1986 and other applicable law.