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
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Original Message:
Sent: 11/4/2025 3:24:00 PM
From: Connie Jubitz
Subject: Challenging MIFUs
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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