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comment_50664

We have purchsed GE enFlow blood/fluid warmers.  I have no idea how to validate them.  Any ideas are welcome.

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  • This is what I have in my validation procedure.  The IQ (did we "install" it the way the manufacturer wants us to?) and OQ (does it do what the manufacturer says it does?) I get from the user's manual

comment_50665

I would make certain that the alarm sounds when the temp is too high and that the temps are verifiable with a certified thermometer. 

comment_50683

This is what I have in my validation procedure.  The IQ (did we "install" it the way the manufacturer wants us to?) and OQ (does it do what the manufacturer says it does?) I get from the user's manuals.  The PQ is to make sure it opererates the way YOU need it to at your facility.

  1. Equipment only: prior to validation, the BioMed department will inspect the equipment and perform an electrical safety check.  The equipment will then be assigned a unique tracking ID#.  The following elements will be performed:
    1. Installation qualification: demonstrates that the equipment is properly installed in the environmental conditions specified by the manufacturer.
    2. Operational qualification: demonstrates that the equipment operates as intended.
    3. Performance qualification: demonstrates that the equipment performs as expected for its intended use and that the output meets expectations in a normal working environment.

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