Regulatory Open Forum

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  • 1.  Reprocessing Medical Devices

    Posted 06-Mar-2018 12:58
    Hi everyone, I was looking for some guidance in terms of the agencies guidelines; "Reprocessing medical devices" 2011, particularly validation. I have been using a test house in the UK for purposes of cleaning and validation protocols and reports but wondered if anyone had experience of using US test houses. I would appreciate any recommendations.

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    STEVEN BAKER
    Midvale UT
    United States
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  • 2.  RE: Reprocessing Medical Devices

    Posted 07-Mar-2018 06:15
    We currently use Nelson Labs for our cleaning validations. Wuxi Apptec should also be able to perform these type studies, as well as Toxikon. All are 17025 and offer GLP options.

    Thanks,
    Melinda

    Please excuse any typos or brevity.
    Sent from my iPhone.


    Original Message


  • 3.  RE: Reprocessing Medical Devices

    Posted 07-Mar-2018 09:10
    Agree with Melinda on those companies.  I have used Nelson Labs primarily, but I am probably biased because I have used Nelson Labs since early 90s but there are definitely others that offer cleaning validation services in the U.S.  Just get a number of quotes and choose a company that you feel comfortable with your product.  Cleaning validation can be quite complicated depending on the type of device because of the complexity or type of materials on the device.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


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