What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part II)

Archive for: January, 2021

News

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part II)

In the first part of this blog (Elmed blog #41) it was pointed out that the FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). The FDA’s concern with the content and the “validity” of manufacturers’ IFUs was codified on March 17, 2015...

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What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part I)

The FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). These IFUs are supposed to provide reprocessing personnel with the necessary information and steps to safely and thoroughly reprocess reusable medical devices and surgical instruments. Included in every IFU are specific instructions on...

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New Study Finds Amyloid Protein Transmission Through Contaminated Instruments

A recent study by the University College of London Institute of Neurology found that Amyloid beta pathology - protein deposits in the brain - might have been transmitted to young, healthy patients several decades earlier by contaminated surgical instruments.1 This is the latest finding to be added to the every-growing list...

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