May 19, 2016

Endoscope Sampling Kit Now Available

With their flexibility and complex components, endoscopes present unique cleaning and disinfecting challenges. Endoscope manufacturers, regulatory bodies, and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. The concern over...

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March 20, 2015

Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance.  Based on the content and addition of Appendix E, this...

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