FDA, CDC & ASM Recommendations for Duodenoscope Surveillance The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other...

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...

FDA, CDC and ASM are Providing Recommendations for Healthcare Facilities That Choose to Implement Duodenoscope Surveillance and Culturing Webinar March 22, 2018 from 1-2:30 PM (Eastern Time) The U.S. Food...

New Study Finds Amyloid Protein Transmission Through Contaminated Instruments A new study by the University College London Institute of Neurology finds that Amyloid beta pathology - protein deposits in the...

FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part IV In Part I of this blog (1/26/18) we discussed the fact that the FDA has identified a subset...

FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part III In Part I of this blog (1/26/18) we began an analysis of the FDA’s list of “Greater Risk”...

FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part II In Part I of this blog (1/26/18) we discussed the fact that the FDA has identified a subset...

FDA List of “Greater Risk” Medical Devices and Validated IFUs: Part I The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and...

Creutzfeldt-Jakob Disease (CJD) & the Challenges of Surgical Instrument Reprocessing Creutzfeldt-Jakob disease (CJD), commonly referred to as the human equivalent of mad cow disease, is caused by rogue, misfolded protein aggregates...

Detecting Bioburden & Biofilm on Surgical Instruments Prior to Sterilization Data from the Centers for Disease Control and Prevention (CDC) indicate that over 30,000 patients die annually from surgical infections. Many...