"Greater Risk" Devices

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...

ECRI Institute’s “Top 10 Health Technology Hazards for 2017”: Part 2 In Part I of this series (12/22/17) we introduced ECRI Institute’s Health Devices Group “Top 10 Health Technology Hazards for...

ECRI Institute’s “Top 10 Health Technology Hazards for 2017”: Part 1 ECRI Institute is an independent, nonprofit research organization that researches the best approaches to improving patient care. Since 1971,...

FDA Safety Communication: Duodenoscope Recall by Fujifilm © On July 21, 2017, Fujifilm© issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all...