RQM+ Medical Device and In Vitro Diagnostic Blog

on 8 July 2024 | By Jonathan Gimbel, PhD, RQM+ Vice President, Technical

The EPA published a final rule this year requiring EtO sterilization facilities to significantly reduce EtO emissions. Since EtO sterilization is used for approximately 50% of sterile medical devices (estimated at over 20 billion devices sold in the U.S every year) [1], this...

on 5 September 2013 | By Ryan Kasun

On the news this morning, I heard a story that got me thinking about risk management. The headline was “Eight N.H. patients possibly exposed to fatal brain disease”. Further research about the situation reveals just how complex this case is.