Global Regulators Promote UDI Standardization with New Guide The International Medical Device Regulators Forum (IMDRF) has just released a proposed UDI Application Guide for public comment.1 The guide provides...
What do you do with instruments that are found to still be contaminated after decontamination? One of the many benefits of being a member of the Association for the...
Preventing The Problem With Biofilms In May of this year we examined the initial news report on a hospital that had an outbreak of contaminated surgical instruments. Last month we...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part V) In Part I of this blog series, we discussed the FDA’s mandate that all reusable...
Palestine Children's Relief Fund PCRF is dedicated to providing medical and humanitarian relief to Arab children throughout the Levant, regardless of their nationality, politics or religion. PCRF is a six-time...
Biofilm Was Probable Cause Of Contaminated Instruments At Hospital Last month we examined the initial news report on a hospital that had a large outbreak of contaminated surgical instruments (Novo...
FDA Seeks to Reduce Risk of Surgical Fires, Patient Injuries Surgical instruments and numerous medical devices are a chief ignition source for fires in the operating room. These instruments and...
Surgical Site Infections Dropped 61% In Patients Following Colorectal Surgery Surgical site infections (SSIs) dropped 61% over two years in patients undergoing colorectal operations in Hawaiian hospitals who were participating...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part IV) In Part I of this blog series we discussed the FDA’s mandate that all reusable medical...
FDA Announces Plans to Improve Medical Device Safety and Innovation The FDA recently proposed steps to improve the government's system for overseeing medical device safety and new product/device innovation. For...
