Hospital Forced To Cancel Surgeries For A Week Due to Contaminated Instruments
On May 10, 2018 Porter Adventist Hospital in Denver, Colorado had to cancel all surgeries for a week due to contaminated surgical instruments being found in the O.R. after reprocessing. While this happened a few years ago, it is a great example of the incredible importance of pre-cleaning at point...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part IV)
In Part I of this blog (Elmed blog 41) we discussed the FDA’s mandate that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices (IFUs). “FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the...
What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part III)
In Part I of this blog (Elmed blog number 41) we discussed the FDA’s mandate that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). “FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the...
