Blog

Category: News

News

What do you do with instruments that are still contaminated after decontamination?

One of the many benefits of being a member of the Association for the Advancement of Medical Instrumentation (AAMI) is being able to read and participate in the “AAMI Members Discussion Group.” This great tool allows AAMI members from around the world to post questions and get input, ideas and...

Read More...
News

Preventing Surgical Infections Caused By Biofilms

In an earlier blog we examined the report on a Denver hospital that had a large outbreak of contaminated surgical instruments (Elmed blog 47, March 10, 2021). This tragic event caused a lot of significant, painful and costly consequences to the hospital and their patients. Specifically “On May 10, 2018...

Read More...
News

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part V)

This Five-Part Series has dealt with the FDA’s mandate that all reusable medical device manufacturers provide validated instructions for successfully reprocessing their devices. “FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and...

Read More...
News

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...

Read More...
News

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...

Read More...
News

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...

Read More...
News

AAMI Steam Sterilization Standard ST79 Updated

On January 20, 2021 the Association for Advancement of Medical Instrumentation (AAMI) published four amendments to ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. These four new amendments are designed to provide sterile reprocessing technicians/personnel with updated guidance to help them comply with accrediting bodies...

Read More...
News

What Does An Instrument Manufacturer Have To Do To Validate Their Cleaning IFUs? (Part II)

In the first part of this blog (Elmed blog #41) it was pointed out that the FDA mandates that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). The FDA’s concern with the content and the “validity” of manufacturers’ IFUs was codified on March 17, 2015...

Read More...
News

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 devices (IFUs). These IFUs are supposed to provide reprocessing personnel with the necessary information and steps to safely and thoroughly reprocess reusable medical devices and surgical instruments. Included in every IFU are specific instructions on...

Read More...
News

New Study Finds Amyloid Protein Transmission Through Contaminated Instruments

A recent study by the University College of London Institute of Neurology found that Amyloid beta pathology - protein deposits in the brain - might have been transmitted to young, healthy patients several decades earlier by contaminated surgical instruments.1 This is the latest finding to be added to the every-growing list...

Read More...
© 2021  ELMED Incorporated    Site by Black Line IT.