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PATIENT HARM CAUSED BY IMPROPER/INADEQUATE INTRUMENT REPROCESSING

Improper or inadequate decontamination, cleaning and sterilization of surgical instruments continues to be a major source of patient harm that is preventable through proper practice and adherence to manufacturers’ instructions for use (IFUs). The problem of contaminated instruments being returned to the O.R. and causing patient harm was first addressed...

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CAN A VISUALLY CLEAN SURFACE STILL HIDE DANGEROUS CONTAMINATION?

One of the biggest challenges for healthcare personnel today is ensuring that all items that come into contact with patients are clean and free of dangerous organic contaminates. This includes not just surgical instrumentation, but any and all reusable medical devices, patient care equipment, over-bed tables, call buttons, stainless steel...

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Protecting Reprocessing Workers From Dangerous Chemical Agents AAMI TIR67

The Association for the Advancement of Medical Instrumentation (AAMI) developed a new technical information report (TIR) to help reduce the risks associated with chemicals and sterilants used in reprocessing medical devices.  This is an important safety issue for all healthcare personnel involved with reprocessing medical devices. According to the CDC,...

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The Importance Of Pre-Cleaning Instruments At Point Of Use (Part II)

In Part I of this blog (Elmed blog #53) we discussed the fact that over the past year there has been an increased emphasis and a lot more attention placed on pre-cleaning surgical instruments at the point-of-use. The goal is to ensure pre-cleaning of instruments immediately after use and prior...

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The Importance Of Pre-Cleaning Instruments At Point Of Use (Part I)

Over the past year there has been a lot of increased emphasis and attention placed on pre-cleaning surgical instruments at the point of use prior to transport to sterile reprocessing. This new, increased emphasis on pre-cleaning is important to you, your facility and most importantly, to your patients and their...

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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...

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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...

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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...

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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...

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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...

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