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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...

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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...

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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...

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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...

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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...

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Can Validated IFUs Help In The Fight Against Sepsis?

Sepsis is a leading cause of death in U.S. hospitals, according to the Sepsis Alliance, a nationwide advocacy group committed to fighting sepsis throughout the country. More than 1 million people contract a severe case of sepsis each year in the United States. Tragically, up to 50 percent of patients diagnosed...

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FDA List of “Greater Risk” Medical Devices and Validated IFUs Part IV

In Part I of this blog (Elmed blog 34) we discussed the fact that the FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission after reprocessing and represent a high risk of infection (subclinical or clinical) if they are not, or simply cannot...

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FDA List of “Greater Risk” Medical Devices and the Need for Validated IFUs for Laparoscopic Instruments (Part III)

In Part I of this blog (1/26/18) we began an analysis of the FDA’s list of “Greater Risk” medical devices and the need for validated IFUs to ensure clean, sterile, moisture-free instruments to protect patients from harm/death. The FDA has identified a subset of medical devices that pose a greater...

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FDA List of “Greater Risk” Medical Devices and Validated IFUs Part II

In Part I of this blog we discussed the fact that the FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not, or cannot be, adequately reprocessed. According to data...

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News

FDA List of “Greater Risk” Medical Devices and Validated IFUs Part I

The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient...

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