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

Archive for: October, 2020

News

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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News

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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News

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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News

Creutzfeldt-Jakob Disease (CJD) and the Challenges of Surgical Instrument Reprocessing

Creutzfeldt-Jakob disease (CJD), commonly referred to as the human equivalent of mad cow disease, is caused by rogue, misfolded protein aggregates termed prions, which are infectious and cause fatal damages in the patient’s brain. The Centers for Disease Control and Prevention (CDC) defines prions as “abnormal, pathogenic agents that are transmissible...

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