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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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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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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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Detecting Bioburden and Biofilm on Surgical Instruments Prior to Sterilization

Data from the Centers for Disease Control and Prevention (CDC) indicates that over 30,000 patients die annually from surgical infections. Many of these surgical infections are caused by surgical instruments that remain contaminated with bioburden and/or biofilm after reprocessing. Even more troubling is the fact that when patients died from...

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ECRI Institute’s “Top 10 Health Technology Hazards” Part II

In Part I of this series (Elmed blog #30) we introduced ECRI Institute’s Health Devices Group “Top 10 Health Technology Hazards for 2017.” This annual list identifies the greatest sources of danger to patients and offers practical, proven recommendations for reducing those risks and improving patient outcomes. The list details...

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ECRI Institute’s “Top 10 Health Technology Hazards” Part I

ECRI Institute is an independent, nonprofit research organization that researches the best approaches to improving patient care. Since 1971, ECRI Institute has been producing publications (i.e., Health Devices), reports and materials to help improve the effectiveness, safety, and economy of health services.1 Even though this list was compiled in the...

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How to Properly Disinfect Reusable Medical Devices Part IV

In Part III of “How to Properly Disinfect Reusable Medical Devices” (Elmed blog #28) we discussed various disinfectants that are commercially available for use in healthcare facilities along with their intended uses. In Part IV of this series we will continue our look at various FDA approved disinfectants. The goal...

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How to Properly Disinfect Reusable Surgical Instruments Part I

Disinfection is the process designed to eliminate all pathogenic microorganisms from reusable surgical instruments prior to sterilization. In most instances, reusable surgical instruments and medical devices are disinfected by the use of approved liquid chemicals or by wet pasteurization. There are numerous variables that can affect the efficacy of the...

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