Discussions in Infection Control

An independent site by Lawrence F Muscarella PhD -- a national authority on the causes and prevention of healthcare-associated infections and related errors.

Category: Aseptic Technique

Aseptic Technique Cardiopulmonary Perfusion Machine Flash Sterilization Greenville Memorial Hospital Heater-Cooler Devices Ice Dispensers Mycobacterium abscessus Nontuberculous Mycobacteria ("NTM") Outbreak Investigations Tap Water

Greenville Health System Settles a Lawsuit Claiming Negligence Caused a Patient’s Infection, Death

July 13, 2015 Lawrence F Muscarella PhD

July 13, 2015 — South Carolina’s Greenville Health System has settled a wrongful death lawsuit with the family of a surgical patient who died in 2014 from an unusual infection…

Aseptic Technique Biological Indicators Carbapenem-Resistant Enterobacteriaceae (CRE) Critical Device Classifications Disease Transmission Endoscope Reprocessing Flexible "ENT" Laryngoscopes Food and Drug Administration High-Level Disinfection Hydraulic Fluid Infection Prevention Instrument Drying Intermediate-Level Disinfection Liquid Chemical Sterilization Low-Level Disinfection Noncritical Ophthalmic Instruments Patty Murray (U.S. Senator) Rigid Laryngoscopes Semicritical Devices Skin Electrodes (Reusable) Sterility Sterilization Toxic Anterior Segment Syndrome

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices

February 7, 2015 Lawrence F Muscarella PhD

February 5, 2015 — This article presents Dr. Muscarella’s response submitted in August 2011 to the federal Food and Drug Administration (FDA), in reply to the Agency’s request earlier that…

Adulterated Devices Ambulatory Surgery Centers Aseptic Technique Association of periOperative Registered Nurses Automated Endoscope Reprocessors Biological Indicators Central Sterile Processing Chemical Indicators Design Control Device Recalls Endoscope Reprocessing Flash Sterilization Flash Sterilization Food and Drug Administration Immediate-Use Steam Sterilization Infection Prevention Instrument Drying Instrument Reprocessing Liquid Chemical Sterilization Low-Temperature Sterilization Misbranded Devices Monitoring Rinse Water Operating Rooms Product Labeling Steam Sterilization STERIS STERIS System 1 STERIS System 1E Water Filtration

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

November 7, 2014 Lawrence F Muscarella PhD

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…

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January 24, 2024 Lawrence F Muscarella PhD
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In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model

January 8, 2024 Lawrence F Muscarella PhD
Adulterated Devices Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT MAJ-2315 Misbranded Devices Olympus TJF-Q190V Single-Use Endcap with Elevator Warning letters (FDA)

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

August 2, 2023 Lawrence F Muscarella PhD
Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Escherichia coli Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Gastroscopes Have Been Linked to A Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

January 6, 2023 Lawrence F Muscarella PhD