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: Sterilization

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Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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

Advocate Lutheran General Hospital American Society of Gastrointestinal Endoscopy Antibiotic-Resistant Bacteria Carbapenem-Resistant Enterobacteriaceae (CRE) Centers for Disease Control and Prevention Colonoscopy Corrective and Preventive Actions Device Contamination Device Recalls Disease Transmission Disinfection Endoscope Reprocessing Endoscope Sampling Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Ethylene Oxide Gas FUJIFILM Gastrointestinal Endoscopy GI Endoscopes Healthcare-Acquired Infections Infection Prevention Instrument Reprocessing Olympus Pentax Quality Assurance Quality System Regulation Society of Gastroenterology Nurses and Associates Sterilization USA Today

USA TODAY: “Deadly bacteria on medical scopes trigger infections”

January 21, 2015 Lawrence F Muscarella PhD

The USA TODAY article that everyone in the field is talking about: “Deadly bacteria on medical scopes trigger infections” (By: Peter Eisler, 6:21 p.m. EST January 21, 2015) Important quotes…

510(k) Clearances Automated Endoscope Reprocessors Biological Indicators De Novo Classifications Endoscope Reprocessing Food and Drug Administration Glutaraldehyde Liquid Chemical Sterilants Liquid Chemical Sterilization Spore Strip Tests Sterility Sterility Assurance Level Sterilization STERIS System 1 STERIS System 1E

The Use of Biological Indicators to Monitor Liquid Chemical Sterilants: The FDA’s Position, 2014

November 25, 2014 Lawrence F Muscarella PhD

November 25, 2014 — The proper use of “BIs” – or biological indicators – in the healthcare setting is crucial to assess the effectiveness of the sterilization process. Failure to…

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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