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: Food and Drug Administration

Automated Endoscope Reprocessors Auxiliary Water Channel Bedside Cleaning Biofilms Cleaning Agents Colonoscopes Creutzfeltd-Jakob Disease Delayed Reprocessing Disease Transmission Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Glutaraldehyde High-Level Disinfection Infection Prevention Instrument Reprocessing MAJ-855 Water Tube ortho-phthalaldehyde Peracetic Acid Prolonged Immersion Semicritical Devices Sterilization

Transmission of Infection during Gastrointestinal Endoscopy

April 15, 2013 Lawrence F Muscarella PhD

This post provides the abstract of a peer-reviewed article, co-authored by Dr. Nelson and Dr. Muscarella, entitled: “Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy.” This article…

ABTOX Plazlyte System Adulterated Devices Automated Endoscope Reprocessors Biological Indicators Disease Transmission Endoscope Damage Food and Drug Administration Gastrointestinal Endoscopy Immediate-Use Steam Sterilization Infection Prevention Instrument Reprocessing Investigational Devices Liquid Chemical Sterilization Low-Temperature Sterilization Misbranded Devices Peracetic Acid Sleeping Dogs Sterilization STERIS STERIS System 1 STERIS System 1E

History of the STERIS System 1: A Detailed Review

January 9, 2013 Lawrence F Muscarella PhD

September 18, 2013 — This article discusses the history of the STERIS System 1 Liquid Chemical Processor and its de facto recall (by the Food and Drug Administration). Click here…

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Adverse Event Reports Case Reviews Colonoscopes Colonoscopy Endoscope Reprocessing Risk Assessment Salmonella

17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria, FDA Reports Reveal

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