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: Risk Management

510(k) Clearances Adulterated Devices American Society of Gastrointestinal Endoscopy carbapenem Carbapenem-Resistant Enterobacteriaceae (CRE) Data Validation Design Control Device Recalls Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Food and Drug Administration Food Drug and Cosmetic Act Gastrointestinal Endoscopy GI Endoscopes Investigational Devices Misbranded Devices Olympus Olympus TJF-Q180V Risk Management

Considerations Not Addressed in the FDA’s Communication Discussing Olympus’ New Instructions for Reprocessing the TJF-Q180V Duodenoscope

March 27, 2015 Lawrence F Muscarella PhD

March 27, 2015 — On March 26, 2015, the FDA issued a safety communication: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here. This Olympus safety communication…

Auxiliary Water Channel Best Practices Carbapenem-Resistant Enterobacteriaceae (CRE) Colonoscopes Colonoscopy Disease Transmission Disposable Irrigation Tubing Endoscope Reprocessing Endoscope Sampling Esophagogastroduodenoscopy (EGD) Gastrointestinal Endoscopy GI Endoscopes Healthcare Quality, Safety Healthcare-Acquired Infections Hepatitis (B and C) Viruses Infection Prevention Joint Commission (JCAHO) Klebsiella pneumoniae Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae MAJ-855 Water Tube Medical Errors Mycobacterium abscessus Product Labeling Pseudomonas aeruginosa Quality Assurance Risk Management Serratia spp. Superbugs Surveys Tap Water The Reuse of Single-Use Devices

Tap Water Used for Irrigation during GI Endoscopy: A Recommendation and Assessment of the Infection Risk

May 20, 2014 Lawrence F Muscarella PhD

February 18, 2014 — This article discusses the potential for healthcare-associated infections (HAIs) associated with the use of tap water, compared to sterile water, for irrigation (and/or cleansing the endoscope’s…

Advocate Lutheran General Hospital Antibiotic-Resistant Bacteria Automated Endoscope Reprocessors Best Practices Biofilms Carbapenem-Resistant Enterobacteriaceae (CRE) Centers for Disease Control and Prevention Disease Transmission Disinfection E. coli Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Environmental Contamination Escherichia coli Esophagogastroduodenoscopy (EGD) Ethylene Oxide Gas Sterilization FUJIFILM Gastrointestinal Endoscopy GI Endoscopes Handwashing Sinks Healthcare-Acquired Infections High-Level Disinfection Infection Prevention Intermediate-Level Disinfection Klebsiella pneumoniae Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae Olympus Outbreak Investigations Pentax Peracetic Acid Pseudomonas aeruginosa Risk Management Serratia marcescens Transmission-Based Precautions

Multiple Outbreaks of a ‘Nightmarish Bacteria’ Linked to Contaminated Endoscopes in the U.S and Europe: Has a ‘Smoking Gun’ Been Found?

January 29, 2014 Lawrence F Muscarella PhD

A popular Sunday morning television news show aired a segment on January 15, 2014, that provided helpful advice about a concerning outbreak of “nightmare bacteria” that had been linked just…

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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

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