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: Patty Murray (U.S. Senator)

510(k) Clearances Data Validation Duodenoscopes Echo-endoscopes Endoscopic Ultrasound (EUS) FUJIFILM ED-530XT Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae Olympus TJF-Q180V OXA-48-producing Patty Murray (U.S. Senator) Pentax ED-3490TK Soluscope

The Redesigned Olympus Duodenoscope Has Been Linked to a ‘Superbug’ Cluster The device's original design was recalled in January 2016 amid concerns about its safety.

March 22, 2017 Lawrence F Muscarella PhD

March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I…

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Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices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

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January 8, 2024 Lawrence F Muscarella PhD
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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