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: Carbapenem-Resistant Enterobacteriaceae (CRE)

Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin-Resistant Bacteria Device Recalls Duodenoscopes Endoscope Reprocessing Klebsiella pneumoniae Medical Device Reports (MDRs) Multidrug Resistant Strains O-ring Contamination Pseudomonas aeruginosa Superbugs

A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug Is enough being done to improve safety? The recall of several bronchoscope models is also discussed.

October 1, 2018 Lawrence F Muscarella PhD

October 1, 2018 (updated: Oct. 5, 2018; edited: Oct. 8, 2020) — A bronchoscope’s use has been linked again to a “superbug” outbreak, this time involving “multiple patients,” according to…

Bronchoscopes Carbapenem-Resistant Enterobacteriaceae (CRE) Cystoscopes Echo-endoscopes FDA's Supplemental Measures Flexible "ENT" Laryngoscopes Food Drug and Cosmetic Act Gastroscopes

New Guidance to Prevent Other Types of Flexible Endoscopes From Transmitting Superbugs A new practice is provided to prevent contaminated gastroscopes, echo-endoscopes and other types of flexible endoscopes from infecting patients with multidrug-resistant bacteria

March 26, 2018 Lawrence F Muscarella PhD

March 26, 2018 (updated May 16, 2018) — Advice for preventing flexible endoscopes from transmitting potentially life-threatening “superbugs” is the focus of new research, which provides a new clinical practice…

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm) — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

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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
Adverse Event Reports Ambu Centers for Medicare and Medicaid Services (CMS) COVID-19 Endoscope Reprocessing Rebuttals Single-Use TPT Medicare Payment Status

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