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.

Tag: MAUDE

Adverse Event Reports Colonoscopes Duodenoscopes Endoscope Reprocessing Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

September 27, 2022 Lawrence F Muscarella PhD

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

Adverse Event Reports Bronchoscopes Colonoscopes Cystoscopes Duodenoscopes ENT Endoscopes Flexible "ENT" Laryngoscopes Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Olympus GF-UCT180 Pentax ED-3490TK Single-Use Disposable Devices Urological Endoscopes

Contamination of Flexible Endoscopes and Associated Infections | A Comprehensive Review and Analysis of FDA Adverse Event Reports

January 28, 2022 Lawrence F Muscarella PhD

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

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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