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

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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