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 Food and Drug Administration Food Drug and Cosmetic Act Informed Consent Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

May 13, 2025 Lawrence F Muscarella PhD

Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…

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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