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: Misbranded Devices

510(k) Clearances Adulterated Devices American Society of Gastrointestinal Endoscopy carbapenem Carbapenem-Resistant Enterobacteriaceae (CRE) Data Validation Design Control Device Recalls Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopic Ultrasound (EUS) Food and Drug Administration Food Drug and Cosmetic Act Gastrointestinal Endoscopy GI Endoscopes Investigational Devices Misbranded Devices Olympus Olympus TJF-Q180V Risk Management

Considerations Not Addressed in the FDA’s Communication Discussing Olympus’ New Instructions for Reprocessing the TJF-Q180V Duodenoscope

Mar 27, 2015 Lawrence F Muscarella PhD

March 27, 2015 — On March 26, 2015, the FDA issued a safety communication: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here. This Olympus safety communication…

Adulterated Devices Ambulatory Surgery Centers Aseptic Technique Association of periOperative Registered Nurses Automated Endoscope Reprocessors Biological Indicators Central Sterile Processing Chemical Indicators Design Control Device Recalls Endoscope Reprocessing Flash Sterilization Flash Sterilization Food and Drug Administration Immediate-Use Steam Sterilization Infection Prevention Instrument Drying Instrument Reprocessing Liquid Chemical Sterilization Low-Temperature Sterilization Misbranded Devices Monitoring Rinse Water Operating Rooms Product Labeling Steam Sterilization STERIS STERIS System 1 STERIS System 1E Water Filtration

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

Nov 7, 2014 Lawrence F Muscarella PhD

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…

Bedside Cleaning Byrne Medical Central Sterile Processing Checklists Colonoscopes Colonoscopy Delayed Reprocessing Disease Transmission Disposable Irrigation Tubing Endoscopic Retrograde Cholangiopancreatography (ERCP) ERBE Esophagogastroduodenoscopy (EGD) Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Healthcare-Acquired Infections High-Level Disinfection HIV Infection Prevention Instrument Reprocessing Medical Errors Medivators Misbranded Devices Product Labeling Quality Assurance Quality System Regulation Reusable Biopsy Valves Risk Assessment Single-Use Disposable Devices Sterility Sterilization STERIS The Reuse of Single-Use Devices US Endoscopy Veterans Health Administration

“Disposable” Irrigation Tubing Used During Gastrointestinal Endoscopy A review of several marketed irrigating tubing kits.

Aug 15, 2013 Lawrence F Muscarella PhD

August 15, 2013 (updated: January 27, 2015) — This article by Dr. Muscarella is the 2nd in a series of three that discusses disposable tubing used for irrigation during gastrointestinal (GI) endoscopy.…

You missed

Adverse Event Reports Device Recalls Duodenoscopes with Disposable Components Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Esophagogastroduodenoscopy (EGD) FUJIFILM ED-580XT 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

Aug 2, 2023 Lawrence F Muscarella PhD
Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

Jan 6, 2023 Lawrence F Muscarella PhD
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

Sep 27, 2022 Lawrence F Muscarella PhD
Alcohol Rinsing Endoscope Drying Endoscope Reprocessing

Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying

Feb 22, 2022 Lawrence F Muscarella PhD