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: Product Labeling

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

November 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,”…

Auxiliary Water Channel Best Practices Carbapenem-Resistant Enterobacteriaceae (CRE) Colonoscopes Colonoscopy Disease Transmission Disposable Irrigation Tubing Endoscope Reprocessing Endoscope Sampling Esophagogastroduodenoscopy (EGD) Gastrointestinal Endoscopy GI Endoscopes Healthcare Quality, Safety Healthcare-Acquired Infections Hepatitis (B and C) Viruses Infection Prevention Joint Commission (JCAHO) Klebsiella pneumoniae Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae MAJ-855 Water Tube Medical Errors Mycobacterium abscessus Product Labeling Pseudomonas aeruginosa Quality Assurance Risk Management Serratia spp. Superbugs Surveys Tap Water The Reuse of Single-Use Devices

Tap Water Used for Irrigation during GI Endoscopy: A Recommendation and Assessment of the Infection Risk

May 20, 2014 Lawrence F Muscarella PhD

February 18, 2014 — This article discusses the potential for healthcare-associated infections (HAIs) associated with the use of tap water, compared to sterile water, for irrigation (and/or cleansing the endoscope’s…

Auxiliary Water Channel Best Practices Byrne Medical Central Sterile Processing Colonoscopes Colonoscopy Delayed Reprocessing Device Contamination Disease Transmission Disinfection Disposable Irrigation Tubing Endoscope Reprocessing ERBE Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Hepatitis (B and C) Viruses High-Level Disinfection HIV Infection Prevention MAJ-855 Water Tube Manufacturers Medical Errors Medivators Product Labeling Quality Assurance Risk Management Semicritical Devices Single-Use Disposable Devices STERIS The Reuse of Single-Use Devices US Endoscopy

Guidance for the Safe Use of “Disposable” Irrigation Tubing Used During GI Endoscopy

October 17, 2013 Lawrence F Muscarella PhD

October 17, 2013 — This is the third and final article in a series discussing disposable tubing used for irrigation during gastrointestinal (GI) endoscopy. This is the most complete set…

You missed

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