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

510(k) Clearances Automated Endoscope Reprocessors Biological Indicators De Novo Classifications Endoscope Reprocessing Food and Drug Administration Glutaraldehyde Liquid Chemical Sterilants Liquid Chemical Sterilization Spore Strip Tests Sterility Sterility Assurance Level Sterilization STERIS System 1 STERIS System 1E

The Use of Biological Indicators to Monitor Liquid Chemical Sterilants: The FDA’s Position, 2014

November 25, 2014 Lawrence F Muscarella PhD

November 25, 2014 — The proper use of “BIs” – or biological indicators – in the healthcare setting is crucial to assess the effectiveness of the sterilization process. Failure to…

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,”…

Advocate Lutheran General Hospital Antibiotic-Resistant Bacteria Automated Endoscope Reprocessors Biofilms Carbapenem-Resistant Enterobacteriaceae (CRE) Colonoscopes Colonoscopy Design Control Disease Transmission Disinfection Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Escherichia coli Esophagogastroduodenoscopy (EGD) Ethylene Oxide Gas Sterilization Food and Drug Administration Gastrointestinal Endoscopy GI Endoscopes Glutaraldehyde High-Level Disinfection Klebsiella pneumoniae Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae Low-Temperature Sterilization Patient Notification Quality Assurance Quality System Regulation Root Causes Analysis Shelf Life, Storage Transparency Veterans Health Administration

Risk of Transmission of Superbugs during Gastrointestinal Endoscopy

October 16, 2014 Lawrence F Muscarella PhD

Click here (PDF format) or here (HTML format) to read Dr. Muscarella’s “Risk of transmission of carbapenem-resistant Enterobacteriaceae and related ‘superbugs’ during gastrointestinal endoscopy” (World J Gastrointest Endosc 2014; 6(10):457-474.)…

You missed

Case Reviews Centers for Disease Control and Prevention Cosmetic Surgery Mycobacterium abscessus Nontuberculous Mycobacteria ("NTM") Outbreak Investigations Public Disclosure

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic

May 6, 2024 Lawrence F Muscarella PhD
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