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: Sterility

Aseptic Technique Biological Indicators Carbapenem-Resistant Enterobacteriaceae (CRE) Critical Device Classifications Disease Transmission Endoscope Reprocessing Flexible "ENT" Laryngoscopes Food and Drug Administration High-Level Disinfection Hydraulic Fluid Infection Prevention Instrument Drying Intermediate-Level Disinfection Liquid Chemical Sterilization Low-Level Disinfection Noncritical Ophthalmic Instruments Patty Murray (U.S. Senator) Rigid Laryngoscopes Semicritical Devices Skin Electrodes (Reusable) Sterility Sterilization Toxic Anterior Segment Syndrome

Response to the FDA’s Draft Guidance Document on the Reprocessing of Reusable Medical Devices

February 7, 2015 Lawrence F Muscarella PhD

February 5, 2015 — This article presents Dr. Muscarella’s response submitted in August 2011 to the federal Food and Drug Administration (FDA), in reply to the Agency’s request earlier that…

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…

Aseptic Technique Best Practices Colonoscopes Colonoscopy Disease Transmission Endoscope Reprocessing Esophagogastroduodenoscopy (EGD) Fungal infections Gastrointestinal Endoscopy GI Endoscopes Healthcare Quality, Safety Healthcare-Acquired Infections Hepatitis (B and C) Viruses HIV Infection Prevention Legionella Legionnaires' Disease Multi-Dose Medicine Vials Outbreak Investigations Patient Notification Published Infection Rates Quality Assurance Single-Dose Medicine Vials Sterility Syringes or Needles Transparency Veterans Health Administration

Recent Cases of Infection during GI Endoscopy and Other Surgical Procedures: A Focus on Patient Notification

September 30, 2014 Lawrence F Muscarella PhD

September 30, 2014 — This article discusses a number of recent instances of transmission of the hepatitis C virus and other infectious agents during gastrointestinal (GI) endoscopy and other surgical…

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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