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: Liquid Chemical Sterilants

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…

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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

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January 6, 2023 Lawrence F Muscarella PhD