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.

Tag: Superbugs

510(k) Clearances Carbapenem-Resistant Enterobacteriaceae (CRE) Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Ted Lieu USA Today

USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”

April 21, 2015 Lawrence F Muscarella PhD

Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…

FDA Updates

April 8, 2015 Lawrence F Muscarella PhD

The following lists most of the FDA’s recently issued updates, safety communications and alerts discussing the manual and automated cleaning and disinfection of side-viewing duodenoscopes (or, ERCP endoscopes). Recommendations provided…

Carbapenem-Resistant Enterobacteriaceae (CRE) Carbapenems Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Gastrointestinal Endoscopy GI Endoscopes Olympus Olympus TJF-Q180V Ted Lieu

Congressman Lieu Asks Questions of Endoscope Manufacturers in the Wake of Several Deadly “Superbug” Outbreaks

March 30, 2015 Lawrence F Muscarella PhD

U.S. Rep. Ted Lieu (D-Calif.) has written letters to the Olympus Corporation of the Americas (Center Valley, PA) and to Pentax Medical (Montvale, NJ) asking a number of questions in…

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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