FDA Archives - Discussions in Infection Control

Wed. Oct 16th, 2024

522 Order Carbapenem-Resistant Enterobacteriaceae (CRE) Colistin Duodenoscopes Food Drug and Cosmetic Act FUJIFILM MCR-1 gene Medical Device Reports (MDRs) Olympus Pentax Postmarket surveillance studies Warning letters (FDA)

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

March 15, 2018 Lawrence F Muscarella PhD

March 15, 2018 (1:14 pm) — The three manufacturers of duodenoscopes sold in the U.S. have not complied with the requirements of an order the FDA issued to each in…

DEC Duodenoscope Duodenoscopes Duodenoscopes Olympus TJF-160F Pentax ED-3490TK Pentax ED34-i10T Pentax ED34-i10T2 Single-Use Disposable Devices

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

September 25, 2017 Lawrence F Muscarella PhD

Sept. 25, 2017 (Monday; 11:47am) — The FDA announced last week that it has “cleared the first duodenoscope with a disposable distal cap” for use in U.S. hospitals, calling this…

Automated Endoscope Reprocessors Duodenoscopes Endoscope Reprocessing Endoscopic Retrograde Cholangiopancreatography (ERCP) Food and Drug Administration Food Drug and Cosmetic Act Postmarket surveillance studies

FDA Orders Endoscope Manufacturers to Perform Safety Studies

October 6, 2015 Lawrence F Muscarella PhD

October 6, 2015 — Yesterday the U.S. Food and Drug Administration (FDA) ordered the three manufacturers of certain specialized medical endoscopes sold in the U.S. to perform “postmarket” surveillance studies.…

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Bronchoscopes Centers for Medicare and Medicaid Services (CMS) Endoscope Reprocessing Gastroscopes Infection Prevention Rebuttals TPT Medicare Payment Status

FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

FDA Orders Endoscope Manufacturers to Perform Safety Studies

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Dr. Muscarella’s Responses, Proposals, and Recommendations to Medicare to Prevent Hospital-Acquired Infections

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

17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria, FDA Reports Reveal

In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model

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FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies

FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

FDA Orders Endoscope Manufacturers to Perform Safety Studies

You missed

Dr. Muscarella’s Responses, Proposals, and Recommendations to Medicare to Prevent Hospital-Acquired Infections

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

17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria, FDA Reports Reveal

In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model