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Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication
Date Issued: February 19, 2015 Audience: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Patients considering endoscopic retrograde cholangiopancreatography (ERCP) procedures Medical Specialties: Gastroenterology, Infection Control Device: All ERCP endoscopes (side-viewing duodenoscopes) Figure 1: Close-up view of an ERCP endoscope tip. Purpose: The FDA wants…
Materials posted for Feb. 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) – Guidance for Industry and Food and Drug Administration Staff (PDF
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Presentations added to CDRH Industry Basics Workshop Webinar ? November 4, 2014
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FDA Voice blog: The Meaning of Wearing Red
By: Margaret A. Hamburg, M.D. Last night I had the pleasure of attending the annual Woman’s Day Red Dress awards ceremony in New York City. The event is one of the highlights of American Heart Month, and it was created by that magazine to educate Americans about, and help fight, heart disease, which has become…
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications – Guidance for Industry and Food and Drug Administration Staff (PDF
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Updates to Tubing and Luer Misconnections: Preventing Dangerous Medical Errors
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Class I Medical Device Recall: Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue
Use: The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve…
Summary Information for: Koning Breast CT
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