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FDA Says Endoscope Makers Failed to Report Superbug Problems

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~~~~NBCNews1

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Federal regulators have uncovered new violations by the manufacturer of medical scopes recently linked to outbreaks of deadly “superbug” bacteria at U.S. hospitals.

Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company’s scope in 2012, according to a warning letter posted online Monday by the Food and Drug Administration. Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks.

Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them. The infections reported to the company involved a bacterial strain called pseudomonas, which can cause pneumonia, severe sickness and death in hospital patients.

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Click link below for article and video:

http://www.nbcnews.com/health/health-news/fda-says-endoscope-makers-failed-report-superbug-problems-n411241

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Popular Acne Meds Can Cause Allergic Reactions: FDA

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~~~~NBCNews1
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Health officials are warning that ingredients in some popular acne products including brands such as Proactiv, Neutrogena, Aveeno and Clean & Clear have been linked to potentially life-threatening allergic reactions.

Products containing benzoyl peroxide or salicylic acid can cause rare but potentially dangerous reactions or severe irritation, Food and Drug Administration said Wednesday.

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Doctors Save Life Of Kaiba Gionfriddo, Ohio Boy, By 3-D ‘Printing’ Him An Airway Tube

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In a medical first, doctors used plastic particles and a 3-D laser printer to create an airway splint to save the life of a baby boy who used to stop breathing nearly every day.

It’s the latest advance from the booming field of regenerative medicine, making body parts in the lab.

In the case of Kaiba (KEYE’-buh) Gionfriddo, doctors didn’t have a moment to spare. Because of a birth defect, the little Ohio boy’s airway kept collapsing, causing his breathing to stop and often his heart, too. Doctors in Michigan had been researching artificial airway splints but had not implanted one in a patient yet.

In a single day, they “printed out” 100 tiny tubes, using computer-guided lasers to stack and fuse thin layers of plastic instead of paper and ink to form various shapes and sizes. The next day, with special permission from the Food and Drug Administration, they implanted one of these tubes in Kaiba, the first time this has been done.

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!!PrintedAirTube1

!!PrintedAirTube2A 3-D Printer

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.Click link below for story, video, and slideshow:

http://www.huffingtonpost.com/2013/05/22/3d-print-airway-tube-kaiba-gionfriddo_n_3322217.html?icid=maing-grid7|myaol|dl4|sec1_lnk3%26pLid%3D317382

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