US Food and Drug Administration (FDA)

Aout 4 million years ago, a cave was forming in the Delaware Basin of what is now Carlsbad Caverns National Park in New Mexico. From that time on, Lechuguilla Cave remained untouched by humans or animals until its discovery in 1986—an isolated, pristine primeval ecosystem. When the bacteria found on the walls of Lechuguilla were analyzed, many of the microbes were determined not only to have resistance to natural antibiotics like penicillin, but also to synthetic antibiotics that did not exist on earth until the second half of the twentieth century...

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Soom, a pioneer in utilizing barcode and knowledge graph technologies to bridge information gaps between data sources and physical products, has introduced SoomSafety, an iOS mobile app that allows users to scan a medical device and receive instructions for use, safety and recall information directly from the device manufacturer and U.S. Food and Drug Administration (FDA). "We built SoomSafety to help patients and caregivers relying on implanted medical devices and using medical devices at home answer one critical question, 'Is this medical device safe to use?'" said Charlie Kim, President and CEO of Soom. "Our technology makes it possible to connect previously siloed medical device data, giving patients-and their caregivers-more proactive control over their health and safety."

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The U.S. Food and Drug Administration's Premarket Approval pathway allows high-risk medical devices on the market with only one study to prove their safety and effectiveness, and there are a limited number of studies done post-market, according to research published in Journal of the American Medical Association. Medical device regulation in the U.S. is more rigorous than in other parts of the world, but "the difference is, in many European countries they have much better capacity to follow devices once they are in practice," senior author Joseph S. Ross, M.D., of the Yale University School of Medicine, told Reuters.

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Superbugs, disease-causing microbes that have mutated to become resistant to antibiotics, are a threat to the lives of hundreds of thousands of people today and many millions tomorrow. These organisms turn curable illnesses such as tuberculosis, gonorrhea, and pneumococcal pneumonia into deadly ones. This looming public health disaster has many causes. Overuse of antibiotics by humans and the routine use of antibiotics to help farm animals grow faster are key causes in the United States. One worrisome cause that has received virtually no attention until now is wastewater from drug manufacturing facilities in India and China, where a large portion of the world’s antibiotic supply is produced...

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