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Senate proposes new safety requirements for reusable devices

Senate proposes new safety requirements for reusable devices
February 9, 2016

The Senate Committee on Health, Education, Labor and Pensions today favorably reported a bill requiring manufacturers of reusable medical devices like duodenoscopes to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also seeks to clarify FDA guidance on when manufacturers should seek clearance from the agency before marketing their products.

Between 2012 and 2015, there were 25 incidents of drug-resistant infections related to closed-channel duodenoscopes, affecting 250 patients worldwide, according to a recent report.

Breaking News

Legislators ask for national surveillance of neurological illnesses

February 9, 2016
The Senate health committee today recommended the establishment of a national surveillance system for neurological diseases.The objective of the “Advancing…
Breaking News

Senate proposes EHR fix for physicians, patients

February 9, 2016
The U.S. Senate Committee on Health, Education, Labor and Pensions unanimously recommended a measure today that would improve the use of electronic health records for…
Breaking News

New bill supports young researchers

February 9, 2016
The Senate health committee recommended a bill today that would improve opportunities for new researchers in the United States. The “Next Generation Researchers…
In the Journals

Nanophthalmic eyes show some significant improvements with high-powered IOL

February 9, 2016
Implantation of a foldable high-powered IOL significantly improved uncorrected distance visual acuity and spherical equivalence in nanophthalmic eyes, according to a…
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In the Journals

Researchers: Ideal myopia-controlling contacts will target many mechanisms

February 1, 2016
Paul Gifford, PhD, FAAO, and Kate Louise Gifford, BAppSc(Optom) determined through a literature review that contact…
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IOP taken with contact lens sensor correlates with visual field changes

February 4, 2016
Researchers determined that the use of 24-hour IOP measurements obtained via a contact lens sensor were associated with…
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Featured

Children with uncorrected hyperopia have deficits in early literacy

February 8, 2016
Researchers found that preschool or kindergarten children with uncorrected hyperopia associated with reduced binocular…
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