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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…
In the Journals

Hormone therapy appears safe for women on anticoagulants

February 9, 2016
Hormonal therapy did not appear associated with an increased risk for recurrent venous thromboembolism or uterine bleeding among women on therapeutic anticoagulation…
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…
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CME

Updates in Immunotherapy – Philadelphia 2015

This activity is supported by an educational grant from Merck & Co., Inc.

The promise of immunotherapy in oncology has become a reality with the US Food and Drug Administration (FDA) approval…
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Meeting News CoverageVideo

VIDEO: Screening for Barrett's esophagus not feasible with current methods

January 23, 2016
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CME

World Lung Updates: Immunotherapy in NSCLC

This activity is supported by an educational grant from Genentech, Inc and Merck & Co., Inc.

Globally, lung cancer is the leading cause of cancer-related deaths. Non-small cell lung cancer (NSCLC) accounts for…
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