Medical Company May Be Falling Short Of Its Patient Safety Ideals

NPR, October 6, 2014. The Masima device company created a Patient Safety Movement Foundation but didn’t investigate reports that its devices harmed patients. “When a company refuses to respond in any way to the FDA other than to say that the FDA is wrong on every issue, that’s not very credible,” Zuckerman said. “Especially when users made complaints that the company’s product put patients at risk,” she said.

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Medical Devices Lack Safety Evidence, Study Finds

The Wall Street Journal, September 29, 2014. The majority of moderate to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.

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Diversity in Clinical Trials

The Wall Street Journal, August 28, 2014. In response to a law passed two years ago, the FDA was directed to assess the extent to which women and minorities are represented in clinical trials and also devise a plan to bolster their participation. The requirement was made in response to concerns that drugs and devices may often be used by subsets of the population on whom the products were not actually tested.

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