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Medtech Losers of 2015: Duodenoscopes

DuodenoscopesA particular type of flexible endoscope used to diagnose and treat diseases of the liver, bile duct, and pancrease, the duodenoscope came under a harsh spotlight this year following reports of numerous outbreaks of carbape

nem-resistant enterobacteriaceae infections. It appears that in some cases, these scopes remained contaminated despite undergoing reprocessing.

This year, FDA published a number of recommendations and finalized a guidance document on reprocessing reusable medical devices. The agency has also required the three makers of duodenoscopes sold in the United States—Olympus America, Inc., Fujifilm Medical Systems, USA, Inc., and the PENTAX Life Care Division of Hoya Corp.—to submit plans for postmarket surveillance studies on whether reprocessing and cleaning instructions work and what is needed to make sure scopes are not contaminated.

Ineffective cleaning of flexible endoscopes recently made the top spot on the Emergency Care Research Institute’s list of Top 10 Health Technology Hazards for 2016.

          

 [image courtesy of RENJITH KRISHNAN/FREEDIGITALPHOTOS.NET]
Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.
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