FDA Approves Olympus Q180V Redesign After Recall
Reuters reports the U.S. Food and Drug Administration (FDA) has approved a new design for Olympus’ reusable duednoscope meant to correct a issue that resulted in an Carbapenem-Resistant Enterobacteriaceae (CRE) outbreak last year.
Olympus’ Duodenoscopes Issues
After the source of a CRE outbreak was reveled to be Olympus’ Q180V reusable duodenoscopes, the company started to recall the devices. Subsequent investigations revealed that Olympus had not updated safety protocols after a redesign.
The design of the complicated devices was linked to increased risks of drug resistant infections even when cleaned properly.
In total, 180 patents were exposed to the CRE superbug with two deaths linked to the outbreak between October 2014 and January 2015.
Physicians use duodenoscopes to diagnose and treat problems in the gastrointestinal tract. In just the United States alone, over 500,000 procedures are performed every year.
About Olympus’ Recall and Design Modifications
According to Reuters, the company is voluntarily recalling its original model to fix them as quickly as they can.
New design modifications and labeling are intended to reduce the risk of bacterial infections after procedures. The safety protocols are now up to date with the new model.
The Food and Drug Administration is asking healthcare providers to meticulously follow cleaning directions to avoid the spread of superbugs.