Endoscope Manufacturer Sold Modified Device Without FDA Approval

March 4, 2015 2:33 PM

5 0

Endoscope Manufacturer Sold Modified Device Without FDA Approval

A manufacturer of medical devices whose endoscopes were linked to an outbreak of a drug-resistant superbug at a hospital in Los Angeles last month never got the Food and Drug Administration’s approval before selling the instruments with modifications, an investigation by CNN has revealed. The federal agency requires manufacturers to seek permission to put new models on the market if the updated versions include “labeling changes, technology or performance specifications changes, and materials changes.”

The manufacturer, Olympus, began selling its updated endoscopes, which have small cameras on the ends and are used to examine the digestive systems of hospital patients, in 2010. The FDA was not aware of the change until late 2013 or early 2014, according to the CNN report.

Read more

To category page

Loading...