FDA warns three duodenoscope manufacturers about spread of superbugs

Editor's Note

The Food and Drug Administration (FDA) sent warning letters August 12 to three manufacturers of duodenoscopes involved in transmitting deadly bacteria earlier this year, the Boston Globe reports.

The FDA says the companies (Olympus, Pentax, and Fujifilm) failed to:

• report problems with the scopes as required by law (Olympus and Pentax)
• ensure the devices could be adequately cleaned (Pentax and Fujifilm).

The FDA is giving the companies 15 business days to respond with plans to correct the violations. 

The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency's strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.