FDA cites endoscope manufacturers for role in superbug outbreak
The Food and Drug Administration (FDA) this week issued warning letters to three makers of duodenoscopes linked to two drug-resistant superbug outbreaks, according to a Modern Healthcare article. Olympus, Fujifilm, and Hoya Corp. were cited for failures in the production of the endoscopes and in how they handled adverse event reports.
Olympus was cited for failing to file timely incident reports involving 16 patients who contracted Pseudomonas after surgery. The company didn’t report the infections until three years after finding out in 2012 that the cases were linked to contaminated scopes. The FDA requires device makers to report adverse events involving their devices within 30 days after becoming aware of potential safety issues.
Fujifilm was cited for failing to ensure that design requirements were met, and the FDA cited Fujifilm and Hoya for failure to adequately test scope cleaning procedures.
Read the Modern Healthcare article.