California ‘Superbug’ Outbreak Prompts FDA Alert on Device

The complex design of endoscopes that have been linked to a “superbug” outbreak at the UCLA Health System in California may hinder proper cleaning, the U.S. Food and Drug Administration has warned.

The hospital system said seven patients were infected with a potentially deadly, drug-resistant strain of bacteria and that more than 100 may have been exposed to it between October and January. The bug may have contributed to the death of two patients, UCLA said.

The FDA said it wanted to raise awareness among healthcare professionals that the complex design of the devices — flexible tubes that are threaded through the mouth, throat and stomach to drain fluids from blocked pancreatic and biliary ducts — is associated with a risk of multidrug-resistant infections even when a manufacturer’s cleaning instructions are followed correctly.

Makers of the devices, known as duodenoscopes, include Olympus Corp., Fujifilm Holdings Corp. and Pentax Medical. An FDA spokeswoman said the agency has been working with federal partners, manufacturers and other stakeholders to better understand what can be done to mitigate them.