Sen. Murray calls for FDA guidance after superbug outbreak

Sen. Patty Murray (D-Wash.) wants the Food and Drug Administration to release new guidance and best practices for reusable medical devices following the spread of a deadly superbug at a medical center in Seattle. 

Contaminated devices, known as duodenoscopes, led to an outbreak of a multidrug-resistant superbug at the Virginia Mason Medical Center in Seattle. Of the 32 patients infected with carbapenem-resistent Escherichia coli (CRE), 11 died, according to media reports. 

In addition to updated guidance on cleaning and disinfecting duodenoscopes for reuse, Murray said the FDA should work with manufacturers to better detail propoer reprocessing on the device labels. 

“Due to their complicated and intricate design, duodenoscopes are harder to clean and disinfect than many reusable medical devices,” Murray said in her letter to the FDA.

“Yet in Seatte, parallel assessments of duodenoscope reprocessing procedures by both the Washington State Department of Health and the Centers for Disease Control found that duodenoscopes used by Virginia mason routinely failed to pass testing for pathogenic bacteria, despite strict adherence by the hospital staff to the manufacturer’s labeling.”