FDA Knew About Endoscope “Superbug” Risk in 2009

February 20, 2015 — Reuters reports that contaminated endoscopes have been linked to at least five major outbreaks of infection since 2009, but no new safety requirements have been imposed on manufacturers by the FDA.

The outbreaks raise concern that the FDA and device-makers are not providing adequate recommendations regarding sterilization of the devices, such as requiring ethylene-oxide gas sterilization or banning designs that are impossible to clean.

An outbreak of infection at UCLA hospital has exposed 179 people, infected 7, and caused two deaths. The outbreak has been traced to a duodenoscope, which is a type of endoscope that is inserted down a patient’s throat. The FDA has warned that the complex design of the scope makes it nearly impossible to sterilize.

An increasing number of infection outbreaks in the last few years are raising concern that the FDA and device-makers are not providing hospitals with adequate information about how to sterilize the devices.

Contaminated medical scopes have been linked to at least five major outbreaks since 2009, according to Reuters:

• January 2015 — Virginia Mason Medical Center in Seattle said bacteria spread through contaminated medical scopes has infected 32 people over two years, including 11 who died.
• March-July 2013 — Advocate Lutheran General Hospital in Chicago said 44 patients were infected with antibiotic-resistant CRE infections, including 38 who underwent endoscopic procedures involving the pancreas or bile ducts. In total, 243 people were exposed during ERCP, but most were only “colonized,” not infected.
• 2012 — Moffitt Cancer Center in Tampa, Florida had an outbreak of antibiotic-resistant infection. Four patients died after undergoing duodenoscope procedures.
• 2012 — University of Pittsburgh Medical Center had a duodenoscope-related outbreak. The hospital “determined that the normal process [of disinfecting] failed to eliminate all bacteria.”
• December 2008 – August 2009 — Outbreak in France infects 16 people, including 8 who developed bloodstream infections, after ERCP procedures. Afterward, the FDA issued its first Safety Communication about disease transmission from endoscopes.