Deadly Bacteria Spread Through Contaminated Endoscopes Pose Major Health Risk

The spread of deadly bacteria through contaminated endoscopes has become a major health concern, sparking lawsuits from patients and prompting medical device regulators to act. A recent study published in the journal Infection Control and Hospital Epidemiology found that even with enhanced cleaning procedures, 3 percent of endoscopes tested positive for contamination at Virginia Mason Medical Center, where a fatal outbreak occurred. This finding has significant implications, as the hospital performs around 1,800 procedures per year using the scopes, resulting in approximately one contaminated scope per week.

Key Takeaways:

• Despite enhanced cleaning procedures, 3 percent of endoscopes at Virginia Mason Medical Center remain contaminated after use.
• This translates to approximately one contaminated scope per week, assuming the same rate applies to other hospitals.
• The FDA has not instructed hospitals to hold all ERCP scopes for testing before use in the next procedure, despite the example set by Virginia Mason Medical Center.
• Olympus, the manufacturer of one of the affected endoscope models, has issued new cleaning instructions, but the company has not shipped hospitals a new brush to reach intricate parts of the scope.
• The FDA can't quantify the risk of infection from contaminated medical devices, but estimates approximately 1 million procedures took place in 2013 and 2014.
• The Centers for Disease Control and Prevention has published protocols for hospitals that want to culture scopes in between operations, but does not make blanket recommendations.
• Testing scopes for pathogens regularly is already routine in some countries, including Australia.

Statistics:

• 3% of endoscopes at Virginia Mason Medical Center tested positive for contamination after enhanced cleaning procedures.
• Approximately 1,800 procedures per year are performed using ERCP endoscopes at Virginia Mason Medical Center.
• One contaminated scope per week is estimated to result from the 3% contamination rate at Virginia Mason Medical Center.

Sources:

• "Deadly Bacteria Spread Through Contaminated Endoscopes Pose Major Health Risk" by Bloomberg News, citing the journal Infection Control and Hospital Epidemiology.
• FDA guidelines for cleaning reusable medical equipment, released on March 12, 2015.
• CDC protocols for hospitals that want to culture scopes in between operations.
• Olympus new cleaning instructions for ERCP endoscopes.
• FDA alert issued in February 2015 regarding the potential for scopes to be impossible to clean fully.
• WASHINGTON POST-BLOOMBERG--04-05-15 0942ET.