Germs on a scope, so bad they’ve earned the name SUPERBUG, are resulting in dangerous and deadly outcomes. At UCLA Medical Center, 179 patients were exposed to residual body fluids remaining on reusable devices used in an endoscopic procedure, even after they were decontaminated. Of those, seven were actually infected and of the seven, two have died.

Litigation

The families of at least five patients have filed product liability lawsuits against the maker of the scope, Olympus Medical Systems Group.

This isn’t the first round of litigation for reusable endoscopes. A class action suit was brought in 2012 against a medical center asserting that it failed to properly clean, sterilize and disinfect endoscopes, resulting in increased risk of becoming infected.

The official name of the SUPERBUG is carbapenem-resistant Enterobacteriaceae, usually called CRE. More cases of CRE infection are being reported nationwide, so more lawsuits are likely to be filed.

The Problem

The scopes used go by the name of Endoscopic Retrograde Cholangiopancreatography, or ERCP duodenoscopes. They are used during endoscopic procedures that diagnose and treat problems in the liver, pancreas and bile ducts.

UCLA said they thoroughly cleaned the reusable devices, exceeding both Olympus’ standards and guidelines followed nationally. Despite these efforts body fluids and organic debris from earlier use stayed in crevices, leading to infection in the patients when it was used again.

UCLA said there are two possible solutions:

  • The recommended cleaning standards can be revised, so the device is completely free of contaminants.
  • Or the device must be redesigned so it is possible to thoroughly eliminate lingering CREstrong<.

Nationwide Concerns

The Centers for Disease Control and Prevention (CDC) has reported infections are up all over the country. In fact, at least one medical facility in each of 42 states has been affected. The CDC has warned about CRE for more than 10 years, but infections keep increasing.

It is seven times more common now than it was a decade ago. This is especially alarming for healthcare professionals because CRE is resistant to antibiotics, making treatment very difficult.

The Takeaway

Lawsuits will rise in response to the problem. To be safe, all manufacturers and users of medical devices, especially the scope used for ERCP, need to be sure they comply with all federal and state regulations. This includes the mandatory reporting of adverse events that involve a medical device.

In order to limit their liability, makers need to review their labels, warnings, and instructions to make it clear how to effectively eliminate the possibility of transmitting CRE. Medical facilities must educate all personnel about the need to follow instructions for decontamination and sterilization. They must also explain the risk to patients when using the devices.