Olympus Releases Urgent Instructions for Cleaning Device Linked to Superbug

Olympus, the largest manufacturer of a medical device at the forefront of recent U.S. superbug outbreaks, unveiled new cleaning instructions for its equipment Thursday and urged healthcare providers to implement the instructions immediately.

In its 13-page letter, the devicemaker said that a small-bristle brush able to clean potentially deadly pathogens from the devices in question — known as duodenoscopes — would be sent out by May 8.

Since duodenoscopes are reusable, they must be cleaned extensively after each use to mitigate bacteria transference from patient to patient.
Olympus did not discuss whether the devices would be safe to use until the brushes arrive in hospitals. In the interim, the company recommends cleaning the duodenoscopes using the previous guidelines.

The FDA — who signed off on the devicemaker’s instructions and included them in its own  safety communications Thursday — does not suggest that patients wait until new brushes arrive to undergo duodenoscope procedures, but earlier instructed doctors to discuss the risks and benefits with their patients.

From October through January, seven Ronald Regan UCLA Medical Center patients, two of whom died, were exposed to antibiotic-resistant bacteria believed to have been spread by improperly disinfected Olympus duodenoscopes, federal regulators said. The microbes were able to spread even when the devicemaker’s instructions were followed, they added.

The regulators cited that the instrument included a movable part known as an elevator that is exceptionally difficult to access.
The Olympus letter recommends raising and lowering the elevator mechanism three times while the device is in a disinfectant. Furthermore, the area surrounding the elevator should be cleaned with two different-sized brushes — one that hospitals already have access to and the one that Olympus is sending by May 8.

Duodenoscopes — specialized endoscopes designed for visual examination of the duodenum or portion of the small intestine closest to the stomach —  are used in endoscopic retrograde cholangiopancreatography procedures, which usually are conducted to drain fluids emanating from the pancreatic and biliary ducts blocked by cancer-causing tumors, gallstones and other obstructions.

More than 500,000 ERCPs using duodenoscopes are carried out in the U.S. every year. — Jason Scott