More patients may have been infected with the CRE superbug via contaminated medical scopes made by Olympus Corp. than previously thought, health officials have warned.
What’s the Problem?
The Olympus duodenoscope is at the center of recent superbug outbreaks at the Ronald Reagan UCLA Medical Center and Virginia Mason Medical Center in Seattle.
“We suspect endoscope-associated transmission of bacteria is more common than recognized and not adequately prevented by current reprocessing guidelines,” said Kristen Wendorf, a doctor at King County’s public health department in Seattle.
Health officials called it “especially disturbing” that Virginia Mason had followed Olympus’ instructions for cleaning the duodenoscopes, but still had a CRE outbreak that infected 32 patients.
In all 3 recent outbreaks, patients undergoing routine endoscopic retrograde cholangiopancreatography (ERCP) procedures with an Olympus duodenoscope were infected with CRE bacteria, which are resistant to most antibiotics.
The outbreak at Virginia Mason was only detected after the King County health department asked local hospitals to send it samples of CRE found in any of their patients. The county’s lab subsequently determined that 3 Virginia Mason patients had tested positive for a specific type of CRE with the same genetic markers, leading to an investigation into the source of the infections.
Wendorf said it was likely the outbreak would have gone unnoticed if the health department hadn’t gathered samples of the bacteria and investigated the links. Few states have conducted such research to detect potential outbreaks, she said.
After it was determined that Virginia Mason patients continued to be infected despite it following manufacturer-recommended cleaning protocol, the facility sent its 8 duodenoscopes to Olympus for review. The company found that 7 of the 8 scopes had hidden mechanical defects that could have helped passed the bacteria from patient to patient. Olympus performed maintenance on thew scopes, but still they couldn’t be properly cleaned after being used on patients.
Of the 32 patients infected at Virginia Mason, 11 died. All had been diagnosed with pancreatic cancer, colon cancer or other serious illnesses.
The hospital now manually cleans the duodenoscopes, going beyond Olympus’ recommended protocol by quarantining the devices for 48 hours. This allows staff to get the results of culture tests which can detect any remaining bacteria. Even despite these measures, 3% of the facility’s scopes are coming back dirty, requiring the process to be repeated again.
Olympus Warned Europe About Endoscope Problems 2 Years Before U.S. Superbug Outbreak
Olympus Corp. may have known about problems with cleaning its duodenoscopes nearly 2 years before superbug outbreaks hit UCLA and Cedars-Sinai, according to the Los Angeles Times. The finding raises questions as to why hospitals in the U.S. weren’t notified earlier.
“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions,” Rep. Ted Lieu (D-Los Angeles) told the Times.