Reports of a new superbug outbreak abroad have called the safety of Olympus' redesigned duodenoscope into question.

Bacteria Colonize Body Tissue

Medical device experts are questioning the safety of Olympus' redesigned duodenoscope, after new reports surface of a superbug outbreak in a foreign hospital.

Superbug Outbreak Abroad Raises New Doubts

When a series of antibiotic-resistant bacteria outbreaks swept through hospitals across the world, Food & Drug Administration researchers soon linked the problem to the duodenoscope, a medical device used to visualize portions of the small intestine. In 2016, industry-leading manufacturer Olympus redesigned its own device, eliminating a specific component that allowed duodenoscopes to harbor bacteria, including "superbugs," microorganism strains that have become resistant to multiple antibiotics.

A new outbreak, however, has placed the manufacturer's modifications into doubt. In December, five patients in a foreign hospital contracted a strain of Klebsellia pneumoniae, a bacteria marked by genetic changes that make it invulnerable to the vast majority of antibiotics. Reports submitted to federal regulators in February of 2017 say that all five patients were treated with the same Olympus-made duodenoscope. The device had been recalled and modified in October, the LA Times reports.

Expert: Scope Redesign May Be No Improvement

While the foreign health facility's location and name have not been released, prominent medical safety experts are already questioning Olympus' efforts to solve a crisis that has now been linked to at least 25 bacterial outbreaks world-wide. "Does this new 'fix' work?" asks Lawrence Muscarella, senior technical advisor at LFM Healthcare Solutions, who discovered the new outbreak reports while searching through FDA data on medical device complications.

In a blog post breaking the story, the medical device expert noted that Olympus had filed the reports in February of 2017, nearly three months after the infections had occurred. It is not yet clear whether the company failed to report the incident in a timely manner. Muscarella says the new report appears to be "the first on record to associate a life-threatening superbug cluster" with Olympus' newly-designed duodenoscope.

Duodenoscopes are re-usable. After one procedure, physicians are able to sterilize the device and move on to a new patient. It has became clear, however, that the device's design makes thorough sterilization nearly impossible. Even when the manufacturer's cleaning instructions were followed to the letter, duodenoscopes would transmit virulent pathogens between patients.

Olympus Waited 3 Years To Warn Officials, Public

The FDA approved Olympus' new device in January of 2016, also signing off on a revamped cleaning protocol. It's unclear whether the duodenoscope linked to this most recent outbreak was sterilized according to the manufacturer's instructions. There is little doubt, though, that Olympus could have acted sooner. In fact, internal corporate documents made public during the course of litigation have forced the company itself to admit that mistakes may have been made.

Olympus Duodenoscope Statement

Like any major corporation, Olympus has chosen its words carefully, but the company's publics comments have been remarkably candid, all things considered:

"We recognize that, with the benefit of hindsight, it is possible to consider whether Olympus and others in the medical community should have made different choices[,] especially with today's knowledge about the emerging threat of multi-drug resistant organisms, such as Carbapenem-resistant Enterobacteriaceae (CRE)."

Extensive reporting by the LA Times has shown that Olympus became aware of problems with the duodenoscope's design as early as 2012, after an outbreak of antibiotic-resistant bacteria in the Netherlands. The company wouldn't notify hospitals or regulators in the United States until three years later, when a similar outbreak at the University of California, Los Angeles left three patients dead.

Senate, DOJ Investigate Company's Actions

Soon, Senator Patty Murray, a Democrat from Washington State, was leading a congressional probe into the issue, concluding that Olympus-made duodenoscopes could "trap and transmit bacteria" even after being sterilized. The US Department of Justice is conducting a parallel investigation, issuing subpoenas to Olympus, along with two other duodenoscope manufactuers, Fujifilm Holdings and Pentax Medical.

As the world's leading supplier of the device, Olympus has received the most attention, along with the lion's share of product liability lawsuits filed by injured patients and their families. Antibiotic-resistant bacteria are associated with extraordinarily high death rates. The strain implicated in most duodenoscope outbreaks, Carbapenem-resistant Enterobacteriaceae (CRE), kills around 50% of infected patients, the Centers for Disease Control says.

The Legal Herald

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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