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How Olympus' Scope Problems Got So Unbelievably Bad

The timeline of events appears to show U.S. regulators stuck between a rock and a hard place as unclean scopes resulted in deadly superbug outbreaks that led to a major recall, not to mention an unprecedented U.S. Department of Justice lawsuit settlement.

Chris Newmarker and Brian Buntz

CDC CRE
Investigators links Olympus duodenoscopes to infections involving carbapenem-resistant Enterobacteriaceae (CRE). Some CRE bacteria have become resistant to most available antibiotics, and are able to kill up to half the patients they infect, according to the U.S. CDC. (Image courtesy of the Centers for Disease Control and Prevention)

Olympus Corp. of the Americas, the largest distributor of endoscopes in the United States, is now stuck with a $646 million settlement of criminal and civil complaints over kickbacks to doctors--the largest ever for a medical device company.

It has engaged in a recall of a type of scope called a duodenoscope that is involved in 500,000 procedures a year in the U.S., and has been linked to deadly superbug outbreaks across the country.

The storyline for the scope debacle has had many twists and turns. Recently, it came to light that Olympus had warned European regulators about the potential of its duodenoscopes to spread infection but didn't do so in the United States. And shortly after theLA Times broke the story of the outbreak last year, FDA learned that the latest version of Olympus' TJF-Q180V duodenoscope hadn't received regulatory clearance. FDA later announced that it wouldn't be recalling the device because doing so could cause a shortage. In January, Olympus apparently convinced FDA to clear the device in a modified form meant to allow easier cleaning. Then in January, Olympus announced that it was recalling all of its TJF-Q180V devices .

Answers appeared hard to come by at  FDA in the year leading up to the January recall of TJF-Q180V duodenoscopes--with roughly 4400 devices getting their forceps elevator mechanisms replaced with an easier-to-clean forceps elevator design.

The agency summed up the problem in an October 2015 communication ordering postmarket surveillance studies of the duodenoscopes: "As there are no alternative devices for [endoscopic retrograde cholangiopancreatography procedures], the FDA believes at this time that the continued availability of duodenoscopes is in the best interest of the public health." Such ECRP procedures, FDA said, "are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions."

Potentially deadly superbug outbreaks caused by duodenoscopes were not isolated incidents, however. In fact, there were at least 25 outbreaks sickening at least 250 patients in the United States and Europe between 2012 and 2015, according to a report released in January by the office of U.S. Sen. Patty Murray, D-WA, the top Democrat on the Senate Health, Education, Labor, and Pensions Committee.

The duodenoscopes' movable "elevator" mechanism at the tip, while improving efficiency and effectiveness, was challenging to disinfect, according to FDA. Superbug outbreaks cropped up after the introduction of closed-channel duodenoscopes, including with the TJF-Q180V. The closed-channel scopes were supposed to seal off the device's elevator wire channel from contaminants, but proved especially tough to clean and disinfect.

Here is a timeline of major events in the case:

March 18, 2014

FDA notified Olympus that it needed to submit a 510(k), for its "closed" elevator channel TJF-Q180V model, which had never been cleared for marketing. In a letter sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a "closed" elevator channel rather than an "open" elevator channel, were significant and impacted the safe use of the device.

The U.S. Senate report says: "Throughout 2014, FDA investigated the infections but did not issue any safety communications to inform hospitals of the risk posed by even duodenoscopes that are reprocessed according to manufacturers' instructions and reprocessed with cleared AERs."

It took FDA nearly 18 months from the time the agency learned of duodenoscope-linked infections for it to issue a safety communication, according to the report.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

February 2015

Scrutiny grows after news that at least seven patients were infected and two died from duodenoscope-related infections at UCLA's Ronald Reagan Medical Center.

March 2015

Lawsuits mount against Olympus over the TJF-Q180V.

March 26, 2015

The FDA issued a safety communication with validated instructions for cleaning and disinfecting the TJF-Q180V while the 510(k) submitted by Olympus was still under review. The validated instructions issued at that time remain the same.

May 2015

An advisory panel to the Food and Drug Administration recommended drastically improving cleaning techniques for duodenoscopes.

May 2015

The Virginia Mason Medical Center in Seattle, also the site of a deadly superbug outbreak, joins a widow's lawsuit against Olympus Corp. The hospital claims that Olympus misled its administrators, too, about infection dangers related to duodenoscopes.

August 4, 2015

FDA further elaborated about what hospitals and other healthcare facilities might do to prevent deadly superbug outbreaks related to duodenoscopes. FDA recommended one of four cleaning methods on top of following the device manufacturer's cleaning instructions.  None of the four options that FDA outlined were great, though, when it comes to decontaminating the complex devices.

August 17, 2015

FDA makes public letters to Olympus, as well as competing duodenoscope makers Pentax and Fujifilm, that FDA found inadequacies during March and April inspections at their Japanese and U.S. factories.

October 5, 2015

On October 5, 2015,  FDA ordered the three companies that manufacturer duodenoscopes marketed in the U.S. (Olympus, Fujifilm, Pentax) to conduct 522 postmarket surveillance studies to better understand how duodenoscopes are reprocessed in real-world settings.

December 2015

An Olympus employee in the Netherlands found contamination in a TJF-Q180V duodenoscope as early as 2012, but the Japanese multinational for years did not raise alarms in the U.S., according to an LA Times investigation.

Olympus was mum about the TJF-Q180V problems in the United States, even as it issued "important safety advice" in Europe in 2013, and another European safety alert about tainted scopes in 2014, according to the report.

January 13, 2016

A scathing report is released by the office of U.S. Sen. Patty Murray, D-WA, the top Democrat on the Senate Health, Education, Labor, and Pensions Committee. During much of the superbug outbreak, Olympus and FDA failed to alert the U.S. public, according to the report, which found faults in both FDA's 510(k) process and postmarket surveillance system. The Senate report backed up claims that the LA Times investigation made in December: Olympus for years failed to disclose the extent of problems to FDA and the U.S. public.

Suggested reforms in the Senate report included legislation to require and promote unique device identifiers (UDIs) in insurance claims, electronic health records, and device registries for faster FDA identification of problems.

January 15, 2016

Two days after the release of the U.S. Senate report, FDA and Olympus announced that Olympus would voluntarily recall about 4400 TJF-Q180V scopes currently used in healthcare facilities throughout the country by August 2016, replacing their forceps elevator mechanisms. The newer TJF-Q180V, just 510(k) cleared, created a tighter seal and reduced the potential for leakage of patient fluids and tissue into the closed elevator channel.

March 1, 2016

Olympus Corp. of the Americas will have to pay a total $646 million to settle criminal and civil complaints that it paid kickbacks and bribes to health providers in both the United States and Latin America, the U.S. Justice Department announces. Even worse, federal prosecutors alleged that Olympus lacked training and compliance programs at the same time it was paying the bribes. Unlike other medtech companies, Olympus did not have a compliance officer until 2009, and did not hire an experienced compliance professional until August 2010.

Olympus in a statement shared by a spokesman acknowledged the company's responsibility for past conduct, saying that it "does not represent the values of Olympus or its employees." The company said that it is committed to complying with all laws and regulations and its own code of conduct, as well as achieving its mission to "help people around the world lead safer, healthier and more fulfilling lives."

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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