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Deadly infections from medical scopes go unreported, raising health risks

Peter Eisler
USA TODAY
Willie “Bill” Warner, 55, died in 2013 with a superbug infection he contracted after being treated with a duodenoscope at a North Carolina hospital.

Corrections and clarifications: This story originally was published Aug. 5, 2015; it initially misspelled the name of Kevin Kavanagh

Reports of superbug outbreaks linked to a specialized type of medical scope continue to climb, but government efforts to assess the public health risk are stymied: No one knows how often the infections occur — or where.

Duodenoscopes, which are run down the throat to treat intestinal problems, have been tied to scores of infections and more than a dozen deaths at hospitals in Los Angeles, Chicago, Seattle and other cities. Indiana's health department recently notified federal officials of two more scope-related infections that have not been disclosed previously.

But for every duodenoscope-related illness that's reported, countless others are not, an ongoing USA TODAY investigation finds.

Many suspicious illnesses in duodenoscope patients never come to the attention of federal authorities, including cases identified by the newspaper in Massachusetts, Pennsylvania, North Carolina and other states. So federal health officials know the cause of the problem — bacteria can lodge in the scopes' recesses and move from patient to patient — but they can't discern its prevalence or the magnitude of the threat it may pose.

Some duodenoscope-associated infections aren't catalogued because hospitals and health departments can't make a definitive link to the devices. Countless others never get detected, mistaken for other, more routine infections. And even when infections are confirmed as scope-related, they sometimes go unreported because hospitals and health departments aren't necessarily required to alert federal authorities.

Alex Kallen is an infectious-disease physician and medical officer in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention.

"The number of transmissions is basically unknowable," says Alex Kallen, an infectious-disease physician who coordinates epidemiological investigations at the Centers for Disease Control and Prevention. "There is clearly a detection problem in identifying [duodenoscope-related] infection clusters."

When the infections do come to light, Kallen adds, the CDC "does not have a mandatory system for reporting these outbreaks." Instead, the agency relies on hospitals and local health departments to report outbreaks on their own initiative.

Duodenoscopes are used about 650,000 times a year in the USA, often to treat blockages in the bile and pancreatic ducts, such as gallstones and tumors. The Food and Drug Administration warned of the scopes' contamination risks in February, soon after USA TODAY first reported on the problem. But the agency said infection rates appear low and advised that duodenoscopes remain far safer and less invasive than other surgical options for many critical procedures.

"They're saying the [scopes'] benefit is high, and that's true, but they don't really know the risks, because they don't have solid data on complications," says Kevin Kavanagh, an ear, nose and throat doctor who heads Health Watch USA, a patient safety group. "Without knowing the true risks, it's not really an informed decision. It's a judgment call."

THE CASES NOT COUNTED

The mystery unfolded over several months: Ten patients at UMass Memorial Medical Center all were infected with the same drug-resistant bacteria after treatment with duodenoscopes.

Working with the Massachusetts Department of Public Health, investigators at the Worcester hospital took cultures from the devices, hunting for evidence of the bacteria. But they came up empty; the scopes had been cleaned and reused repeatedly by the time doctors recognized their potential role in the outbreak, which ended in 2013.

Investigators found the cases were "associated with" the scopes, the health department said in a statement, but "no link … was clearly established."

The CDC's list of scope-related outbreaks makes no mention of the cases at UMass Memorial — no report was filed with the agency and none was required. In fact, the CDC, which is chiefly responsible for identifying and addressing public health threats, has been notified of scope-related outbreaks in just nine hospitals.

But the problem is far more widespread.

The FDA, which requires medical device companies to report safety incidents involving their products, has received more than 100 notifications of duodenoscope-associated infections from manufacturers since 2013 — and each report can involve multiple patients.

The Centers for Disease Control and Prevention is based in Atlanta.

Yet even that FDA tally is incomplete: USA TODAY revealed in April that some scope-related infections haven't been disclosed in the manufacturer reports, and the agency acknowledges that compliance is spotty. What's more, the FDA reports are stripped of identifying information, so even when a device problem is disclosed, the public has no way to know where it occurred or how many people were affected.

"Because of the underreporting, we just don't know the extent of this [duodenoscope] problem," says Lisa Fonkalsrud, president of the Society of Gastroenterology Nurses and Associates. Given the uncertainties in identifying and confirming infections, she adds, "there is no real way to kind of wrap your arms around it."

USA TODAY's investigation first revealed in January that duodenoscopes had been tied to several superbug outbreaks, igniting a nationwide controversy that led to an ongoing federal investigation of the devices' three manufacturers: Olympus, Pentax and FujiFilm.

In its February safety advisory, the FDA warned that all three companies' scopes can trap bacteria in an "elevator" mechanism that controls tiny surgical tools at the devices' tip. Even if scopes are cleaned and disinfected properly between uses, it said, the bacteria can survive.

Just this week, the FDA suggested additional measures hospitals can adopt to check scopes for residual bacteria and kill surviving microbes. But even with those steps, which are voluntary and costly, "the risk of infection transmission cannot be completely eliminated," the agency said.

The challenge is identifying the casualties.

THE ELUSIVE LINK

Elsie Florian's infection surfaced quickly after doctors at Pittsburgh's Allegheny General Hospital used a duodenoscope to treat her for a blocked bile duct. Tests revealed CRE, a drug-defying bacteria with mortality rates of 40% or more.

"I went on the computer and saw all the stories about people getting these infections from [duodenoscopes]," says Jena Bence, Florian's granddaughter. "We kept waiting for [Allegheny] to be mentioned, but it never was."

Florian died in April. A "hospital-acquired" infection was listed as the possible cause, but Allegheny said in a statement that it "did not find any definitive evidence of a scope association … through bacterial cultures performed on [the] devices."

The cultures are a notoriously elusive way to link a scope to an infection: It can be weeks before the illness emerges and a culture is taken, and scopes typically have been cleaned and reused repeatedly in the interim.

Still, that matching-culture standard was applied when CRE infected duodenoscope patients at Carolinas Medical Center in Charlotte.

In May, Carla Warner told an FDA advisory panel that her husband, Bill, fought CRE for eight months after a duodenoscope procedure at the hospital in 2013. She recounted his 60-pound weight loss and the torture of watching his excruciating pain.

"Would you be willing to allow a [duodenoscope] to be used on yourself or a family member?" she asked.

Bill Warner wasn't the only duodenoscope patient at Carolinas Medical to contract CRE, but the hospital and the state Health Department concluded there was no connection. "We cultured the duodenoscopes," the hospital said in a statement, "and did not isolate CRE."

Yet there's no rule that says a matching bacterial culture is needed to link a duodenoscope to a suspicious infection.

Last year, Thomas Jefferson University Hospital in Philadelphia notified the CDC of CRE infections in eight patients treated with duodenoscopes. The hospital cultured its scopes and found no bacteria matching the strain causing the infections. Ultimately, the CDC listed the episode as a duodenoscope-associated outbreak, though, according to the hospital, "no definitive link between the patients and scopes was found."

"A negative [duodenoscope] culture should not be relied on to rule out a scope as a source of an outbreak," says Kallen, the CDC official. "There doesn't necessarily have to be a positive duodenoscope culture; it is more of a preponderance of evidence. … If you have other epidemiological links, the scope might well be the source."

Even when there is hard epidemiological evidence linking a scope to patient infections, cases still go unreported to the CDC.

In late 2012, doctors at UPMC Presbyterian Hospital in Pittsburgh investigated a cluster of CRE infections among patients treated with duodenoscopes. Cultures of the scopes revealed the presence of CRE bacteria and, based on that and other epidemiological evidence, investigators concluded that the infections were tied to the devices.

The hospital made no secret of the outbreak — it alerted the state and local health departments, its physicians published their findings and described the investigation at professional conferences, and hospital officials spoke in local news reports about the scopes' association with the infections. But the CDC wasn't notified, so there's no mention of the case on the agency's list of duodenoscope-associated infections.

THE CASES NOT SEEN

Many experts say duodenoscopes have spread bacteria for decades, but any resulting illnesses typically would have involved routine bugs that could come from anywhere. When an infection cropped up, doctors simply treated it with antibiotics, the infection resolved, and no one gave much thought to its source.

That changed with the emergence in recent years of antibiotic-resistant superbugs.

The tip of a duodenoscope contains a small mechanism that can trap bacteria and pass infections from patient to patient as the device is reused, according to the Food and Drug Administration. The scope, which is run down a patient's throat to treat intestinal problems, often is used for a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).

"Some transfer of bacteria [from duodenoscopes] is not even going to cause disease … and if you get [an infection] that's relatively minor, that also isn't going to get much attention," says Stephen Kralovic, a physician who helps direct infectious disease response for the Department of Veterans Affairs medical system. "It's only when you see something like CRE, because of its virulence, that the problem becomes apparent."

When hospitals see CRE and other antibiotic-resistant "red flag" bacteria, they typically move aggressively to identify the source. When duodenoscopes began spreading infections from CRE and other drug-defying bacteria around 2012, the devices' contamination issues started to get noticed.

Still, public health officials believed initially that the problem was user error, concluding that hospitals were not following scope manufacturers' instructions for cleaning and disinfecting the devices. It wasn't until early last year that the CDC warned practitioners that the devices could remain contaminated even when instructions for "reprocessing" them were followed precisely.

Determining the true incidence rate for scope-related infections "is going to be an important area for research," says Colleen Schmitt, a physician and past president of the American Society for Gastrointestinal Endoscopy. "We want to get that information to our members as well, so we can be sure we understand the extent of the problem."

THE HUMAN TOLL

For patients and their families, the stakes are enormous.

Elsie Florian's family has filed a lawsuit against Olympus, which made the scope used for her procedure. It alleges that the company knew about the contamination problem with its duodenoscopes and failed to properly alert regulators and the medical community.

"They knew this could happen, that's what's most aggravating," says Deborah Smoody, Florian's daughter.

Olympus, which faces several lawsuits over the safety of its duodenoscopes, declined to comment on the Florian case; it argues in court filings that the factual allegations are non-specific and the case should be dismissed. Olympus, Pentax and FujiFilm all say they are working with the FDA to assess any changes that may be necessary in their scopes' designs or cleaning protocols.

Elsie Florian of Munhall, Pa., died in 2015 with a superbug infection after being treated with a duodenoscope for a blocked bile duct. Her daughter, Deborah Smoody, left, and Elsie's granddaughter, Jena Bence, want people to know about the risks associated with duodenoscopes.

Before her surgery, Florian, 76, volunteered regularly at a seniors' center and considered a move to the more social setting of a seniors' community. Once the infection attacked, she grew frail, bouncing between the hospital and a nursing home, relying on oxygen machines to breathe.

Florian insisted she'd recover: She was determined to attend her granddaughter's wedding a couple of months away in Colorado.

She died three weeks before the trip.

"No one else should have to go through what we did," Smoody says. "People should know how often this is happening."

Follow USA TODAY Investigative Reporter Peter Eisler on Twitter: @ByPeterEisler

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