Risk of Superbug Infections Caused by Scopes Greater Than Previously Thought; Cases Often Go Unreported

While the media have been reporting many stories of dangerous superbug infections linked to medical scopes all across the country, the problem is more widespread than previously thought because many of the infections are not reported, according to a recent investigation by USA Today.

Duodenoscopes, which are used to treat intestinal problems by running them down the throat, have been identified as the cause of several deadly infections at hospitals in cities such as Seattle, Chicago, Los Angeles, and Indianapolis.

Bacteria can lodge in the recesses of the duodenoscopes, transmitting the deadly bacteria from patient to patient. But tying patient illnesses to the scopes can be tricky, and many times the infections are mistaken for more routine illnesses, the article stated.

While many of these infections have been reported to federal authorities, the Centers for Disease Control and Prevention (CDC) does not have a mandatory system for medical facilities to report infection outbreaks from duodenoscopes, according to the article.

Real-Life Impact

Many typical American families have been affected by infections from duodenoscopes. USA Today told the story of the deaths of Bill Warner and Elsie Florian, who both contracted CRE, a drug-resistant bacteria with a mortality rate of 40 percent or more, after procedures with scopes at different hospitals.

Warner fought CRE for eight months after a procedure at Carolinas Medical Center in Charlotte, North Carolina, the article stated, where other patients had also been infected with CRE. His widow, Carla Warner, told an FDA advisory panel that her husband lost 60 pounds and was in excruciating pain from the infection in 2013.

In the USA Today article, the hospital stated it had cultured the duodenoscopes and did not isolate CRE, and the state health department declared there was no connection between the scope and the infection.

“Would you be willing to allow a [duodenoscope] to be used on yourself or a family member?” Carla Warner asked in the newspaper.

Like Warner, the hospital where Florian got sick, Pittsburgh’s Allegheny General Hospital, did not find “definitive evidence” linking the scope used in her procedure to her CRE infection.

Florian became sick very shortly after treatment with a duodenoscope for a blocked bile duct. An active woman before getting sick at the age of 76, she became frail and needed oxygen machines to breathe after the procedure, according to USA Today. She insisted she would recover and attend her granddaughter’s wedding in a couple months.

Unfortunately, Florian died three weeks before she was to make the trip. Her possible cause of death was a “hospital-acquired” infection. Her family is one of several who have filed lawsuits against Olympus, the company that made the duodenoscope.

“No one else should have to go through what we did,” Deborah Smoody, Florian’s daughter, said in USA Today. “People should know how often this is happening.”

Difficult to Track Infections

“The number of transmissions is basically unknowable,” Alex Kallen, an infectious-disease physician who coordinates epidemiological investigations at the CDC, said in the USA Today article. “There is clearly a detection problem in identifying [duodenoscope-related] infection clusters.”

The USA Today investigation reported that duodenoscopes are used about 650,000 times per year in the United States to treat problems such as gallstones and other blockages in the bile and pancreatic ducts. The Food and Drug Administration (FDA) warned about infection risks from the scopes in February, but also said the rate of infections appeared low, and said using duodenoscopes is safer and less invasive than surgical alternatives.

Duodenoscopes are not the only scopes being linked to infectious bacteria. A Los Angeles Times article reported that patients have been exposed to bacteria, as well as human tissue and dried blood, left inside scopes used to examine the lungs, colon, bladder, and stomach.

A federal database tracks injury reports related to these other scopes, including a scope used to see inside the bladder that was linked to bacteria that sickened three patients with bacteria. That device was sent to the manufacturer, which found “foreign substances” despite cleaning, according to the article. But even though that incident was reported to the federal government, the reporting is mostly voluntary, making the actual size of the problem difficult to determine.

Both articles report a two-fold problem: the difficulty of knowing how many infections have been caused by these devices, coupled with the difficulty of getting the devices completely clean.

USA Today stated that the FDA has received more than 100 notifications from scope manufacturers of infections linked to duodenoscopes since 2013, and each report can involve multiple patients. But the FDA acknowledges that compliance from manufacturers to report the infections is problematic.

The federal government is investigating the three manufacturers of duodenoscopes, Olympus, Pentax, and Fujifilm.

In addition, “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,” the article stated.

Is the Scope Really Clean?

Even when medical facilities follow all the procedures to clean duodenoscopes and other medical scopes, it is difficult to remove all of the bacteria.

USA Today reported that for duodenoscopes, bacteria can get trapped in the “elevator” mechanism that controls tiny surgical tools at the device’s tip, according to the FDA. Even if duodenoscopes are cleaned and disinfected properly between uses, the bacteria can survive, the FDA said.

The FDA recently suggested additional steps to check for and kill surviving bacteria in the duodenoscopes, but according to the USA Today article, the FDA also acknowledges that the costly, voluntary steps can’t completely eliminate the risk of infection transmission.

The Los Angeles Times reported that researchers have found bacteria on scopes even when they are cleaned and disinfected according to manufacturers’ and other guidelines. Michelle Alfa, a professor at the University of Manitoba, tested devices for traces of blood and protein after they had been cleaned at a Canadian hospital. She discovered that 9 percent of gastroscopes, 7 percent of colonoscopes, and 4 percent of bronchoscopes still had traces of potentially infectious material.

In the wake of the infectious outbreaks from duodenoscopes, the FDA has approved new rules that require manufacturers of new duodenoscopes to prove they can be disinfected, the Los Angeles Times reports. But the rule does not apply to devices already on the market, meaning hospitals can continue to use the scopes indefinitely.

Why Are Infections Happening Now?

Duodenoscopes and other scopes have probably always spread bacteria, but the advent of drug-resistant superbugs thrust the infections into the spotlight. When someone got sick after a procedure in the past, the illness was often minor and could be treated with simple antibiotics. Because of that, most patients and physicians did not worry about the source of the infection, according to the USA Today article.

But now, bacteria can lead to much more dangerous, difficult to treat, and often deadly, infections.

The CDC has recommended that healthcare leaders coordinate efforts to prevent the spread of the deadly superbugs, according to a Fierce Healthcare blog item. Specifically, they need to do a better job of warning about possible infections when patients transfer to another facility.

The attorneys of Morrow Kidman Tinker Macey-Cushman, PLLC, are committed to patient safety and represent patients who have been harmed by preventable medical errors, including hospital-acquired infections, in Seattle and across Washington. Schedule a free consultation by calling us or contacting us online.

Sources:

• USA Today – Deadly infections from medical scopes go unreported, raising health risks
• Los Angeles Times – Serious infections tied to medical scopes go far beyond issues with a single device
• Fierce Healthcare – CDC: Superbugs on the rise because facilities don’t work together