Endoscope infections at Virginia Mason prompt broader safety fears

Physicians and regulators face a tough dilemma in the wake of the recent disclosure that dozens of patients at Virginia Mason Medical Center in Seattle were infected with a deadly bacteria spread by a type of endoscope essential for treating certain conditions but difficult to disinfect because of its design.

Experts say the device can't be taken off the market because it reduces the need for riskier open procedures, but also say it needs to be redesigned.

Thirty-two patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) from November 2012 to January 2014 at Virginia Mason were sickened by Carbapenem-resistant enterobacteriaceae (CRE), a drug-resistant superbug spread from patient to patient by duodenoscopes used in the procedures. Eleven of those patients died, but it's unclear whether the infections caused their deaths because they all had been diagnosed with other conditions.

In recent years, there have been three similar though less severe bacterial outbreaks associated with CRE-contaminated duodenoscopes reported at hospitals in Chicago and Pittsburgh. Experts say disinfection protocols were followed in all three cases, so it's likely that the duodenoscope's design makes it difficult to remove all traces of bacteria.

Experts say this is a national problem, particularly because the CRE bug is difficult to treat. “Clinicians don't have many tools to treat patients with CRE,” said Chris Lavanchy, engineering director for the ECRI Institute, a not-for-profit organization that studies medical products and services.

The infections raise broader questions about who is responsible for preventing and correcting duodenoscope infection problems. Officials at Virginia Mason say the design of the device and less-than-rigorous disinfection standards promulgated by the Food and Drug Administration and the device's manufacturers are at fault. Others say some hospitals are not following the basic cleaning guidelines.

There are also concerns that patients, their families and the general public were not notified about the duodenoscope-related infections at Virginia Mason when the outbreak occurred. Some say prompt notification could have prevented further infections. The infections were first made public last fall in a little-noticed abstract published at a conference of the Infectious Diseases Society of America.

“The really big issue here is that this wasn't publicly known when it was happening,” said Lisa McGiffert, director of the Safe Patient Project at Consumers Union. “Other hospitals are using these scopes.”

The FDA said agency officials first became aware in 2013 of the issue with duodenoscope-related CRE infections. It plans to issue final guidance this year on the use of duodenoscopes for ERCP procedures. The agency said in a written statement it is “actively engaged with the manufacturers of duodenoscopes used in the U.S., and with other government agencies such as the CDC, to develop solutions to minimize patient risk associated with these issues.”

Despite the concerns about patient risk, physicians say duodenoscopes are an important tool and shouldn't be pulled from the market. “This is an instrument that has frankly revolutionized the way we take care of a lot of problems,” said Dr. Andrew Ross, section chief for gastroenterology at Virginia Mason. “If we didn't have it, we would send lots of patients for open surgeries.”

About half a million ERCP procedures are performed in the U.S. each year. Physicians rely on duodenoscopes to examine and treat diseases of the bile or pancreatic duct. They are not the same type of endoscopes used in routine endoscopies and colonoscopies. Virginia Mason performs between 1,500 and 1,800 ERCPs a year, making it one of the largest volume centers in the U.S. for the procedure.

The number of infections associated with duodenoscopes is not increasing, but the severity of the bacterial infection that is resistant to antibiotics is fueling the debate about the device's design and how best to disinfect it, said Dr. Colleen Schmitt, president of the American Society for Gastrointestinal Endoscopy.

The devices are outfitted on their tips with an “elevator wire channel,” which allows the physician to move the scope into the bile duct or pancreatic duct. It's this part of the device that is difficult to disinfect and most likely the part that spreads infection. “This is an instrument that's really hard to clean,” Ross said. “It's hard to reprocess even if you follow the guidelines.”

In a September 2014 report examining the Virginia Mason infections, the Centers for Disease Control and Prevention said the “complex design of the duodenoscopes makes them challenging to consistently reprocess and (raises) additional questions about the frequency with which duodenoscopes should be examined by the manufacturer.”

None of the three manufacturers that market duodenoscopes in the U.S. said they plan to redesign the elevator wire channel of the duodenoscope at this time. A spokesman for Pentax Medical said the company continually reviews the design of all of its endoscopes. Olympus and Fujifilm Medical Systems said they are working with the FDA as the agency evaluates its concerns with the scopes.

Contaminated endoscopes, including duodenoscopes, have been linked to more healthcare-associated outbreaks than other any medical device, according to a commentary published in October in the Journal of the American Medical Association. But until recently, those outbreaks were determined to be the result of damaged devices and inadequate hospital cleaning practices.

The antibiotic-resistant infections at Virginia Mason and other hospitals may serve as a catalyst for manufacturers to redesign the scopes, ECRI's Lavanchy said.

The authors of the JAMA commentary also said that manufacturers should consider developing new devices that can be sterilized instead of disinfected, and that clinicians should report cases of infections, so that regulators and public health officials have a more accurate sense of the number of endoscope-related infections.

A new disinfection process also should be considered, Ross said. Virginia Mason has adopted a much more complex and time-consuming cleaning process for its duodenoscopes.

The hospital, which is noted for its quality-improvement program spearheaded by CEO Dr. Gary Kaplan, was contacted in 2013 by state officials who found the CRE organism showing up on voluntarily submitted samples from the hospital given as part of a routine CRE survey.

In the fall of 2013, Virginia Mason then linked the CRE infections to the duodenoscopes, which carried the bacteria despite going through the standard disinfection process recommended by the manufacturer and cleared by the FDA.

At Virginia Mason, duodenoscopes are now disinfected, cultured for bacteria and held for 48 hours before they are again cultured. The entire process takes about two and a half days. Standard disinfection practices take between 60 and 90 minutes.

Because of the time required for the new cleaning process, the hospital purchased an additional 20 scopes—it previously owned eight—to ensure that there are enough devices available for procedures. The scopes cost about $37,000 each.

It's unclear whether other hospitals are adopting similarly stringent cleaning processes. Experts say hospitals and physicians are just now becoming aware of the potential for deadly infections associated with duodenoscopes.

“I would describe this as emerging,” ECRI's Lavanchy said. “Over time it's going to spread and become gradually more of a concern.”

Follow Jaimy Lee on Twitter: @MHjlee