Endoscope contagion raises questions about FDA oversight

The latest outbreak of a deadly drug-resistant bacterial infection spread through contaminated endoscopes has prompted calls for re-evaluating the adequacy of currently recommended cleaning and reprocessing procedures. It's also led some observers to question why the Food and Drug Administration didn't act sooner despite previous outbreaks involving the scopes.

Leaders at Ronald Reagan UCLA Medical Center, where as many as 179 people were exposed to drug-resistant bacteria while undergoing endoscopic procedures, say the manufacturer-recommended protocols they followed were inadequate.

Between Oct. 3 and Jan. 28, two patients at the Los Angeles hospital died and as many as seven others were infected with carbapenem-resistant enterobacteriaceae, or CRE, an infection resistant to most antibiotics. They were exposed while undergoing endoscopic retrograde cholangiopancreatography procedures, said Dr. Zachary Rubin, UCLA Medical Center's director of clinical epidemiology and infection prevention.

His hospital's outbreak and several other recent outbreaks involving duodenoscopes suggest the problem may lie with the recommendations from the manufacturers, Rubin said. The ERCP procedures are a minimally invasive way to treat blockages in the pancreas and bile duct.

UCLA officials said their investigation found that staff fully adhered to the manufacturer's recommendations on properly sterilizing the devices. “The fact that we've identified this infection in a couple of different hospitals now suggests that the routine process we were using was just not quite adequate even though at the time they were FDA-approved,” Rubin said.

In response to the UCLA outbreak, the FDA issued an advisory last week that the complex designs of duodenoscopes “might impede the ability to effectively clean, disinfect and sterilize reusable devices.” The agency acknowledged that even strict adherence to manufacturers' disinfection instructions will not fully eliminate the risk.

Rubin said after Jan. 28, the hospital began treating duodenoscopes with ethylene oxide gas to further sterilize the devices. Subsequently, there have been no additional CRE infection cases, he said.

Virginia Mason Medical Center in Seattle experienced a similar CRE outbreak from contaminated duodenoscopes, involving 32 patients between November 2012 and January 2014. Eleven of those patients died, though many had other serious illnesses.

Dr. Andrew Ross, Virginia Mason's head of gastroenterology, said his hospital now takes 2½ days to reprocess duodenoscopes. The hospital has spent $1 million to buy 20 new devices and hired an additional full-time lab employee. “Since we implemented this process, we have not had another patient have an infection transmitted,” Ross said. “With a year's worth of data in our rearview mirror, we're fairly confident we have contained the problem.”

Some experts say these incidents highlight the complexity of disinfecting or reprocessing these devices. The duodenoscopes are outfitted on their tips with an “elevator wire channel,” which allows the scope to be moved 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, Ross said.

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.”

Three manufacturers market duodenoscopes in the U.S.: Fujifilm Medical Systems, Pentax Medical and Olympus, which is the supplier for UCLA. None provided comment for this article.

The FDA has known since at least 2007 of a possible problem with the reprocessing of reusable endoscopes. The topic was discussed at a June 2011 workshop held by the agency's Center for Devices and Radiological Health. “Contamination is often found in unexpected sections of the device,” Dr. Michelle McMurry-Heath, the center's associate director for science, said at the meeting. “Sometimes following the labeling instructions did not seem to adequately clean the device, and sometimes manufacturers included unclear and confusing reprocessing instructions.”

In its advisory released last week, the FDA said it had received 75 adverse medical-device reports between January 2013 and December 2014 regarding duodenoscopes with possible transmission of microbial pathogens to approximately 135 patients.

Dr. Terry Fairbanks, director of MedStar Health's National Center for Human Factors in Healthcare, said he's surprised the FDA did not issue its advisory warning sooner. “The response is finally occurring because we killed some more patients,” he said. “We should be evaluating risk based on potential threat, not just past harm to patients.”

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