Surgical Infections from Dirty Duodenoscopes Highlighted in Senate Report

A new senate report warns that in recent years there were more hospital outbreaks involving surgical infections from duodenoscopes than were initially reported, calling the FDA’s response to the problem unacceptably slow. 

A minority staff report (PDF) was released last week by Senator Patty Murray, ranking member of the U.S. Senate’s Health, Education, Labor and Pensions Committee, which was tthe result of a year-long investigation into the causes and responses to antibiotic resistant infection outbreaks linked to medical scopes used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, known as duodenoscopes.

Issues have surfaced in recent years with surgical infections caused by difficulty cleaning the scopes between patients, even when manufacturer instructions are followed by the hospital or medical provider. The devices have been linked to several high-profile hospital infection outbreaks involving aggressive, antibiotic resistant “superbugs”, which have caused a number of severe injuries and deaths.

National attention has been focused on the problem since a widely publicized duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

FDA reviewers determined that the “reprocessing” instructions provided by the manufacturer were inadequate, and that even if the recommended steps were followed to clean the ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

According to the new Senate report, infection outbreaks linked to duodenoscopes were occurring in the U.S. and Europe since 2013 and 2014, suggesting that the FDA has lagged in responding to the problems. The report found that the FDA’s current monitoring system for medical devices was not up to the task of identifying problems and protecting patient safety.

“Following the tragic impacts outbreaks have had on patients and families in my home state and across the nation, I made it my priority to ensure we fully understood how this could have happened in the first place, and what could be done to protect patients going forward,” Senator Murray said in a press release issued together with the report. “Patients should be able to trust that the devices they need for treatment are safe and effective. Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and, in this case, allowed tragedies to occur that could have, and should have, been prevented.”

According to the report, between 2012 and Spring of 2015, closed-channel duodenoscopes were linked to 25 different antibiotic-resistant infection outbreaks worldwide, which sickened at least 250 patients.

The study also found that Olympus, one of three medical device manufacturers that make duodenoscopes, had seen two independent lab reports by early 2013 warning that closed-channel duodenoscope models could spread bacterial infections even after cleaning. However, the report found that Olympus kept that information from FDA regulators, hospitals and patients.

Hospitals also dropped the ball in raising the alarm, the report found, citing at least 16 separate times when hospitals in the U.S. successfully traced infection outbreaks to duodenoscopes but failed to warn the medical community.

No Duodenoscope Recalls Likely

While there have been calls for the medical scopes to be recalled due to the infection risk, the FDA notes that there are no alternative devices available to perform ERCP procedures, so there will not be any duodenoscope recalls, as it is in the best interest of public health to leave the devices on the market.

In May, an FDA advisory committee determined that the devices “do not provide a reasonable assurance of safety and effectiveness” due to the difficulty cleaning them. The panel said that manual cleaning is still important and needs to continue, but also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.

Despite the concerns, the panel also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the FDA to develop a guide of best practices to make sure that manufacturer instructions are followed, in addition to the need for better instructions overall.

Also in August, the FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures. Olympus Corp. issued expanded cleaning instructions which were approved by the FDA earlier this year.

Several duodenoscope infection lawsuits have already been filed  against Olympus over the infections linked to the UCLA outbreak, and it is possible that FujiFilm will face similar cases. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.