Cleaning Instructions for Olympus ERCP Duodenoscopes Validated By FDA

Federal regulators have validated new cleaning instructions for two models of Olympus duodenoscopes, which have been under intense scrutiny since being linked to a number of infection outbreaks. 

The FDA issued a safety communication on March 15 saying that it has validated new reprocessing instructions for the Olympus TJF-160F and TJF-160VF model duodenoscopes. The new instructions for cleaning the devices will replace those on the current labeling.

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, used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, 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.

This is the latest in a number of new reprocessing instructions meant to alleviate the problem by Olympus and other duodenoscope manufacturers.

“The FDA reviewed the updated reprocessing instructions and the validation data and determined that they meet the Agency’s expectations,” the FDA stated in the communication. “We recommend that facilities using Olympus’ 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon as possible.”

The announcement comes after a year of review of the instructions, which were originally submitted in March 2015.

Duodenoscope Infection Concerns

In January, a report by the staff of Senator Patty Murray, ranking member of the U.S. Senate’s health, Education, Labor and Pensions Committee, found that 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.

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.

In May of 2015, 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.

The FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures in August 2015.

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.