Olympus Knew Duodenoscopes Were Spreading Infections During ERCP Procedures: Report

It appears that Olympus Corp. knew that its duodenoscopes were linked to antibiotic-resistant infection outbreaks as early as 2012, but failed to take actions to address the problem or warn the medical community about problems cleaning the device between patients, according to a U.S. Senate report. 

Duodenoscopes are medical devices used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, which involves use of the scope to examine the bile ducts, pancreatic duct or gallbladder. However, problems with cleaning the endoscopes have emerged in recent years, with several high-profile “superbug” infection outbreaks linked to the devices, even when facilities following the recommendations provided by Olympyus and other manufacturers.

The report (PDF), released in January by the minority staff of the U.S. Senate Health, Education, Labor and Pensions Committee, indicates that duodenoscopes may have been linked to more than two dozen outbreaks of antibiotic resistant infections worldwide. However, the FDA is expected to release its own report on the problems later this week, and the agency reportedly told the Senate it found a significantly higher number of duodenoscope infection problems.

Concerns about the risk of ERCP duodenoscope infections began to gain widespread media attention in early 2015, after nearly 200 patients treated at California’s UCLA Medical Center were told that they may have been exposed to a deadline bacteria known as carbapenem-resistant enterobacteriaceae (CRE). After at least seven confirmed infections were identified among individuals who underwent an ERCP involving use of duodenoscopes at UCLA, problems were identified with the cleaning instructions provided by Olympus.

Similar outbreaks at other hospitals have been linked to devices made by Olympus and other manufacturers, with reports suggesting that a movable “elevator” at the tip of the device may trap pathogens and blood from prior patients, even when recommended reprocessing steps are followed to clean the device between techniques.

In addition to the UCLA outbreak, the Senate report found at least two dozen other incidents of antibiotic-resistant infections linked to duodenoscopes worldwide between 2012 and the Spring of 2015. Of the 25 incidents, at least 19 involved a device manufactured by Olympus, which apparently knew for years that their endoscopes were likely a vector for the transmission of infections, some of which resist standard antibiotic drugs.

“By the fall of 2012, Olympus was aware that its duodenoscopes had been linked to antibiotic-resistant infections, including superbug infections, caused by life-threatening multidrug-resistant organisms at hospitals in both the United States and Europe,” the Senate report indicates. “By early 2013, independent laboratory tests of at least two different closed-channel duodenoscopes showed the devices remained contaminated after careful repeated cleaning and reprocessing. Despite this, Olympus issued no safety alerts or guidance to hospitals and physicians in the United States until February 2015 – almost three years after first realizing the problem in April 2012.”

While the Senate report found 250 cases of duodenoscope infections being diagnosed, the FDA, in response to Senate inquiries, reported that their own research indicated there were at least 350 such infections from January 1, 2010 to October 31, 2015.

The Senate report blames Olympus, as well as the other two duodenoscope manufacturers, such as Pentax and Fujifilm, for failing to adequately determine that their procedures for cleaning the devices actually worked. The investigators determined that none of them had sufficient data to back up claims that their cleaning procedures were effective, and they failed to consistently report information on infections believed to be linked to the scopes.

The FDA has not revealed the other hospitals or manufacturers involved in the incidents, and officials expect to release a report by Friday.

Broken Patient Safety System

In addition to concerns about a lack of action by duodenoscope manufacturers, the Senate report also suggests that many hospitals failed to do their part to warn of problems.

“[T]he investigation established that although at least 16 separate domestic hospitals traced antibiotic-resistant infections directly to ERCP procedures, as a group, the facilities generally failed to quickly raise alarms with FDA and CDC,” the report notes. “In some cases, hospitals completely failed to make the required reports of infections to the devices’ manufacturers. This limited and slow reporting by hospitals likely impaired FDA’s ability to accurately assess the frequency and severity of outbreaks of duodenoscope-linked infections.”

The report also blasted the FDA’s oversight protocols, which it says leaves the opportunity for similar problems in the future.

“The investigation provides a vivid example of the failure of FDA’s current system for tracking and monitoring the safety of medical devices on the market (the postmarket surveillance system),” the report states. “FDA’s postmarket surveillance system relies too heavily on self-reporting from manufacturers and hospitals with competing priorities that weigh against full and fast disclosure of patient safety concerns. This passive postmarket surveillance system inhibits FDA’s ability to quickly identify information related patient health and device safety. Until a system is implemented that allows FDA to independently monitor, track, and assess the performance of devices, the agency will not be able to adequately identify risks to patient safety from particular devices like duodenoscopes and move quickly to address those risks.

In May 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 FDA panel of outside experts also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the agency 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. In addition, manufacturers have issued new cleaning instructions, and some have redesigned the elevator tips believed to be the area where blood and tissue get trapped to make them easier to clean.

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.