FujiFilm Duodenoscope Infections Targeted By New Cleaning Instructions

Amid continuing concerns about the risk of infections from endoscopes that are reused on multiple patients, Fujifilm Medical Systems has released new cleaning instructions for a type of duodenoscope that has been linked to a number of recent infection outbreaks at hospitals nationwide. 

The FDA issued a safety communication on December 23, indicating that it has validated new reprocessing instructions for the ED-530XT duodenoscope by Fujifilm. The agency says that the new instructions for cleaning the device between patients should reduce the risk of the endoscopic tools spreading blood borne diseases.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning the devices between patients have resulted in a number of recent hospital infection outbreaks involving aggressive, antibiotic-resistant “superbugs”, which have been linked to a number of severe injuries and deaths.

The new reprocessing instructions come after 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.

The infections weree linked to problems with the “reprocessing” instructions used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

The FDA recommends that health care facilities using the FujiFilm ED-530TX train staff to follow the new instructions and implement them as soon as possible. The FDA is still undergoing the process of validating new reprocessing instructions for Fujifilm’s 250 and 450 models.

The new reprocessing instructions follow orders issued by the FDA in October for the three main duodenoscope manufacturers, Fujifilm, Olympus and Pentax Life Care, to conduct new post-market surveillance studies on the use of duodenoscopes in health care facilities. The goal of the studies is to better understand how the devices are reprocessed in real-world settings.

No Duodenoscope Recalls Likely

While there have been calls for duodenoscopes 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 August, the FDA posted a warning letter to Fujifilm, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. The two other duodenoscope manufacturers, Pentax and Olympus, also received FDA warning letters.

The letters, issued on August 12, suggest that duodenoscope makers knew for years that their devices were linked to infection outbreaks, but failed to warn the FDA or address the problem. The companies are also currently under investigation by the Department of Justice.

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.