FDA Clears Custom Ultrasonics Reprocessors For Cleaning Some Duodenoscopes

Federal regulators are giving doctors the all clear on using Custom Ultrasonics reprocessors for cleaning some duodenoscopes, after urging them to stop using the sterilization devices two years ago. 

In a safety communication issued on April 10, the FDA told medical specialists and health care providers that Custom Ultrasonics has passed validation testing of its System Plus Automated Endoscope Reprocessors (AERS).

The agency indicates that the devices can achieve “high-level” disinfection of the Olympus TJF-180V duodenoscope and the Pentax ED-3490TK duodenoscope, and that it can be used to reprocess those devices. However, the AERs are not approved to reprocess FujiFilm duodenoscopes, which have open elevator wire channels.

In November 2015, the FDA issued a recall of Custom Ultrasonics automated endoscope reprocessors (AERS), after determining that the manufacturer had failed to prove the devices properly cleaned endoscopes. However, the agency appeared to back off of the endoscope washer recall later, telling medical professionals that the AERs can be used to reprocess some types of devices, but not duodenoscopes, which are a specific type of endoscope linked to a number of infection outbreaks in recent years. This safety communication makes that decision an official revision to the recall notice.

In August 2016, the FDA issued another safety communication urging doctors not to use the devices for duodenoscopes because they could not be guaranteed to thoroughly clean them.

Duodenoscope Infection Problems

Duodenoscopes are a type of scope 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 Olympus Corp. and other manufacturers.

The problems with 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, one of three duodenoscope manufacturers.

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 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.

Last month, the FDA issued warning letters to duodenoscope manufacturers for failing to keep up with postmarketing studies that were required following the outbreaks.

Several duodenoscope infection lawsuits have 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.