FDA Orders Studies on Duodenoscope Infection Transmission Factors

Following a number of infection outbreaks linked to endoscopic surgical tools that could not be properly cleaned between patients, even when medical providers followed the manufacturer’s instructions, federal regulators have ordered new clinical studies to evaluate how the devices are cleaned in the real world. 

Olympus America, Inc. Fujifilm Medical Systems U.S.A., Inc., and Hoya Corp.’s Pentax Life Care Division are being required by the FDA to conduct new post-market surveillance studies on the use of duodenoscopes in health care facilities. The goal of the new studies, announced in a press release on October 5, is “to better understand how the devices are reprocessed in real-world settings.”

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning the devices between patients have resulted in a number of recent outbreaks involving aggressive, antibiotic-resistant infections that have caused severe injuries and deaths.

The order comes on the heels of a recent outbreak of antibiotic-resistant “superbug” infections linked to Olympus duodenoscopes, which were reported in August at Huntington Memorial Hospital in Pasadena, California.

That outbreak followed a number of duodenoscope hospital infection outbreaks were reported earlier this year, including an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that was revealed in February by UCLA’s Ronald Reagan Medical Center. The outbreak caused at least seven infections, two deaths, and raised concerns that nearly 200 other patients had been placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections have been 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 hopes the new mandatory studies will help the agency analyze the effectiveness of the current cleaning instructions and how they are implemented in real-world hospital settings. The agency indicates that the collected data will help it make decisions that will reduce the risk of duodenoscope infections and outbreaks.

Specifically, the agency wants manufacturers’ studies to help FDA regulators determine whether current instructions provided to healthcare professionals on reprocessing the devices are sufficient, what percentage of scopes are still contaminated after the manufacturers’ instructions have been accurately followed, and what contributes to contaminated devices and what would be necessary to decontaminate them.

No Duodenoscope Recalls Likely

The agency 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 Olympus, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. Two other duodenoscope manufacturers, Pentax and Fujifilm, 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. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.