FDA Warns Duodenoscope Makers Over Failure to Do Postmarket Studies

Megan Brooks

March 09, 2018

The US Food and Drug Administration (FDA) has sent warning letters to duodenoscope manufacturers Olympus, Fujifilm, and Pentax for failing to conduct the required postmarketing surveillance studies to assess the effectiveness of reprocessing the devices.

In 2015, as part of ongoing efforts to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, the FDA ordered the three companies to conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices. 

The companies are required to do a study to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, as well as a "human factors" study to assess how well-trained hospital staff are in following the reprocessing instructions, the FDA explains in a statement released today.

To date, Olympus hasn't started collecting data, and Pentax and Fujifilm have not provided adequate data on the required "sample and culture" studies, the agency says.

Olympus and Pentax also have not complied with requirements for their respective human factors studies to assess how well hospital staff are following reprocessing instructions, while Fujifilm has been meeting its requirements for its human factors study, the FDA says.

Long-term Problem

The potential association between the spread of multidrug-resistant bacteria and duodenoscopes first came to light in 2013. From January 2013 through December 2014, the FDA received 75 medical device reports involving about 135 patients related to possible microbial transmission from reprocessed duodenoscopes. Upon further investigation, it became clear that patients were becoming infected even when hospitals followed manufacturers' reprocessing instructions.

In 2015, the FDA warned that the complex design of duodenoscopes used during endoscopic retrograde cholangiopancreatography (ERCP) may impede effective cleaning. The agency recommended additional steps healthcare facilities can take to clean infection-prone duodenoscopes beyond meticulously following the manufacturer's instructions.

The FDA has been working closely with all three duodenoscope manufacturers to review validated processing instructions and take corrective actions to remove and replace from the market models with faulty designs that made them difficult to clean and reprocess.

"The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we've seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real world clinical settings and whether we need to take additional action to further improve the safety of these devices," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the statement. "We expect these device manufacturers to meet their study obligations to ensure patient safety."

Olympus, Fujifilm, and Pentax are expected to notify the FDA in writing by March 24 how they will achieve study milestones. For the sample and culture study, the FDA expects 50% of samples collected in the study to be processed by August 31, 2018, and 100% by the end of 2018. For Olympus's and Pentax's human factors studies, the agency expects 50% of testing to be completed by May 31, 2018, and 100% by June 30, 2018.

"If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties," the agency says.

Companies Respond

When asked for comment, all three companies emphasized their commitment to patient safety and working with the FDA.

Mark Miller, vice president of corporate and medical communications for Olympus Corporation of the Americas, told Medscape Medical News, "We are committed to addressing the issues identified in the letter and are working diligently to provide the requested information."

Fujifilm told Medscape Medical News, "The health and safety of patients are Fujifilm's number one priority, and we continually work with the FDA to ensure that our products and processes meet FDA requirements." Fujifilm is currently conducting a 522 postmarket surveillance study and is working to comply with the data requirements as needed, the company noted.

Pentax Medical told Medscape Medical News that it is "reviewing the letter closely and intends to respond within FDA's requested timeline. PENTAX Medical has been working closely with FDA in developing the study plans and is committed to continuing to work with FDA to resolve the outstanding issues and complete the postmarket surveillance studies."

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