FDA Warns Duodenoscope Manufacturers Over Studies

Regulatory NewsRegulatory News | 09 March 2018 |  By 

All three manufacturers of duodenoscopes in the US drew warning letters on Friday for failing to conduct postmarket surveillance studies and submit the data to the US Food and Drug Administration (FDA).

Following nationwide outbreaks of infections associated with bacteria transmitted to patients who underwent surgery with contaminated duodenoscopes over the past few years, the agency has “taken important steps to improve the reprocessing of duodenoscopes,” FDA Center for Devices and Radiological Health Director Jeff Shuren said in a statement. The reusable and flexible tubes are used during surgical procedures that can be potentially life-saving.

A major step FDA took to help address the problem involved its October 2015 orders on the three US manufacturers -- Olympus, Fujifilm Medical Systems, and Pentax Medical -- to report study findings of healthcare facilities’ ability to properly clean and disinfect their duodenoscopes.

“Specifically, as part of their approved study plans, all three manufacturers are required to conduct 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 following the reprocessing instructions,” FDA said.

As part of the data requirements, the firms were directed to address three specific questions that relate the use of their duodenoscopes in real-world clinical settings, including: After use of your firm’s labeled reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?

The manufacturers’ plans for the required studies were approved in 2016 and 2017 under FDA’s expectations for data collection phases to begin within 15 months after the 522 orders were issued. However, Fujifilm and Pentax have yet to provide sufficient data, and Olympus has yet to begin its data collection process, despite receiving FDA advisories last year and earlier this year that cautioned over “not meeting the milestones per the agreed study plan and timeline.”

FDA said it has been working in collaboration with all three firms since 2013 -- when it “learned about a potential association between multi-drug resistant bacteria and duodenoscopes” -- to take corrective actions, such as reviewing validated processing instructions, and removing from the market models “with faulty designs that made them difficult to clean and reprocess.”

Agency staff also worked in collaboration with the American Society for Microbiology to provide healthcare facilities with the standardized protocols, released last month, for duodenoscope surveillance sampling and culturing.

According to Shuren, FDA has already “seen a reduction in reports of patient infections” but the firms’ studies are needed in order 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.”

The agency expects all three firms to submit their plans for how they will achieve study milestones by March 24.

Spokesperson for Olympus, Mark Miller, told Focus the firm is “closely reviewing” the warning letter so that it can issue a response to FDA “in a timely manner” as it “takes this matter very seriously.” He added that the firm is “working diligently to provide the requested information.”

Fujifilm spokesperson Lauren Geloso told Focus the firm “is actively engaged in a 522 postmarket surveillance study,” adding that “while certain milestones have been attained,” the warning letter notes a “failure to provide sufficient data and comply with requirements of certain aspects of the study.”

According to Geloso, the agency “has not objected to the continued marketing” of Fujifilm products in the US and the firm will “continue to work to meet FDA requirements.”

Pentax did not immediately respond to requests for comment.



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