The US Food & Drug Administration has issued official warnings to three duodenoscope manufacturers, saying the companies have failed to conduct federally-mandated studies on the real-world feasibility of cleaning the reusable medical devices.
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In 2015, officials at the FDA ordered Olympus, Fujifilm and Pentax to perform their own postmarket surveillance studies to determine whether or not hospitals are able to effectively sterilize duodenoscopes after use.
"Specifically," the FDA writes, "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."
Three years later, none of the companies have upheld their end of the bargain, FDA regulators say. Neither Pentax nor Fujifilm have provided the federal agency with enough data. Olympus, the largest duodenoscope manufacturer, hasn't even started collecting data for the study, the FDA reports.
"The FDA has taken important steps to improve the reprocessing of duodenoscopes," says Dr. Jeff Shuren, director of the agency's Center for Devices and Radiological Health. "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."
If appropriate, the results of postmarket surveillance studies could lead to additional regulatory action, Dr. Shuren added.
According to the Regulatory Affairs Professionals Society, the FDA has given Olympus, Fujifilm and Pentax until March 24, 2018 to provide updates on how they plan to meet their study obligations.
In a statement, Olympus spokesperson Mark Miller said his company was "closely reviewing" the warning letter. "Olympus takes this matter very seriously," Miller said. "We are committed to addressing the issues identified in the letter and are working diligently to provide the requested information."
Over the last five years, a wave of virulent bacterial outbreaks have been traced back to duodenoscopes, a type of reusable medical device used to create images in the small intestine.
In Chicago, Los Angeles, Pittsburgh and several European cities, doctors reported severe cases of Carbapenem-resistant Enterobacteriaceae, or CRE, a dangerous bacterium that has become invulnerable to multiple forms of antibiotics. After investigation, experts at the FDA confirmed that, due to the difficulty of disinfecting a complex medical device after each use, the life-threatening "superbugs" were being transmitted inside hospitals by duodenoscopes.
Dozens of patients filed suit, accusing Olympus, Fujifilm and Pentax, the world's largest duodenoscope manufacturers, of manufacturing a defective device and placing unsuspecting patients in harm's way. In fact, several hospitals, including Seattle's Virginia Mason Medical Center, have even leveled their own lawsuits against the companies.
Implicitly, regulators at the Food & Drug Administration have agreed with these claims. Since 2013, experts at the agency have been working hand-in-hand with Olympus, Fujifilm and Pentax to develop new designs that would make the devices easier to clean, also working to "remove and replace models from the market with faulty designs."
Alongside basic design work, the FDA focused on creating an evidence-based process for sterilization. The preliminary results of that work were released on February 26, 2018, when the FDA, the Centers for Disease Control and Prevention and the American Society for Microbiology published a book of new guidelines on testing duodenoscopes for bacterial contamination.
The document, "Duodenoscope Surveillance Sampling & Culturing," provides a voluntary set of best practices, developed in collaboration with device manufacturers, to help medical professionals screen duodenoscopes for the presence of superbugs.
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