FDA doesn't like it when manufacturers ignore the agency's orders, as all three companies that make duodenoscope should probably have figured out by now. The company said it issued warning letters Friday to Olmpus, Pentax, and Fujifilm for failing to comply with post-market surveillance requirements to assess the effectiveness of reprocessing the devices.
As part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, FDA in 2015 ordered these manufacturers to conduct a post-market surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices. Specifically, as part of their approved study plans, all three companies 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 hospitals are following the reprocessing instructions.
FDA said Olympus has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data. Olympus and Pentax also have not complied with requirements for their respective human factors studies, the agency noted. Fujifilm, however, has been meeting its human factors study requirements.
“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 post-market 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,” said Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) and are used during endoscopic retrograde cholangiopancreatography, a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In 2013, FDA learned about a potential association between drug-resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that device users were following proper manufacturer cleaning and disinfection or sterilization instructions.
FDA said it expects that Olympus, Fujifilm, and Pentax will submit a plan by March 24 that outlines how study milestones will be achieved. For the sampling and culturing study, the agency expects 50% of samples collected in the study to be processed by the end of August and 100% by the end of 2018. FDA also said it expects 50% of Olympus' and Pentax's human factors studies to be completed by the end of May, and 100% by the end of June.
If the companies fail to adequately respond to the warning letter, FDA said it may take additional action such as seizure, injunction, and civil money penalties.
Last year FDA cleared the first duodenoscope to feature a disposable distal cap, which could go a long way toward addressing the infection risk associated with these devices. The disposable distal cap feature of the Pentax ED34-i1OT model from Pentax America is expected to improve access for cleaning and reprocessing.