By Jonathan Springston, Editor, Relias-AHC Media
The FDA recently issued warning letters to Olympus, Fujifilm, and Pentax, warning the companies that they have not met their federally mandated obligations to provide data about proper cleaning and disinfection of duodenoscopes.
In 2015, the agency ordered the three companies to conduct postmarket surveillance studies to determine if healthcare professionals were properly reprocessing the devices. Further, these companies were to collect samples from reprocessed devices to understand the types of possible contamination. More than two and a half years later, the FDA says that Olympus has not started data collection and that Pentax and Fujifilm have provided inadequate data.
“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 a statement. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”
The feds called for testing and data collection after learning of a possible connection between duodenoscopes and multi-drug-resistant bacteria, which could linger even after users properly followed cleaning, disinfecting, and sterilizing procedures.
In the upcoming April issue of Same-Day Surgery, experts offer tips to surgical professionals about how to create better reprocessing guidelines for all equipment. Tips include assigning a point person to oversee reprocessing, developing site-specific training and processes, and creating consistency to avoid common errors.