The FDA said today it issued warning letters to Olympus (TYO:7733), Fujifilm Holdings (TSE:4901), and Hoya‘s Pentax Medical over failures to comply with federal orders to conduct postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes.
The order, issued by the federal watchdog in 2015, required all three manufacturers to conduct postmarket surveillance studies to determine whether healthcare facilities were able to properly clean and disinfect duodenoscopes.
Manufacturers were also required to conduct a study to sample and culture reprocessed duodenoscopes in clinical use to learn about issues that contribute to contamination, and a human factors study to explore hospital staff training in relation to reprocessing instructions, the FDA said.
“To date, Olympus has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data, as required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. 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; Fujifilm has been meeting its requirements for its human factors study,” the FDA wrote in a report posted today.
The federal watchdog said it expects Olympus, Fujifilm and Pentax will submit plans by March 24 outlying how they will reach their milestones. The FDA said it is hopeful that 50% of samples collected for the sampling and culturing studies will be completed and ready to be processed by August 31, with 100% completed by the end of 2018.
For Olympus’ and Pentax’s human factors studies, the FDA said it expects 50% of testing will be done by May 31, with 100% completed by June 30.
“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 FDA wrote.
In February, the FDA said that it, alongside the Centers for Disease Control and Prevention, the American Society for Microbiology and other endoscope culturing experts, released standardized protocols for duodenoscope surveillance sampling and culturing to help reduce the risk of transmitted infections.
“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. We expect these device manufacturers to meet their study obligations to ensure patient safety,” FDA Center for Devices and Radiological Health Dr. Jeff Shuren said in a prepared statement.
