FDA Cracks Down on Duodenoscope Manufacturers Again

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 ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news