FDA issues warning letters to Olympus, Fujifilm, Pentax over duodenoscope issues

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 ho...
Source: Mass Device - Category: Medical Devices Authors: Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Holdings Hoya Corp. Olympus Pentax Medical Source Type: news