FDA orders ‘scope makers to launch postmarket studies

The FDA today ordered a trio of Japanese duodenoscope makers to run post-market surveillance studies to evaluate how the devices are reprocessed in real-world conditions, after a deadly rash of so-called “superbug” outbreaks this year were linked to the devices. The string of deadly infections were attributed to duodenoscopes made by Olympus (TYO:7733),  Fujifilm Holdings (TSE:4901) and Hoya‘s (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March, some of which led to patients’ deaths. The 3 companies have 30 days to submit their post-market surveillance plans to the FDA, which warned them in August about violations found during spring inspections at plants in the U.S. and Japan, and provide specifics on how well healthcare providers follow the devices’ cleaning and disinfection instructions. “This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinica...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Holdings Hoya Corp. Olympus Pentax Source Type: news