https://www.massdevice.com/fda-issu...pus-fujifilm-pentax-over-duodenoscope-issues/
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 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.
sounds about right.
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 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.
sounds about right.
