- Hostile work environments, low pay and inadequate training for duodenoscope reprocessors are key challenges that must be addressed to cut down on high levels of contamination and patient injuries related to the devices, experts at an FDA advisory committee said Thursday.
- Panel members were hesitant to require terminal sterilization instead of manual cleaning of the devices or a hasty switch to single-use duodenoscopes, saying such steps could limit the supply of the devices, which are used in endoscopic retrograde cholangiopancreatography procedures to diagnose and treat pancreas and bile ducts illnesses.
- The expert panel convened in response to adverse event reports of infections and deaths associated with the devices manufactured by Olympus, Fujifilm and Pentax continue to be disclosed to FDA after peaking in 2015.
Challenges related to infections and deaths have brought scrutiny of duodenoscopes from Congress as well as FDA. In May, Senate HELP Committee Ranking Member Patty Murray, D-Wash., doubled down on a 2016 committee investigation into the safety of the devices.
And in April, FDA released adverse event data that showed three deaths, 45 patient infections and 159 cases of device contamination related to inadequate reprocessing of the devices between Oct. 15, 2018, and March 31, 2019.
Both the agency and Murray have pushed Olympus, Fujifilm and Pentax to continue to collect postmarket data. And in August, FDA recommended healthcare facilities to begin transitioning to duodenoscopes with disposable parts after it found high levels of contamination in devices with fixed endcaps.
Multiple presenters and panel members expressed concern divergent lengthy instructions for reprocessing from the three major duodenoscope manufacturers are contributing to difficulties during the cleaning process of the devices.
Olympus told MedTech Dive it would take the recommendations of the panel into account to improve its duodenoscope devices.
"We will continue to look for improvements in duodenoscope reprocessing that reduce the risk of patient infection, listening carefully to our customers' additional priorities, which include the need for high clinical performance without negatively impacting the overall costs of healthcare for these critical procedures," Ross Segan, Olympus' chief medical safety officer, said in a statement.
One presentation at the advisory panel specifically cited bullying within the workplaces of reprocessors as one contributing factor to high turnover, leading to poor practices.
But FDA does not have jurisdiction over imposing certification of workers or their training, steps that may help improve the quality of work done by reprocessors, advisory committee voting chair Frank Lewis, a retired doctor, said.
"We're facing the issue that perhaps the greatest remediation to the problem is not subject to FDA control, and I'm not quite sure how to address that," Lewis said. "So, in whatever way you might work with manufacturers or other agencies to try to affect improvements would probably lead to greater positive effects."
It is unclear what steps will be taken next by FDA. But both Ambu, a Danish medical device company, and Boston Scientific are currently working with the agency to bring single-use duodenoscopes to the market. Ambu senior market manager of GI systems, Patrick Hurley, told the panel the company anticipates FDA clearance in 2020.
But the panel warned single-use scopes would contribute to significantly to medical waste, adding that a full transition to disposable scopes is not possible in the short term.