Device Sterilization, Duodenoscopes Focus Of Planned Meeting
The US FDA is asking stakeholders to weigh in on a common device sterilization procedure and the contagion risks of reprocessed duodenoscopes ahead of a November panel meeting.
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While AdvaMed has remained relatively quiet over the recent closures of ethylene oxide (EtO) sterilization facilities, the medical device industry advocacy group is taking on critics in Georgia, where two facilities have been paused to upgrade their operations to reduce EtO emissions. Critics – including the Atlanta Journal-Constitution’s editorial board – say the chemical is associated with increased risk for cancer for nearby residents, but AdvaMed and its supporters say there’s no evidence to back that up.
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
Regulators are reaching out to industry and the public-at-large for ideas that would help develop new sterilization methods that could reduce or replace the need for ethylene oxide used to treat difficult-to-clean medical devices. They are also looking for ways to reduce the risk and environmental impact of the sterilizing agent.